FDA Alerts

New Epilepsy Rx Gets FDA Nod
The U.S. Food and Drug Administration yesterday approved Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in patients age 16 years and older with epilepsy.
Rare Brain Infections Tied to MS Rx
FDA is warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS).
FDA Approves New Leg Prosthesis for Amputees
The U.S. Food and Drug Administration today authorized use of the first prosthesis marketed in the U.S. for adults who have amputations above the knee and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis.
New Treatment for Chronic Back Pain Approved
Today the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain.
Case of Rare Brain Infection Reported in MS Patient Taking Tecfidera
FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died.
FDA: "Feng Shi Ling" Contains Undeclared Drug Ingredients
The Food and Drug Administration is advising consumers not to purchase or use “Feng Shi Ling,” a product promoted and sold as an herbal medication for arthritic pain associated with rheumatoid arthritis and osteoporosis.
New Labeling for Embeda ER Describes Abuse-Deterrent Properties
The U.S. Food and Drug Administration today approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Rx for Rare Genetic Disorder Now Approved for Patients of All Ages
The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age.
FDA Approves New Abuse-Deterrent Painkiller
The US Food and Drug Administration (FDA) has approved a new painkiller designed to limit abuse.
FDA Allows Marketing of Device to Help People Walk After Spinal Cord Injury
The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury.