Health Highlights: Feb. 21, 2007

Wednesday, February 21, 2007; 12:00 AM

Here are some of the latest health and medical news developments,compiled by editors ofHealthDay:

Diabetes Drug Linked to Fractures in Females

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The U.S. Food and Drug Administration issued a safety alert Wednesday on drug maker GlaxoSmithKline warning doctors that long-term use of its diabetes drug Avandia (rosiglitazone) has been linked to an increased incidence of fractures in females.

The company outlined the results of a safety review of a large-scale study involving 4,360 patients with recently diagnosed type 2 diabetes mellitus. The review found that female Avandia users experienced more fractures of the upper arm, hand, or foot than did female patients who received the two other medications in the study, metformin and glyburide. The incidence of fractures in male users was similar in all three drugs.

The company is advising doctors to consider the risk of fractures when prescribing Avandia to female patients.

And, according toMarketWatch, a spokesman for Glaxo said the company was in talks with European Union regulators about sending a similar letter to European doctors.

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Vaccine Safety Group Reports Adverse Gardasil Reactions

An analysis of reports of serious medical problems following vaccination against cervical cancer with Merck & Co.'s Gardasil found that two-thirds of patients required additional medical care, a vaccine safety group said Tuesday.

The National Vaccine Information Center (NVIC) looked at a report from the federal Vaccine Adverse Event Reporting System (VAERS) on problems following vaccination against the human papillomavirus (HPV) during the last six months of 2006.

Of 385 adverse events reported, two-thirds required further attention and one-third occurred in children 16 and under. In almost 25 percent of those cases, patients also received one or more of 18 vaccines that Merck did not study, in combination with Gardasil, NVIC said in a prepared statement.

As a result, NVIC called on the U.S. Food and Drug Administration, as well as the U.S. Centers for Disease Control and Prevention to warn parents and physicians that Gardasil should not be combined with other vaccines. They also urged that young girls be monitored for at least 24 hours after vaccination and that any reports of adverse events be made as soon as possible to VAERS.


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