Drug Recalls and Alerts - 2006 (Discontinued in May 2006)

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The Drug Recalls and Alerts section of eMedicineHealth was discontinued in May 2006. For further information on drug recalls and alerts, please see:

RxList.com

FDA MedWatch

5/12/2006

Meta-analysis Concludes Higher Frequency of Suicidal Behavior with Paroxetine

Prescribing information for paroxetine (Paxil, Paxil CR) has been updated to include new information regarding a higher frequency of suicidal behavior in adults (particularly young adults) compared to placebo.

A recent meta-analysis was conducted to examine suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders. Major Depressive Disorder (MDD), other depression, and non-depression disorders were the diagnoses described in the meta-analysis. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were nonfatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These data suggest that the higher frequency observed in young adults across psychiatric disorders may extend beyond the age of 24 years.

It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.

More information is available at FDA MedWatch.

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5/5/2006

Acute Phosphate Nephropathy Reported with Oral Sodium Phosphate Medications

The United States Food and Drug Administration (FDA) notified healthcare professionals and consumers of reports of acute phosphate nephropathy with use of oral sodium phosphates (OSP). Acute phosphate nephropathy is a type of acute renal failure that is a rare, but serious adverse event associated with the use of OSP for bowel cleansing. Documented cases of acute phosphate nephropathy include 21 patients who used an OSP solution (eg, Fleet Phospho-soda or Fleet ACCU-PREP) and one patient who used OSP tablets (Visicol). Circumstances that increase risk of acute phosphate nephropathy include advanced age, kidney disease, dehydration, and medication use that affect renal perfusion or function (eg, diuretics, angiotensin converting enzyme [ACE] inhibitors, angiotensin receptor blockers [ARBs], and possibly nonsteroidal anti-inflammatory drugs [NSAIDs]).

More information is available at FDA MedWatch.

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5/5/2006

Class I Recall for Respironics PLV Continuum Ventilator

A Class 1 recall has been issued for Respironics PLV Continuum Ventilator. The device is a mechanical ventilator used to control or assist breathing. The ventilator is intended for home, institutional, and portable settings and may be used for invasive as well as noninvasive ventilation. A design flaw can cause lead wires in the air flow valve to break during use. When this happens the ventilator stops providing mechanical ventilation. Customers should safely transition patients in their care from the PLV Continuum Ventilator onto other comparable patient support devices. If customers do not have a suitable ventilator to use for their patients, they should contact Respironics at 760-918-7328 to make suitable substitute arrangements.

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

More information is available at FDA MedWatch.

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5/4/2006

Acetaminophen Recalled Due to Labeling Error

The United States Food and Drug Administration (FDA) has issued a recall of Goldline brand Extra Strength Genapap 500 mg (acetaminophen) Caplets and Tablets and Extra Strength Genebs 500 mg (acetaminophen) Caplets and Tablets due to a labeling error. Specifically, the product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period (ie, 4 grams/day). The erroneous label indicates not to exceed 12 tablets or caplets in a 24 hour period (ie, 6 grams/day). In the event the maximum dosage of 8 tablets or caplets in a 24 hour period is exceeded, there may be an increased risk of acetaminophen toxicity to the liver, which may cause adverse health effects. There have been no reports of serious illness or injury relating to this labeling matter.

More information is available at FDA MedWatch.

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4/28/2006

NeutraGard Anticavity Rinse Products Recalled

A recall has been issued for all lots and all flavors of NeutraGard 0.05% Neutral Sodium Fluoride Anticavity Treatment Rinse and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse packaged in clear 160z plastic bottles. The products were recalled because they may be contaminated with Burkholderia cepacia and Pseudomonas aeruginosa bacteria.

B cepacia bacteria poses little medical risk to healthy people. However, the bacteria may affect individuals with certain health problems like a weakened immune system or chronic lung diseases, such as cystic fibrosis. The effects of B cepacia range from no symptoms to serious respiratory infections, especially in patients with cystic fibrosis.

P aeruginosa may cause urinary track infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns, or those with cancer or AIDS.

Dental offices and consumers who have the product should discontinue use and destroy it or return the product to the place of purchase for further investigation. For more information regarding this recall, please view the link below.

More information is available at FDA MedWatch.

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4/28/2006

Safety Reminders for Baxter's Colleague Infusion Pumps

The United States Food and Drug Administration (FDA) is recommending that all healthcare providers take important safety steps when using the Colleague Volumetric Infusion Pump manufactured by Baxter Healthcare Corporation. The Colleague pump has exhibited a variety of problems, including under-infusion, battery failures, false alarms and failure to alarm. Over the past year, Baxter has issued four urgent safety notices and recalls for Colleague infusion pumps (see eMedicine Recalls and Alerts 2/2/2006).

