Health Highlights: Dec. 17, 2004
Liver Risk Seen in ADHD Drug Stem Cells Used to Mend Skull Damage AMA: Alcoholic Beverage Ads Target Kids FDA Warns About Pesticides Found in Ginseng Woman Reportedly Died From AIDS Drug During Government Testing FDA Scientists Felt Pressure to Approve Drugs: Report
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:
Liver Risk Seen in ADHD Drug
Eli Lilly & Co. is warning doctors to discontinue the use of its attention deficit/hyperactivity disorder (ADHD) drug Strattera in patients who may have liver disease.
The company announced Friday that two patients taking the drug suffered "severe" liver injury, and that it was adding a stronger warning on the label.
The drug is approved for both adults and children with ADHD. A U.S. Food and Drug Administration statement said that one patient was an adult, and the second was a teenager; both were taking Strattera for several months, and both have since recovered fully.
The Lilly statement urged patients taking the drug to call their doctor immediately if they experience yellowing on their skin or in the whites of their eyes, if their skin itches, if their urine is dark, or if they experience pain or tenderness in the upper ride side of their abdomen. All could signal a liver problem.
According to Lilly, 2 million patients have taken Strattera.
Stem Cells Used to Mend Skull Damage
German scientists say they're the first to use stem cells to grow human bone, using the master cells to repair skull damage on a 7-year-old girl, the Associated Press reports.
Two years earlier, the unidentified girl had been involved in a fall, which destroyed portions of her skull totaling about 19 square inches, the wire service said. Prior surgeries had failed to correct the problems, and the girl was forced to wear a helmet.
Now she's helmet-free, the AP said, thanks to the stem cell procedure reported in December's Journal of Cranio-Maxillofacial Surgery. The missing parts have been replaced by solid albeit thin bone, the researchers at the Justus-Liebig University Medical School said.
Lead surgeon Dr. Hans-Peter Howaldt said the stem cells derived from the girl's body fat were mixed with portions of her bone, and that the technique appeared to have created new bone tissue. The bone chips appeared to instruct the stem cells to make more bone, Howaldt speculated, although it wasn't possible to prove this theory, he conceded.
"I cannot prove that our success comes from the stem cells alone, but the combination of the two things simply worked," the wire service quoted him as saying.
AMA: Alcoholic Beverage Ads Target Kids
Sweet alcoholic drinks dubbed "alcopops" are being aggressively marketed to young people who aren't old enough to drink, new research from the American Medical Association (AMA) suggests.
Girls, specifically, are being lured by ads for the beverages, which often have a higher alcoholic content than beer, according to an account in the Chicago Sun-Times.
A national AMA poll of more than 700 youths found that in the prior six months, 31 percent of girls and 19 percent of boys ages 12 to 18 had consumed the drinks, including Mike's Hard Lemonade, Smirnoff Ice, and Jack Daniels Original Hard Cola.
Teen girls said they drank alcopops more than any other alcoholic beverage, and half of girls ages 16 to 18 reported seeing ads for the drinks, the Sun-Times said. By contrast, the AMA said, alcopops were the least preferred alcoholic beverage among women 21 and older, a separate poll of 2,700 adults found.
FDA Warns About Pesticides Found in Ginseng
The U.S. Food and Drug Administration has issued a nationwide warning after having discovered residue of untested pesticides in ginseng imported by a New Jersey firm.
The FDA says U.S. marshals seized a quantity of ginseng from FCC Products, Inc. of Livingston, N.J., and found residue from the chemicals procymidone and quintozene. And while the agency says the distribution was probably small, it issued the nationwide alert for anyone who may have bought the ginseng from the company because the chemicals haven't been officially tested for how well they're tolerated by humans.
"A raw agricultural commodity or a processed food or feed is deemed to be unsafe and adulterated, and subject to FDA enforcement action, if a pesticide chemical residue for which no tolerance has been set is present in food," the FDA said in a statement.
Ginseng is an herbal root, usually from Asia, that is often used to increase energy levels. It is classified as a food supplement and not usually subject to FDA regulations.
Woman Reportedly Died From AIDS Drug During Government Testing
A pregnant woman enrolled in government-run clinical trials died last year when doctors continued to give her an experimental AIDS regimen despite signs of liver failure, the Associated Press reported Thursday.
The therapy tested on 33-year-old Joyce Ann Hafford of Memphis, Tenn., included the antiretroviral drug nevirapine. Used since the early 1990s, the drug could cause lethal liver problems over time, which the government had warned about over the last four years, the AP reported.
Hafford was taking the drug in an attempt to protect her soon-to-be-born son, Sterling, from contracting HIV at birth.
NIH officials now acknowledge that the drug most likely caused her death, but told the wire service that disclosure of this information to family members is usually left to the doctors who treat such patients. Family members claim they were never told the reason for her death.
The NIH says Hafford should have signed a 15-page consent form that specifically warned of the possibility of liver failure. Her family says she didn't know of any such warning, while the AP said the disclosure document contained page after page of complex medical terms like "hypersensitivity reactions."
The AP this week released several reports on nevirapine, alleging that the government continued to push for the drug's use both in the United States and abroad, despite experts' growing concerns that it might be unsafe.
FDA Scientists Felt Pressure to Approve Drugs: Report
Nearly 20 percent of U.S. Food and Drug Administration scientists polled two years ago said they had been pressured to approve new drugs, despite concerns about the medications' safety, the Washington Post reported Thursday.
The 2002 survey of almost 400 FDA scientists also found that more than one-third of respondents weren't confident about the agency's ability to adequately assess the safety of drugs pending approval, the newspaper said.
And once drugs were already on the market, just 34 percent of those polled were completely or mostly confident of the agency's ability to monitor the medication's safety, the survey found.
The survey was conducted by the inspector general of the FDA's parent agency, the U.S. Department of Health and Human Services. It appeared to support the allegations of FDA drug reviewer Dr. David Graham, who in testifying about the recent withdrawal of the painkiller Vioxx told Congress that the FDA wasn't able to keep some drugs that appeared to be unsafe from the market. Graham also alleged that FDA reviewers were intimidated into voicing approval for medications, despite their reservations, the Post said.
Only a portion of the survey was made public last year. The entire survey was to be released Thursday by two public interest groups that obtained it under the Freedom of Information Act, the newspaper said.