FDA Alerts
FDA approves Onfi to treat severe type of seizures
On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets ( clobazam ) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.
FDA Approves Prolia for osteoporosis
On September 16, 2011, the U.S. Food and Drug Administration granted approval for denosumab ( Prolia , Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture.
FDA Drug Safety Communication: Reclast
The U.S. Food and Drug Administration (FDA) has approved an update to the drug label for Reclast ( zoledronic acid) to better inform healthcare professionals and patients of the risk of kidney (renal) failure.
FDA approves Botox to treat specific form of urinary incontinence
The U.S. Food and Drug Administration today approved Botox ( onabotulinumtoxinA ) injection to treat urinary incontinence in people with neurologic conditions such as spinal cord injury and multiple sclerosis who have overactivity of the bladder.
FDA Drug Safety Communication: Tysabri
The U.S. Food and Drug Administration (FDA) continues to evaluate the risk of progressive multifocal leukoencephalopathy ( PML ), a rare but serious brain infection, associated with use of Tysabri ( natalizumab ) for the treatment of multiple sclerosis (MS) and Crohn's disease.
FDA Drug Safety Communication: Bisphosphonates and Esophageal Cancer
The U.S. Food and Drug Administration (FDA) is continuing to review data from published studies to evaluate whether use of oral bisphosphonate drugs is associated with an increased risk of cancer of the esophagus (esophageal cancer).
Tylenol Extra Strength Caplets, 225 Count Bottles Recalled
McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S.
Medication Errors Resulting From Name Confusion
The U.S. Food and Drug Administration (FDA) is alerting the public to medication error reports in which patients were given risperidone ( Risperdal ) instead of ropinirole ( Requip ) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
A New Drug for Your Restless Legs
On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets ( gabapentin enacarbil ), a once-daily treatment for moderate-to-severe restless legs syndrome ( RLS ).
New FDA Approved Device for Safer Brain Bypass Surgery
The FDA has approved a device that helps surgeons perform brain surgery safely on high-risk patients who are in danger of having a stroke.The FDA-approved surgical kit enables neurosurgeons to reroute the blood flow around an aneurysm of patients at greater risk of stroke during standard bypass surgery.