In addition to the recommendations made by Baxter Healthcare Corporation, the FDA is strongly recommending the following measures:

Avoid using Colleague pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life-threatening
Have back-up infusion pumps available to mitigate any disruption of infusion therapy
Monitor patients and check the infusion pumps frequently Report any problems as soon as possible to Baxter and FDA
Consider evaluating other options for infusion therapy if your facility relies primarily or entirely on Colleague infusion pumps.

The FDA is mindful of concerns about the availability of replacement units and is working with Baxter to resolve problems with the Colleague pump as quickly as possible.

More information is available at FDA MedWatch.

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4/25/2006

Promethazine (Phenergan) Contraindicated in Children Younger than 2 Years

Breathing problems, some causing death, have been reported to the United States Food and Drug Association (FDA) when promethazine (Phenergan and other brands) was used in children younger than two years old. The reports included seven deaths and 22 cases of respiratory depression. Parents and caregivers should also be careful and get a doctor's advice about giving promethazine HCl in any form to children age two and older.

The prescribing information on all products, brand name and generic, has been changed to reflect these strengthened warnings. Promethazine is an antihistamine used in cough and cold products and antinausea products. The drug is available as tablets and suppositories under the brand name Phenergan. It is also available as generic products, including tablets, suppositories, injectables, and syrups.

More information is available at FDA MedWatch.

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4/25/2006

Oxygen Regulator Fires and Explosions

The United States Food and Drug Administration (FDA) and the National Institute for Occupational Safety and Health (NIOSH) notified healthcare professionals that 12 incidents have been reported in which regulators used with oxygen cylinders have burned or exploded, in some cases injuring personnel. Some of the incidents occurred during emergency medical use or during routine equipment checks. FDA and NIOSH believe that improper use of gaskets/washers in these regulators was a major factor in both the ignition and severity of the fires, although there are likely other contributing factors. FDA and NIOSH recommend that plastic crush gaskets never be reused, as they may require additional torque to obtain the necessary seal with each subsequent use. This can deform the gasket, increasing the likelihood that oxygen will leak around the seal and ignite.

More information is available at FDA MedWatch.

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4/18/2006

VITROS Immunodiagnostic Products Signal Reagent Recalled

A Class 1 recall has been issued for VITROS Immunodiagnostic Products Signal Reagent (by Ortho-Clinical Diagnostics). The reagent is a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy. A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests.

Hospitals and diagnostic laboratories with the affected lot numbers should discontinue using any remaining reagent and should follow the enhanced Quality Control procedure provided by Ortho-Clinical Diagnostic for each pack in all lots of VITROS Signal Reagent until further notice. Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results should discuss them with their physicians - cardiac disease, hepatitis (A,B, or C), thyroid disorders, HIV and pregnancy.

Lots numbers included in the recall are:

Lot 8350, catalog #107 2693
Lot 8530, catalog #106 2693

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

More information is available at FDA MedWatch.

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4/17/2006

Class I Recall Issued for Blackstone's ICON Modular Fixation System

A Class I recall has been issued for ICON Modular Fixation System (by Blackstone Medical, Inc.). The Fixation System is a collection of components that allows surgeons to assemble a construct including screws, connectors and rods. The construct is implanted in or near the patient's spine, and is intended to immobilize and stabilize spinal segments at the site of spine surgery. The recall was initiated because components in the system may fail after the devices have been implanted. There may be potential for serious injury in specific patients. Hospitals and surgeons should review their records to identify patients who have the recalled products, and contact these patients. Patients who may have concerns regarding their ICON fixation devices should contact their physician.

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

More information is available at FDA MedWatch.

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4/17/2006

Ultilet Insulin Syringes Recalled Due to Bacterial Contamination

A recall has been issued for Ultilet Insulin Syringe 30 gauge, ½ mL (cc) because of possible bacterial contamination with Bacillus cereus and Staphylococcus intermedius. Possible risks include local infection due to injection with a contaminated syringe and introduction of contaminating organisms into sterile insulin vial. Contamination may degrade the insulin, leading to problems maintaining insulin levels.

The recalled Lot # is 5GEXI (NDC # - 08326-3002-50). The product was distributed to the following states: Florida, New York, Massachusetts, Alabama, South Carolina, North Carolina, Colorado, Texas, Michigan, and Arkansas. For any question related to the case consumers should call 1-800-354-8460.

More information is available at FDA MedWatch.

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4/11/2006

Increased Incidence of Serious Fungal Infection with Soft Contact Lenses

The United States Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) notified all healthcare practitioners and consumers of an increase in the number of reports in the United States of a rare, but serious fungal infection of the eye in soft contact lens wearers. The infection, a fungal keratitis (corneal infection) caused by the Fusarium fungus, may cause vision loss requiring corneal transplants.

