FDA Alerts
FDA Approves New Seizure Drug
The US Food and Drug Administration approved Fycompa (perampanel) tablets to treat partial onset seizures in patients with epilepsy who are ages 12 years and older.
FDA Drug Safety Communication: Mirapex and Heart Failure
The US Food and Drug Administration (FDA) is informing the public about a possible increased risk of heart failure with Mirapex (pramipexole), a drug used to treat Parkinson’s disease and restless legs syndrome.
FDA Issues Alert on Reumofan Plus
The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.
Hospira Alert: Carpuject May Contain More Than the Intended Fill Volume
FDA is alerting healthcare providers of a potential safety risk in some Carpuject pre-filled cartridges manufactured by Hospira , Inc.
Cardiovascular Monitoring With Gilenya
The U.S. Food and Drug Administration (FDA) has completed its evaluation of a report of a patient who died after the first dose of multiple sclerosis drug Gilenya ( fingolimod ).
Potential Dangers of Multiple Sclerosis Treatment
The U.S. Food and Drug Administration is alerting health care professionals and patients about injuries and death associated with the use of an experimental procedure sometimes called “liberation therapy” or the “liberation procedure” to treat chronic cerebrospinal venous insufficiency ( CCSVI ).
FDA Warning About Fentanyl Patches
FDA reminds patients, caregivers, and healthcare professionals of the importance of appropriate storage, use, application, and disposal of fentanyl patches (including Duragesic and generic products) to prevent potential life-threatening harm from accidental exposure to the active ingredient, fentanyl .
New Drug for Alzheimer's Disease
The U.S. Food and Drug Administration approved Amyvid ( Florbetapir F 18 Injection) a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline.
FDA Approves Generic Boniva
The U.S. Food and Drug Administration approved the first generic versions of Boniva ( ibandronate ) tablets, a once-monthly product to treat or prevent osteoporosis in women after menopause.
FDA Approves Exparel For Postsurgical Pain Management
Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved EXPAREL (TM) ( bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia.