News

FDA MedWatch: Valproate - Risk of Impaired Cognitive Development in Children Exposed In Utero
FDA notified healthcare professionals that children born to mothers who take the anti-seizure medication valproate sodium or related products (valproic acid and divalproex sodium) during pregnancy have an increased risk of lower cognitive test scores than children exposed to other anti-seizure medications during pregnancy. This conclusion is based on... (see more at this link) (06/30/11)

FDA MedWatch - Coumadin 5 mg Tablets May Have Higher than Expected Potency
Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company testing of tablets from a returned bottle found a tablet to be higher in potency than expected. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice. More (05/04/11)

FDA MedWatch: Tysabri (natalizumab): Update of Healthcare Professional Information
FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn's disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. More (04/26/11)

FDA MedWatch - Topamax (topiramate): Recall - Musty Odor
NOTICE: Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is recalling two lots of Topamax (topiramate) 100mg Tablets. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. There have been no reported serious adverse events caused by the presence of TBA in Topamax. RECOMMENDATION: Patients taking Topamax 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program. More (04/15/11)

NINDS Alert: SAMMPRIS Trial Stops Enrollment Due to a Higher Risk of Stroke and Death in the Stented Group
The National Institute of Neurological Disorders and Stroke (NINDS) has stopped enrollment in a clinical trial that is evaluating whether intracranial angioplasty combined with stenting adds benefit to aggressive medical therapy alone for preventing stroke in patients with symptomatic intracranial arterial stenosis. The Stenting and Aggressive Medical Management for Preventing Recurrent stroke in Intracranial Stenosis (SAMMPRIS) study is the first prospective randomized multicenter trial to compare aggressive medical management alone versus aggressive medical management plus angioplasty combined with stenting in patients with symptomatic high grade (70-99%) stenosis of a major intracranial artery (intracranial carotid, middle cerebral artery, intracranial vertebral artery, and basilar artery). Full NINDS Alert (PDF) (04/13/11)

CDC Clinical Reminder: Spinal Injection Procedures Performed without a Facemask Pose Risk for Bacterial Meningitis
The Centers for Disease Control and Prevention (CDC) is concerned about the occurrence of bacterial meningitis among patients undergoing spinal injection procedures that require injection of material or insertion of a catheter into epidural or subdural spaces (e.g., myelogram, administration of spinal or epidural anesthesia, or intrathecal chemotherapy). Outbreaks of bacterial meningitis following these spinal injection procedures continue to be identified among patients whose procedures were performed by a healthcare provider who did not wear a facemask (e.g., may be labeled as surgical, medical procedure, or isolation mask),[1] with the most recent occurrence in October 2010 (CDC unpublished data). This notice serves as a reminder that facemasks should always be worn by healthcare providers when performing these spinal injection procedures. More (04/06/11)

FDA MedWatch - Dabigatran Capsules: Special Requirements
Due to the potential for product breakdown from moisture and loss of potency, dabigatran capsules should only be dispensed and stored in the original bottle or blister package. Pharmacists should only dispense Pradaxa in the original manufacturer bottle with the original dessicant cap. Do not repackage Pradaxa capsules in standard amber pharmacy vials. Patients should not store or place Pradaxa capsules in any other container, such as pill boxes or pill organizers. Open only one bottle of Pradaxa at a time. Once the bottle is opened, the product must be used within 60 days. More (03/31/11)

FDA Approves Gadavist (gadobutrol) on March 14, 2011
Gadavist is the sixth gadolinium-based contrast agent (GBCA) approved by the FDA for use in patients undergoing magnetic resonance imaging of the central nervous system. It is indicated for adults and children ages 2 years and older. Gadavist is more concentrated than the other GBCAs and should be administered at half the volume. Gadavist is currently considered to be one the GBCAs with a lower risk of nephrogenic systemic fibrosis NSF, and is not one of the GBCAs that is contraindicated in patients with acute kidney injury or chronic, severe kidney disease. Those receiving Gadavist during the studies reported headache and nausea as the most common adverse reactions. Other adverse events associated with Gadavist included hypersensitivity reactions, involving cardiovascular, respiratory, or skin effects ranging from mild to severe. More (03/17/11)