Both the FDA and CDC are investigating these occurrences. The CDC received reports of 109 cases of suspected fungal keratitis in 17 different States. Twenty-eight of the 30 cases reported wearing soft contact lenses. The majority of the individuals (26) reported using a Bausch & Lomb ReNu brand contact lens solution in the month prior to the onset of infection.

Healthcare practitioners should refer patients presenting with a microbial keratitis immediately to an ophthalmologist for immediate treatment and report cases of fungal keratitis in contact lens wearers to FDA. Contact lens wearers should use good hygiene practices that include:

Washing hands with soap and water, and dry (lint free method) before handling lenses
Wear and replace lenses according to the prescribed schedule
Follow the specific lens cleaning and storage guidelines from the doctor and the solution manufacturer
Keep the contact lens case clean and replace every 3-6 months
Remove lens immediately if the wearer experiences symptoms such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling
Wearing contact lenses overnight may increase risk of fungal infection

More information is available at FDA MedWatch.

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4/7/2006

Pegaptanib (Macugen) May Cause Severe Allergic Reaction

The prescribing information for pegaptanib injection (Macugen) has been changed to include rare reports of anaphylaxis (including angioedema) following intravitreous administration. Pegaptanib is indicated for the treatment of neovascular (wet) age-related macular degeneration.

More information is available at FDA MedWatch.

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4/4/2006

ACCU-CHEK Ultraflex Infusion Sets Recalled

A nationwide recall of all ACCU-CHEK Ultraflex infusion sets has been issued due to the potential for the tubing to separate at the luer lock connection. Separation at the connection may interrupt insulin administration and result in inadequate blood glucose control.

Alternative infusion sets to replace the ACCU-CHEK Ultraflex during the recall include ACCU-CHEK Tender or ACCU-CHEK Rapid-D.

More information is available at FDA MedWatch.

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3/31/2006

Davol/Bard Composix Kugel Mesh Recall Expanded

Davol/Bard and the US Food and Drug Administration (FDA) have notified healthcare professionals of an expanded recall of Composix Kugel Mesh to include Oval, Large Oval and Large Circle Kugel mesh patches (see eMedicine Recalls and Alerts 3/2/06 for original recall). The recall now includes Oval, Large Oval and Large Circle Kugel mesh patches. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break and lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs). The product descriptions and lot numbers affected by the most recent recall are included in the link below.

More information is available at FDA MedWatch.

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3/31/2006

Ossur Total Knee Prosthetic Device Recalled

A worldwide recall has been issued for Ossur Total Knee prosthetic device. The models affected by the recall include 1100, 1900, 2000, and 2100. The company's initiation of the recall is based on a finding that some units of the Total Knee device may contain faulty pins based in the axis of the knee. At this time, there have been no incidents or injuries resulting from this situation that have been reported to the company.

More information is available at FDA MedWatch.

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3/30/2006

Diazepam Rectal Gel (Diastat) Recalled

A recall has been issued for diazepam rectal gel (Diastat) after the manufacturer received complaints concerning small cracks at the base of the plastic tip of the applicators. The defect results in medication leakage when the plunger is depressed, potentially resulting in suboptimal dosage and therapeutic response. Diastat is indicated for rectal administration for selected individuals with epilepsy, despite stable regimens of antiepileptic drugs; require intermittent use of diazepam to control episodes of increased seizure activity. Any product with a cracked tip should be returned to their pharmacy for immediate replacement. Pharmacists should inspect all Diastat on their shelves and contact Rx Hope at 1-800-511-2120 for replacement product.

More information is available at FDA MedWatch.

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3/17/2006

Sepsis and Death Following Mifepristone (Mifeprex)

The United States Food and Drug Administration (FDA) has been informed of two additional deaths following medical abortion with mifepristone (Mifeprex). See eMedicine Recall and Alert July 20, 2005. The FDA received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories. An investigation of the circumstances associated with these cases is ongoing and cause of death has yet to be confirmed. Medical providers and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment.

More information is available at FDA MedWatch.

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3/15/2006

Denileukin (Ontak) with Vision Impairment

The prescribing information for denileukin (Ontak) has been updated to include cases describing loss of visual acuity that is usually associated with loss of color vision. While recovery was reported in some of the affected patients, most patients reported persistent visual impairment. Denileukin is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma.

More information is available at FDA MedWatch.

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3/10/2006

Illegal Anabolic Steroids Sold as Dietary Supplements

The United States Food and Drug Administration (FDA) has discovered that several drugs marketed as dietary supplements claiming anabolic properties. The products are promoted for building muscle and increasing strength. These products are unapproved for classification as dietary supplements and may cause serious long=term adverse health consequences in men, women, and children. Problems associated with anabolic steroids include liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, and short stature in children. Anabolic steroids are also associated with causing adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.

Consumers who have any of the following products should stop taking them and return them to their place of purchase.

