Drug Recalls and Alerts - 2005

Click here for all 2006 Recalls and Alerts.

Click here for all 2004 Recalls and Alerts.

Click here for all 2003 Recalls and Alerts.


Fraudulent Avian Flu Therapies

The United States Food and Drug Administration (FDA) has issued warning letters to nine companies marketing bogus flu products. The companies claim that their products could be effective against preventing the avian flu or other forms of influenza. The FDA is not aware of any scientific evidence that demonstrates the safety or effectiveness of these products for treating or preventing avian flu. Use of these products could harm consumers or interfere with conventional treatments. The fraudulent treatments are described in the warning letters listed in the following link.

Find more information at FDA MedWatch.


Additional Failures Reported with Guidant ICDs

Malfunctions of Guidant's implantable cardioverter defibrillator (ICD) devices continue to emerge (see initial eMedicine Recall and Alert from July 19, 2005). Fourteen additional clinical occurrences exhibiting failure for the Contack Renewal and Renewal-2 devices have been documented since October, 2005. As of December 21, 2005, a total of 35 clinical failures, including 5 patient deaths, have been reported worldwide. Four additional clinical failures have occurred for the Ventak Prism 2DR since October, 2005 including 2 patient deaths.

The following is a summary of the previous public health notifications regarding the device failures.

Degraded insulation in these devices can lead to the inappropriate shorting of a defibrillation pulse back into the circuit. This can damage the circuit, causing the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. At the time of the July 14, 2005 Public Health Notification, at least two deaths attributable to this failure mode had been reported. At the time of the October 13, 2005 update, at least 4 deaths were attributable to this failure mode. We recommended replacement of any device that had demonstrated the failure mode. We recommended that, in the absence of demonstrated failure, the decision about replacement be made by the patient in consultation with his or her physician and should be based on the patient's condition, medical history, and other pertinent factors. Recommendations for follow-up of patients who retain the device were provided in the initial notification. Because there are no signs of impending device failure, and there is no test that predicts whether or when any particular device will fail, the FDA concluded that there is insufficient evidence to support the value of a commanded shock as a means to check for pending failures.

Find more information at FDA MedWatch.


NeutroSpec Marketing Suspended Due to Deaths and Life-Threatening Adverse Effects

Marketing for technetium (99m Tc) fanolesomab (NeutroSpec, by Palatin Technologies) is being suspended immediately due to serious safety concerns. NeutroSpec is an antibody radiolabeled with technetium-99m, indicated for radiologic imaging of patients five year or older with unclear signs and symptoms of appendicitis. The Food and Drug Administration (FDA) received reports from Palatin Technologies of 2 deaths and 15 additional life-threatening adverse events in patients receiving NeutroSpec. These events occurred within minutes of administration and included shortness of breath, low blood pressure, and cardiopulmonary arrest. A review of all post-marketing reports showed an additional 46 patients who experienced adverse events that were similar but less severe. All of the reactions occurred immediately after NeutroSpec was administered.

The decision to suspend marketing was based on the life-threatening nature of the events and the availability of other means to diagnose appendicitis that do not carry these risks. Healthcare providers should immediately discontinue use of existing stocks of NeutroSpec and contact Palatin Technologies regarding their return (888-744-1414).

Find more information at FDA MedWatch.


Class I Recall Issued for Meridian Hemodialysis Instrument

A Class I recall has been issued for Baxter Healthcare Corporation's Meridian Hemodialysis (HD) Instrument (Product Codes 5M5576 and 5M5576R). There have been reports of hemolysis (ie, red blood cell destruction) related to kinks in the blood tubing sets used with the device. To date, there have been reports of one death and at least one serious injury, associated with kinking of blood tubing sets routed through both channels of the clips mounted on the front of the Meridian.

This classification does not require the return of Meridian instruments currently in the market. In a September 28, 2005 letter, Baxter directs customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the risk of blood tubing kinks.

Baxter also provided labels with the September 28, 2005, customer letter to be affixed to Meridian instruments. The labels clearly display the proper routing of the blood tubing sets. Further, Baxter asks that all care providers be trained on this procedure. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.

A Class I recall is issued when a drug or device may pose serious health risks to some users.

Find more information at FDA MedWatch.


Methotrexate Preservative-Free Injection Recalled

A recall has been issued for one lot of methotrexate preservative-free (PF) injection 1 gram/vial (NDC 55390-143-01, by Bedford Laboratories). The affected lot is #859142, expiration date September, 2007. Low levels of ethylene glycol were found in the product. Human use of PF methotrexate formulations that contain ethylene glycol is not permissible for intrathecal administration.

Find more information at FDA MedWatch.


New Warning Regarding Paroxetine Use While Pregnant

The United States Food and Drug Administration (FDA) has determined that exposure to paroxetine (Paxil) in the first trimester of pregnancy may increase the risk for birth defects (1.8-fold increase), particularly heart malformations (1.5-fold increase). The majority of the cardiovascular defects observed were ventricular septal defects. Paroxetine's pregnancy category has been changed from C to D and new data and recommendations have been added to the prescribing information. The FDA is analyzing the final results the information leading to this change and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.

FDA pregnancy category D states:
There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Physicians who are caring for women receiving paroxetine should alert them to the potential risk to the fetus if they plan to become pregnant or are currently in their first trimester of pregnancy. Discontinuing paroxetine therapy should be considered for these patients. Women who are pregnant, or planning a pregnancy, and currently taking paroxetine should consult with their physician about whether to continue taking it. Women should not stop the drug abruptly without discussing the best way to discontinue paroxetine with their physician.

Find more information at FDA MedWatch.


Fatal and Serious Cardiopulmonary Events Associated with NeutroSpec

Postmarketing reports of serious and life-threatening cardiopulmonary events have been reported following the administration of Technetium (99m Tc) fanolesomab (NeutroSpec). Technetium fanolesomab is a radiodiagnostic agent consisting of a murine IgM monoclonal antibody formulated to be labeled with technetium, and is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older. Onset of these events generally occurred within minutes of injection. Two deaths attributed to cardiopulmonary failure within 30 minutes of injection have been reported. Additional cases of serious cardiopulmonary events including cardiac arrest, hypoxia, dyspnea and hypotension required resuscitation with fluids, vasopressors, and oxygen.

