The FDA is investigating the risk of stroke, heart attack, and death in men taking this FDA-approved product. Formulations include the topical gel, transdermal patch, buccal system (applied to upper gum or inner cheek), and injection. The first publicatio

FDA is requiring manufacturers to lower the recommended dose for sleep drugs approved for bedtime use that contain this active ingredient. New data show that blood levels in some people who take this medication may be high enough the morning after use to

Peripheral neuropathy has been associated with the use of this class of antimicrobials. The potential damage may occur soon after these drugs are taken and may be permanent. FDA has required that the drug labels and medication guides for all these drugs b

This agent is one of the most widely used medicines in the U.S., but the FDA warned that it can cause rare but serious skin reactions. It is a common active ingredient to treat pain and reduce fever and is included in many over-the-counter products. These

This anticoagulant should not be used to prevent stroke or blood clots in people who have mechanical heart valves. The FDA is requiring the drug label to carry a warning against the use of the drug in patients with mechanical heart valves. A clinical tria

The FDA issued an approved change to the warning labels of this antihypertensive. The drug, marketed as brand and generic, can cause intestinal problems known as “sprue-like enteropathy.” Symptoms of this include severe chronic diarrhea with substantial w

FDA and industry have taken action to protect consumers from the risk of severe liver damage, which can result from taking too much of this medication. All manufacturers of prescription combination drug products with more than 325 mg per tablet, capsule,

The FDA has warned the public that this antimicrobial can cause abnormal changes in the electrical activity of the heart that may lead to a potentially fatal irregular heart rhythm. Patients at particular risk for developing this condition include those w

Night Bullet, marketed as a dietary supplement for male enhancement, has been recalled because FDA tests found trace amounts of compounds of a drug that is not listed on the label. Night Bullet was sold nationwide between October 2012 and March 2013 to w

In April 2014, the FDA issued a proposed rule that would extend the agency’s tobacco authority to cover these additional products that meet the legal definition of a tobacco product.

The FDA has requested clinical trial data from the manufacturer of this agent to investigate a possible association between use of this type 2 diabetes drug and heart failure. This request resulted from a study  published in the NEJM, which reported an in

The FDA alerted consumers, pharmacy and health care professionals to a nationwide recall of one lot of this medication because of the possibility that the tablets in these bottles may have actually contained tablets with 500 mg of acetaminophen.

New data suggest that the risks associated with long-term, daily use of antibacterial soaps may outweigh the benefits. There are indications that these certain ingredients in these soaps may contribute to bacterial resistance to antibiotics, and may have

The Alcohol and Tobacco Tax and Trade Bureau of the FDA approved this powdered product on April 8, 2014 – however on April 21, 2014 it was announced that this product was approved in error because of a labeling discrepancy. The company behind this product

Compounded unit dose syringes of this medication were recalled on March 18, 2013 due to reports of five cases of endophthalmitis, after an ophthalmologist administered the drug to treat macular degeneration. This agent is NOT approved to treat macular deg

This anticonvulsant can cause blue skin discoloration and eye abnormalities characterized by pigment changes in the retina. FDA does not currently know if these changes are reversible. Pigment changes in the retina have the potential to cause serious eye

The FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of these OTC products, resulting in serious adverse effects on organs, such as the kidneys and heart, and

The FDA has concluded that this antimicrobial used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin. Based on an FDA analysis of data

The FDA has identified herbal/dietary products (e.g. Bethel 30, Maxiloss Weight Advanced Softgels, Burn 7) containing this agent that was withdrawn from the US market in 2010 as a potential threat to consumers because the drug substantially increases bloo

The use of this agent with alcohol and/or CNS depressant drugs can lead to severe respiratory depression that may lead to loss of consciousness, coma and death. It is FDA-approved to reduce attacks of cataplexy and to treat daytime sleepiness in narcoleps

Significant liver injury was found to be associated with this medication in a large clinical trial. Increases in liver enzymes were found mostly during the first 18 months of therapy.This agent is a prescription medicine used to help increase low sodium l

New actions are being taken to address a safety concern with codeine use in certain children after surgery to remove tonsils or adenoids to treat sleep apnea. Deaths have occurred in children who received codeine following these surgeries. A new boxed war

The FDA has asked, and Ariad Pharmaceuticals has agreed, to suspend marketing and sales of this medication because of the risk of life-threatening blood clots and severe narrowing of blood vessels. Data from clinical trials and postmarketing reports show

The FDA continues to warn the public about this product, promoted as a dietary supplement for the treatment of arthritis, osteoporosis, bone cancer and other conditions. The product contains hidden prescription drug ingredients that can cause potentially

This injection has been recalled because of reports of severe allergic reactions—including death—that occurred within 30 minutes after a small percentage of patients received their first dose of the drug intravenously. This medication was used to treat an