FDA Alerts
Voluntary Recall Issued for Certain Sterile Medications
The US Food and Drug Administration (FDA) is warning of potentially contaminated sterile medications.
Rare Risk of Long-Lasting Erections from ADHD Medications
FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as priapism.
FDA Wants Antibacterial Soap Makers to Show Their Products Work
Antibacterial soaps are thought to help stop the spread of germs, but research has not shown that these soaps work any better at preventing illness than plain soap. The FDA wants to change that.
Cymbalta Goes Generic
The U.S. Food and Drug Administration today approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions.
FDA Approves Sovaldi for Chronic Hepatitis C
The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection.
FDA Talks Safety of HeartStart Defibrillator
Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the U.S. Food and Drug Administration said today in a new safety communication for users of these previously recalled devices.
FDA Warns of Serious Skin Reactions with Anti-Seizure Rx
The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death.
FDA Removes Restrictions on Avandia
The U.S. Food and Drug Administration today announced it is requiring the removal of certain restrictions on prescribing and use of the diabetes drug Avandia (rosiglitazone) to reflect new information regarding the cardiovascular risk of the medicine.
FDA Approves First Adjuvanted Vaccine for Prevention of Bird Flu
The U.S. Food and Drug Administration today approved the first adjuvanted vaccine for the prevention of H5N1 influenza, commonly known as avian or bird flu.
FDA Approves New Treatment for Hepatitis C Virus
The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.