Arthritis Drugs and Heart Attacks
Millions of Americans have turned to Vioxx and Celebrex for relief from pain associated with osteoarthritis.
Both drugs have been involved in a high-stakes marketing war. Celebrex brings in $2.3 billion a year for drug maker Pharmacia while Vioxx, with 33 million prescriptions written, rakes in $1.7 billion for Merck.
Doctors who prescribe the drugs say they are safer than ibuprofen and aspirin because they cause less intestinal bleeding long term, but new research suggests the drugs could put certain patients at risk for heart attack.
In one study presented to the Food and Drug Administration earlier this year, patients taking Vioxx suffered about four heart attacks per 1,000 patients. Those taking the painkiller naproxen, sold as Aleve, had about one heart attack per 1,000 people.
The risk is still considered low, but some doctors are calling on the FDA to change warning labels on both drugs to include heart attack risk, which has patients very concerned.
Arthritis specialist Dr. Israeli Jaffe says his phones haven't stopped ringing since the headlines hit the newsstands.
"Patients call and they say, 'This medicine that you're giving me is going to give me a heart attack,'" he says.
Dr. Jaffe, who frequently prescribes both drugs, believes the concerns are overblown. He says Vioxx and Celebrex greatly reduce stomach bleeding and ulcers, side effects of aspirin and some other pain relievers. But because Vioxx and Celebrex increase clotting, they can put certain arthritis sufferers at risk for heart attack, so he says most at-risk patients take low doses of aspirin in addition to their Vioxx or Celebrex.
"With that and these drugs, they are still safer and they are cardioprotected," he says, because aspirin has been proven to have beneficial effects for the heart.
Studies show the class of COX-2 inhibitors sold as Vioxx and Celebrex offer no such protection, so critics want the warnings clearly laid out so the public is informed.
There is an increased risk of stomach bleeding when aspirin is taken in conjunction with Celebrex or Vioxx.
Both Merck and Pharmacia have maintained Vioxx and Celebrex are safe.
The FDA advisory committee has recommended that labels on both drugs include stern warnings about cardiac risks, but the FDA has not yet made a final decision on this.
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