Health Highlights: June 16, 2009

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

FDA Experts Recommend Gout Drug's Approval

An expert panel advising the U.S. Food and Drug Administration voted 14-1 on Tuesday to recommend that the full agency approve the Savient Pharmaceuticals drug Krystexxa (pegloticase), Dow Jones reported.

Last week, the FDA released documents saying that although the drug appeared to relieve the painful, swollen joints that characterize gout, it was concerned about the higher rate of cardiovascular side effects that surfaced during clinical testing.

    • FDA Experts Recommend Gout Drug's Approval
    • No Proof Anti-Aging Hormones Effective: AMA
    • FDA Targets Bogus Treatments for H1N1 Swine Flu
    • Experts Challenge Benefits of Moderate Alcohol Consumption

About 24 percent of clinical trial participants who took Krystexxa had a serious adverse effect, compared with 12 percent of those who took a non-medicinal placebo. Six deaths were reported among those who took the drug, versus three deaths among those who didn't. But the FDA "noted that many of them had pre-existing heart conditions," the Associated Press reported.

The FDA has been reviewing the approval application from the drug's maker since December, the AP said.

Gout, which affects an estimated 8 million Americans, is caused by the buildup of too much uric acid in the body.

The full agency is not bound by the recommendations of its expert panels but usually follows them. The FDA's decision is expected by the end of July.


No Proof Anti-Aging Hormones Effective: AMA

There's no scientific proof that anti-aging hormones are effective, says the American Medical Association, which on Monday adopted a new policy on purported aging remedies.

For example, the AMA says, evidence indicates that long-term use of human growth hormone (HGH) to deal with aging-related issues might carry more risks, such as diabetes and tissue swelling, than benefits, the Associated Press reported.

The AMA says there's also no proof that hormones called bio-identicals are safer than traditional estrogen and progesterone products in treating menopause symptoms.

Those who promote the use of anti-aging hormones, the AMA says, need rigorous studies to support their claims, according to the AP report.

The new policy on products such as HGH, DHEA and testosterone was adopted at the group's annual meeting in Chicago.


FDA Targets Bogus Treatments for H1N1 Swine Flu

The U.S. Food and Drug Administration has sent more than 50 warning letters to Web sites selling illegal products that claim to diagnose, prevent, mitigate, treat or cure the H1N1 swine flu virus. As a result, more than 66 percent of the Web sites have removed the offending claims or products, the agency said.

The unapproved, uncleared or unauthorized products targeted by the FDA include:

  • An electronic instrument that claimed to strengthen the immune system and prevent H1N1 virus-related symptoms.
  • A shampoo that claimed to protect against the virus.
  • A supplement that claimed to cure H1N1 infection within 4 to 8 hours.
  • A dietary supplement that claimed to protect infants and children from contracting the H1N1 flu virus.

"Unapproved, uncleared or unauthorized products that claim to diagnose, mitigate, prevent, treat or cure the 2009 H1N1 flu are illegal and a potentially significant threat to the public health," the FDA said in a news release.

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