Anabolic Xtreme Superdrol; manufactured for Anabolic Resources LLC, Gilbert, Arizona
Methyl-1-P; manufactured for Legal Gear, Brighton, MI

More information is available at FDA MedWatch.

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3/9/2006

FDA Offers Guidelines to Improve Hospital Bed Safety

The United States Food and Drug Administration (FDA) has issued guidelines designed to reduce the occurrence of hospital bed entrapments. Over the past 21 years, the FDA has received 691 entrapment reports over this period. In these reports, 413 people died, 120 were injured, and 158 were near-miss events with no serious injury as a result of intervention. These events occurred when part of a patient's body becomes caught between parts of the bed, such as in the space between the mattress and the side rail. This can cause strangulation and death. Entrapments have occurred in a variety of patient care settings, including hospitals, nursing homes, and private homes. The guideline identifies special issues associated with hospital bed systems, provides design recommendations for manufacturers of new hospital beds, and provides suggestions for health care facilities on ways to assess existing beds for potential entrapment risks.

More information is available at FDA MedWatch.

For additional information: http://www.fda.gov/cdrh/beds/

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3/2/2006

Monthly Monitoring of LFTs Required for Duration of Treatment with Bosetan

Changes have been made to the prescribing information for bosentan (Tracleer, by Actelion) to emphasis the risk for liver toxicity. Bosentan is a drug used to treat primary pulmonary hypertension (PPH). The labeling changes are based on rare cases of liver toxicity reported to the manufacturer and the United States Food and Drug Administration (FDA). These reports underscore the continued need to monitor each month for liver function tests (LFTs) for the duration of bosentan therapy.

Bosentan is only available to patients via the Tracleer Access Program (TAP). Part of the TAP program requires the distributor calls patients each month to remind them of the need for monthly liver function tests; and, if a woman of childbearing potential, to have a pregnancy test done. These tests are required prior to the monthly refill shipment of bosentan. In cases where the patient is not sure if they have had the required tests in the preceding month, the distributor calls the prescribing physician to inform them of the patient's response.

More information is available at FDA MedWatch.

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3/2/2006

Tissue from Human Donors May Cause Increase Risk of Communicable Disease

Information continues to be discovered regarding human tissues recovered by BioMedical Tissue Services (BTS). The tissue, including human bone, skin, and tendons, was recovered by BTS from human donors who may not have met United States Food and Drug Administration (FDA) donor eligibility requirements and who may not have been properly screened for certain infectious diseases. As part of its ongoing investigation, the FDA has become aware of additional information regarding the reliability of donor blood samples that is important for health care providers to consider. The FDA strongly recommends that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing. While it is believed that the risks from these tissues are low because the tissues were routinely processed using methods to help to reduce the risk of infectious disease, the actual infectious risk is unknown.

More information is available at FDA MedWatch.

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3/2/2006

Recall for Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE

A Class I recall has been issued for Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE. The patch is used to repair ventral (incisional) hernias caused by thinning or stretching of scar tissue that may form after previous surgery. The "memory recoil ring" that opens the Composix Kugel Mesh Patch after it has been inserted into the intra-abdominal space can break. This can lead to bowel perforations and/or chronic intestinal fistulae (abnormal connections or passageways between the intestines and other organs).

Affected lot numbers include:

41XMXXXX - M = 2002
41XNXXXX - N = 2003
43XMXXXX - M = 2002
43XNXXXX - N = 2003
43XOXXXX - O = 2004
43XPXXXX - P = 2005

If the lot number does not contain the letters M, N, O, or P as the 4th character, the lot is not affected by this recall. A Class I recall is issued when a drug or device may pose serious health risks to some users.

More information is available at FDA MedWatch.

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3/1/2006

Cefazolin Injection Recalled Due to Bacterial Contamination

A recall has been issued for four lots of Cefazolin for Injection, 1 g/10 mL vials. Cefazolin is an injectable antibiotic used in a hospital environment to treat skin and respiratory infections. The product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus). The contaminated products may pose a serious or life-threatening risk for some patients.

The recalled lots contain 379,975 vials. The Sandoz product lot numbers include: C4650 and C4537. The Watson product lot numbers include C4689 and C4665. Hospitals, clinics, and users should stop using the affected lots immediately and return any unused product. Patients who feel that they may have experienced an adverse reaction to recalled product should seek medical help. Patients or users can contact the firm at (315) 476-7418.

More information is available at FDA MedWatch.

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3/1/2006

Update on Prisma Continuous Renal Replacement System

The United States Food and Drug Administration (FDA) has issued an update to its August 2005 preliminary public health notification for the Gambro Prisma Continuous Renal Replacement Therapy (CRRT) device (see eMedicine's Recalls and Alerts for August 19, 2005). The device is used for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. Approximately 1,900 units have been distributed to hospitals in the United States. This device has caused or contributed to a number of serious adverse events by removing excessive amounts of fluid from patients undergoing CRRT. The FDA is aware of 9 deaths and 11 serious injuries associated with the excessive fluid removal problem.

