PHARMACY

Merck issues voluntary recall of pediatric vaccine

BY Drew Buono

ATLANTA Merck is recalling about 1.2 million doses of a pediatric vaccine used to protect against meningitis, pneumonia and other serious illnesses after the company discovered the equipment used to make the vaccine was contaminated with bacteria, according to published reports.

Julie Gerberding, the director of the Centers for Disease Control and Prevention, said there was no health threat to children who may have received the recalled vaccine, known as the Hib vaccine. The recall involves vaccines that were shipped starting in April 2007.

Merck is one of two providers of the Hib vaccine, which is given to children in three doses, typically at the ages of two months, four months and 12 months. The vaccine is designed to protect against illnesses caused by the bacterium Haemophilus influenzae type B, and is unrelated to seasonal influenza, health officials said.

The recall involves 11 lots of a Hib vaccine, Pedvaxhib, and two lots of a combination vaccine for both Hib and hepatitis B sold under the brand name Comvax, Merck said.

Federal health officials said the recall is precautionary and there’s currently no evidence the vaccine itself was contaminated. However, Merck said because it could not assure the sterility of the vaccine it was recalling lots shipped from April through November. Sanofi Aventis is the other Hib vaccine provider. Anne Schuchat, the director of CDC’s immunization center, said Sanofi has agreed to increase its production of the Hib vaccine.

Merck likely won’t resume production until the third quarter of 2008 and shipments until the fourth quarter, most likely resulting in a temporary shortage of the widely used vaccine.

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FDA grants Mylan tentative approval for generic Lamictal

BY Drew Buono

PITTSBURGH, Pa. Mylan Pharmaceuticals has received tentative approval from the Food and Drug Administration for a generic version of Lamictal.

Lamictal, by GlaxoSmithKline is used to treat epilepsy and bipolar I disorder. The generic version, lamotrigine, will be available in 25 mg, 100 mg, 150 mg and 200 mg tablet strengths.

The drug had sales of about $1.97 billion for the 12 months ended Sept. 30, 2007.

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NoMoreClipboard.com, ReliefInsite.com partner to offer online pain management module

BY Drew Buono

FORT WAYNE, Ind. NoMoreClipboard.com and ReliefInsite.com have teamed up to ease pain management for patients, practitioners and caregivers. The two have incorporated a free pain management module into the NoMoreClipBoard.com interface.

NoMoreClipboard.com, an online personal health record company, works with health care providers and industry groups to simplify transactions between patients, providers and payors, saving each party significant time and effort. Within NoMoreClipboard.com, patients or caregivers can store information such as allergies, medications and medical conditions in a secure environment. The patient can then choose to share their records with selected health care providers, and NoMoreClipboard.com takes care of securely transferring the record to physicians on behalf of the patient. ReliefInsite.com is a health care information technology company that provides secure online pain management services.

The ReliefInsite.com pain management module within NoMoreClipboard.com allows patients to share their daily pain diary with doctors, nurses, therapists, family members and friends. In addition, ReliefInsite.com offers dynamic, real-time graphical reports to help improve patient compliance, and assists case managers by monitoring therapy effectiveness with time-stamped records, revealing the interaction between pain levels and the patient’s personal and professional lifestyle.

“NoMoreClipboard.com allows patients to store and manage health information and share it with their health care providers, easily and seamlessly,” said Jeff Donnell, NoMoreClipboard.com vice president of marketing. “The ReliefInsite pain management module makes our personal health record even more valuable for the 50 million Americans who currently suffer from chronic pain.”

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