Any patient who receives NeutroSpec should be closely monitored for at least one hour following product administration. Resuscitation equipment and appropriately trained personnel must be readily available during this time. Patients with underlying cardiopulmonary conditions may be at higher risk for serious complication. NeutroSpec administration to these patients should only follow careful consideration of the known and potential risks and benefits, including the possibly higher risks.

Find more information at FDA MedWatch.


Severe Anemia Reported with Erythropoietin Products

The prescribing information for darbepoetin alfa (Aranesp) and epoetin alfa (Epogen, Procrit) has been revised to provide updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias. These adverse events are associated with neutralizing antibodies to erythropoietin in patients treated with these products. This has been reported predominantly in patients with chronic renal failure receiving these products by subcutaneous injection. Recommendations for evaluation and treatment are provided in the new prescribing information in the links below.

Find more information at FDA MedWatch.

For additional information:


NovoSeven Coagulation Factor VIIa and Risk of Thromboembolism

The prescribing information for recombinant coagulation factor VIIa (NovoSeven) has been updated to warn about an increased risk of arterial thromboembolism (blood clots). NovoSeven was studied in elderly, nonhemophiliac, individuals with intracerebral hemorrhage (bleeding within the brain). The studied showed an increased risk of thromboembolic adverse events including myocardial ischemia (decreased oxygenated blood to the heart muscle), myocardial infarction (heart attack), and cerebral ischemia and/or infarction (stroke).

Find more information at FDA MedWatch.


Molecular Biologics Ordered to Cease Manufacturing and Distribution Due to Violations

The United States Food and Drug Administration has ordered Molecular Biologics (MBI Distributing, Inc.) to cease drug manufacturing and distribution until it corrects manufacturing deficiencies and other violations. MBI manufactures over-the-counter (OTC) drugs. MBI's product line includes eye drops sold under the brand names Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs. These products are sold by retailers nationwide.

The FDA determined that manufacturing controls were lacking to ensure sterility of its eye drops. FDA has also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of the firm's OTC pain relieving drugs, Biogesic, Bio-Ice, and Bio-Heat, do not provide adequate warnings for their safe use. FDA recommends that consumers, health care providers, and caregivers dispose of the Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C brands of eye drops and the Biogesic, Bio-Ice, and Bio-Heat pain relieving drugs.

Find more information at FDA MedWatch.


Alpha-1 Blocking Agents Associated with Intraoperative Floppy Iris Syndrome

Prescribing information has been revised to include new information for alpha-1 blocking agents, such as doxazosin (Cardura), tamsulosin (Flomax), terazosin (Hytrin). These medications are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) and hypertension (except tamsulosin). A surgical condition termed Intraoperative Floppy Iris Syndrome (IFIS) has been observed during phacoemulsification cataract surgery in some patients treated with alpha-1 blockers. Most of these reports were in patients taking the alpha-1 blocker when IFIS occurred, but in some cases alpha-1 blocker had been stopped prior to surgery. It is recommended that patients being considered for cataract surgery, as part of their medical history, be specifically questioned to ascertain whether they have taken alpha-1 blockers. If so, the ophthalmologist should be prepared for possible modifications to their surgical technique that may be warranted should IFIS be observed during the procedure.

Find more information at FDA MedWatch.


Gen Teal Eye Products Recalled Due to Lack of Sterility

A recall has been issued for seven lots of two products, GenTeal Gel and GenTeal GelDrops (by Novartis), due to lack of sterility assurance. The eye products are intended for use to relieve dry eyes. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people.

Five lots of GenTeal Gel include about 142,500 tubes that were distributed nationwide from March to November 2004. Two lots of GenTeal GelDrops include about 12,000 dropper bottles that were distributed nationwide in October 2005.

The recall was initiated following test results for GenTeal Gel that indicated the presence of mold in a small number of samples in each of the five lots. The species of mold that is suspected is generally not harmful, but has the potential to cause an eye infection in susceptible people, especially in those with compromised immune systems.

Find more information at FDA MedWatch.


Long-Acting Beta2-Adrenergic Inhalers and Increased Risk of Severe Acute Exacerbations

The United States Food and Drug Administration has notified manufacturers of long-acting bronchodilating medication inhalers for asthma (Advair Diskus, Foradil Aerolizer, and Serevent Diskus) to update their existing product labels with new warnings and a Medication Guide for patients that describe the increased chance of severe asthma episodes, and death when those episodes occur. All of these products contain long-acting beta2-adrenergic agonists (LABAs). Even though LABAs decrease the frequency of asthma episodes, these medicines may make acute asthma episodes more severe when they occur. A Medication Guide with information about these risks will be given to patients when a prescription for a LABA is originally dispensed or refilled.

LABAs are reserved as add-on therapy only when patients have not responded adequately to other medications for asthma, such as low-to-medium dose inhaled corticosteroids. Patients must be aware to seek medical treatment immediately if their asthma worsens, no matter what their treatment consists of.

LABAs are used for long-term control and prevention of asthma symptoms, for preventing wheezing (bronchospasm) caused by exercise in adults and children and for long-term control of wheezing in adults with chronic obstructive pulmonary disease. The new warnings are about LABA-use for asthma. Information is not available to know whether there are similar concerns when LABAs are used for exercise-induced wheezing or chronic obstructive pulmonary disease.

Find more information at FDA MedWatch.


