Health Highlights: Nov. 17, 2004
Depo-Provera to Get Tough Safety Warning FDA Defends Its Handling of Vioxx Review FDA Asks Congress to Fund New Flu Vaccine System Want to Lose Weight? Get Lots of Sleep, Diet With Your Dog Possible Major Advance in Psoriasis Research Reported Confusing Drug Labels Can Pose Threat to Patients: Study
Here are some of the latest health and medical news developments, compiled by editors of HealthDay:
Depo-Provera to Get Tough Safety Warning
The U.S. Food and Drug Administration on Wednesday announced that the strongest possible warning will appear on packages of the contraceptive Depo-Provera, citing the risk of lost bone density after long-term use.
The move marks the second time in three days that the agency has put a so-called black box warning on a reproductive health drug used by women. On Monday, a similar warning was added to RU-486, the morning-after pill, after reports of rare occurrences of infection in users.
Although the FDA said that Depo-Provera, an injectable contraceptive, has been used safely for decades, it added that "the drug may result in significant loss of bone density, and that the loss is greater the longer the drug is administered," the agency said in a statement. Moreover, the FDA added, the bone loss may not be reversible once a woman stops using the drug.
The black-box warning, designed to point out serious effects of the drug, said that women should use Depo-Provera for two years or longer only if other methods of birth control are inadequate.
FDA Defends Its Handling of Vioxx Review
Responding to public criticism of its handling of the controversial arthritis pain drug Vioxx, the U.S. Food and Drug Administration on Wednesday defended its oversight of the monitoring process and said it acted in the best interests of the public's safety.
The FDA has been criticized from several quarters for not acting aggressively enough when safety concerns arose about Vioxx, as well as other medications, including certain antidepressants. In September, the maker of Vioxx, Merck & Co., pulled the drug from the market after a large study found that it doubled the risk of heart attack and stroke when taken for longer than 18 months, the Associated Press reported.
In response to critics, FDA Acting Commissioner Lester Crawford said the agency has a "well-documented and long-standing commitment to openness and transparency in its review of marketed drugs."
Crawford's statement, released one day before the Senate Finance Committee's scheduled hearing on Vioxx, also said the FDA initiated and paid for reviews of Vioxx and antidepressants after those drugs had hit the market, the AP said. "That is evidence the system is working," Crawford said.
Critics contend the FDA ignored risks associated with Vioxx and some antidepressants, then intimidated its own reviewers when they pointed to safety concerns in both cases, the AP said.
FDA Asks Congress to Fund New Flu Vaccine System
Congress needs to fund new ways of developing the flu vaccine so the United States can avoid a repeat of this year's shortage, the acting chief of the U.S. Food and Drug Administration told a Senate panel on Tuesday.
Dr. Lester Crawford said the current system relies on millions of chicken eggs, while many experts believe creating the vaccine using genetically engineered flu virus grown in human and monkey cells may be faster and more efficient, the Associated Press reported.
The FDA's parent agency, the U.S. Department of Health and Human Services, has requested $100 million to speed the transition, according to the wire service. Senate Aging Committee Chairman Larry Craig (R-Idaho) initially told the hearing that the $100 million was "in the budget," but he later cautioned that the appropriation still had to survive ongoing budget negotiations.
At the same hearing, a top infectious disease expert from the U.S. Centers for Disease Control and Prevention said that while this year's flu season has been mild so far, it was important for the nation's health system not to let its guard down.
"[Flu] is one of the most unpredictable diseases," Dr. Mitchell Cohen told the panel.
Want to Lose Weight? Get Lots of Sleep, Diet With Your Dog
Dieting with your dog and getting lots of sleep may help you achieve and maintain a healthy weight, according to studies presented this week at a meeting of the North American Association for the Study of Obesity.
In one study, Columbia University researchers found that people who get less than four hours of sleep a night were 73 percent more likely to be obese than people who got seven to nine hours of shuteye each night, the Associated Press reported.
People who got about five hours of sleep were 50 percent more likely to be obese and those who got six hours of rest were 23 percent more likely to be obese.
In the second study, Chicago researchers found that both dogs and their owners lost more weight and kept it off when they went on a diet and exercised together. The dogs actually got better results than their owners. But the dog owners said dieting and exercising with their dogs made it more fun than normal.
"If you're looking for motivation and social support to lose weight, you probably don't have to look any further than the pet in your own home," researcher Dr. Robert Kushner of Northwestern Medical School told the AP.
Possible Major Advance in Psoriasis Research Reported
Scientists at Leicester University in Great Britain have identified a genetic variant in people with psoriasis, a finding that could prove a major advance in understanding the causes of the skin condition.
The research could also lead to the development of new, targeted drugs to treat psoriasis.
The scientists found that a variant of a gene called CDSN is much more common in people with psoriasis. The CDSN gene is responsible for the adhesion and shedding of skin cells, BBC News Online reported.
"This variant may confer susceptibility to psoriasis by causing an accumulation of CDSN protein, which in turn could contribute to the inflammatory response observed in the skin of [psoriasis] patients," said lead researcher Richard Trembath.
In people genetically predisposed to psoriasis, the condition can be triggered by such things as stress or bacterial infections.
Confusing Drug Labels Can Pose Threat to Patients: Study
Complex drug names and designs on prescription drug labels can pose a threat to patients, say researchers at the Applied Vision Research Institute at the University of Derby in the United Kingdom.
They found that drug labels can confuse both patients and pharmacists and lead to mistakes. The researchers said about a quarter of all medication errors are caused by confusing labels.
"Many tablets have unusual names which can look confusingly similar. Medicinal packages can also be similar in shape and color and this can cause problems, either to the consumer who might be rushing to make a purchase, or the pharmacist in selecting the pack from the shelf," institute director Alastair Gale told BBC News Online.
"Existing as well as new labeling and packaging designs need to be assessed appropriately to help minimize the potential for human error," he said.