| Date |
Product(s) |
Safety Issue and Web Address |
| December 21, 2007 |
Fentanyl transdermal system (Duragesic and generics) |
Update highlighting information on appropriate prescribing and use in light of continued reports of death and life-threatening adverse events related to fentanyl overdose. |
| December 12, 2007 |
Carbamazepine (Carbatrol, Equetro, Tegretol, and generics) |
Increased risk of serious skin reactions (Stevens-Johnson syndrome and toxic epidermal necrolysis) in patients with a particular human leukocyte antigen allele, HLA-B*1502. |
| December 10, 2007 |
Omeprazole (Prilosec) and Esomeprazole (Nexium) |
Update of safety review finding that long-term use is not likely associated with an increased risk of heart problems. |
| December 4, 2007 |
Desmopressin acetate (DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) |
Reports of severe hyponatremia and seizures in children and removal of primary nocturnal enuresis indication for intranasal formulations. |
| November 20. 2007 |
Varenicline (Chantix)1 |
Ongoing safety review of reports of suicidal thoughts and aggressive and erratic behavior. |
| November 19, 2007 |
Rosiglitazone maleate (Avandia, Avandamet, and Avandaryl) |
Update highlighting new labeled warning about the potential increased risk of myocardial ischemia. |
| November 14, 2007 |
Phosphodiesterase type 5 (PDE5) inhibitors [sildenafil (Viagra and Revatio) vardenafil (Levitra),and tadalafil (Cialis)] |
Potential risk of sudden hearing loss. |
| November 14, 2007 |
Cefepime (Maxipime)1 |
Ongoing safety review to further evaluate the risk of death in patients treated with cefepime. |
| November 8, 2007 |
Erythropoiesis Stimulating Agents (ESAs) [darbepoetin alfa (Aranesp), (epoetin alfa (Epogen, (Procrit)] |
Update: New revisions to the product labeling to clarify the evidence for safety and effectiveness in cancer and chronic kidney failure patients. |
| October 25, 2007 |
Aprotinin (Trasylol)1,2 |
Ongoing safety review re-evaluating the overall risks and benefits in light of preliminary findings of a randomized trial in a cardiac surgery population (BART study). |
| October 16, 2007 |
Exenatide (Byetta) |
Reports of acute pancreatitis. |
| October 12, 2007 |
Perflutren Micro-bubble Contrast Agents (Definity and Optison) |
Reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography. |
| October 1, 2007 |
Bisphosphonates [alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel with Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa)]1 |
Ongoing safety review to further evaluate the risk of atrial fibrillation in patients who take bisphosphonates. |
| September 26, 2007 |
Fentanyl buccal tablets (Fentora) |
Reports of serious adverse events, including death, with prescribing to non-opioid-tolerant patients, misunderstanding of dosing instructions, or inappropriate substitution for other fentanyl- containing products. |
| September 17, 2007 |
Haloperidol (Haldol, Haldol Decanoate, and Haldol Lactate) |
Increased risk of Torsades de Pointes and QT prolongation. |
| September 11, 2007 |
Ceftriaxone sodium (Rocephin) |
Reports of fatal interactions in neonates treated with ceftriaxone and intravenous calcium-containing products. |
| August 17, 2007 |
Codeine |
Report of very rare, but serious side effect (morphine overdose) in nursing infants whose mothers are taking codeine and are ultra-rapid metabolizers of codeine. |
| August 15, 2007 |
Nonprescription cough and cold drug products |
Reports of serious and life-threatening adverse events associated with overdose and misuse of these products in children, especially in children under 2 years of age. |
| August 14, 2007 |
Rosiglitazone maleate (Avandia, Avandamet, and Avandaryl); Pioglitazone hydrochloride (Actos, Actoplus Met, and Duetact) |
Increased risk of developing congestive heart failure or worsening of heart failure.
• Rosiglitazone maleate
• Pioglitazone HCl |
August 9, 2007
(updated December 10, 2007) |
Omeprazole (Prilosec) and Esomeprazole (Nexium)1 |
Ongoing safety review of potential risk of heart attacks, heart failure, and heart-related sudden deaths based upon two small long-term clinical studies in patients with severe gastroesophageal reflux disease. |
| July 2, 2007 |
Omalizumab (Xolair) |
Update highlighting revisions to product labeling and a new medication guide to address the risk of anaphylaxis. |
| June 29, 2007 |
Colistimethate (Coly-Mycin M and generics) |
Report of death of a patient with cystic fibrosis after use of a liquid solution of colistimethate that was premixed for inhalation with a nebulizer. |
| June 15, 2007 |
Propofol (Diprivan and generics) |
Reports of chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia. |
Drug Safety Communications
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