Health Highlights: March 17 2006
Two More U.S. Women Die After Using Abortion Pill Problems Plague U.S. Anthrax Vaccine Program Israel Confirms First H5N1 Bird Flu Outbreak Alzheimer's Drug Study Causes Concern FDA Committees to Review New ADHD Drug
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Two More U.S. Women Die After Using Abortion Pill
Two more women have died after using the RU-486 abortion pill, U.S. health regulators said Friday in warning doctors to watch for a rare but deadly infection implicated in earlier deaths of four others who used the pill.
Since 2000, at least six women in the United States have died after taking RU-486, but the Food and Drug Administration can't prove the drug was to blame in any of those cases, the Associated Press reported.
In four cases in California, women who took the pill died from sepsis, an infection of the bloodstream. Those women did not follow FDA-approved instructions for using the drug.
The FDA statement also emphasized that abortion providers should stick to the officially approved regimen when giving RU-486, Mifeprex, and an accompanying drug, misoprostol, The New York Times reported.
The FDA instructions call for women to swallow three tablets of Mifeprex, followed by two tablets of misoprostol two days later. In the California cases, the final two tablets were inserted vaginally instead of being swallowed by the women. This "off-label" use does not have FDA approval but is widely recommended by abortion clinics, the AP reported.
The FDA said it hasn't confirmed the cause of death in the two latest cases, but an agency spokeswoman told the AP that the circumstances and symptoms matched those of the California cases.
Mifeprex has been used in more than 500,000 medical abortions in the United States since its approval in September 2000. The risks of death from infection after using the pill are similar to the risks after surgical abortions or childbirth, officials said according to the Times report.
Problems Plague U.S. Anthrax Vaccine Program
The U.S. government's push to develop a new anthrax vaccine is mired in problems and won't achieve a November deadline to stockpile 25 million doses of a new vaccine, the Washington Post reports.
VaxGen Inc., the California company in charge of the $1 billion project, has reported failure in a major human test and has fallen at least a year behind schedule. The company told the Post that it has isolated the problem with the new vaccine and is well on the way to correcting it.
Even so, there's no chance the company will be able to meet the November deadline to deliver 25 million doses of the new vaccine into the U.S. national stockpile. That means that VaxGen will default on its contract with the government, unless federal authorities grant the contract extension requested by the company.
The delay in the VaxGen program has prompted the U.S. government to buy five million doses of an older, controversial anthrax vaccine, which is enough to treat two million people, the Post reported.
Officials at the U.S. Health and Human declined to discuss the VaxGen situation, but noted they've stockpiled enough antibiotics to treat 40 million people after a large-scale anthrax bioterrorism attack.
Israel Confirms First H5N1 Bird Flu Outbreak
Israel has confirmed its first outbreak of the deadly H5N1 bird flu, Israel Radio reported Friday.
According to the radio, the Agriculture Ministry confirmed that H5N1 caused the deaths of more than 11,000 turkeys on two farms in the Negev Desert and another farm near Jerusalem.
Israeli officials have ordered the slaughter of tens of thousands of turkeys and imposed quarantines around all three farms as part of the effort to control the spread of the virus, the Associated Press reported.
Five people have been admitted to hospitals and are being observed for symptoms of bird flu, but officials said they did not think the patients had contracted the disease.
The H5N1 virus was detected in Egypt last month and it's possible that the disease may have entered Israel from that country, said Israeli Agriculture Minister Zeev Boim.
Since 2003, the H5N1 virus has been found in Asia, Europe, Africa and the Middle East and led to the slaughter of tens of millions of domestic fowl. The virus has killed more than 100 people.
Alzheimer's Drug Study Causes Concern
Some health experts are concerned about a study that found an unusual number of deaths among patients taking Aricept, the most popular drug to treat Alzheimer's disease.
The study included 974 patients with dementia related to heart disease. There were 11 deaths among patients taking Aricept but no deaths among patients taking a placebo. The U.S. Food and Drug Administration is analyzing the study results, The New York Times reported.
The study was conducted by Eisai, a Japanese pharmaceutical company that sells Aricept, which is also sold by Pfizer. An Eisai spokesperson said Aricept is safe and the company is not recommending any changes to the drug's label.
Some experts say the findings suggest that Aricept and related drugs may increase the risk of heart disease. They say that's a potential cause for concern because Aricept provides, at best, only mild benefits for Alzheimer's patients, the Times reported.
Last year, a British study concluded that Aricept does not delay the onset of disability or the need for nursing-home care for Alzheimer's patients. The study said the drug provided little overall benefit and was not cost-effective.
FDA Committees to Review New ADHD Drug
The drug Sparlon -- associated with 31 cases of increased suicide risk, aggression or psychosis during clinical trials for treatment of attention deficit hyperactivity disorder in children -- will be discussed March 22 at a meeting of the U.S. Food and Drug Administration's Pediatric Advisory Committee.
The following day, the FDA's Psychopharmacologic Drugs Advisory Committee will review a new drug application for Sparlon as a treatment for ADHD. The drug is currently marketed as a treatment for narcolepsy, under the name Provigil.
A central issue in the committee's discussion is likely to be what warnings Sparlon must carry and how the non-stimulant drug will be distinguished from more traditional ADHD stimulant drugs, such as Adderall.
Last fall, the FDA issued an "approvable letter" for Sparlon as a treatment for ADHD.