Merck issues voluntary recall of pediatric vaccine
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.
FDA grants Mylan tentative approval for generic Lamictal
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.
NoMoreClipboard.com, ReliefInsite.com partner to offer online pain management module
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.
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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.
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