Enteral Feeding Formula Mislabeled as Diabetisource AC

A recall has been issued for an enteral feeding formula that was incorrectly labeled as Diabetisource AC 1.5 liter bottles (by Novartis Nutrition Corporation). The mislabeled nutritional feeding formula was distributed nationwide to healthcare institutional facilities. The recall affects 2712 bottles (Lot 2135L) that actually contained Resource Diabetic TF, a tube feeding formulated for diabetes. Additionally, the affected product was shipped in cartons correctly labeled as Resource Diabetic TF lot 2135L, however, the bottles were incorrectly labeled as Diabetisource AC Lot 2135L. The two products are not nutritionally equivalent. These bottles contain sodium and calcium caseinate, components of milk. Individuals with an allergy or severe sensitivity to milk should avoid this product.

Healthcare institutions that have received shipping cartons labeled Resource Diabetic TF lot number 2135L or bottles labeled Diabetisource AC 1.5 Liter bottles lot 2135L should contact Novartis Customer Services at 1-800-333-3785.

Find more information at FDA MedWatch.


Electromagnetic Interference Risk with Telemetry Operating in 460-470 MHz Frequency

The United States Food and Drug Administration (FDA) has issued a Public Health Notification regarding increased risk for electromagnetic interference in any medical telemetry systems operating in the 460-470 MHz frequency bands after December 31, 2005. This interference could compromise patient safety. In January 2006 the Federal Communications Commission will begin issuing new licenses for mobile radio transmitters to operate in the 460-470 MHz band.

According to tests conducted by the FDA, the transmitters operating under new licenses in this frequency band can interfere with medical telemetry systems. This could lead to lapses in patient monitoring and missed alarm events, putting patients at risk. The anticipated interference will not be limited to urban areas. Any medical facility in the vicinity of a mobile radio could be affected.

Find more information at FDA MedWatch.


Higher Estrogen Exposure Recognized with Ortho Evra Contraceptive Patch

The prescribing information for Ortho Evra Contraceptive Patch has been updated to include information regarding the risk for higher estrogen exposure compared to most birth control pills. In general, increased estrogen exposure may increase the risk of blood clots. However, it is not known whether women using Ortho Evra are at a greater risk of experiencing these serious adverse events.

The Food and Drug Administration (FDA) advises women to talk to their doctor or healthcare provider about whether the patch is the right method of birth control for them.

Find more information at FDA MedWatch.


Alefacept (Amevive) Contraindicated in Individuals Infected with HIV

The prescribing information for alefacept (Amevive) has been revised to include new information in the contraindications. Alefacept reduces CD4+ T lymphocyte counts and should not be administered to individuals infected with HIV. Reduction of CD4+ T lymphocytes may accelerate HIV disease or increase complication of HIV.

Alefacept is indicated for moderate-to-severe chronic plaque psoriasis.

Find more information at FDA MedWatch.


FDA Warns Marketer of Unapproved "Alternative Hormone Therapies"

The United States Food and Drug Administration (FDA) has taken action against companies marketing unapproved "Alternative Hormone Therapies". The FDA has determined these alternative hormones to be unapproved new drugs that have not been found safe and effective to treat or prevent certain serious or life-threatening diseases.

Warning letters have been sent to 16 dietary supplement and hormone cream marketers. The alternative therapies are often promoted as 'natural' or 'safe' compared to approved hormone treatments.

Find more information at FDA MedWatch.


False Elevations of Glucose Levels with Maltose, Galactose, or Xylose

Inappropriate insulin administration and consequent life-threatening or fatal hypoglycemia (low blood sugar) has been reported due to erroneous test results obtained from patients receiving parenteral products containing maltose or galactose, or oral xylose. Maltose, galactose, and xylose are sugars that cross-react with certain glucose measuring systems. The false elevations have occurred when using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. Falsely elevated glucose results will not be observed when using GDH-NAD systems for patients receiving products containing the listed cross reacting sugars.

Cases of true hypoglycemia can go untreated if the hypoglycemic state is masked by false elevation of glucose readings. A preliminary listing of U.S. products that may cause glucose test interference is provided.

Find more information at FDA MedWatch.


Alcohol Consumption Results in Toxicity with Morphine Extended-Release Capsules (Avinza)

A warning has been added to the prescribing information for morphine extended-release capsule (Avinza) regarding toxicity and alcohol consumption. Drinking alcohol or taking medications that contain alcohol, such as cough syrups or liquid cold medications, while taking Avinza may result in the rapid release and absorption of a potentially fatal dose of morphine.

Find more information at FDA MedWatch.


Disinfection Protocol for Vapotherm 2000i Respiratory Gas Questioned

New information obtained by the United States Centers for Disease Control (CDC) suggests that the newly developed chlorine dioxide disinfection protocol recommended by the manufacturer for disinfecting Vapotherm® devices and cartridges may not achieve sustained bacterial control in some instances. Cultures of Ralstonia spp have occurred. However, a similar experiment to test the efficacy of the chlorine dioxide protocol on a mixed population of heterotrophic bacteria, conducted by an internationally recognized authority on biofilms contracted by Vapotherm®, showed no growth of organisms immediately following and several days after chlorine dioxide treatment. These two tests of the chlorine dioxide disinfection protocol each involved only one machine and therefore the data must be interpreted with caution. However, the findings do suggest that under certain circumstances, this disinfection protocol might not achieve sustained microbial control. It should also be noted that some institutions had reported no growth of Ralstonia spp. in samples obtained from machines and cartridges that had been disinfected using the protocol that was formerly recommended by the firm.

Vapotherm 2000i Respiratory Gas Administration device is used to add moisture and warm breathing gases through a nasal canula for patients receiving supplemental oxygen.

Find more information at FDA MedWatch.


Severe Skin and Mucous Membrane Reaction Reported with Ibritumomab (Zevalin)

The prescribing information for ibritumomab (Zevalin) has been changed to include a warning describing severe skin and mucous membrane reactions. These reactions have been reported with typical therapeutic regimens during post-marketing surveillance, of which some reactions have been fatal. Patients experiencing a severe cutaneous or mucocutaneous reaction should not receive any further components of the ibritumomab therapeutic regimen and should seek prompt medical evaluation. Similar events have been associated with rituximab (Rituxan), a component of the ibritumomab therapeutic regimen.

