When Merck abruptly pulled Vioxx off the shelves in September 2004, Merck had spent $78 million advertising the blockbuster drug which was supposed to protect the digestive tract – a common problem among NSAIDs. The recall occurred because of the discovery that increased cardiovascular risks were present leading to Vioxx injury lawsuits.
Vioxx (valdecoxib) is a COX-2 inhibitor made by Merck & Co. When COX-2 inhibitors entered the market in 1999, the new generation of medications was deemed the “super aspirin” because it claimed to be safer than traditional NSAIDs like aspirin, ibuprofen, naproxen, etc.
In addition, there is still significant controversy about how well Vioxx is actually able to protect the digestive tract over older medications. After an FDA panel met for three days to decide on the safety issues that surfaced after the Vioxx recall regarding the entire class of COX-2 drugs, the panel voted in favor of allowing a possible return of Vioxx in a close 17-15 vote. The FDA generally accepts its panel’s recommendations, though the panel did unanimously say cardiac risks still exist.
In September 2004, the public was shocked when Merck & Co. announced it was recalling its popular blockbuster arthritis painkiller Vioxx from the market. Patients and doctors alike were shocked, feeling there was an absence of Vioxx warning prior to the withdrawal. The highly popular drug had made $2.5 billion in sales in the United States in 2003 alone.
Many patients questioned why there was a lack of Vioxx warning considering the FDA’s announcement that patients taking the drug had a 50 percent greater chance of heart attacks and sudden cardiac arrest than people taking standard painkillers. Another study showed the rate of heart attacks per year among people on placebo pills compared to Vioxx users was .52 percent versus .74 percent for the drug users.
FDA whistleblower David Graham, M.D., has testified that Vioxx warnings were in fact present but ignored by the federal agency. As a result, Graham has estimated that as many as 140,000 people may have suffered heart attacks, with as many as 30,000 to 40,000 deaths because of Vioxx use.
Vioxx Side Effects
In February 2005, the Food and Drug Administration held an advisory panel meeting to discuss the future of COX-2 drugs in light of the Vioxx side effects, resulting in a withdrawal of the drug from the market. The Vioxx side effects included potentially deadly cardiovascular events, including heart attacks and stroke, and studies on the other two COX-2 drugs, Celebrex and Bextra, indicated the heart attacks might be a class wide effect.
The panel’s goal was to decide on more set guidelines on the medications since the discovery of the Vioxx side effects, as well as among Celebrex and Bextra users, left millions of patients and doctors confused about their medication. After the meeting wrapped up, patients and doctors were still trying to weigh what the risks of Vioxx side effects really were. The panel members agreed that cardiac Vioxx side effects were present, but voted 17-15 barely favoring allowing the drug to possibly return to the market.
The latest bind will leave many patients trying to weigh the risks of possible Vioxx side effects alongside their doctors. Should Vioxx return to the market, it would carry black box Vioxx side effects warnings, the strictest FDA issued drug warnings. Even though the FDA does not have to take the panel’s recommendations, the agency usually does.
Vioxx and Heart Attacks
Whistleblower and FDA safety officer David Graham, M.D., created major headlines when he claimed the FDA pressured its own scientists about Vioxx and heart attacks and other cardiac concerns. Vioxx was taken off the market in September 2004, after a study discovered Vioxx patients have a 50 percent greater likelihood of heart attacks and sudden cardiac arrest than people taking standard painkillers.
Graham estimated as many as 140,000 people may have suffered Vioxx and heart attacks, resulting in as many as 30,000 to 40,000 deaths. The Vioxx and heart attacks discovery created an immediate frenzy, calling into question the safety of the entire class of drugs it belonged in. A special panel of experts convened in February 2005 to discuss the events leading up to the Vioxx and heart attacks and other cardiac effects discovery, as well as to discuss the future of all COX-2 drugs, which includes Vioxx, Celebrex and Bextra.
The expert committee made a controversial decision in an almost even split vote of 17-15 in favor of Vioxx returning to the market. The experts did not say Vioxx and heart attacks risks were not of concern, merely noting the entire drug category should come with strong warnings about the heart attacks and strokes risks.
Vioxx and Heart Disease
Conflicting advice over the safety of COX-2 drugs, including Vioxx, Celebrex and Bextra, resulted in the February 2005 FDA advisory panel meeting. For the 66 million people with arthritis or joint pain, the FDA advisory panel’s recommendations were much anticipated as doctors and patients alike were unsure of how to properly assess the drugs’ risks and benefits.
The three-day meeting was controversial, resulting in a close 17-15 vote in favor of a Vioxx return, despite the committee members saying heart risks were present and that the entire category should come with strong warnings about the heart attacks and strokes. If Vioxx does return, those with Vioxx and heart disease risk factors could be encouraged to completely avoid use of the drug.
A large portion of COX-2 drug patients are older, however, and will have more Vioxx and heart disease risk factors because of it. In patients over the age of 60, Vioxx and heart disease risks can commonly include high blood pressure, high cholesterol and narrowed arteries. Potential Vioxx and heart disease risks should be discussed individually with qualified doctors.
If you or a loved one has suffered adverse effects as a result of Vioxx, contact our attorneys today for a free case evaluation.