Health Headlines - June 2

FDA Approves Reclast Use Once Every Two Years

Reclast has received U.S. approval as an osteoporosis treatment that can be used once every two years, drug maker Novartis AG announced Monday.

The Associated Press reported that the drug was already being used in the U.S. and Europe as a once-a-year infusion therapy to treat postmenopausal osteoporosis in women, to increase bone mass in men with osteoporosis, and to treat and prevent osteoporosis caused by steroid treatment.

The U.S. Food and Drug Administration approval for use of Reclast once every two years is based on research involving more than 500 post-menopausal women with low bone mass, Novartis said. A single infusion of the drug significantly increased bone mineral density at two years, the study found.

According to Novartis, osteoporosis affects about 10 million women and men in the United States, the AP reported.

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Low Glycogen Linked to Drinking-Related Violence: Study

People who always become aggressive or violent when they drink may have low glycogen levels, a problem that could be remedied with medication and regular meals, suggest Finnish researchers.

They analyzed the insulin and glycogen levels of 49 men with alcohol problems who committed violent acts when drinking and compared them to a control group of 40 healthy men, Agence France Presse reported.

During eight years of follow-up, 17 of the 49 men with alcohol problems committed at least one new act of violence while drinking. The study found that those men had higher insulin levels and lower glycogen levels than the other men with alcohol problems who didn't commit any additional acts of violence, or men in the control group.

The findings "might suggest that substances increasing glycogen formation and decreasing the risk of hypoglycemia might be potential treatments for impulsive violent behavior," wrote researchers at the University of Helsinki, and those at Helsinki University Hospital, AFP reported.

Regular eating habits while drinking alcohol may also prevent violence, the scientists added.

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Bausch & Lomb Settling Contact Lens Solution Lawsuits

Contact lens maker Bausch & Lomb Inc. has so far paid out about $250 million to settle nearly 600 lawsuits related to fungal infections linked to its contact lens solution ReNu MoistureLoc, and still has to resolve dozens more claims the Associated Press reported.

The solution, used for cleaning, storing and moistening soft contact lenses, is blamed by more than 700 people in the United States and Asia for exposure to a potentially blinding infection called Fusarium keratitis, the AP said.

In the United States, there were 180 confirmed cases in 35 states between June 2005 and September 2006, according to the U.S. Centers for Disease Control and Prevention.

Seven people in the United States had to have an eye removed due to infection and at least 60 more needed vision-saving corneal transplants, the AP reported.

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Researchers ID Genetic Link to Drug-Induced Liver Injury

A genetic link associated with drug-induced liver injury in some people who take the antibiotic Flucloxacillin has been identified by the International Serious Adverse Event Consortium (SAEC). Flucloxacillin is widely used in Europe and Australia but isn't sold in the United States.

Researchers found that the HLA-B*5701 gentype was associated with Flucloxacillin-related liver injury. HLA-B is one of a number of highly variable genes on chromosome 6 that control immune function. The findings, published in the July issue of the journal Nature Genetics, may help identify patients at increased risk for drug-induced liver injury (DILI).

"These findings provide the research community with novel genomic data on DILI events and make an important contribution to the science of drug safety," Dr. Janet Woodcock, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, said in a news release. "By making these data available, the research community will have better tools to evaluate predictive biomarkers for adverse events such as DILI. This type of collaborative research will eventually reduce a patient's likelihood of experiencing serious, and sometimes life-threatening, adverse drug events."