Special caution must be used and caregivers must adhere strictly to the labeled operating instructions, including the Manufacturer's Instructions for Use, Operator's Manual, and the User Interface on the Prisma(r) System control panel. Caregivers must pay particular attention to the "Incorrect Weight Change Detected" alarms. These alarms are designed to alert the user of a potential fluid imbalance that has occurred during the course of CRRT. If treatment is continued without resolving the cause of these alarms, excessive fluid may be removed from the patient, and this can result in serious injury or death.

Find more information at FDA MedWatch.

3/1/2006

Cefazolin Injection Recalled Due to Bacterial Contamination

A recall has been issued for four lots of Cefazolin for Injection, 1 g/10 mL vials. Cefazolin is an injectable antibiotic used in a hospital environment to treat skin and respiratory infections. The product was distributed by Sandoz, Inc. of Broomfield, CO and Watson Pharmaceuticals, Inc. of Corona, CA. Certain lots of the active ingredient used to manufacture the product have been shown to contain microbial contamination (Bacillus pumilus, Staphylococcus hominis, Propionibacterium acnes, or Micrococcus luteus). The contaminated products may pose a serious or life-threatening risk for some patients.

The recalled lots contain 379,975 vials. The Sandoz product lot numbers include: C4650 and C4537. The Watson product lot numbers include C4689 and C4665. Hospitals, clinics, and users should stop using the affected lots immediately and return any unused product. Patients who feel that they may have experienced an adverse reaction to recalled product should seek medical help. Patients or users can contact the firm at (315) 476-7418.

Find more information at FDA MedWatch.

2/28/2006

Natalizumab (Tysabri) Clinical Trials for MS Allowed to Proceed

The United States Food and Drug Administration (FDA) has lifted the clinical hold on Biogen-IDEC's clinical trials of natalizumab (Tysabri) for patients with multiple sclerosis (MS). Patients with relapsing-remitting MS, who had previously been treated with the drug in clinical trials may again obtain the drug under as an Investigational New Drug (IND). Biogen-IDEC had previously suspended marketing of natalizumab and all further dosing of patients in on-going clinical trials. This decision was made after confirmation of one fatal case and one additional case of severely disabling progressive multifocal leukoencephalopathy (PML) in patients receiving natalizumab for MS. A third case of PML, this one fatal, in a patient with Crohn Disease had been identified shortly thereafter. See eMedicine Recalls and Alerts 2/28/2005.

The FDA has since received detailed information from Biogen-IDEC about the condition of all available patients who had received natalizumab in clinical studies under an IND. No additional cases of PML were identified. In addition, Biogen will be monitoring patients very closely for PML when studies resume. While the FDA remains very concerned about the potential for PML associated with natalizumab use, existing data suggest that natalizumab may be effective against MS, which is a devastating neurologic disease. The FDA has decided to allow studies to resume under IND to obtain more information that may permit us to understand the true degree of risk and/or benefit from natalizumab.

Find more information at FDA MedWatch.

2/22/2006

Gentlease Powdered Infant Formula Recalled

A recall has been issued for one lot of Gentlease powdered infant formula (lot #BMJ19). Metal particles up to 2.7 millimeter in size were found in the formula. If an infant were to inhale the infant formula into the lungs, the presence of these particles could present a serious risk to the infant's respiratory system and throat. Approximately 41,464 cans (24-ounce) of the affected lot was distributed, beginning on December 16, 2005, through many major retail stores across the country.

Consumers should check the lot # and expiration date embossed on the bottom of the can (lot #BMJ19, use by 1 Jul 07). Consumers who have a can of this batch of Gentlease powdered infant formula should not use the product and should contact Mead Johnson at 888-587-7275 immediately.

Find more information at FDA MedWatch.

2/16/2006

Gatifloxacin Package Insert Revised to Include Diabetes Contraindication

The prescribing information for gatifloxacin (Tequin) has been revised to include an update of the existing warning on hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and will now include a contraindication for use in individuals with diabetes mellitus. The changes also include information identifying other risk factors for developing low blood sugar and high blood sugar, including advanced age, renal insufficiency, and concomitant glucose-altering medications while taking gatifloxacin. Specific wording of these additions and revisions to the prescribing information is pending FDA review and approval.

Find more information at FDA MedWatch.

2/15/2006

Nimodipine Medication Errors Linked to Death and Serious Adverse Events

Changes to the prescribing information for nimodipine (Nimotop), including a boxed warning has been made to notify prescribers about deaths and serious, life-threatening adverse effects when the liquid contents of the oral capsule are mistakenly administered by the intravenous route or other parenteral routes. Adverse events observed include cardiac arrest, cardiovascular collapse, hypotension, bradycardia, and death. Nimodipine is approved for oral administration to improve neurological outcome after subarachnoid hemorrhage.

