Drug Recalls and Alerts - 2003
 
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Click here for all 2004 Recalls and Alerts.
 


12/8/2003

Acetaminophen Class I Recall

Dixon's APAP Acetaminophen 325 mg Analgesic Tablets (Magno-Humphries, Inc) has been recalled. The class I recall was issued for bottles of 100 tablets with lot number 319687 and expiration date March, 2005. The lot recalled affects 504 bottles distributed nationwide since August, 2003. Instead of containing the labeled 325 mg strength tablets, the bottles contain acetaminophen 500 mg tablets. Acetaminophen ingested in large doses can cause liver toxicity and liver failure.

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.
 
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12/8/2003

Class I Recall Issued for ComfortGel Nasal Masks

The FDA Center for Devices and Radiological Health has issued a Class I recall for ComfortGel Nasal Masks (Respironics, Inc). These masks are used in conjunction with CPAP devices during treatment for obstructive sleep apnea or for respiratory failure. Exhaled CO2 is exhausted from an exhalation port built into the mask. The user instructions state that the mask contains an exhalation port and does not require the use of a separate exhalation device; however, the product was distributed without the exhalation port. Without the port in the breathing circuit, it is likely that increased CO2 rebreathing and associated oxygen deficiency can occur. In some cases, suffocation may result.

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.
 
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11/23/2003

Leflunomide (Arava) Associated with Rare Liver Toxicity and Infections

Worldwide postmarketing experience with leflunomide (Arava, Aventis Pharmaceuticals) has reported rare, serious liver injury, including cases with fatal outcome. Most cases occurred within 6 months of therapy initiation and included multiple risk factors for liver toxicity.

Postmarketing reports also included rare occurrences of severe infections, including sepsis, which may be fatal. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.

Find more information at FDA MedWatch.
 
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11/23/2003

Sevoflurane and CO2 Creates Fire Risk

Fire or extreme heat may occur in the respiratory circuit of anesthesia machines when sevoflurane (Ultane, by Abbott Laboratories) is used in conjunction with a desiccated CO2 absorbent. Although ongoing investigations have not yet identified the exact etiology, Abbott has issued a "Dear Health Care Professional" letter and describes the event as rare and gives specific steps to reduce the risk. Click on the link below to view the letter.

Find more information at FDA MedWatch.
 
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11/4/2003

Additional Blood Clots and Severe Allergy Reports with CYPHER Coronary Stent

Blood clots and hypersensitivity reactions continue to be reported with use of the Sirolimus-Eluting CYPHER Coronary Stent (see previous eMedicine Alert from July 8, 2003; Thrombosis Reports with CYPHER Stent Evaluated). As of October 20, 2003, the US Food and Drug Administration (FDA) has received more than 290 reports (at least 260 reports from the United States and more than 25 outside the US) involving sub-acute thrombosis (SAT) associated with the CYPHER stent. More than 60 SAT reports described patient deaths and the remaining reports involved injury requiring medical or surgical intervention.

The FDA has also received more than 50 reports describing hypersensitivity reactions, including some deaths. The hypersensitivity symptoms reported include: pain, rash, respiratory alterations, hives, itching, fever, and blood pressure changes.

Find more information at FDA MedWatch.
 
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11/4/2003

Triple NRTI Clinical Study Associated with Virologic Failure and NRTI Resistance

Early virologic nonresponse (91%) and nucleoside reverse transcriptase inhibitor (NRTI) resistance (50-95%) has been observed at a high rate in a Gilead Sciences-sponsored clinical study. Participants in the study were treatment-naive (ie, no previous treatment for HIV) took a once-daily, 3-drug NRTI regimen. The NRTI regimen contained didanosine enteric coated beadlets (Videx EC), lamivudine (Epivir), and tenofovir (Viread).

The new information is consistent with several recent clinical studies evaluating the use of 3 NRTIs simultaneously. Suboptimal virology response has also been reported with abacavir, didanosine, and stavudine, as well as another regimen containing abacavir, didanosine, and zidovudine. Similarly, early virologic failure and high resistance rates have been reported with abacavir, lamivudine, and tenofovir (see eMedicine Recalls and Alerts 8/1/03, Nonresponse Reported in HIV Infection Treated with 3-Drug Regimen Including Lamivudine, Abacavir, and Tenofovir).

