Anti Lemming : Jedes Medikament hat seine Risiken
FDA begins 3-day hearing on safety of painkillers
By Val Brickates Kennedy & Jenny Robertson
Last Update: 12:29 PM ET Feb. 16, 2005
WASHINGTON (MarketWatch) - The Food and Drug Administration began three days of public hearings on the safety of the nation's leading painkillers on Wednesday, with regulators slated to vote on Friday on whether to allow Pfizer's Celebrex and Bextra to stay on the market.
A joint panel comprised of members of the FDA's Arthritis and Drug Safety and Risk Management Advisory committees will be hearing presentations from medical experts and industry representatives on whether several of the leading pain pills can trigger heart attacks or strokes in certain patients.
Over the next three days, the FDA joint panel will be examining safety data on the following pain relievers: Merck's (MRK: news, chart, profile) Vioxx and Arcoxia; Pfizer's (PFE: news, chart, profile) Celebrex and Bextra; Wyeth's (WYE: news, chart, profile) Lodine; Novartis' (NVS: news, chart, profile) Prexige; and the over-the-counter drugs naproxen and ibuprofen. All of the medications belong to a class of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs).
Vioxx, Celebrex, and Bextra belong to a particularly controversial subset of NSAIDs called Cox-2 inhibitors. Cox-2 drugs were once considered superiod to NSAIDs because they don't cause the stomach bleeding or ulcers associated with long-term use of other NSAIDs.
Vioxx is no longer on the market while Arcoxia and Prexige have yet to be approved.
Merck stunned the healthcare industry in September when it abruptly yanked its highly popular pain reliever Vioxx from the market after a clinical study linked long-term use to a higher incidence of stroke and heart attack.
Since that time, several other studies have emerged linking other pain relievers-- namely Celebrex, Bextra and naproxen-- to cardiovascular problems. Many medical experts have also noted that an increasing amount of data indicates many NSAIDs can raise blood pressure, especially when taken in higher doses. High blood pressure is a major contributor to cardiovascular problems.
As a result, the FDA panel will be voting on whether to require NSAIDs to carry warning labels advising patients and doctors that they should be used with caution by patients who might be at risk of developing cardiac problems. The panel will also be voting as to whether to request that additional cardiovascular safety studies be run on the drugs.
But of most interest to the pharmaceutical community will be Friday's dealings, when the panel is scheduled to vote on whether to recommend that Bextra and Celebrex be removed from the market. The panel will also vote on whether to formally rescind Vioxx's approval, even though the drug is no longer on the market in the U.S. All three drugs are still available in the European Union.
Traditionally, the FDA has followed the recommendations of its advisory panels.