FDA Alerts

Hepatitis C and HIV Drug Interactions
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.
Proton Pump Inhibitors and Stomach Acid
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 ).
FDA Approves Gleevec for Rare Gastrointestinal Cancer
The U.S. Food and Drug Administration granted Gleevec ( imatinib ) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda
Cephalon , Inc. is voluntarily recalling Treanda ® ( bendamustine HCL ) for Injection 25mg / 8mL ; lot TB30111 , expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.
FDA Approves Inlyta to Treat Patients With a Type of Advanced Kidney Cancer
The U.S. Food and Drug Administration today approved Inlyta ( axitinib ) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
FDA Versus Ranbaxy
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.
Voraxaze Approved To Treat Toxic Methotrexate Levels
The U.S. Food and Drug Administration approved Voraxaze ( glucarpidase ) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
FDA Drug Safety Communication: Adcetris (brentuximab vedotin)
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 Issues Voluntary Nationwide Recall of Certain Over-The-Counter Products
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.
Drug Safety Communication: SSRI use during pregnancy
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 ).