Drug Safety Communications - Volume 1, Number 4, Summer 2008

DateProduct(s)Safety Issue and Web Address
August 25, 2008Natalizumab (Tysabri)Update highlighting two new cases of progressive multifocal leukoencephalopathy (PML) in patients who received Tysabri monotherapy.
August 21, 2008Simvastatin (Zocor and generics), Ezetimibe/Simvastatin (Vytorin) and Ezetimibe (Zetia)1Ongoing safety review to further evaluate a potential increased incidence of cancer in patients treated with Vytorin (a combination of simvastatin plus ezetimibe) in light of preliminary findings of SEAS trial.
August 18, 2008Exenatide (Byetta)Update highlighting new reports of hemorrhagic or necrotizing pancreatitis.
August 12, 2008Naltrexone for extended-release injectable suspension (Vivitrol)Reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis.
August 8, 2008Simvastatin (Zocor and generics), Ezetimibe/Simvastatin (Vytorin), Niacin extended-release/Simvastatin (Simcor), used with amiodarone (Cordarone and generics)Increased risk of rare and potentially fatal muscle injury, rhabdomyolysis, in patients treated concurrently with amiodarone and simvastatin, particularly with simvastatin doses greater than 20 mg daily.
July 30, 2008Erythropoiesis Stimulating Agents (ESAs) [epoetin alfa (Procrit, Epogen) and darbepoetin alfa (Aranesp)]Update highlighting additional safety-related changes to the labeling to clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should not be initiated.
July 29, 2008Mitoxantrone hydrochloride (Novantrone and generics)Alert informing healthcare professionals about additional recommendations for cardiac monitoring in patients with multiple sclerosis (MS) before initiating treatment and prior to administering each dose of mitoxantrone.
July 24, 2008Abacavir (Ziagen) and Abacavir-containing medications [abacavir/lamivudine (Epzicom), abacavir/lamivudine/zidovudine (Trizivar), and generics]Alert informing healthcare professionals about an increased risk of serious hypersensitivity reactions (HSRs) in patients who test positive for the human leukocyte antigen (HLA) allele, HLA-B*5701.
July 17, 2008Perflutren Micro-bubble Contrast Agents (Definity and Optison)New revisions to the Boxed Warning, Warnings, and Contraindications sections of the product labeling about the continued risk of serious cardiopulmonary reactions with specific recommendations on intensive monitoring for patients with pulmonary hypertension or unstable cardiopulmonary conditions and close observation of patients without these underlying conditions.
July 8, 2008Fluoroquinolone Antimicrobial Drugs [ciprofloxacin (Cipro and generic ciprofloxacin), ciprofloxacin extended release (Cipro XR and Proquin XR), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and ofloxacin (Floxin and generic)]Update highlighting a new labeled Boxed Warning and Medication Guide about an increased risk of developing tendinitis and tendon rupture.
June 16, 2008Antipsychotics [prochlorperazine (Compazine), haloperidol (Haldol), loxapine (Loxitane), thioridazine (Mellaril), trifluoperazine (Stelazine), molindone (Moban), thiothixene (Navane), perphenazine (Trilafon),pimozide (Orap), fluphenazine(Prolixin) chlorpromazine(Thorazine), aripiprazole (Abilify), clozapine (Clozaril, FazaClo), quetiapine (Seroquel), paliperidone (Invega), ziprasidone (Geodon) risperidone (Risperdal), olanzapine (Zyprexa), olanzapine and fluoxetine (Symbyax)]Update highlighting information on increased risk of death in elderly patients treated for dementia-related psychosis with both conventional and atypical antipsychotic drugs. Antipsychotics are not approved for the treatment of dementia-related psychosis.
June 6, 2008Becaplermin (Regranex)Update on new revisions to product labeling indicating an increased risk of mortality secondary to malignancy in patients with diabetes mellitus.
June 4, 2008Tumor Necrosis Factor (TNF) Blockers [infliximab (Remicade), etanercept (Enbrel) adalimumab (Humira), and certolizumab (Cimzia)]1Ongoing safety review to evaluate the potential risk of lymphoma and other cancers in children and young adults.
May 30, 2008Chlorofluorocarbon (CFC) propelled Albuterol Inhalers (Proair HFA Inhalation Aerosol, Proventil HFA Inhalation Aerosol, and Ventolin HFA Inhalation Aerosol)Advisory highlighting transition and phase out of chlorofluorocarbon (CFC) propelled albuterol inhalers to HFA propelled albuterol inhalers.
May 16, 2008Mycophenolate mofetil (Cellcept) and Mycophenolic Acid (Myfortic)Reports of infants born with serious congenital anomalies, including microtia and cleft lip/palate, following exposure to mycophenolate mofetil exposure during pregnancy.
May 16, 2008Varenicline (Chantix)Update highlighting revisions to product labeling and new Medication Guide to address the risk of serious neuropsychiatric adverse events.
May 14, 2008Cefepime (Maxipime)Update highlighting information on FDA's current analysis to re-evaluate the risk of death in patients treated with cefepime.


1 Early Communication about an Ongoing Safety Review

Page created: September 18, 2008; Last updated: December 3, 2008

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