FDA strengthens heart attack, stroke risk warnings for NSAID pain medications

People regularly taking a common type of painkiller called an NSAID may be at greater risk for heart attack or stroke than previously thought. The U.S. Food and Drug Administration (FDA) has strengthened existing warnings of potentially deadly heart attack and stroke risk for a class of pain medications known as non-steroidal anti-inflammatory drugs (NSAIDs). NSAID labeling already warns of … Read More

Questions raised on codeine safety in children

The top drug safety agencies in the U.S. and Europe have raised concerns about the risks associated with codeine in children’s cold-and-cough medicine. This month, the U.S. Food and Drug Administration (FDA) announced it is investigating the safety of codeine-containing cold-and-cough medicine for children younger than 18 due to the risk of potentially serious side effects. These can include slowed … Read More

FDA warns supplements, meds can be dangerous blend

Mixing medications with dietary supplements, such as vitamins and herbal products, can be dangerous, the U.S. Food and Drug Administration (FDA) has cautioned. Certain dietary supplements can boost the effects of other medications as well as change how the human body processes medications, according to the FDA, thereby changing the blood levels of that medication. “[Patients] may be getting either … Read More

FDA Plans New Regulations for More Reliable Diagnostics

On July 31st, 2014, the FDA announced that they would be taking two steps to ensure the reliability of diagnostic tests. First, the FDA has issued guidance on the development of in vitro diagnostic companion devices. These are tests designed to be used in conjunction with a medication to identify patients who may or may not benefit from the treatment. … Read More