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 to MarketWatch, a spokesman for Glaxo said the company was in talks with European Union regulators about sending a similar letter to European doctors.
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.
The report follows on the heels of Merck's decision Tuesday to stop lobbying state governments for laws mandating that pre-teen girls be vaccinated against cervical cancer. The Wall Street Journal has reported that Merck had initially been successful in convincing such state leaders as Texas Gov. Rick Perry to order the vaccinations, but many parent and advocacy groups objected, saying it might encourage youngsters to have pre-marital sex and infringed on their freedom of choice.
The FDA approved Gardasil in 2006 to prevent two strains of the sexually-transmitted HPV. Studies have shown that these two strains result in almost 70 percent of all cervical cancer cases.
U.S. Stillbirths Decline, Racial Disparities Persist: Study
Stillbirths in the United States declined significantly between 1990 and 2003, but the fetal mortality rate for non-Hispanic black women was more than double that of non-Hispanic white women, a new report released Wednesday by the U.S. Centers for Disease Control and Prevention(CDC) shows.
The study, "Fetal and Perinatal Mortality, United States: 2003," looked at fetal deaths among all racial and ethnic groups occurring at 20 weeks of gestation or more. The fetal mortality rate for non-Hispanic black women was 11.56 per 1,000, compared to 4.94 per 1,000 for non-Hispanic white women. "While we can see that progress has been made in preventing fetal mortality, it is also clear that substantial disparities remain along race and ethnic lines, " said the study's lead author, Marian MacDorman, senior social scientist in the Division of Vital Statistics at the CDC's National Center for Health Statistics.
Among other findings in the report:
The number of fetal deaths per 1,000 live births declined an average of 1.4 percent a year from 1990-2003.
The decline since 1990 occurred among pregnancies 28 weeks of gestation and longer, while the fetal death rate for pregnancies 20-27 weeks of gestation has changed little since 1990.
American Indian women had a fetal death rate of 6.09 per 1,000 live births -- 24 percent higher than that for non-Hispanic white women. For Hispanic women, the rate was slightly higher than that for non-Hispanic white women (5.46 per 1,000), and the rate for Asian or Pacific Islander women was similar to that of non-Hispanic white women (4.98 per 1,000).
Dispose of Prescription Drugs in Kitchen Waste, EPA Urges
Government experts say unsavory waste such as kitty litter and old coffee grounds can keep unwanted prescription drugs out of the wrong hands.
New drug disposal guidelines urge consumers to mix unused, unneeded or expired drugs with undesirable substances and to discard them in nondescript containers to avoid reuse. And, while the time-honored habit of flushing drugs down the toilet can also be used, officials warned that could create environmental problems if proper disposal instructions on the safety label are disregarded.
"Following these new guidelines will protect our nation's waterways and keep pharmaceuticals out of the hands of potential abusers," Environmental Protection Agency administrator Stephen L. Johnson said in a prepared statement Wednesday. Some pharmacies will also collect drugs for safe disposal, the agency added.
Scientists Close in on Genetic Code for Lou Gehrig's Disease
Johns Hopkins researchers say they've identified 34 unique variations in the human genetic code that predisposes people to the non-inherited form of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease.
The 34 single nucleotide polymorphisms, or SNPs, were found among 276 unrelated subjects and appear to be good candidates for further study of the neurodegenerative disease, the scientists said Tuesday in a prepared statement. The team used a new technology, known as "SNP chips" -- a kind of computer chip coated with tiny beads -- to scan the genome.
"Although we haven't located the exact gene responsible for sporadic ALS, our results seriously narrow the search and bring us that much closer to finding what we need to start developing treatments for the disease," Dr. Bryan J. Traynor, of the Department of Neurology at Johns Hopkins University School of Medicine in Baltimore, said in the statement. One in about 2,000 people are at risk yearly of developing the disease, and 10,000 Americans a year die from ALS.
The findings were published in this month's online edition of the journal Lancet Neurology.