The U.S. Food and Drug Administration (FDA) is notifying healthcare professionals and patients that drug interactions between the hepatitis C virus ( HCV ) protease inhibitor Victrelis ( boceprevir ) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors ( atazanavir , lopinavir , darunavir ) can potentially reduce the effectiveness of these medicines when they are used together.

The U.S. Food and Drug Administration (FDA) is informing the public that the use of stomach acid drugs known as proton pump inhibitors ( PPIs ) may be associated with an increased risk of Clostridium difficile–associated diarrhea ( CDAD ).

The Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a consent decree of permanent injunction against generic drug manufacturer Ranbaxy in the U.S. District Court of Maryland.

The U.S. Food and Drug Administration (FDA) is notifying the public that two additional cases of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection that can result in death, have been reported with the lymphoma drug Adcetris ( brentuximab vedotin ).

Novartis Consumer Health, Inc. ( NCH ) announced that it is voluntarily recalling all lots of select bottle packaging configurations of Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier, in the United States. NCH is taking this action as a precautionary measure because the products may contain stray tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets.

The U.S. Food and Drug Administration (FDA) is updating the public on the use of selective serotonin reuptake inhibitor ( SSRI ) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn ( PPHN ).

The U.S. Food and Drug Administration and the Federal Trade Commission (FTC) today issued seven Warning Letters to companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss.

Q: Why are drugs evaluated by the FDA? A: Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research ( CDER ) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research. Q: Does FDA test drugs? A: No. It is the responsibility of the company seeking approval to market a drug to conduct laboratory and animal tests on the safety and effectiveness of a proposed new drug and then to submit that information to FDA for review by CDER physicians,...

The U.S. Food and Drug Administration (FDA) is informing healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [ drotrecogin alfa (activated)].

The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris ( asenapine maleate ).