Drug Safety Communications - Volume 1, Number 3, Spring 2008

Drug Safety Communications posted by FDA from January 1, 2008 to April 30, 2008 (advisories are available at http://www.fda.gov/cder/drug/DrugSafety/DrugIndex.htm)


DateProduct(s)Safety Issue and Web Address
April 25, 2008Heparin sodium injectionUpdate on heparin and heparin-containing medical products and new information about a contaminant, oversulfated chondroitin sulfate, in the heparin.
April 10, 2008Mycophenolate mofetil (CellCept) and Mycophenolate acid (Myfortic) 1Ongoing safety review to evaluate the potential risk of progressive multifocal leukoencephalopathy (PML).
March 27, 2008Becaplermin (Regranex) 1Ongoing safety review of possible increased risk of cancer in patients with diabetes mellitus based upon a health insurance database study.
March 27, 2008Ziagen (Abacavir) and Videx (Didanosine) 1Ongoing safety review of potential risk of myocardial infarction based upon a large observational study to evaluate the short and long-term adverse effects of treatment with anti-HIV drugs.
March 27, 2008Montelukast (Singulair) 1Ongoing safety review of reports of behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide.
March 21, 2008Darunavir etalolate (Prezista)Highlighting new labeled warnings about potential risk of hepatotoxicity.
March 18, 2008Tiotropium bromide inhalation powder (Spiriva HandiHaler)Ongoing safety review to evaluate the potential risk of stroke based upon the pooled analysis from 29 placebo controlled studies.
March 11, 2008Long-Acting Hydrocodone-containing cough product (Tussionex Pennkinetic Extended-Release Suspension)Reports of serious adverse events, including death due to respiratory depression, associated with overdose and misuse of the product in all age groups, especially in children under 6 years of age for whom the product is not recommended.
March 5, 2008Long-Acting Beta Agonists (LABAs) [salmeterol xinafoate (Serevent Diskus), fluticasone propionate; salmeterol xinafoate (Advair Diskus, Advair HFA), formoterol fumarate (Foradil Aerolizer, Perforomist) butenoside; formoterol fumarate dehydrate (Symbicort), aformotrol tartrate (Brovana)]Update highlighting an ongoing benefit/risk assessment of LABAs in children with asthma.
February 29, 2008Tiotropium bromide inhalation powder (Spiriva HandiHaler) and formoterol fumarate inhalation powder (Foradil Aerolizer)Highlighting the correct use of Spiriva and Foradil capsules after receiving reports of patients swallowing the capsules rather than placing the capsules in the inhalation devices.
February 11, 2008 (updated February 28, 2008 and April 25, 2008)Heparin sodium injectionReports of serious allergic reactions and severe hypotension following the administration of Baxter's multi-dose vials of heparin sodium injection and temporary suspension of the marketing of the product.
February 8, 2008Botulinum toxin Type A (Botox and Botox Cosmetic ) and Botulinum toxin Type B (Myobloc) 1Ongoing safety review of reports of systemic adverse reactions including respiratory compromise and death, occurring mostly in children treated for cerebral palsy-associated limb spasticity.
February 1, 2008Varenicline (Chantix)Update highlighting new labeled warnings and precautions about the potential risk of neuropsychiatric symptoms.
January 31, 2008Antiepileptic drugs [carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR), felbamate (Felbatol) , gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), oxcarbazepine (Trileptal), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote, (Depakote ER, Depakene, Depacon), zonisamide (Zonegran)]Increased risk of suicidal behavior or ideation in patients who received antiepileptic drugs compared to the placebo group in randomized clinical studies of eleven drugs.
January 25, 2008Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia) 1Ongoing data review evaluating the overall cardiovascular benefits of ezetimibe with simvastatin combination therapy. Preliminary findings suggest no benefit of combined ezetimibe and simvastatin over simvastation alone.
January 17, 2008Nonprescription cough and cold drug productsUpdate of safety review findings that over-the-counter (OTC) cough and cold medicines should not be used to treat infants and children less than 2 years of age because of serious and potentially life-threatening adverse events.
January 16, 2008Edetate disodium (Endrate and generics)Reports of death in children and adults who were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) during intravenous chelation therapy.
January 7, 2008Bisphosphonates [alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and zoledronic acid (Reclast, Zometa)]Reports of severe and incapacitating musculoskeletal pain in patients taking bisphosphonates.
January 3, 2008Erythropoiesis Stimulating Agents (ESAs) [darbepoetin alfa (Aranesp), epoetin alfa (Epogen), epoetin alfa (Procrit)] 1Increased risk of death and tumor progression in patients with cancer who received ESAs for treatment of chemotherapy-induced anemia.


  1. Early Communication about Ongoing Safety Review.


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