The United States Food and Drug Administration (FDA) has received reports of medication administration errors in which nimodipine was given incorrectly. The Institute for Safe Medication Practice's (ISMP) description of the problem explains the occurrences happen after administering nimodipine for patients unable to swallow the capsule. For patient unable to swallow nimodipine capsules whole, the liquid contents from nimodipine capsules should be placed in an oral syringe and clearly labeled for oral use only. Nimodipine must NOT be administered intravenously or by any parenteral route.

Find more information at FDA MedWatch.

For additional information: http://www.ismp.org/Tools/FDASafetyAlerts.asp#01202006

2/14/2006

Balanced Salt Solution Recalled due to Endotoxin Contamination

The United States Food and Drug Administration (FDA) has issued a recall of all brands and sizes of Balanced Salt Solution manufactured by Cytosol Laboratories, Inc. The products were found to have elevated and dangerous levels of endotoxin bacteria. Balanced Salt Solution is a drug used by health professionals to irrigate a patient's eyes, ears, nose and/or throat during a variety of surgical procedures including cataract surgery. The FDA has received reports of a serious and potentially irreversible eye injury called Toxic Anterior Segment Syndrome (TASS) which occurs when a contaminant, such as endotoxin, enters the anterior segment of the eye during surgery and causes an inflammatory reaction. The FDA has also received complaints relating to injuries in over 300 patients who were given balanced salt solution manufactured by Cytosol Laboratories.

The balanced salt solution products subject to the recall order were manufactured by Cytosol Laboratories, Inc. for distribution under three labels:

AMO Endosol, distributed by Advanced Medical Optics, Inc (AMO), Santa Ana, Calif
Cytosol Ophthalmics, distributed by Cytosol Ophthalmics, Lenoir, NC
Akorn, distributed by Akorn, Inc, Buffalo Grove, Ill

Find more information at FDA MedWatch.

2/13/2006

Benzocaine Sprays for Mouth and Throat Linked to Methemoglobinemia

The United States Food and Drug Administration (FDA) has issued a Public Health Advisory regarding the development of methemoglobinemia associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. The problem occurs when practitioners use multiple sprays, and sprays of longer duration than recommended. Significant systemic absorption is likely to occur with overuse (up to 35 percent of benzocaine applied to mucous membranes can be systemically absorbed). This advisory applies only to benzocaine sprays used in the mouth and throat, not to other benzocaine products or to benzocaine sprays applied to exterior skin.

Methemoglobinemia is a condition where too much of the hemoglobin in red blood cells becomes unable to bind and carry oxygen. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market.

Find more information at FDA MedWatch.

2/8/2006

Aprotinin's (Trasylol) Safety Following CABG Examined

The United States Food and Drug Administration (FDA) has issued a public health advisory notify both healthcare professionals and consumers of recently published studies describing serious renal and cardiovascular toxicity following aprotinin (Trasylol) administration to patients undergoing coronary artery bypass grafting surgery (CABG). An observational study published in The New England Journal of Medicine reported that aprotinin may be associated with increased risk of myocardial infarction, stroke and renal dysfunction. Another publication (Transfusion, on-line edition, January 20, 2006) has reported that aprotinin administration may increase the risk for renal toxicity.

The FDA is working with the authors of the publications and aprotinin's manufacturer to carefully evaluate the risks and benefits associated with its use in CABG. The FDA anticipates the public presentation of the recently reported information and other data at an advisory committee in the near future. The FDA will notify health care providers and patients in a timely fashion as new information becomes available.

Find more information at FDA MedWatch.

For additional information: http://content.nejm.org/cgi/content/short/354/4/353

2/6/2006

Bacterial Meningitis Risk Continues Beyond 24 Months Following Cochlear Implant Insertion

New information regarding the risk of meningitis in children with cochlear implants has been published in the February 2006 issue of the journal "Pediatrics". This new information is based on a CDC study and updates previous information from 2002 and 2003. The new information shows that children with cochlear implants with a positioner remain at increased risk of bacterial meningitis caused by the bacteria Streptococcus pneumoniae beyond 24 months after implantation. Cochlear implants with a positioner were manufactured only by Advanced Bionics Corporation. None have been implanted since July, 2002.

See eMedicine Recalls and Alerts July 24, 2002 and August 1, 2003.

Find more information at FDA MedWatch.

2/2/2006

Class I Recall Issued for All Models of Baxter's Colleague Volumetric Infusion Pumps

A Class I recall has been issued for all models of Baxter's Colleague Volumetric Infusion Pumps. The pumps are used to control amounts of medication or other fluids to patients during intravenous (IV), intraarterial, epidural, or other infusion routes. The recall was issued for several reasons, including the following conditions:

Battery undercharging
False alarms causing shutdown
Gearbox wear
Under infusion
Undetected upstream occlusion

Any of these problems may delay or interrupt therapy, potentially resulting in harm to the patient. 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.