Based on these results, tenofovir is not recommended in combination with didanosine and lamivudine when considering a new treatment regimen for therapy-naive or therapy-experienced individuals with HIV infection.

Find more information at FDA MedWatch.
 
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10/28/2003

FDA Issues Warning for THG

The Food and Drug Administration (FDA) has issued a warning regarding tetrahydrogestrinone (THG) being sold as a dietary substance. The FDA considers THG a nonapproved drug, therefore it cannot legally be sold in the United States. THG is a synthetic "designer" anabolic steroid derived by simple chemical modification from gestrinone, another anabolic steroid. Gestrinone is explicitly banned by the United States Anti-Doping Agency. THG use by athletes as an alternative to other banned anabolic steroids was recently disclosed by the US Anti-Doping Agency.



Find more information at FDA MedWatch.
 
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10/27/2003

Mysis Laboratory Software Class I Recall

A Class I recall notice has been issued for Misys Healthcare Systems laboratory information system software. The software is used to manage patient specimens in the laboratories to assist in the diagnosis and treatment of a patient. Versions 5.2, 5.23, and 5.3 of the software have demonstrated a defect which may omit quality assurance information in the patient report. Use of the defective laboratory information system software could allow the release of potentially life-threatening results without quality assurance validation.

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.
 
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10/27/2003

FDA Analysis Continues of Pediatric Suicide and Antidepressants

Suicide and suicide attempts by pediatric patients receiving antidepressants have been reported in medical journals, lay press articles, and Food and Drug Administration (FDA) spontaneous reports. The reports are very difficult to interpret due to the absence of control groups, since suicide also occurs in untreated patients with depression. The FDA completed a preliminary review of suicide reports for 8 antidepressant drugs studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed.

The FDA Psychopharmacologic Drugs Advisory Committee and the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee will discuss further analysis at its meeting scheduled on February 2, 2004.

Find more information at FDA MedWatch.
 
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10/1/2003

Repaglinide (Prandin) Blood Levels Significantly Increased With Gemfibrozil (Lopid) Coadministration

A study in healthy volunteers resulted in significantly increased repaglinide (Prandin) blood levels when coadministered with gemfibrozil (Lopid). Repaglinide's blood levels were further increased when itraconazole was added; however, itraconazole alone (without gemfibrozil) exhibited less pronounced increases. Blood glucose concentration changes were also affected, resulting from enhanced and prolonged pharmacodynamic effects of repaglinide.

Repaglinide pharmacokinetic changes are attributed to CYP450 inhibition by gemfibrozil and itraconazole. Caution is warranted if medical therapy necessitates using these medications in combination. Practitioners should closely monitor blood glucose levels and adjust repaglinide doses to decrease hypoglycemic risk.

Find more information at FDA MedWatch.
 
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10/1/2003

Class I Recall of Chlamydia Assay

The FDA Center has issued a Class I recall notice for the VIDAS Chlamydia Assay (bioMerieux, Durham, NC). The assay is used in laboratories on specimens collected from either symptomatic or asymptomatic patients for the qualitative detection of Chlamydia infections. Raw material (bovine serum albumin) contained in the reagent strip accelerates degradation of the product, thereby false negative results have been reported.

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.
 
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10/1/2003

FD&C Blue No. 1 Dye Associated with Toxicity and Death

The FDA has issued an alert to healthcare professionals regarding toxicity reports, including death, associated with FD&C Blue No. 1 (Blue 1) in enteral feeding solutions. In these reports, Blue 1 was intended to help detect and/or monitor for pulmonary aspiration in patients with enteral feeding tubes. The reports describe blue discoloration of the skin, urine, feces, or serum. Some reports were associated with serious complications (eg, refractory hypotension, metabolic acidosis, death). Case reports indicate that seriously ill patients, particularly those with increased gut permeability (eg, septic patients), may be at greater risk for these complications.

