Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions

Audience: Psychiatry, Patients [Posted 09/01/2011]

ISSUE: FDA notified healthcare professionals and patients that serious allergic reactions have been reported with the use of Saphris (asenapine maleate). The Contraindications, Warnings and…

Reclast (zoledronic acid): Drug Safety Communication – New Contraindication and Updated Warning on Kidney Impairment

Audience: Endocrinology, Pharmacy, Patient ISSUE: FDA notified healthcare professionals and patients of an update to the drug label for Reclast (zoledronic acid) regarding the risk of kidney failure. Cases of acute renal failure requiring dialysis…

FDA Warns of Celexa Risks

Antidepressant Celexa could pose a risk of fatal heart complications, FDA officials are warning doctors. The health regulators are currently advising doctors not to prescribe high doses of the drug. The drug can interfere with the heart’s electrical activity at doses above 40 milligrams, according to an online posting by the FDA. The label for Celexa previously stated that some patients should receive 60 milligrams, but the FDA has changed that language to reflect more current advice. The updated Celexa …

H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall – Inadequate Microbial Testing

Audience: Pharmacy, Consumer, Risk Manager ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub…

Celexa (citalopram hydrobromide): Drug Safety Communication – Abnormal Heart Rhythms Associated With High Doses

Audience: Psychiatry, Cardiology ISSUE: FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in…

Massachusetts Sues J&J Over Risperdal Marketing Practices

Massachusetts’ attorney general is suing Johnson & Johnson’s Ortho-Mcneil-Janssen unit for the alleged inappropriate marketing strategies of the antipsychotic drug Risperdal. According to a statement, J&J failed to disclose an increased risk of death associated with the drug. The case is Massachusetts v. Ortho-McNeil-Janssen Pharmaceuticals Inc., 11-2811, Commonwealth of Massachusetts, Suffolk Superior Court (Boston). Risperdal is approved for the treatment of schizophrenia and bipolar mood disorder. But the company has marketed the drug for the treatment of dementia in the …

McNeil Announces New Dosing Instructions for Tylenol

Johnson & Johnson’s McNeil Consumer Healthcare Division is announcing new plans to lower the recommended dosing instructions for single-ingredient Extra-Strength Tylenol (acetaminophen) in an attempt to prevent accidental overdose and liver damage. The company also plans to reduce the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen products in 2012. Labels on the bottles will now list the maximum daily dose as six pills, or a total of 3,000 milligrams, down from eight pills a day or …

Vasopressin Injection USP, Multiple Dose Vials: Recall – Sub-Potency

Audience: Risk Manager, Pharmacy ISSUE: American Regent, Inc. is conducting a nationwide voluntary recall of multiple lots of Vasopressin Injection, USP to the Retail/Hospital level. This product recall was initiated by American Regent, Inc. because…

Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review – Possible Increased Risk of Death

Audience: Pediatrics, Endocrinology [UPDATED 08/04/2011] FDA has determined that, at this time, the evidence regarding recombinant human growth hormone and increased risk of death is inconclusive. In its analysis of the SAGhE study, FDA identified…

Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects

Audience: OBGYN, Pharmacy, Infectious Disease ISSUE: FDA is informing the public that treatment with chronic, high doses (400-800mg/day) of Diflucan (fluconazole) during the first trimester of pregnancy may be associated with a rare and distinct set…