Find more information at FDA MedWatch.


Misinterpretation of Blood Glucose Meters Reported

A problem with blood glucose meters made by Abbott Diabetes Care, Alameda, Calif may cause misinterpretation of the units or measurement. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose interpretation by the user. Users in the United States should make sure that their meter reading is displayed as mg/dL because an inaccurate reading can lead to taking the wrong dose of insulin or dietary changes, resulting in higher levels of sugar in the blood or hyperglycemia. Several cases of hyperglycemia due to glucose meter misinterpretation have been reported to the United States Food and Drug Association (FDA).

Find more information at FDA MedWatch.


Pemoline Will No Longer Be Available in U.S.

The United States Food and Drug Administration has concluded that the overall risk of liver toxicity from pemoline (Cylert, miscellaneous generic products) outweighs the benefits. In May 2005, Abbott chose to stop sales and marketing of their brand of pemoline (Cylert) in the U.S. All generic companies have also agreed to stop sales and marketing of pemoline. Pemoline is a central nervous system stimulant indicated to treat Attention Deficit Hyperactivity Disorder (ADHD). It is considered second line therapy for ADHD due to reports of life-threatening liver failure.

Pemoline will remain available through pharmacies and wholesalers until supplies are exhausted to allow time for patients to transition to alternative therapy.

Find more information at FDA MedWatch.


Increased Risk of Liver Toxicity with Duloxetine (Cymbalta)

The prescribing information for duloxetine (Cymbalta, by Eli Lilly) has been revised with a warning of increased risk of liver injury (eg, hepatitis, cholestatic jaundice) in people with preexisting liver disease. The new warning is based on postmarketing reports of cases describing hepatitis with abdominal pain, hepatomegaly (enlarged liver), and elevated liver enzymes up to 20 times the upper limit of normal. This broadens the already stated precaution of use in individuals with liver impairment due to alcohol abuse to include other individuals with chronic liver disease. Duloxetine is not recommended for anyone with any liver impairment.

Duloxetine is a selective serotonin reuptake inhibitor indicated for depression and diabetic peripheral neuropathic pain.

Find more information at FDA MedWatch.


ENTERYX Recalled Due to Serious Adverse Events, Including Death

A recall for all ENTERYX (by Boston Scientific) procedure kits and injector single packs has been issued. Serious adverse events involving unrecognized transmural injections into the structures surrounding the esophagus have occurred, including one death.

ENTERYX was approved by the FDA in April 2003. It is a permanently implanted device used to help patients with symptoms of gastroesophageal reflux disease (GERD). The device is a solution made up of a polymer and a solvent that is implanted by injection into the wall of the lower esophagus. Once implanted, the polymer solidifies to a spongy substance to help prevent reflux of stomach contents up into the esophagus. Once injected, the material cannot be removed.

The FDA has advised physicians to immediately stop injecting ENTERYX and follow the manufacturer's procedures for returning unused product (customer service telephone is 888-272-1001). Additional recommendations from the FDA include:

  • Advise patients to seek medical evaluation immediately if they experience the onset of symptoms which may indicate transmural injection (eg, chest or epigastric pain, flu-like or respiratory symptoms, syncope [fainting], or flank pain)
  • Perform tests as clinically indicated to rule out transmural injection (eg, chest x-ray, barium swallows, chest/abdominal CT scans)
  • Advise patients to continue with their regularly scheduled follow-up appointments; if needed, go immediately to an emergency room if they experience chest pain or syncope

Find more information at FDA MedWatch.


Guillain Barre Syndrome Reported with Meningococcal Vaccine

The United States Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) have issued a notification to consumers and healthcare providers describing five reports of Guillain Barre Syndrome (GBS) associated with meningococcal conjugate vaccine A, C, Y, and W135 (Menactra, by Sanofi Pasteur). The FDA and CDC are continuing to evaluate the reports to determine if the vaccine caused the adverse event or it was coincidental.

GBS is a serious neurological disorder that may suddenly appear in otherwise healthy individuals or may be caused by an infection. Increasing weakness in the legs and arms may occur that increases in severity necessitating hospitalization. Meningococcal vaccine is administered to prevent meningococcal infection, a major cause of bacterial meningitis that affects 1 in 100,000 people each year. The infection can be life-threatening, 10-14 percent result in death and 11-19 percent of those that survive have permanent disability.

Anyone with knowledge regarding adverse effects following vaccine administration is encouraged to report them to the Vaccine Adverse Event Reporting System (see link below for VAERS).

Find more information at FDA MedWatch.

For additional information:


Suicidal Thinking With Atomoxetine (Strattera)

The prescribing information for atomoxetine (Strattera) now includes warning statements alerting health care providers of an increased risk of suicidal thinking in children and adolescents being treated with this medication. Atomoxetine is indicated to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6 years or older), adolescents, and adults.

A medication guide is also being developed to provide information for patients and parents when atomoxetine is dispensed. Patients being treated with atomoxetine should be closely observed for clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior, especially during the initial few months of drug therapy, or at times of dose changes, either increases or decreases.

Find more information at FDA MedWatch.


Fluorouracil Injection Recalled

A nationwide recall has been issued for fluorouracil injection 50 mg/mL (500 mg/10 mL Single Dose Vial by American Pharmaceutical Partners, Inc. and Sicor Pharmaceuticals, Inc.). The potential for invisible glass particles containing silica and aluminum exist in some vials. The affected lot number is 101710 (NDC Number 63323-117-10).

Find more information at FDA MedWatch.


Early Pregnancy Exposure to Paroxetine (Paxil, Paxil CR) Suspected to Cause Congenital Malformations

Changes to the paroxetine (Paxil, Paxil CR) prescribing information describe a retrospective epidemiologic study showing major congenital malformation in infants born to women taking antidepressants during the first trimester of pregnancy. The study showed an increase in the risk of overall major congenital malformations for paroxetine compared to other antidepressant exposure.