Find more information at FDA MedWatch.
 
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8/26/2003

Daclizumab (Zenapax) Updated Warnings Include Increased Mortality

Two new warning statements have been added daclizumab's (Zenapax) prescribing information.

When used as part of an immunosuppressive regimen including cyclosporine, mycophenolate mofetil, and corticosteroids, daclizumab may be associated with increased mortality. In a randomized, double-blind, placebo-controlled trial for the prevention of allograft rejection in 434 heart transplant recipients receiving concomitant daclizumab, cyclosporine, mycophenolate mofetil, and corticosteroids, mortality at 6 and 12 months was increased in those patients receiving daclizumab compared to those receiving placebo (7% vs 5%, respectively at 6 months; 10% vs 6%, respectively at 12 months). Most of the increased mortality appeared related to increased severe infection incidence. Coadministration with antilymphocyte antibody therapy may also be a factor in some of the fatal infections.

A second warning was also added to the package insert. Severe, acute (onset within 24 h) hypersensitivity reactions including anaphylaxis have been observed with first exposure to daclizumab and upon re-exposure.

Find more information at FDA MedWatch.
 
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8/26/2003

Tenofovir May Decrease Atazanavir Virologic Response

Two studies have concluded that tenofovir (Viread) decreases atazanavir (Reyataz) AUC and Cmin by 25% and 40% respectively. When atazanavir was administered with ritonavir (ie, "boosted" atazanavir) and tenofovir, AUC and Cmin increased 1.2 and 4-fold higher than the respective values observed for unboosted atazanavir given alone. Based on these results, clinicians should use caution when administering unboosted atazanavir with tenofovir. Unboosted atazanavir may be less effective when administered with tenofovir and lead to loss or lack of virologic response and possible resistance.

Find more information at FDA MedWatch.
 
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8/26/2003

Class I Recall of ProbeTec ET Device

The FDA has issued a class I recall for ProbeTec ET Instrument, an in-vitro diagnostic medical device used for the detection of Chlamydia and gonorrhea. A component of the in-vitro diagnostic device was incorrectly installed causing false-positive and false-negative results.

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.
 
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8/20/2003

Administering Unboosted Reyataz with Viread may Make Reyataz Less Effective

BMS and the Food and Drug Administration (FDA) notified clinicians caring for HIV-infected patients of important new safety data concerning the coadministration of Reyataz (atazanavir sulfate) and Viread (tenofovir disoproxil fumarate). Clinicians should use caution when administering unboosted Reyataz with tenofovir DF. Unboosted Reyataz may be less effective due to decreased atazanavir concentrations in patients taking Reyataz and tenofovir DF. As a result the coadministration of unboosted Reyataz with tenofovir DF may lead to loss or lack of virologic response and possible resistance to Reyataz.

Find more information at FDA MedWatch.
 
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8/1/2003

Daclizumab (Zenapax) Updated Warnings Include Increased Mortality

Two new warning statements have been added to prescribing information for daclizumab (Zenapax).

When used as part of an immunosuppressive regimen including cyclosporine, mycophenolate mofetil, and corticosteroids, daclizumab may be associated with increased mortality. In a randomized, double-blind, placebo-controlled trial for the prevention of allograft rejection in 434 heart transplant recipients receiving concomitant daclizumab, cyclosporine, mycophenolate mofetil, and corticosteroids, mortality at 6 and 12 months was increased in those patients receiving daclizumab compared to those receiving placebo (7% vs 5%, respectively at 6 months; 10% vs 6%, respectively at 12 months). Most of the increased mortality appeared related to increased severe infection incidence. Coadministration with antilymphocyte antibody therapy may also be a factor in some of the fatal infections.

A second warning was also added to the package insert. Severe, acute (onset within 24 h) hypersensitivity reactions, including anaphylaxis, have been observed with first exposure to daclizumab and upon re-exposure.

Find more information at FDA MedWatch.
 
