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FDA News Alerts  

 Safety Alerts on Drugs from the U.S. Food and Drug Administration's MedWatch:

Clopidogrel bisulfate (marketed as Plavix)
FDA to conduct safety review to evaluate differences in efffectiveness, genetic factors, potential drug interactions.
Mon, 26 Jan 2009 14:00:00 EDT

Topical Anesthetics
Patients, healthcare professionals, and caregivers alerted to serious hazards of using skin numbing products for relieving pain from mammography and other medical tests and conditions, especially when applied to a large area of skin or when the area of application is covered.
Fri, 16 Jan 2009 14:00:00 EDT

Singulair (montelukast)
FDA provided updated information to its March 2008 Early Communication.
Tue, 13 Jan 2009 14:45:00 EDT

Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Update of Safety Review
The FDA has completed its review of the final clinical study report of ENHANCE and issued an update.
Thu, 08 Jan 2009 15:15:00 EDT

Innohep (tinzaparin sodium injection)
[UPDATE] Dear Healthcare Professional letter issued re: increased risk of death in elderly patients with renal insufficiency
Wed, 31 Dec 2008 20:01:00 EDT

Stryker Custom Cranial Implant Kits
Class 1 recall because sterility cannot be assured.
Wed, 24 Dec 2008 10:40:00 EDT

Hydromorphone HCl 2 mg Tablets
Nationwide recall of a single lot due to potential for oversized tablets.
Wed, 24 Dec 2008 10:40:00 EDT

Weight Loss Pills
Products contain undeclared, active pharmaceutical ingredients that may put consumers' health at risk.
Mon, 22 Dec 2008 17:40:00 EDT

Greenline-D MacIntosh No. 3 Laryngoscope Blades
Class 1 recall due to potential for piece of blade to break off during procedure.
Fri, 19 Dec 2008 15:00:00 EDT

October 2008 Safety Labeling Changes
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
Fri, 19 Dec 2008 11:56:00 EDT

Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
Reports of acute phosphate nephropathy, a type of acute kidney injury, associated with the use of oral sodium phosphate products.
Thu, 11 Dec 2008 15:40:00 EDT

Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences
Recall issued because the devices may leak cerebrospinal fluid which may cause inflammation of brain, spinal cord, or abdominal membranes, pressure on the wound created by implantation of the device, or failure of the shunt system.
Thu, 11 Dec 2008 12:09:00 EDT

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