Health -
News Sections
Celebrex, Bextra can stay on market: FDA panel
CTV.ca News Staff
Date: Saturday Feb. 19, 2005 7:52 AM ET
A panel of experts from the U.S. Food and Drug Administration has concluded that the popular painkillers Celebrex and Bextra should be allowed to remain on the market.
The panel decided that the possible benefits from the drugs, both made by Pfizer, outweigh the chances of cardiovascular problems.
The panel did note that both drugs still pose an increased risk for heart problems.
The vote for Celebrex was nearly unanimous; committee members noted that Celebrex seemed to have the least heart side effect of the drugs examined, although some complained about the lack of needed data.
But the panel was deeply divided in voting to allow sales of Bextra to continue: 14 voted for it, 10 against, and eight abstained.
The arthritis and drug safety advisory committees were to address another popular painkiller, Vioxx, later in the day.
Health Canada has sent observers to the FDA hearings and is also conducting its own investigation into the safety of the drugs. It's expected to make recommendations on their future use within six to eight weeks.
Health Minister Ujjal Dosanjh says Health Canada always listens to what other jurisdictions do, but will make its own decision.
"All of the jurisdictions -- EU, FDA and Health Canada -- all of these regulators look at each other, but they don't necessarily follow each other,'' he said.
Merck's Vioxx was pulled from the shelves on Sept. 30 after a long-term study found the drug posed a risk of hundreds to thousands of additional heart attacks.
Both Bextra and Celebrex remained for sale on the U.S. market.
All three drugs belong to a now-controversial class of drugs known as Cox-2 inhibitors and are commonly used to treat the pain of arthritis.
They have become very popular because they reduce pain without causing stomach problems like nonsteroidal anti-inflammatory drugs, or NSAIDs.
The advisers are still working on recommendations to the FDA about whether further testing is needed and whether any special warnings or limits that should be placed on them.
The FDA usually follows advice from its panels.
Donsanjh has said that Health Canada may decide to put special warnings and dosage limits on the Cox-2 inhibitors painkillers that remain on the market.
Australian has already done that, ordering special "black box" warnings be added to the labels of the drugs. The warnings caution of increased risk of heart problems for some people taking the medication.
User Tools
Related Stories
Related Websites
Most Popular
Most Viewed News Stories
Most Talked about Stories
If 5000 jobs can be so vital to the nation's economy, they should get what they ask for in bargaining. Simple.
Email