Drugs and Diseases » Warnings

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

admin — Fri, 02 Sep 2011 23:59:45 +0000

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…

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

admin — Fri, 02 Sep 2011 23:59:43 +0000

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…

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

admin — Sat, 27 Aug 2011 14:59:49 +0000

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…

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

admin — Thu, 25 Aug 2011 01:35:49 +0000

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…

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

admin — Fri, 05 Aug 2011 19:59:52 +0000

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…

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

admin — Fri, 05 Aug 2011 19:59:51 +0000

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…

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

admin — Thu, 04 Aug 2011 13:00:34 +0000

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…

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Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification – Undeclared Drug Ingredient

admin — Wed, 27 Jul 2011 22:00:05 +0000

Audience: Consumer [Update 07/27/2011] – Intercharm Inc., is recalling Slimforte Slimming Capsules, Slimforte Slimming Coffee, and Botanical Slimming Soft Gel to the consumer/user level. These products are sold as dietary supplements and marketed…

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CardioGen-82 PET Scan: Drug Safety Communication – Increased Radiation Exposure

admin — Wed, 27 Jul 2011 22:00:04 +0000

Audience: Nuclear Medicine, Radiology, Patients [UPDATED 07/26/2011] FDA notified healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics, Inc. has decided to…

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Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification – Undeclared Drug Ingredient

admin — Wed, 27 Jul 2011 22:00:04 +0000

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Zyvox (linezolid): Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

admin — Wed, 27 Jul 2011 22:00:03 +0000

Audience: Infectious Disease, Psychiatry, Family Practice ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the antibacterial drug linezolid (Zyvox) is given to patients taking psychiatric medications that work…

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CardioGen-82 PET Scan: Drug Safety Communication – Increased Radiation Exposure

admin — Wed, 27 Jul 2011 22:00:03 +0000

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Methylene Blue: Drug Safety Communication – Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications

admin — Wed, 27 Jul 2011 21:59:59 +0000

Audience: Emergency Medicine, Critical Care Medicine, Psychiatry ISSUE: FDA has received reports of serious central nervous system (CNS) reactions when the drug methylene blue is given to patients taking psychiatric medications that work through the…

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Chantix (varenicline): Label Change – Risk of Certain Cardiovascular Adverse Events

admin — Mon, 25 Jul 2011 09:00:00 +0000

Audience: Family Medicine, Cardiology [UPDATED 07/22/2011] FDA has approved an updated drug label for Chantix (varenicline) to include information about the efficacy and safety of the drug in two patient populations who may benefit greatly from…

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Multaq (dronedarone): Drug Safety Communication – Increased Risk of Death or Serious Cardiovascular Events

admin — Sun, 24 Jul 2011 02:00:00 +0000

Audience: Healthcare Professionals ISSUE: FDA notified healthcare professionals that it is reviewing data from a clinical trial that evaluated the effects of the antiarrhythmic drug Multaq (dronedarone) in patients with permanent atrial…

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