FDA Launches Safety Reviews of Three Medications
Safety reviews of Regranex Gel (becaplermin), Ziagen (abacavir) and Videx (didanosine) are being conducted by the U.S. Food and Drug Administration, the agency announced. All three are FDA-approved medications.
The review of Regranex Gel, a skin product used to heal leg and foot ulcers, was prompted by study data suggesting there may be an increased risk of death from cancer in diabetic patients who use the gel. While the review is ongoing, health care professionals should discuss the risks and benefits of the product with patients, the FDA said.
Recent findings from a study on anti-HIV drugs indicate that patients infected with HIV-1 who take Ziagen or Videx may have an increased risk of heart attack.
Until the safety review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, the FDA said.
Drug Store Test May Settle Paternity Question
A $29.99 paternity kit that's now available at some 4,300 Rite Aid drug stores in 30 states may help settle the question, "Who's Your Daddy" for thousands of curious families, MSNBC reports.
The do-it-yourself Indentigene test, produced by Sorenson Genomics of Salt Lake City, uses DNA to determine paternity. The kit includes swabs for collecting cheek cell samples from the possible father and the child. It's recommended that the mother provide her cells, too, to help bolster the results.
Cheek cells are mailed to a Sorenson lab for analysis. Results -- a probability figure -- are available online, by telephone or by mail in three to five business days, MSNBC reported. The total cost is about $150, including a $120 lab fee. For an additional $200, a more sophisticated test can be performed that meets legal requirements for determining paternity, the network said.
The Sorenson lab is accredited by the AABB (formerly known as the American Association of Blood Banks). But this type of test doesn't have to be reviewed by the U.S. Food and Drug Administration nor is certification required under the federal Clinical Laboratory Improvement Amendment, MSNBC pointed out.
Identigene's chief operating officer, Douglas Fogg, said most users appear to be buying the kit to settle social questions, not legal ones. Experts told MSNBC that it's still to be decided whether results of this test would stand up in court, especially given that such a test taken at home is subject to fraudulent use.
Fogg said he expects to sell at least 52,000 of the kits this year.
Physical Restraint Use in Nursing Homes Declines
In recent years, there's been a 40 percent decline in the use of physical restraints -- such as wheelchair belts or bed rails -- on nursing home patients in the United States, according to a report from the U.S. Agency for Healthcare Research and Quality.
In 2006, about 5.9 percent of 1.5 million long-term patients were repeatedly physically restrained, compared with 9.7 percent in 2002, the Associated Press reported.
States where physical restraints were used most often in 2006 included: California (13.4 percent), Arkansas (13.2 percent), and Oklahoma (11.5 percent). Restraints were used on nursing home patients least often in Nebraska (1.3 percent), and Iowa, Kansas and Maine (2 percent).
The overall decline in the use of physical restraints is the result of efforts by federal and state governments and the nursing home industry to do away with what was once a common practice, the AP reported.
Recalls for Rocker Toys and Warming Bears
Two recalls of Chinese-made products were announced Thursday by the U.S. Consumer Product Safety Commission.
One involves about 122,000 Rock 'N Ride plush rocker toys distributed by Tek Nek Toys International L.P. of Southlake, Texas. The base of the rocker can become unstable and allow the rocker to tip forward or backward, posing a fall hazard. The company has received 35 reports of rockers tipping over, including 10 reports of injuries such as bumps, bruises and lacerations.
Consumers should take these rockers away from children and contact Tek Nek at 888-686-2728 for a free replacement base.
The other recall includes about 113,000 Cozy Warming Polar Bears distributed by Avon Products Inc. The buckwheat-filled warming pouch inside the bears can overheat and ignite when heated in a microwave oven, posing a fire and burn hazard. Avon has received 41 reports of product overheating, including six reports of minor burns.
Consumers should stop using the warming bears and return the warming pouch for a full refund. For more information, contact Avon at 877-217-0916.
Large Increase in Kidney Disease Hospitalizations: Report
Between 1980 and 2005, the number of hospitalizations for kidney disease in the United States increased from 416,000 to 1.6 million, says a study published Thursday in the Morbidity and Mortality Weekly Report from the U.S. Centers for Disease Control and Prevention.
Hospitalization rates for kidney disease, including chronic and acute kidney failure, were consistently higher (30 percent to 40 percent) among men than women, increasing from 25 to 66.5 per 100,000 in men and from 17.8 to 45.8 per 100,000 in women.
In 2005, about 61.4 percent of hospitalized kidney disease patients were 65 and older, compared to 49.9 percent in 1980. An increasing number of kidney disease-related hospital admissions were associated with diabetes or high blood pressure, the study said.
The report authors said more research is needed to learn why hospitalization rates for kidney disease are increasing and to better understand the link between kidney disease and chronic conditions such as diabetes and high blood pressure.
In addition, there needs to be increased focus on early detection of kidney disease through screening, and encouraging health-care professionals to standardize criteria for diagnosing kidney disease.
Tobacco Company Helped Fund Lung Cancer Study
There's widespread dismay and concern after it was revealed that researchers who concluded that lung scans may help save smokers from cancer failed to reveal their financial ties to a tobacco company, the Associated Press reported.
The Weill Cornell Medical College researchers didn't disclose the money links to the parent company of cigarette maker Liggett Group Inc. when they submitted two studies to the Journal of the American Medical Association and the New England Journal of Medicine. The studies were published in 2006. News of the tobacco funding was first reported Tuesday in The New York Times.
In a statement released Wednesday, Liggett spokeswoman Carrie Bloom said the company "had not control or influence over the research."
Cornell Dean Dr. Antonio Gotto said there was no attempt to hide the fact the research was co-funded by the tobacco company, the AP reported. Gotto said the university made a public announcement about the funding.
Dozens of organizations, including the American Cancer Society, also funded the Cornell team's research. But the cancer society wouldn't have contributed to the study if it knew "Big Tobacco" was also providing funding, said ACS chief medical officer Dr. Otis Brawley.
A statement released by Dr. John Niederhuber, director of the U.S. National Cancer Institute, said scientists must maintain the trust of patients in research studies and "any breach of that trust is not simply disappointing but, I believe, unacceptable," the AP reported.
Targeting RNA May Lead to New Disease Treatments
By silencing key genetic material in cells, it may be possible to treat a number of kinds of diseases, suggests a study by Danish researchers.
They silenced strands of micro-RNA in the liver cells of monkeys, which resulted in lower cholesterol levels. This was the first time this technique was used in primates. Previous tests were conducted in test tubes and rodents, BBC News reported.
The study, published in the journal Nature, was conducted by a team from Copenhagen-based Santaris Pharma.
The researchers said this technique could eventually prove effective in treating a number of diseases, including liver disease, diabetes, certain types of cancer, and cardiac diseases, BBC News reported.
This could be done by developing a new generation of drugs that silence certain types of RNA, which is believed to be the main regulator of activity within cells. Some types of RNA have been found to be associated with disease.