FDA Alerts
FDA Approves Topamax for Migraine Prevention in Adolescents
Today, the U.S. Food and Drug Administration approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches.
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 Requiring Color Changes to Duragesic Pain Patches to Aid Safety
The US Food and Drug Administration (FDA) is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily.
FDA Investigating Rare Brain Infection in Patient Taking Gilenya (fingolimod)
The US Food and Drug Administration (FDA) is alerting the public that a patient in Europe diagnosed with possible multiple sclerosis (MS) has developed a rare and serious brain infection after taking the drug Gilenya (fingolimod).
FDA Requires Label Changes for Fluoroquinolone Drugs Taken by Mouth or by Injection
The US Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.
Valproate Anti-seizure Products Contraindicated for Migraine Prevention in Pregnant Women
The US Food and Drug Administration (FDA) is advising healthcare professionals and women that the anti-seizure medication valproate sodium and related products, valproic acid and divalproex sodium, are contraindicated and should not be taken by pregnant women for the prevention of migraine headaches.
FDA Approves new Multiple Sclerosis Treatment
The US Food and Drug Administration today approved Tecfidera (dimethyl fumarate) capsules to treat adults with relapsing forms of multiple sclerosis (MS).
FDA Approves Dotarem, a New Magnetic Resonance Imaging Agent
The US Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues in patients ages 2 years and older.
FDA Offers New Guidance on Developing Drugs for Alzheimer’s Disease
Today, the US Food and Drug Administration issued a proposal designed to assist companies developing new treatments for patients in the early stages of Alzheimer’s disease, before the onset of noticeable (overt) dementia.
FDA Approves New Multiple Sclerosis Drug
The US Food and Drug Administration approved Aubagio (teriflunomide), a once-a-day tablet for the treatment of adults with relapsing forms of multiple sclerosis (MS).