| Date |
Product(s) |
Safety Issue and Web Address |
| April 25, 2008 |
Heparin sodium injection |
Update on heparin and heparin-containing medical products and new information about a contaminant, oversulfated chondroitin sulfate, in the heparin. |
| April 10, 2008 |
Mycophenolate mofetil (CellCept) and Mycophenolate acid (Myfortic) 1 |
Ongoing safety review to evaluate the potential risk of progressive multifocal leukoencephalopathy (PML). |
| March 27, 2008 |
Becaplermin (Regranex) 1 |
Ongoing safety review of possible increased risk of cancer in patients with diabetes mellitus based upon a health insurance database study. |
| March 27, 2008 |
Ziagen (Abacavir) and Videx (Didanosine) 1 |
Ongoing 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, 2008 |
Montelukast (Singulair) 1 |
Ongoing safety review of reports of behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide. |
| March 21, 2008 |
Darunavir etalolate (Prezista) |
Highlighting new labeled warnings about potential risk of hepatotoxicity. |
| March 18, 2008 |
Tiotropium 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, 2008 |
Long-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, 2008 |
Long-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, 2008 |
Tiotropium 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 injection |
Reports 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, 2008 |
Botulinum toxin Type A (Botox and Botox Cosmetic ) and Botulinum toxin Type B (Myobloc) 1
| Ongoing 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, 2008 |
Varenicline (Chantix) |
Update highlighting new labeled warnings and precautions about the potential risk of neuropsychiatric symptoms. |
| January 31, 2008 |
Antiepileptic 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, 2008 |
Ezetimibe/Simvastatin (Vytorin), Ezetimibe (Zetia) 1 |
Ongoing 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, 2008 |
Nonprescription cough and cold drug products |
Update 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, 2008 |
Edetate 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, 2008 |
Bisphosphonates [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, 2008 |
Erythropoiesis Stimulating Agents (ESAs) [darbepoetin alfa (Aranesp), epoetin alfa (Epogen), epoetin alfa (Procrit)] 1 |
Increased risk of death and tumor progression in patients with cancer who received ESAs for treatment of chemotherapy-induced anemia. |
Drug Safety Communications
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