A preliminary analysis has recently been conducted which yielded adjusted odds ratios of 2.20 (95% Confidence interval [CI]: 1.34-3.63) for congenital malformations as a whole, and 2.08 (CI: 1.03-4.23) for cardiovascular malformations alone, for paroxetine as compared to the other antidepressants in the database. The prevalences of congenital malformations as a whole and cardiovascular malformation alone were approximately 4% and 2%, respectively. Of the cardiovascular malformations reported in infants whose mothers were dispensed paroxetine, the majority were ventricular septal defects.

It is important to note that because the study was designed to evaluate the relative risk of congenital malformations in infants born to women exposed to antidepressants, the study did not include a comparison to infants who were not exposed to any antidepressant. Therefore, these data should be viewed within the context of the overall prevalence of congenital malformations in the general population, which is estimated in the US to be approximately 3% for any malformation and approximately 1% for cardiovascular malformations alone.

These data and recent published abstracts (see link to Dear Healthcare Professional letter) differ from previous epidemiologic studies, therefore confounding the issue whether a causal relationship exists. Data from the Swedish Medical Birth Registry have not shown evidence of increased major malformations with SSRIs, including paroxetine.

Find more information at FDA MedWatch.


Medication Errors with Toprol-XL, Topamax, and Tegretol-XR

Reports have emerged describing medications errors between Toprol-XL, Topamax, Tegretol, or Tegretol-XR, some of which have lead to adverse events. The errors describe incorrectly written, interpreted, labeled, and/or dispensed prescriptions. Beside names that sound similar, Toprol-XL and Topamax have identical dose strengths of their respective tablets.

  • Toprol-XL (generic name is metoprolol succinate) is indicated to treat hypertension, angina pectoris, and heart failure
  • Topamax (generic name is topiramate) is indicated to treat epilepsy and for prophylaxis of migraine headaches
  • Tegretol, Tegretol-XR (generic name is carbamazepine) is indicated for seizures and trigeminal neuralgia

Find more information at FDA MedWatch.


Injectable Products from Central Admixture Pharmacy Services (CAPS) Recalled

All injectable products manufactured by Central Admixture Pharmacy Services (CAPS), Inc of Lanham, Maryland have been recalled due to sterility concerns. The recall was issued after identifying gram negative rods in two lots of cardioplegia solution manufactured by CAPS. The affected injectable products have been distributed to hospitals in Maryland, Delaware, Washington DC, and Virginia.

The link below provides a full list of injectable products distributed and affected by the recall. Nonsterile injectables could present a serious hazard and lead to life-threatening sepsis.

Find more information at FDA MedWatch.


Updated Information on Cardiotoxicity of Trastuzumab (Herceptin)

Preliminary analysis of a study (Study NSABP B-31) involving women with breast cancer who received trastuzumab (Herceptin) for treatment demonstrated a significant increase in cardiotoxicity (heart failure). NSABP B-31 compared the addition of trastuzumab to standard therapy and standard therapy without trastuzumab. Among patients initiated on trastuzumab, 30.5% required at least one dose delay because of a slight decrease in left ventricular ejection fraction (LVEF), a test that indicates heart failure. In 18.6% of patients, trastuzumab was discontinued prior to completing 1 year of therapy because of decreased LVEF and symptomatic heart toxicity. Additionally, a statistically significant increase in 3-year cumulative incidence of heart failure was observed in patients who received trastuzumab (4.1%) compared to standard therapy (0.8%) in the NSABP B-31 and another study (N9831) by the North Central Cancer Treatment Group (NCCTG).

Find more information at FDA MedWatch.


Contaminated Mouthwash Causes Bacterial Infections

A nationwide recall has been issued for Alcohol-Free Mouthwash and Hygiene Kits by Medline due to possible bacterial contamination with Burkholderia cepacia. Individuals with weakened immune systems or chronic lung diseases, particularly cystic fibrosis may be more susceptible to contracting an infection from the contaminated mouthwash. Infections attributed to the mouthwash have been confirmed by the Centers for Disease Control (CDC) in Florida and Texas. The product was distributed to hospitals, medical centers, and long-term care facilities nationwide.

Find more information at FDA MedWatch.


Trypan Blue Ophthalmic Solution Recalled Due to Bacterial Contamination

A nationwide recall has been issued for Trypan Blue 0.06% ophthalmic solution by Custom RX Compounding Pharmacy due to possible bacterial contamination with Pseudomonas aeruginosa. The ophthalmic solution is intended for use during cataract surgery.

All unexpired syringes should be returned to Custom RX Pharmacy. The product was distributed to hospitals and clinics in the District of Columbia, Illinois, Maryland, Michigan, Minnesota, Nebraska, North Dakota, and Pennsylvania. The recall includes, but may not be limited to the following lot numbers:

  • 05042005:86@17
  • 05252005:36@13
  • 06282005:91@27
  • 08012005:63@24
  • 08182005:43@17

Find more information at FDA MedWatch.


Safety Alert Issued for Prisma Continuous Renal Replacement System

A safety alert has been issued for the Prisma continuous renal replacement system (all catalog numbers). The alert is a result of several serious injuries and deaths resulting from excessive ultrafiltration (fluid being removed from the patient's body). This problem can occur when the user does not address the cause of the "Incorrect Weight Change Detected" alarm. This alarm should never be overridden without first identifying and removing the cause of the alarm. The device remains appropriate for use when these directions are followed.

Find more information at FDA MedWatch.


Acetaminophen and Cough/Cold Infant Oral Drops Recalled

A recall has been issued for all lots of concentrated infant drops manufactured by Perrigo that are packaged with a dose syringe bearing only a "1.6 mL" measurement. A variety of products are affected by the recall including acetaminophen and, cough and cold preparations containing dextromethorphan with acetaminophen and/or pseudoephedrine.

