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Reports of Suicidal Ideation, Aggressive Behavior, and Drowsiness with Chantix
The FDA is reviewing recent reports of suicidal ideation and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product approved in May 2006. In addition, there are...
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Updated Labeling for Desmopressin Adds Warnings and Removes Indication
The FDA has requested the prescribing information for all desmopressin products (DDAVP, Minirin, Stimate, generics) be updated to include important information about the risk of severe hyponatremia and...
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Additional Black Box Warning for Carbamazepine
The FDA has informed healthcare professionals that the risk of dangerous or even fatal skin reactions (e.g., Stevens Johnson syndrome and toxic epidermal necrolysis) are higher in patients with the...
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DEA Restricts Distribution of 40 mg Methadone Tablet
Due to a reported increase in methadone-related adverse events, manufacturers have agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and...
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Bisphosphonates and Severe Musculoskeletal Pain
The FDA has emphasized the possibility of severe and sometimes incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the...
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New Drug Monograph for Granisetron
The FDA has approved first-time generic formulations for granisetron. Granisetron is equivalent to Kytril, which is indicated for post-operative nausea and vomiting as well as nausea and vomiting...
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Amantadine and Rimantadine on Hold for Influenza A Therapy and Prophylaxis
On the recommendation of the ACIP (Advisory Committee on Immunization Practices), for 2007-08 neither amantadine nor rimantadine should be used for the treatment or prevention of influenza type A in...
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Suicidality and Antiepileptic Drugs
The FDA has analyzed reports of suicidality from placebo-controlled clinical studies of drugs used to treat epilepsy as well as other conditions. Patients receiving AEDs had approximately twice the...
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New Drug Monograph for Alendronate
The FDA has approved first-time generic formulations for alendronate. Alendronate is equivalent to Fosamax, which is indicated for the prevention and treatment of osteoporosis and the treatment of...
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New Drug Monograph for Balsalazide
The FDA has approved first-time generic formulations for balsalazide. Balsalazide is equivalent to Colazal, which is indicated for mild-moderate active ulcerative colitis in both adults and children....
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New Drug Monograph for Pantoprazole
The FDA has approved first-time generic tablet formulations for pantoprazole. Pantoprazole is equivalent to Protonix, and is indicated for erosive esophagitis and hypersecretory conditions. Learn more...
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Hepatotoxicity Warning for Tysabri
The FDA has reported liver injury during use of Tysabri. Signs included markedly elevated hepatic enzymes and total bilirubin, which occurred as early as six days after the first dose. These elevated...
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Neuropsychiatric Events with Tamiflu
The occurrence of neuropsychiatric events associated with the use of Tamiflu, in patients with influenza, has been noted by the FDA. These symptoms, as described in post marketing data, include...
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Additional Pediatric Indication for Abilify
The FDA has approved Abilify for the acute treatment of manic and mixed episodes associated with bipolar I disorder, with or without psychotic features in patients 10-17 years of age. Learn more at...
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New Dosage Forms for OxyContin
OxyContin is now available in an expanded array of tablet strengths. The new extended-release tablets are 15 mg, 30 mg, and 60 mg. The 60 mg tablets are only to be used in opioid-tolerant patients....
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New Drug Monograph for Treanda
The FDA has approved Treanda (bendamustine) for the treatment of chronic lymphocytic leukemia (CLL) in adult patients. Learn more at www.epocrates.com
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New Drug Monograph for Renvela
The FDA has approved Renvela (sevelamer) for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Learn more at www.epocrates.com
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Additional Indication for Aloxi
The FDA has approved Aloxi (palonosetron) for the prevention of postoperative nausea and vomiting for up to 24 hours following surgery. Learn more at www.epocrates.com
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Pediatric Indication for Reyataz
The FDA has approved Reyataz (atazanavir) for the treatment of HIV infection in patients 6-17 years of age. Learn more at www.epocrates.com
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New Drug Monograph for Fenoglide
The FDA has approved Fenoglide (fenofibrate) for the treatment of hyperlipidemia, mixed dyslipidemia, or hypertriglyceridemia. Learn more at www.epocrates.com
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