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FDA: Medical Watch
FDA MedWatch Safety Alerts
Updated: 35 min 52 sec ago
Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
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.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
Recall due to balloon inflation assembly that may not hold air
Categories: NEWS: U.S. Food and Drug Administration (FDA)
CONSTELLATION Vision System: Recall
Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient
Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Slim- 30 Herb Supplement: Undeclared Drug Ingredient
Product found to contain undeclared N-Desmethyl Sibutramine and traces of Sibutramine.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning
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.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk
A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Coumadin 1 mg Tablet Blister Packs: Recall
Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
Warning highlights the risk of severe liver injury and how this risk may be reduced.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Que She Herbal Supplement: Undeclared Drug Ingredients
Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
McNeil Consumer Healthcare Over-The-Counter Products: Recall
UPDATED 07/08/2010. Recall expanded to include lots of 21 products of Benadryl, Tylenol, Childrens Tylenol, Tylenol PM and Motrin.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall
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.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure
A power supply assembly failure can result in the inability to deliver defibrillation therapy.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
Drug failed to demonstrate clinical benefit to patients enrolled in trials.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Magic Power Coffee: Undeclared Drug Ingredient
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.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
Tamiflu: Counterfeit Product Sold on Internet
Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.
Categories: NEWS: U.S. Food and Drug Administration (FDA)
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