The recalled products were sold nationally at retail chains under the following store-brand labels: American Fare, Best Choice, Brooks, Berkley & Jensen, CVS, Dollar General, Eckerd, Equaline, Equate, Family Dollar, Food Lion, Good Neighbor, GoodSense, Healthy Generations, Health Pride, Hy-Vee, Kroger, Leader, Longs, Major, Medicine Shoppe, Meijer, Parklane, Publix, Rite Aid, Safeway, Shop Rite, Sunmark, Target, Today's Health, Top Care, Walgreen, Western Family, and Winn Dixie.

The dosage syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. Until recently these products were provided with a dropper, not the oral dosing syringe, and the dropper had two markings on it ("0.4 mL" and "0.8 mL"). The single mark on the current syringe along with the changeover from the dropper to this syringe has caused some confusion among consumers and health-care professionals and may lead to improper dosing. The following products are being recalled:

  • Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5 ounce and 1 ounce)
  • Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5 ounce and 1 ounce)
  • Cherry Flavor Cough and Cold Infant Drops (0.5 ounce)
  • Cherry Flavor Decongestant and Cough Infant Drops (0.5 ounce)

Find more information at FDA MedWatch.


Counterfeit Atorvastatin (Lipitor) Sold in United Kingdom

An alert has been issued by the US Food and Drug Administration (FDA) regarding a recent recall of a batch of counterfeit atorvastatin (Lipitor) sold in the United Kingdom (UK). Atorvastatin is used to treat high cholesterol. Health authorities in the UK state that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients. Individuals from outside of the UK may have obtained the counterfeit prescription drug through an on-line or storefront operation that does not supply legitimate, FDA-approved products, or through state-run drug importation programs that facilitate the purchase of nonapproved foreign drugs. Consumers who purchase drugs through these arrangements may have received these counterfeit products. Individuals who believe they have purchased the counterfeit drug should stop using it and consult their physician or pharmacist.

The affected product is 20 mg. "Lipitor" and is sold in packages of 28 tablets. The drug packages are marked with batch number 004405K1 and an expiration date of "11 2007." The batch number can be found on the end of the box next to the expiration date and on the foil backing of the drug's blister pack. Legitimate UK Lipitor also has this same batch number.

Find more information at FDA MedWatch.


Complication From Tracheal Stents Prompt Usage Recommendations

The US Food and Drug Administration has issued an alert regarding serious complications associated with metallic tracheal stents in patients with benign airway disorders. Specific actions are being recommended to prevent or minimize problems with the stent. Complications include the development of obstructive granulation tissue, stenosis at the ends of the stent, movement of the stent, mucous plugging, infection, and stent fracture. Removal of the stents can also result in complications, including mucosal tears, bleeding, obstruction, respiratory failure, and pneumothorax. The following recommendations have been issued:

  • Use metallic tracheal stents in patients with benign airway disorders only after thoroughly exploring all other treatment options (such as tracheal surgical procedures or placement of silicone stents). Using metallic tracheal stents as a bridge to other therapies is not recommended, because removal of the metallic stent can result in serious complications.
  • If a metallic tracheal stent is the only option for a patient, insertion should be done by a physician trained or experienced in metallic tracheal stent procedures.
  • If removal is necessary, the procedure should be performed by a physician trained or experienced in removing metallic tracheal stents.
  • Always review the labeling before using the device, especially the indications for use, warnings and precautions. Select patients carefully.

Find more information at FDA MedWatch.


D-TRON Insulin Pump Adapters Error Measures Too Much Insulin

Disetronic Medical Systems and the United States Food and Drug Association (FDA) notified healthcare professionals and patients about a nationwide recall of D-TRON adapters, used with the D-TRONplus insulin pump. The adaptors can potentially over-deliver a maximum amount of up to 1.8 units of insulin. Use of these recalled adapters may pose a potential life-threatening situation to certain children using the pump. Other users who are insulin sensitive may also be at increased risk. The root cause of this issue is a sporadic failure of a valve inside the D-TRON adapter to close completely, which can result in a potential over-delivery of a maximum amount of up to 1.8 I.U. of insulin. Disetronic has notified the caregivers and physicians of the pump users 13 years of age and under to immediately discontinue the use of the affected adapters.

Signs and symptoms of excessive insulin dosing may include: sweating, thirst, confusion, nausea and loss of consciousness. There have been no reports of injury or death associated with the use of the affected D-TRON adapters. Users should contact the Disetronic Pump User Support Group for information regarding replacement of affected D-TRON adapters at 1-800-688-4578.

Find more information at FDA MedWatch.


Follow Up Appointments Advised for Patients with Recalled Defibrillators

Guidant notified healthcare professionals in a letter issued July 22 that one of the safety recommendations made to physicians on June 17 regarding its VENTAK PRIZM, VITALITY, and CONTAK RENEWAL AVT implantable cardioverter defibrillators (ICDs) may significantly increase the risk to patients. Physicians are advised to schedule follow-up visits as soon as possible for patients with devices reprogrammed as per original instructions and for all patients with Atrial Episode Data Storage programmed to less than 20%.

Find more information at FDA MedWatch.


Class 1 Recall of Baxter Volumetric Infusion Pumps

A Class I recall of all models of its Colleague Volumetric Infusion Pumps (by Baxter Healthcare Corporation) has been issued because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem. The affected models are:

  • 2M8151
  • 2M8151R
  • 2M8161
  • 2M8161R
  • 2M8153
  • 2M8153R
  • 2M8163
  • 2M8163R
In addition to the shut-down problem, the device may exhibit two additional failure modes:
  1. Users may inadvertently press the on/off key instead of the start key when attempting to start an infusion
  2. Disconnecting or connecting the pump from the hospital monitoring system while the pump is powered "on" can result in a failure code, requiring the infusion to be restarted
These failures may occur during the infusion of therapy, so it is imperative that health care institutions have a contingency plan to diminish possible disruptions of infusions of life-sustaining drugs or fluids. Approximately 255,000 Colleague Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States.

A class I recall is issued when a drug or device may pose serious health risks to some users.

Find more information at FDA MedWatch.


