FDA Wants New Warnings for Rheumatoid Arthritis Drug: Report
The U.S. Food and Drug Administration wants an updated label for Amgen Inc.'s Enebrel to include warnings that the rheumatoid arthritis drug can be deadly when taken by children, and that the drug can cause serious infections in adults, the Wall Street Journal reported Monday.
In documents posted on its Web site, the FDA said infections, malignancies and neurological problems have been reported among children who have used the drug. These problems are similar to those experienced by some adults, the newspaper reported.
Enebrel is used to treat RA in adults and children and the skin disorder psoriasis in adults. While the drug's use in children is thought to be limited, the FDA said the number of life-threatening pediatric reactions disclosed to the agency's adverse event reporting database was "concerning," the Journal said.
Amgen has applied to the FDA to expand Enebrel's approved usage to include treating children with moderate-to-severe psoriasis. An expert panel advising the agency is set to consider whether to recommend the application when it meets Wednesday, the newspaper said. The full agency isn't bound to follow the suggestions of its advisory panels, but usually does.
"Given these considerable risks associated with [Enebrel], the benefit of this therapy in children with plaque psoriasis would need to be substantial in order to justify its approval and usage in the pediatric plaque psoriasis population," the agency said.
-----
Naltrexone May Help Problem Gamblers: Study
The drug naltrexone, widely used to treat alcohol addition, may also help people with a gambling problem, according to a University of Minnesota study of people who gambled for six to 32 hours a week.
The researchers had 58 men and women take doses between 50 milligrams and 150 milligrams of naltrexone every day for 18 weeks, while 19 others took a placebo. Of the 49 people in the treatment group who completed the study, 40 percent quit gambling for at least one month, compared with 10 percent of those in the placebo group, United Press International reported.
Participants who took the drug also reported a significant decline in the intensity and frequency of their urge to gamble. The findings appear in the Journal of Clinical Psychiatry.
Naltrexone isn't a cure for gambling, but does offer hope to problem gamblers, said study author Dr. Jon Grant, UPI reported.
"This is good news for people who have a gambling problem. This is the first time people have a proven medication that can help them get their behavior under control," Grant said in a prepared statement.
-----
Environmental Group Urges End of Shower Curtains Containing Harmful Chemical
For most of us, the only association we make between a plastic shower curtain and death is the memorable scene with Janet Leigh in the shower right before she meets a very bad end in the movie Psycho.
However, reports U.S. News and World Report, an environmental advocacy group is calling for the phase-out of all shower curtains and other products made with polyvinyl chloride (PVC), which it says can emit a number of harmful materials such as lead and phthalates (the chemicals that give plastic its flexibility) into the bathroom or elsewhere in the home.
The environmental group cited a small study indicating that the substances can be released, the magazine reports, but a previous study by the U.S. Environmental Protection Agency had also found that plastic shower curtains containing PVC could emit toxic substances into the air.
Many major retailers have, or are in the process of, eliminating plastic products made with PVC, U.S. News and World Report says. IKEA hasn't sold shower curtains with PVC for more than a decade, and stores such as Target, Macy's, J.C. Penney and Bed, Bath and Beyond are in the process of replacing PVC products with safer ones.
-----
Pilot Project Tests Cell Phones in TB Fight
The cell phone is joining the arsenal of technology used to keep folks healthy.
A student-led group at the Massachusetts Institute of Technology in Cambridge has developed a way to use cell phones to let tuberculosis patients report their adherence to the drug regimen they must follow. If the tests show patients are adhering to doctor's orders to take all their medication, they get rewarded with free cell phone minutes, the Associated Press reports.
Under the MIT pilot plan, patients test their urine using a strip that reveals a numeric code if it detects TB medicines, which are usually taken for six months. They then text-message the code to their health care provider and get credit toward incentives such as free minutes.
The in-home tests also eliminate the need for health care workers to make several patient-monitoring visits a week, a routine that is often impractical in remote places, said Jose Gomez-Marquez, one of the project's leaders.
Dr. Mario Raviglione, director of a World Health Organization program to fight TB, called the MIT idea "creative." But he told the AP personal visits must continue because systems that depend on patient self-reporting have often failed in the developing world.
In 2006, the most recent year for which statistics are available, 9.2 million people worldwide were diagnosed with tuberculosis, and 1.7 million died, according to AP. The WHO estimates that up to 10 percent of TB deaths are among patients who stop taking medication properly.
-----
Care of Female Veterans Lags at Some VA Hospitals: Report
U.S. female veterans aren't receiving the same quality of care as men at about one-third of Department of Veterans Affairs facilities, according to a VA review obtained by the Associated Press.
While the VA has created women's clinics at many hospitals, more clinicians need to be trained in women's care, and there's a need for more equipment focused on women's health, the document states.
The review, mandated by Congress, seems to support criticism by advocates and some members of Congress that the health care system needs to do more to help female veterans, the AP reported.
Any discrepancies in care are unacceptable and the agency is aggressively tackling the issue, said Dr. William E. Duncan, associate deputy undersecretary for health for quality and safety at the Department of Veterans Affairs.
"We're striving to understand the reason for these health disparities and to eliminate differences in veterans' health care based on personal characteristics," Duncan told the AP.
Currently, women account for about five percent of the VA's population. But that percentage is expected to nearly double in the next two years as more female veterans return home from Iraq and Afghanistan, the wire service said.
No comments:
Post a Comment