1/31/2006

Class I Recall Issued for Flextome Cutting Balloon Systems

A Class I recall has been issued for Boston Scientific Flextome Cutting Balloon Systems. This system is used to open blocked arteries or blood vessels. The recall was issued because the catheter shaft used to place the balloon in the artery may separate during withdrawal of the device from the patient.

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.

1/30/2006

First Years Liquid-Filled Teethers Recalled

A recall has been issued for First Years liquid-filled teethers due to possible bacterial contamination. The liquid inside the teethers may contain pseudomonas aeruginosa and pseudomonas putida which can cause serious illness in children if the teether is punctured and the liquid ingested. The teethers were sold nationwide including major retailers, grocery, pharmacies, and specialty stores from July 2005 to January 2006. The teethers are recommended for infants older than 3 months to soothe gums. Six different styles of liquid-filled teethers are affected by the recall and include:

Disney Days of Hunny Soft Cool Ring Teether (Style # Y1447)
Disney Soft Cool Ring Teether (Style# Y1470)
Disney Soft Cool Ring Teether (Style# Y1490)
First Years Cool Animal Teether (Style# Y1473; fish, zebra, and dinosaur designs)
First Years Floating Friends Teether (Style# Y1474)
Sesame Beginnings Chill and Chew Teether (Style# Y3095)

No illnesses have been reported to date in connection with this problem; however, consumers should stop using the recalled products immediately. Consumers should put the teether in its current condition into a sealed plastic storage bag, place in envelope, and return to: Parent Service Center, RC2/The First Years, 100 Technology Center Drive, Stoughton, Massachusetts, 02072. Consumers should include their mailing address in the envelope to receive a replacement teether and free gift.

Find more information at FDA MedWatch.

1/30/2006

Vapotherm Respiratory Gas Humidifier Recalled

A class 1 recall has been issued for Vapotherm 2000i and 2000h products. These devices deliver moisture to and warm breathing gases through a flexible nasal tube for patients receiving supplemental oxygen. The United States Food and Drug Administration (FDA) received reports of Vapotherm units contaminated with Ralstonia species bacteria and other bacteria. Exposure to these bacteria may cause patients to develop tracheitis, sepsis, pneumonia, or other serious infections, particularly immunocompromised patients or premature newborn infants. The FDA recommends the use of alternative devices until the source of the contamination has been identified. Patients who have been exposed to the Vapotherm system should be monitored for signs and symptoms that may suggest infection and clinicians may want to consider Ralstonia infection in the differential diagnosis of symptomatic patients even if the organism has not been isolated.

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.

1/26/2006

Warning Describes Cutaneous Vascular Toxicities with Hydroxyurea

The prescribing information for hydroxyurea capsules (Droxia, Hydrea) has been updated to include warnings that describe cutaneous vascular toxicities, such as ulcerations and gangrene. These adverse effects were also reported more frequently with concurrent interferon therapy. The prescribing information recommends hydroxyurea be discontinued if cutaneous ulcerations develop, and if indicated, alternative therapy for myeloproliferative disease initiated.

Find more information at FDA MedWatch.

1/20/2006

Telithromycin (Ketek) and Liver Toxicity

The Annals of Internal Medicine published an article reporting three patients who experienced serious liver toxicity following administration of telithromycin (Ketek). These cases were also reported to United States Food and Drug Association (FDA) MedWatch program. Besides the United States, telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan. It is difficult to determine the actual frequency of adverse events from voluntary reporting systems such as the MedWatch program, the FDA is continuing to evaluate the issue of liver problems in association with use of telithromycin in order to determine if labeling changes or other actions are warranted. As a part of this, the FDA is continuing to work to understand better the frequency of liver-related adverse events reported for approved antibiotics, including telithromycin.

Patients who have been prescribed telithromycin and are not experiencing side effects such as jaundice should continue taking their medicine as prescribed unless otherwise directed by their healthcare provider.

Find more information at FDA MedWatch.

1/19/2006

ACCU-CHEK Aviva Blood Glucose Meters Recalled

A worldwide voluntary recall has been issued for specific ACCU-CHEK Aviva Blood Glucose Meters. The meters are used to measure blood sugar levels. The recall is due to the potential for an electronic malfunction which can cause the meter to report an erroneous result or shut down and no longer be used. The recall includes U.S. serial numbers 52500000000 through 52510999999. This recall does not apply to meters with U.S. serial numbers 52511000000 and higher or ACCU-CHEK Aviva test strips.

Find more information at FDA MedWatch.

