| FDA panel OKs Celebrex use for children
Advisers split on whether drug is safe, recommended long-term monitoring
| | |
 WASHINGTON - Federal advisers recommended Wednesday that Pfizer Inc. be allowed to market the painkiller Celebrex as a treatment for children with a devastating form of arthritis, even though they split on whether it was safe. In a 15-1 vote, the advisers said the benefits of the drug outweighed its risks for juvenile rheumatoid arthritis patients 2 and older. They also strongly recommended its safety be monitored for years. The Food and Drug Administration must now weigh the panel's recommendation that it expand approval of Celebrex. The agency isn't required to follow the advice of its expert panels but usually does. Earlier, the FDA's arthritis advisory committee voted unanimously to say the drug was an effective treatment for juvenile rheumatoid arthritis, which affects as many as 60,000 U.S. children. However, in an 8-7 vote, with one abstention, panel members said available data doesn't demonstrate that Celebrex is safe in treating the disease, commonly called JRA. Celebrex is the only member of a class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns they elevate the risk of heart attacks and strokes in adults. FDA reviewers before the meeting had questioned the cardiovascular risks of long-term use of the drug in children. "The feeling was short-term efficacy looked good and short-term safety was not an issue. Long-term safety is totally unknown and needs to be known," said panel member Dr. Joan Bathon, a Johns Hopkins University rheumatologist. The panel recommended the FDA require Pfizer to study the long-term safety of the drug, possibly by creating a registry of patients that would allow their health to be tracked for 10 to 20 years, Bathon said. | Click for related content |
|
|
Top Stories
Surprise hope for recovery from Rett syndrome Stunning experiment reverses autism-relate
Dads' comments may push girls toward bulimia Parental criticism and weight worries affec
Mismatched hearts save babies' lives Lack of immune rejection fuels wrong-blood-type tra
Warning on diarrhea vaccine for infants Twisting of intestines reported after babies rec
Infants form memories early, but also forget Babies lose the information faster than adu
Parents urged to donate newborn's cord blood Can be used for bone marrow transplants to
|
|
Related
10 is the new 15 as kids grow up faster From dating to cellphones, music to makeup, beha
N.H. first state to offer girls free cancer vaccine Starting in January, program will pr
WEDNESDAY, Feb. 14 (HealthDay News) -- Genetic clues that reveal a brain cell's origins
New guidelines for sedating children Doctors, dentists need training to act quickly in c
WEDNESDAY, Feb. 14 (HealthDay News) -- Genetic clues that reveal a brain cell's origins
Docs blast inappropriate ads for children Commercials to blame for many ills from obesit
Parents urged to donate newborn's cord blood Can be used for bone marrow transplants to
Cough medicine drug a hallucinogen for teens Abuse of ingredient in over-the-counter pro
|
LOOKING
FOR
ADVERTISEMENT
Note: This site does not provide medical or any other health care or fitness advice, diagnosis, or treatment. The site and its services, including the information above, are for informational purposes only and are not a substitute for professional medical or health advice, examination, diagnosis, or treatment. Always seek the advice of your physician or other qualified health professional before starting any new treatment, making any changes to existing treatment, or altering in any way your current exercise or diet regimen. Do not delay seeking or disregard medical advice based on information on this site. Medical information changes rapidly and while MyHealth-Mart and its content providers make efforts to update the content on the site, some information may be out of date. No health information on MyHealth-Mart, including information about herbal therapies and other dietary supplements, is regulated or evaluated by the Food and Drug Administration and therefore the information should not be used to diagnose, treat, cure, or prevent any disease without the supervision of a medical doctor.
© copyright reserved by iosh.000webhost.com 2007-2008
|
|
|