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8/1/2003

Nonresponse Reported in HIV Infection Treated with 3-Drug Regimen Including Lamivudine, Abacavir, and Tenofovir

Early virologic nonresponse has been observed at a high rate in a GlaxoSmithKline-sponsored clinical study. The study arm evaluating therapy-naive adults with HIV infection receiving once-daily three-drug combination therapy with lamivudine (Epivir, GSK), abacavir (Ziagen, GSK) and tenofovir (Viread, TDF, Gilead Sciences) has been halted.

The randomized, open-label, multicenter study evaluated the efficacy and safety of efavirenz (Sustiva) or tenofovir (Viread) combined with abacavir and lamivudine in antiretroviral-naive adults. Shortly following study initiation, GlaxoSmithKline received reports from investigators observing poor efficacy in the tenofovir arm, which prompted an interim analysis. The analysis showed the tenofovir arm had 49% of nonresponders vs 5% with efavirenz.

Find more information at FDA MedWatch.
 
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8/1/2003

Bacterial Meningitis Risk Increased with Cochlear Implants

The U.S. Food and Drug Administration (FDA) previously reported that at least 25 cases of meningitis have been diagnosed worldwide in children and adults (age ranging from 21 months to 63 years) who have undergone cochlear implantation for severe-to-profound deafness. Nine known deaths resulted from these cases. Surveys of cochlear implant centers are currently underway and suggest that there are additional, unreported, meningitis cases in the cochlear implant population.

Additionally, the New England Journal of Medicine published a cohort study with a nested case-control investigation, involving 4264 children in the United States who received cochlear implants. Twenty-six children with bacterial meningitis were identified. The incidence of S pneumoniae causing meningitis in children with cochlear implants was 30 times that of the control population.

Immunizations should be up-to-date to decrease meningitis risk in children with cochlear implants. Children 2-5 years old should be immunized with pneumococcal conjugate vaccine (Prevnar) and pneumococcal polysaccharide vaccine (Pneumovax-23). Children older than 5 years and adults should receive one dose of pneumococcal polysaccharide vaccine (if not received previously). (See also New England Journal of Medicine.)

Find more information at FDA MedWatch.
 
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7/28/2003

Growth Hormone Fatalities Reported

Seven fatalities have been reported with somatropin (Genotropin, by Pharmacia & Upjohn Co.) use in pediatric patients with Prader-Willi syndrome. The 7 fatalities were discovered by worldwide, postmarketing surveillance. The patients had one or more of the following risk factors: severe obesity, respiratory impairment history or sleep apnea, or unidentified respiratory infection. Male patients with these factors may be at increased risk.

Find more information at FDA MedWatch.
 
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7/9/2003

Improper Tablet Sequence Prompts Nortrel 7/7/7 Recall

Three lots of Nortrel 7/7/7-28 day oral contraceptives have been recalled following 2 reports that the colored tables in the blister pack are out of sequence. The recalled lots include the following:
  • Lot 290122001
  • Lot 290122002
  • Lot 290122003
Each properly packaged Nortrel 7/7/7-28 day contains 4 horizontal blister pack rows of 7 tablets each. Each row represents one week of tablets. The first (ie, top) row should contain yellow tablets. The second row should contain blue tablets. The third row should contain peach tablets. The fourth (ie, bottom) row should contain white tablets. The colored tablets contain the active hormonal ingredients. The white tablets are placebos that contain no active ingredient. If women discover the tablets are out of sequence, they should immediately consult their health care provider for instructions and contact their pharmacy for a replacement. Women who believe they may have previously taken the drugs from an out-of-sequence package and are concerned about pregnancy or irregular bleeding should consult their health care provider.

Find more information at FDA MedWatch.
 
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5/23/2003

Counterfeit Atorvastatin (Lipitor) Recalled



Atorvastatin (Lipitor) repackaged by MED-PRO (Albers Medical Distributors) has recalled 3 lots of 90-count bottles. The lots affected by the recall are potentially counterfeit.