Package Insert Revised to Warn of Sepsis Associated with Mifepristone (Mifeprex)

The United States Food and Drug Administration (FDA) is aware of four cases of septic deaths in the United States, from September 2003 to June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. The bacteria causing sepsis has been identified in two of the cases as Clostridium sordellii. The other two cases are under ongoing investigation by FDA along with the Centers for Disease Control and Prevention, State and local health departments, and the manufacturer of mifepristone. All cases involve the off-label dosing regimen consisting of mifepristone 200 mg orally, followed by misoprostol 800 mcg intravaginally. The two confirmed cases of Clostridium sordellii did not have the usual signs and symptoms of an infection. Although these deaths are reported from California, all providers of medical abortion and their patients need to be aware of the risks of sepsis. As more information becomes available, FDA will alert the public.

The approved mifepristone regimen for a medical abortion through 49 days of pregnancy is:

  • Day One: Mifepristone 600 mg (3 tablets of 200 mg) orally as a one-time single dose
  • Day Three: Misoprostol 400 mcg (2 tablets of 200 mcg) orally as a one-time single dose
  • Day 14: The patient must return to confirm that a complete termination has occurred. If not, surgical termination is recommended to manage medical abortion treatment failures.

Find more information at FDA MedWatch.


Hemolytic Anemia, Thrombocytopenia, and Serious Infections Observed with Efalizumab (Raptiva)

Postmarketing surveillance has identified reports of immune-mediated hemolytic anemia, thrombocytopenia (low platelet count), and serious infections with efalizumab (Raptiva). The infections observed include necrotizing fasciitis, tuberculous pneumonia, bacterial sepsis with seeding of distant sites, severe pneumonia with neutropenia, and worsening of infection (such as cellulitis or pneumonia) despite antibiotic treatment. Efalizumab is indicated for the treatment of adults with chronic moderate-to-severe plaque psoriasis.

Find more information at FDA MedWatch.


Guidant Warns of Heart Pacemakers Malfunction

Guidant has notified physicians and patients of new safety information for certain models of cardiac pacemakers manufactured between November 25, 1997 and October 26, 2000. A hermetic sealing component used in these devices may experience a gradual degradation (decay), resulting in a higher than normal moisture content within the pacemaker case late in the device's service life. The clinical behaviors associated with this failure mode can result in serious health complications.

Guidant has confirmed twenty reports of pacing loss output associated with this failure mode, including five patients experiencing syncope (fainting). Loss of pacing output has also been associated with presyncope requiring hospitalization. Guidant has received two reports of sustained Maximum Sensor Rate ("MSR") pacing in which heart failure may have developed in association with sustained high rate pacing.

Physicians should consider the unique needs of individual patients and the specific technical recommendations set forth in the July 18, 2005 physician communication. Guidant recommends that physicians consider replacing devices for pacemaker-dependent patients and advises patients to seek medical attention immediately if they notice shortness of breath, dizziness, lightheadedness or a prolonged fast heart rate. A subset of the following devices manufactured between November 25, 1997 and October 26, 2000 are impacted:

These products, which are of an earlier generation design, have not been sold or implanted for the last four years.

As of July 11, 2005, Guidant has identified sixty-nine (69) devices that may have exhibited this failure mode from approximately 78,000 devices distributed with this component. While no pacemaker failures have been reported prior to 44 months of service, the likelihood of these occurrences increases with implant time. Guidant's modeling based on field experience and statistical life-table analysis predicts the rate of failure in the remaining active implanted devices to be between 0.17% and 0.51% over the remaining device lifetime. Of the 78,000 devices originally distributed, approximately 28,000 devices remain implanted worldwide; 18,000 of these devices remain in service in the United States with an average implant age of 69 months.

Find more information at FDA MedWatch.


Expert Panel Provides Guidance on Nesiritide (Natrecor) Use

Recent questions regarding the association of nesiritide (Natrecor, by Scios) with worsened renal function and mortality has prompted an expert panel of cardiology and heart failure specialists to provide a consensus statement (see eMedicine Recalls and Alerts 5/19/05). Dr. Eugene Braunwald, Distinguished Hersey Professor of Medicine, Harvard Medical School, was asked to convene the panel to review and assess important data associated with nesiritide. The panel also provided advice on the ongoing and planned clinical development program for nesiritide, and made recommendations about the appropriate use of the drug. Additionally, an educational campaign to ensure that clinicians understand when nesiritide use is appropriate, and when it is not appropriate was recommended. The following are specific recommendations by the panel:

  • The use of nesiritide should be strictly limited to patients presenting to the hospital with acutely decompensated congestive heart failure who have dyspnea at rest, as were the patients in the largest trial that led to approval of the drug (VMAC). Physicians considering the use of nesiritide should consider its efficacy in reducing dyspnea, the possible risks of the drug summarized above, and the availability of alternate therapies to relieve the symptoms of congestive heart failure.
  • Nesiritide should not be used to replace diuretics. Furthermore, because sufficient evidence is not currently available to demonstrate benefit for the applications listed below, nesiritide should not be used:
    • For intermittent outpatient infusion
    • For scheduled repetitive use
    • To improve renal function
    • To enhance diuresis
  • Scios should immediately undertake a proactive educational program to inform physicians regarding the conditions and circumstances in which nesiritide should and should not be used, as described above. Sponsor supported communications, including review articles of nesiritide, should reflect the above recommendations. Scios should ensure that current and future marketing and sales activities related to nesiritide are consistent with this educational program.
The expert panel's complete report is available at the link listed below.

Find more information at FDA MedWatch.


Hydromorphone Extended Release Capsules (Palladone) Sales Suspended

Purdue Pharma has agreed to suspend sales and marketing hydromorphone extended release capsules (Palladone) due to severe side effects if consumed with alcohol. Drinking alcohol while taking Palladone may cause the rapid release of hydromorphone, leading to high drug levels in the body. Palladone is a time-release formulation of hydromorphone, a potent narcotic painkiller. Palladone is taken once-a-day and the capsule slowly releases a steady amount of hydromorphone into the body over that whole day. If the drug is rapidly released, the high drug levels of hydromorphone may depress or stop breathing, cause coma, or death.

