||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
||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
||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
||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
||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
||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
||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.