The product was repackaged by Med-Pro, Inc., of Lexington, Neb., and the labels say "Repackaged by: MED-PRO, Inc. Lexington, Neb." in the lower left-hand corner. The following lots are involved in the recall:
  • 20722V - 90-tablet bottles, Expiration 09-2004
  • 04132V - 90-tablet bottles, Expiration 01-2004
  • 16942V - 90-tablet bottles, Expiration 09-2004


Patients in possession of recalled lots should discontinue the drug, and return any unused portion to their pharmacies.

Find more information at FDA MedWatch.
 
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5/23/2003

Second Dietary Supplement Found to Contain Sildenafil

On April 9, 2003, eMedicine posted a warning regarding unlabeled sildenafil (Viagra) being contained in the dietary supplement Vinarol. Another dietary supplement (Viga, by Best Life International) has been found to contain unlabeled sildenafil. Viga was sold without a prescription and promoted for increasing desire, confidence, and sexual performance.

Sildenafil is contraindicated with the use of organic nitrates in any form. The interaction may result in profound and life-threatening hypotension and increases myocardial infarction risk. Erectile dysfunction often occurs in patients with diabetes, hypertension, hyperlipidemia, ischemic heart disease, as well as in smokers. Nitrates may be prescribed to control the hyperlipidemia associated with the aforementioned conditions; thus, the risk for the serious drug interaction with Viga is probable.

Find more information at FDA MedWatch.
 
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4/25/2003

Cerebrovascular Events Associated with Risperidone

Elderly patients (mean age 85 years; range 73-97) enrolled in placebo-controlled trials (n=1230) using risperidone (Risperdal) to treat dementia-related psychosis have shown cerebrovascular adverse events (eg, stroke, transient ischemic attack), including fatalities. There was a significantly higher incidence of cerebrovascular adverse events in patients treated with risperidone compared to placebo.

Find more information at FDA MedWatch.
 
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4/16/2003

Worldwide Market Withdrawal of Gynecare Intergel Adhesion Prevention Solution

Gynecare Worldwide (a Johnson & Johnson Company) and the Food and Drug Administration (FDA) have announced a voluntary market withdrawal of Gynecare Intergel Adhesion Prevention Solution. The market withdrawal is based on postmarketing surveillance describing late-onset post-operative pain and repeat surgeries necessitated by the onset of pain, non-infectious foreign body reactions, and tissue adherence. Residual material was discovered during the repeat surgery in some patients.

The product has been distributed worldwide to the following countries: Austria, Canada, Egypt, England, France, Germany, Greece, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Portugal, Republic of Singapore, Saudi Arabia, Scotland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and the United States. Gynecare has established a customer telephone hotline at 1-800-551-7683 to assist with returning the product.

Find more information at FDA MedWatch.
 
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4/9/2003

Dietary Supplement Containing Sildenafil Recalled

Vinarol, a dietary supplement promoted to enhance sexual performance, has been found to contain the prescription drug sildenafil (Viagra). Sildenafil is indicated for treating erectile dysfunction. The Food and Drug Administration and the manufacturers of Vinarol (Ultra Health Laboratories, Inc. and Bionate International, Inc.) have issued a class I recall (ie, may pose serious health risks to some users). The product has been sold over the counter and via the Internet.

Sildenafil is contraindicated with the use of organic nitrates in any form. The interaction may result in profound and life-threatening hypotension and increases myocardial infarction risk. Erectile dysfunction often occurs in patients with diabetes, hypertension, hyperlipidemia, or ischemic heart disease, as well as in smokers. Nitrates may be prescribed to control the hyperlipidemia associated with the aforementioned conditions; thus, the risk for the serious drug interaction with Vinarol is probable.

Find more information at FDA MedWatch.
 
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3/28/2003

Updated Warnings for Lindane Use

Gamma-hexachlorocyclohexane (Lindane) is approved as second-line topical treatment for pediculosis and scabies. Lindane has been marketed since 1951, but was labeled as second-line therapy in 1995 since safer alternative treatments were available. The Food and Drug Administration (FDA) has issued additional warnings since toxicity (often secondary to misuse) continues to be reported.

Neurotoxicity and deaths have been reported with excessive use, oral ingestion, or enhanced topical absorption (especially in children). Populations that are most vulnerable to neurotoxicity are children, small adults (ie, <50 kg), and elderly adults.

