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Weekly Drug News Round Up - October 24, 2012

FDA Releases NECC Customer Lists

At least 23 patient deaths, 308 fungal infections linked to contaminated corticosteroid injections prepared at the NECC Read More...

This week the U.S. Food and Drug Administration (FDA) released lists of customers who received any type of product (not just corticosteroids) from the New England Compounding Center (NECC) shipped on or after May 21, 2012. The lists include customer names and addresses, organized by state, as well as specific products shipped, although these lists, provided by NECC may not be complete or accurate. The FDA advises healthcare providers to follow up with any patient who was given any injectable product from the NECC on or after May 21, 2012 and that product was shipped from the NECC on or after May 21, 2012. These drugs also include medications used in eye surgery, and a heart (cardioplegic) solution. A new report also identifies sterility issues at NECC dating back to 2006.

Energy Drinks May Contain Dangerous Amounts of Caffeine

FDA encourages consumers to report serious adverse events due to energy drinks to the product manufacturer Read More...

You know them, and you may like them. Energy drinks known by brand names such as Monster, Red Bull, and Rockstar are exceedingly popular, especially among youth. But some energy drinks may contain up to 240 mg of caffeine, which can raise the heart rate, blood pressure, and may be fatal in consumers with heart disease. Concern has been raised over recent reports of deaths attributed to mega caffeine in energy drinks. Under current U.S Food and Drug Administration (FDA) rules, companies don't have to reveal beverage caffeine levels, but are required to submit all reports on serious adverse events to FDA within 15 days of receiving them.

Task Force Confirms Risks of HRT for Disease Prevention Outweigh Benefits

HRT may increase the risk for stroke and other conditions when used for prevention of chronic diseases Read More...

The U.S. Preventive Services Task Force has reviewed the 2005 recommendations on the use of hormone replacement therapy (HRT) for prevention of chronic diseases. The 2012 update appears in the Annals of Internal Medicine, and confirms previous findings that estrogen-progestin or estrogen therapy alone may increase the risk for stroke and other conditions when used for prevention of heart disease, dementia, osteoporosis, and other chronic ailments. The benefit in osteoporosis is outweighed by a risk for stroke, gallbladder disease and urinary incontinence, and strong evidence links HRT with a risk for breast cancer and blood clots. Estrogen and progestin combined increase the risk for dementia, and HRT does not protect against, but may worsen heart disease.

Fycompa FDA-Approved for Partial Seizures

Fycompa will be dispensed with a Patient Medication Guide that provides instructions on use and drug safety Read More...

In epilepsy, the activity of nerve cells in the brain is excessive. Partial seizures, the most common type of seizure, affect a localized area of the brain, but seizure activity may spread. The U.S. Food and Drug Administration (FDA) has approved Fycompa (perampanel) tablets to treat partial onset seizures in patients 12 years and older. The Fycompa label has a boxed warning to alert prescribers and patients about the risk of serious neuropsychiatric events, including irritability, aggression, anger, anxiety, paranoia, euphoric mood, agitation, and mental status changes.

Jetrea Okayed for Ocular Vitreomacular Adhesion

Jetrea is first drug approved to treat the eye condition symptomatic vitreomacular adhesion (VMA) Read More...

The U.S. Food and Drug Administration (FDA) has approved Jetrea (ocriplasmin) intravitreal injection for the treatment of symptomatic vitreomacular adhesion (VMA). VMA is an eye condition where the vitreous jelly that fills the center of the eye separates from the macula portion of retina, resulting in tugging that can lead to vision loss or blindness. Previously, surgery known as a vitrectomy was the only available treatment for VMA. Jetrea is a proteolytic enzyme that allows separation of the vitreous and macula and lessens tugging for easier separation. Some common side effects with Jetrea include eye floaters, conjunctival bleeding, light flashes, and blurred vision.