Find more information at FDA MedWatch.


Vision Loss Prompts Labeling Changes for Erectile Dysfunction Medications

The prescribing information for phosphodiesterase-5 (PDE-5) inhibitors that treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra) has been revised to include a warning regarding sudden vision loss. A small number of men have lost vision in one eye after taking medications to treat ED. This type of vision loss is called nonarteritic anterior ischemic optic neuropathy (NAION). NAION causes a sudden loss of eyesight because blood flow is blocked to the optic nerve.

It is not yet confirmed that these drugs cause NAION. This type of vision loss also happens in men who do not take drugs for ED. Individuals with the following conditions have an increased incidence to develop NAION:

  • Heart disease
  • Diabetes
  • High blood pressure
  • High cholesterol
  • Consume tobacco products
  • Currently have certain eye diseases
If vision disturbances occur, stop using Viagra, Cialis, or Levitra and immediately seek medical attention.

Find more information at FDA MedWatch.


Fentanyl Patch's (Duragesic) Safety Information Extensively Revised

Prescribing information for fentanyl transdermal system (ie, fentanyl patch), commonly known by the trade name of Duragesic, has been extensively revised. Changes to the bold, black boxed warning, contraindications, precautions, and dosage sections of the prescribing information have been made. A summary of the changes include:

  • Use only in opioid-tolerant patients is stressed (that is, individuals who are already chronically taking potent schedule II opioid analgesics)
  • Misuse, abuse, and diversion of schedule II narcotics is a criminal offense
  • Respiratory depression risk must be recognized; fentanyl patch is NOT to be used for acute pain, short-term pain control, to manage post-operative pain, mild pain, or intermittent pain.
  • Drug interactions update including:
    • CYP450 3A4 inhibitors (eg, ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone) may increase fentanyl plasma concentration leading to toxicity including fatal respiratory depression
    • Caution with other central nervous system depressants, such as alcohol, other opioids, sedatives, hypnotics, tranquilizers , general anesthetics, phenothiazines, or skeletal muscle relaxants
  • Damaged or cut patches can lead to rapid release of the drug contents and absorption, causing a potential fatal dose of fentanyl
  • Accidental exposure has caused death and other serious medical problems; keep out of children's reach
  • Individuals with chronic pulmonary disease are more susceptible to respiratory depression with fentanyl patches
  • Fentanyl patches should not be used in patients likely to retain CO2, such as individuals with head injuries and intracranial pressure; use with caution for brain tumors
Please refer to the link below for prescribing information changes in their entirety.

Find more information at FDA MedWatch.


Liqiang 4 Dietary Supplement Found to Contain Glyburide

The U.S. Food and Drug Administration (FDA) is warning consumers not to take Liqiang 4 Dietary Supplement Capsules because they contain glyburide. Glyburide is a drug used to lower blood sugar and could have serious, life-threatening consequences in some people.

Glyburide is a drug used to treat diabetes, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities. Consumers who have this product should dispose of it immediately.

The product is sold as part of a shrink-wrapped two bottle set. One of the 90 capsule bottles is labeled Liqiang 4 Dietary Supplement Capsules, the other bottle is promoted as a "bonus pack" of Liqiang 1. At this time FDA is evaluating Liquang 1 and other versions of this line of products to determine their composition and safety. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge CA.

The FDA learned of the potential problem through an anonymous consumer complaint and followed up with testing that revealed the presence of glyburide in this product.

The product has also been termed "Liqiang Xiao Ke Ling" (Liqiang Thirst Quenching Efficacious) in ads in Chinese language publications which also promote it as useful for the control of diabetes and being derived from only natural ingredients.

Find more information at FDA MedWatch.


Update Concerning Guidant Implantable and Cardiac Resynchronization Defibrillators Recall

The United States Food and Drug Administration (FDA) evaluation of the safety and performance of certain implantable defibrillators manufactured by Guidant Corporation continues. Additional information on the relative health risks of the devices will help patients and doctors take appropriate action, if necessary. The FDA has classified the devices into 3 categories based on the probability that the device failure could lead to adverse effects, with Class 1 being the most serious.

Class I contains defibrillators that possess a reasonable probability that if a particular device is malfunctioning, it could cause serious adverse health consequences or death. The devices included in Class I are:

  • PRISM 2 DR, Model 1861 (Manufactured on or before April 16, 2002)
  • CONTAK RENEWAL, Model H135 (Manufactured on or before August 26, 2004)
  • CONTAK RENEWAL 2, Model H155 (Manufactured on or before August 26, 2004)
Class II contains devices subject or a memory error and in rare cases may limit available therapy. Reprogramming the device is recommended and non-invasive software for this problem is expected to be released by the end of the year. Of the 21,000 devices implanted worldwide (18,000 in the US), two incidents have been confirmed, neither resulted in death or injury.
  • Ventak PRISM AVT
Additional Class II devices may fail due to the magnetic switch becoming stuck in the closed position. Four confirmed incidents have been reported out of 46,000 devices. An audible tone signaling that the magnetic switch was closed was heard by the patient or physician. If this tone is heard, patients should immediately contact their physician or go to the hospital emergency room. These include:
  • CONTAK RENEWAL 3 and 4
  • RENEWAL 3 and 4
  • RENEWAL RF Devices

Find more information at FDA MedWatch.


FDA Continues to Review Possible Link of Antidepressants and Suicide

Several recent scientific publications suggest the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, the FDA began a complete review of all available data to determine whether there is an increased risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that:

  • Adults being treated with antidepressant medications, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior. Close watching may be especially important early in treatment, or when the dose is changed, either increased or decreased.
  • Adults whose symptoms worsen while being treated with antidepressant drugs, including an increase in suicidal thinking or behavior, should be evaluated by their health care professional.

Find more information at FDA MedWatch.

Find more information at FDA MedWatch.

For additional information: http://www.fda.gov/cder/Offices/ODS/labeling.htm

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