New labeling includes the following:
  • Boxed-warning emphasizing second-line treatment
  • Limit quantity dispensed to 1-2 ounces to avoid excessive application or reapplication
  • Medication guide for patient use that must be dispensed by the pharmacist with each new prescription
First-line treatment for scabies includes permethrin 5% cream (Elimite, Nix), crotamiton cream (Eurax), or malathion lotion 0.5% (Ovide). Treat lice with pyrethrum 0.33% with piperonyl butoxide shampoo and permethrin cream rinse 1% (Nix, Rid).

Find more information at FDA MedWatch.
 
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3/26/2003

Smallpox Vaccination Temporarily Deferred for Patients with Heart Disease

The Centers for Disease Control and Prevention (CDC) has issued a temporary medical deferral to the smallpox vaccination program for persons who have been diagnosed with heart disease. The CDC is investigating whether smallpox vaccination contributed to heart problems in health care workers who received the vaccine.

Seven cases of heart-related problems have been reported among the 25,645 vaccinated civilian health care providers. The 7 cases observed include 3 cases of myocardial infarction (1 of which resulted in death), angina (2 cases), and myopericarditis (2 cases).

Find more information at FDA MedWatch.
 
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3/18/2003

Dietary Supplement Containing Prescription Medication Recalled

The Food and Drug Administration (FDA) has issued a class I recall for Ancom Antihypertensive Compound Tablets (Herbsland Inc., Tai Chien Inc.), a nonapproved combination product in the United States that has been sold without a prescription, but contains several prescription drug ingredients (eg, reserpine, diazepam, promethazine, and hydrochlorothiazide).

Ancom Tablets were sold without prescriptions as dietary supplements to consumers through distributors and retail stores located in the New York City metropolitan area, specifically Manhattan, Brooklyn, and Queens. This product was also sold via the Internet.

A Class I recall is a situation with reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Find more information at FDA MedWatch.
 
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3/17/2003

Depression and Other Severe Psychiatric Symptoms Linked to Interferon beta-1a (Avonex)

New warnings based on postmarketing surveillance have been added to interferon beta-1a (Avonex) labeling. Depression, suicidal ideation, and/or the development of new or worsening of existing psychiatric disorders have been reported.

The labeling was also updated to include precautions concerning anaphylaxis, pancytopenia, thrombocytopenia, autoimmune disorders, and hepatic injury. A new medication guide for patients that includes safety and administration information will also be available.

Find more information at FDA MedWatch.
 
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3/17/2003

Counterfeit Epoetin alfa (Procrit) Continues

Counterfeit epoetin alfa (Procrit) continues to be discovered (eMedicine previously reported in Recalls and Alerts on 6/11/02 and 5/20/2). The Food and Drug Administration (FDA) and Ortho Biotech Products have alerted the medical community of three counterfeit lots of Procrit 40,000 U/mL (lot P007645 with expiration October, 2004; lots P004677 and P004839 with expiration February, 2004).

The counterfeit lots have been found to contain bacterial contamination. Additionally, FDA testing has demonstrated some counterfeit Procrit contains no active ingredient.

Find more information at FDA MedWatch.
 
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3/7/2003

FDA Proposes Regulations on Dietary Supplements

The Food and Drug Administration has proposed regulations to guarantee accurate labeling and unadulterated dietary supplements. The regulation would require current good manufacturing practices (CGMPs) for dietary supplements in manufacturing, packing, and holding. Standards would be established to ensure that dietary supplements and dietary ingredients would not contain contaminants or impurities and are labeled accurately to reflect the active and inactive ingredients in the product.

Recent analyses by a private sector laboratory observed that a substantial number of dietary supplement products may not contain the amounts of dietary ingredients according to their product labels. The FDA has also encountered dietary supplements that are not accurately labeled or contain contaminants that should not be present or may be harmful. This first step by the FDA will also permit more informative research on dietary supplements in order to improve scientific knowledge on their safety and effectiveness.

