Health Highlights: July 8, 2008

July 8, 2008 RSS Feed Print

  • Thousands of Reactions to Cervical Cancer Vaccine Reported
  • FDA Wants Suicide Warning for Epilepsy Drugs
  • Doctors Urge Senators to Reverse Cuts in Medicare Payments
  • Kennedy Tired But Doing Well During Cancer Therapy

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

Thousands of Reactions to Cervical Cancer Vaccine Reported

Nearly 8,000 reports of adverse reactions to Merck & Co.'s Gardasil vaccine have been filed with the U.S. Centers for Disease Control and Prevention since June 2006, news reports said Tuesday.

Reaction totals for the vaccine -- used to prevent the sexually transmitted human papillomavirus (HPV) that's been linked to cervical cancer in girls and women -- include 15 reports of death and 10 confirmed deaths, but none of the deaths has been tied to the vaccine, CNN said.

Other adverse reactions include reports ranging from injection site pain, nausea and dangerous blood clots to paralysis stemming from a neurological disorder called Guillain-Barré syndrome. The CDC said it's still studying these reports.

The vaccine was approved in 2006 for girls as young as 9 years old. Merck said more than 26 million doses of the vaccine have been distributed worldwide, including almost 16 million in the United States.

The company said the vaccine is safe and effective. In a statement cited by CNN, Merck said a report of an adverse reaction "does not mean that a causal relationship between an event and vaccination has been established -- just that the event occurred after vaccination."

The company and the CDC said they would continue to evaluate the reaction reports.

HPV is believed to infect about half of sexually active women in North America, the Canadian Broadcasting Corp. reported, making it the most prevalent sexually transmitted disease in modern times. Only a relatively small number of those infected go on to develop cervical cancer.

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FDA Wants Suicide Warning for Epilepsy Drugs

The U.S. Food and Drug Administration wants to add a "black box" warning detailing an increased risk of suicide connected with drugs used to treat seizures in people with epilepsy.

On its Web site Monday, the FDA said an analysis released in January of nearly 200 studies showed patients taking anti-seizure drugs were more likely to have suicidal thoughts and behaviors than those taking a placebo. While the reports of problems were extremely rare, the agency said drug-treated patients faced about twice the risk of suicide or suicidal thoughts. On average, those patients experienced suicidal thoughts or behavior 0.43 percent of the time, compared with 0.22 percent for those taking a placebo, the Associated Press reported.

The FDA said it was intent on revising the warning labels for all drugs in the class, although it's not entirely clear why they increase suicidal behaviors, the AP said.

"There seems to be no compelling reason to ignore what appears to be a very clear empirical finding of increase in suicidality, despite no obvious explanation," said FDA Director of Neurology Products Russell Katz.

FDA advisers are to consider the black-box proposal at a meeting on June 10, the news service said.

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Doctors Urge Senators to Reverse Cuts in Medicare Payments

The American Medical Association is waging a full-scale ad campaign urging U.S. Senators to put the brakes on a 10.6 percent cut in Medicare payments to physicians.

The cuts -- required by law to offset higher-than-budgeted Medicare expenses -- took effect July 1, in the absence of enough Senate votes to reverse them. While the House passed a bill to reverse the cuts just before the Fourth of July recess, Republicans blocked a similar measure in the Senate, The New York Times reported.

The bills would reverse the cuts to physicians and make up the shortfall by reducing payments to private insurance companies that offer alternative plans to the traditional federal Medicare program. Senate Republicans and the White House oppose that idea, saying it would ultimately hurt people who depend on the private plans, known as Medicare Advantage.

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