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FDA MedWatch

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FDA MedWatch Safety Alerts
Updated: 23 min 14 sec ago

Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen

Thu, 07/29/2010 - 18:00
Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.

Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

Thu, 07/29/2010 - 14:00
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.

Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Thu, 07/22/2010 - 04:00
Recall due to balloon inflation assembly that may not hold air

Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient

Thu, 07/22/2010 - 04:00
Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.

CONSTELLATION Vision System: Recall

Tue, 07/20/2010 - 19:15
Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.

Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

Tue, 07/20/2010 - 13:36
Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.

Slim- 30 Herb Supplement: Undeclared Drug Ingredient

Mon, 07/19/2010 - 12:32
Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.

Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

Fri, 07/16/2010 - 18:10
Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.

Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

Thu, 07/15/2010 - 18:10
A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.

Coumadin 1 mg Tablet Blister Packs: Recall

Wed, 07/14/2010 - 12:50
Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.

Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

Tue, 07/13/2010 - 19:00
Warning highlights the risk of severe liver injury and how this risk may be reduced.

Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism

Fri, 07/09/2010 - 16:35
Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.

Que She Herbal Supplement: Undeclared Drug Ingredients

Thu, 07/08/2010 - 19:08
Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.

Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

Thu, 07/08/2010 - 17:45
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.

McNeil Consumer Healthcare Over-The-Counter Products: Recall

Thu, 07/08/2010 - 04:00
UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin.

Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall

Sat, 07/03/2010 - 00:15
The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.

LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure

Fri, 07/02/2010 - 17:15
A power supply assembly failure can result in the inability to deliver defibrillation therapy.

Mylotarg (gemtuzumab ozogamicin): Market Withdrawal

Mon, 06/21/2010 - 19:20
Drug failed to demonstrate clinical benefit to patients enrolled in trials.

Magic Power Coffee: Undeclared Drug Ingredient

Mon, 06/21/2010 - 12:30
Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.

Tamiflu: Counterfeit Product Sold on Internet

Thu, 06/17/2010 - 20:00
Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.
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