Find more information at FDA MedWatch.
 
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2/24/2003

Pergolide Linked to Cardiac Valvulopathy

Postmarketing surveillance has identified cases of cardiac valvulopathy during pergolide (Permax) therapy. The pathological assessment of valves that were surgically removed is consistent with valvulopathy associated with carcinoid syndrome and use of other ergot alkaloids.

One or more valves were involved and included aortic, mitral and tricuspid valves. The estimated incidence in the United States of such cases is <0.005%.

Find more information at FDA MedWatch.
 
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2/20/2003

Bronchial Anastomotic Dehiscence Reported with Sirolimus (Rapamune)

Wyeth Laboratories has reported bronchial anastomotic dehiscence cases in de novo lung transplant patients taking sirolimus (Rapamune). The cases were reported by two centers when sirolimus was used as part of an immunosuppressive regimen that included tacrolimus and corticosteroids. Six cases have been reported; and, four of the six cases resulted in death. Sirolimus' safety and efficacy has not been established in lung transplant patients and is not recommended.

Find more information at FDA MedWatch.
 
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2/17/2003

Dispensing Errors Reported with Serzone and Seroquel

Medication dispensing errors between Serzone (nefazodone, an antidepressant) and Seroquel (quetiapine, an antipsychotic) have been reported. The similar sounding proprietary names plus overlapping strengths (100 mg and 200 mg), dosage form (both are tablets), and the same dosing interval (twice daily) are factors contributing to the errors. The reports indicate that both verbal and written prescriptions were incorrectly interpreted. Package changes and patient leaflets have been developed by the manufacturers to assist physicians, pharmacists, and patients in avoiding further mistakes.

Find more information at FDA MedWatch.
 
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1/23/2003

Salmeterol Multi-center Asthma Research Trial (SMART) Results Reinforce National Asthma Guidelines

Salmeterol (Serevent) is an inhaled, long-acting beta2-agonist used to treat asthma. Although the data are inconclusive, recent findings from an interim analysis of a large salmeterol safety study have prompted further review of the potential association between salmeterol and rare, but potentially serious, respiratory adverse events.

The Salmeterol Multi-center Asthma Research Trial (SMART), a 28-week safety study comparing Serevent and placebo in the treatment of asthma, was initiated in July 1996. The SMART study was designed, in agreement with the Food and Drug Administration (FDA), to assess the safety of salmeterol due to safety concerns (eg, intubation, ventilation, respiratory deaths) related to regular use of short-acting or long-acting beta2-agonists in asthma management. An interim analysis of all available data on 25,858 patients was conducted at the end of 2002.

In contrast to current asthma management guidelines, inhaled corticosteroid use was 47% in the entire SMART study population. Only 50% of Caucasian patients and 38% of African-American patients were using inhaled corticosteroid therapy at baseline.

In the total population of patients receiving inhaled corticosteroids at baseline, no significant differences were seen for primary events and asthma-related events, including deaths. However, in the total population of patients not receiving inhaled corticosteroids at baseline, a statistically significant greater number of asthma-related deaths occurred in all patients taking salmeterol compared to those taking placebo.

Patients receiving salmeterol for asthma should typically also receive regular and adequate doses of an effective asthma controller medication (eg, inhaled corticosteroids) and use a prompt-acting beta2-agonist for acute symptoms.

Find more information at FDA MedWatch.
 
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1/8/2003

Estrogen Labeling Warns Against Using for Heart Disease Prevention

Recent revisions to the prescribing information for estrogens and estrogens plus progestin include warnings against use for the prevention of cardiovascular disease.

The warning includes information from the Women's Health Initiative (WHI) study, a landmark study sponsored by the National Institutes of Health that raised concern about the risks of using these products. Increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis were observed in postmenopausal women using an estrogen plus progestin product. Because of these risks, the Food and Drug Administration (FDA) has revised labeling for estrogens with or without progestins. New recommendations state that they should be prescribed at the lowest effective doses and for the shortest duration consistent with the treatment goals and risks for the individual woman.

Find more information at FDA MedWatch.
 
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