1/17/2006

CDC Advises Not to Use Amantadine or Rimantadine for 2005-2006 Influenza Season

The United States Centers for Disease Control and Prevention (CDC) recommend that two common antivirals, amantadine (Symmetrel) and rimantadine (Flumadine), should not be prescribed to treat or prevent influenza during the 2005-2006 influenza season. Laboratory testing by CDC on the predominant strain of influenza (H3N2) currently circulating in the United States shows that it is resistant to these drugs.

Although the primary strategy for preventing complications of influenza infections is annual vaccination, antiviral medications with activity against influenza viruses can be effective for the prophylaxis and treatment of influenza. Two classes of antivirals are currently available-the M2 ion channel inhibitors (ie, the two adamantanes amantadine and rimantadine) and the neuraminidase inhibitors (ie, oseltamivir and zanamivir). The neuraminidase inhibitors are effective for the treatment and prophylaxis of influenza A and B, while the adamantanes are only active against influenza A viruses.

Viral resistance to adamantanes can emerge rapidly during treatment because a single point mutation at amino acid positions 26, 27, 30, 31, or 34 of the M2 protein can confer cross-resistance to both amantadine and rimantadine. The transmissibility of adamantane-resistant viruses is not impaired by any of these amino acid changes. A recent report on the global prevalence of adamantane-resistant influenza viruses showed a significant increase (from 1.9% to 12.3%) in drug resistance over the past 3 years. In the United States, the frequency of drug resistance increased from 1.9% in 2004 to 14.5% during the first 6 months of the 2004-05 influenza season.

The CDC has tested 120 influenza A (H3N2) virus isolates and found that 109 (or 91 percent) were resistant to amantadine and rimantadine. This represents a sharp increase from last year when only 11 percent of isolates tested were resistant and 1.9 percent were resistant the year before that. However, all H3 and H1 influenza viruses tested to date are susceptible to the other commonly used antivirals (oseltamivir and zanamivir).

During this period CDC recommends oseltamivir (Tamiflu) and zanamivir (Relenza) be prescribed if an antiviral medication is needed for the treatment or prevention of influenza. Amantadine is also used to treat the symptoms of Parkinson disease, and should continue to be prescribed for this indication.

For additional information: http://www.cdc.gov/flu/han011406.htm

1/13/2006

FDA Issues Warning for Brazilian Diet Pill and Herbathin

The United States Food and Drug Administration (FDA) has issued a warning to consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury. They contain chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the active ingredient in Prozac). Emagrece Sim and Herbathin were also found to contain Fenproporex, a stimulant that is not approved for marketing in the United States. Consumers are advised not to use the Emagrece Sim and Herbathin products and to return them to the suppliers. There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin, and consumers should exercise caution in using any of these imported products.

Find more information at FDA MedWatch.

1/9/2006

False Negative Test Results Prompt Recall of Ortho's VITROS Hepatitis B Kit

A class 1 recall has been issued for the Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit. An unknown component in the diluting solution of the kit may produce 'Not Confirmed' results for samples found to be positive with the initial test. This can cause some results to be classified as false negatives. False negative results may prevent some patients infected with or carrying the hepatitis B virus from receiving necessary treatment. This is especially true for pregnant women whose tests show false negative results. The company recommends that previously reported results be reviewed.

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.

1/6/2006

New Warnings for WinRho SDF

Revisions to the prescribing information have been made for WinRho SDF. It is an IV immune globulin indicated for treatment of immune thrombocytopenic purpura (ITP) and to suppress the immune response in individuals with Rh negative blood following exposure to Rh positive red blood cells.

Post marketing safety surveillance has shown rare, but severe and sometimes fatal intravascular hemolysis and potentially serious complications, including disseminated intravascular coagulation (DIC) in patients with ITP.

Additionally, IVIG products that contain maltose, such as the liquid formulation of WinRho SDF, have shown falsely high blood glucose levels in certain testing systems. Only blood glucose testing systems that are glucose-specific should be used to test or monitor blood glucose levels in patients receiving this product.

Find more information at FDA MedWatch.

1/5/2006

Macular Edema Reported with Rosiglitazone (Avandia)

Post-marketing surveillance has documented new onset and worsening diabetic macular edema for patients receiving rosiglitazone (Avandia, by GlaxoSmithKline). In the majority of these cases, the patients also reported concurrent peripheral edema. In some cases, the macular edema resolved or improved following discontinuation of therapy and in one case, macular edema resolved after dose reduction.

Macular edema typically occurs in association with diabetic retinopathy, although it is more likely to occur as retinopathy progresses. Risk factors for macular edema include duration of diabetes, presence of retinopathy, hypertension, and poor glycemic control. Symptoms suggestive of macular edema include blurred or distorted vision, decreased color sensitivity, and decreased dark adaptation.

Find more information at FDA MedWatch.