The Deadly Side Effects of COX-2 Inhibitor Drugs
Advocacy Group Battles the FDA and Drugs Makers to Protect Consumers
Jun 16, 2009
In 1988, the cyclooxygenase-II or COX-2 enzyme responsible for pain and inflammation was identified. Many large pharmaceutical companies began research for drugs to block the enzyme to create 'super painkillers' that would be worth millions to a hurting population. As competition heated up, many such drugs called COX-2 selective inhibitors, members of a drug class of non-steroidal anti-inflammatory drugs (NSAIDs), flooded the FDA for approval, targeting pain, arthritis, and menstrual cramps.
The first to hit the market were Merck’s Vioxx (rofecoxib) and Pfizer’s Celebrex (celecoxib) in 1999. Soon afterward, along with their satisfied customers, were their not-so-satisfied ones, those experiencing the adverse side effects listed in the PDR (Physicians Desk Reference) of many NSAIDs, including renal failure, cardiac events, thrombosis, and stroke. Enough evidence of adverse reactions of myocardial infarction and stroke were compiled against Vioxx to induce Merck to voluntarily withdraw it in 2004.
Pain Relief is Worth The Risks
Approximately 32 million Americans suffer from some form of pain and are desperate for relief. Their pain affects their quality of life, their jobs, and their relationships. They leap to purchase anything that promises help, and their naïve trust in its safety is always “If it weren’t safe, why would the Government allow it to be sold?” That question continues to be asked, but it has not protected many consumers from dangerous side effects and death from FDA approved prescription painkillers.
Advocacy groups are working overtime to protect consumers from unsafe prescription drugs (or drugs that would be safer with proper warnings). Black Box Warnings, the strongest warning that the FDA mandates, means medical studies indicate a drug has a significant risk of serious or life-threatening side effects. The FDA is responsible for requiring pharmaceutical makers to place this warning on packaging explaining dangers to consumers.
Under increasing pressure to fast-track supposedly critically-needed drugs, the FDA frequently approves drugs with human clinical trials of less than 3 months, with the understanding that physicians will report side effects for years to come that will complete the drug profile. Drugs are often not sufficiently tested to place these warnings on packaging until many years after release, and sometimes never, as the death count may require they be removed from the market prior to implementing such changes.
Some Drugs Should Never Be Used
Most COX -2 painkillers have been followed closely by the Public Citizen Health Research Organization. Their Worst Pills Best Pills publications (books and newsletters) focus on drugs whose safety is questionable and drug companies whose practices ignore the public safety to continue to sell dangerous or lethal drugs to the public.
Drug Topics Magazine listed the Top 200 Selling Drugs in the U.S. in 2003, of which six were categorized by Worst Pills Best Pills as so dangerous they were on the group’s DO NOT USE list. These included celecoxib (Celebrex) for arthritis / pain; the so-called Alzheimer'sdrug donepezil (Aricept); an oral contraceptive drospirenone (Yasmin 28); esomeprazole (Nexium) the 'purple pill' for heartburn; montelukast (Singulair), for asthma / hay fever; and valdecoxib (Bextra), a COX-2 inhibitor like celecoxib. The combined sales of these six drugs was $8.1 billion in 2003.
Using Consumer Information is the Consumer's Responsibility
The following includes information regarding COX-2 inhibitors, with side effects of renal failure, gastrointestinal damage, and a high risk of cardiac events:
- They do not treat Alzheimer’s symptoms and their use for that is off-label (not FDA approved).
- Painkiller valdecoxib (Bextra) was removed from the market in June 2005, and FDA issued major new warnings for other NSAIDs.
- In May 2006, Celecoxib was listed as causing twice as many heart attacks as older arthritis drugs.
- In December of 2008, numerous NSAIDS were listed to cause high blood potassium.
- In February 2009, NSAIDs were proven to cause dangerous blood pressure fluctuation.
- After more than six statements to the FDA on the dangers of COX-2 inhibitors, specifically Celebrex, Public Citizen Director Dr. Sydney Wolfe petitioned to have both Bextra and Celebrex removed from the market. Pfizer remove Bextra, but FDA allowed just another warning on the best-selling drug (almost 24 million prescriptions), Celebrex. Neither drug protects the gastrointestinal tract as claimed.
- One law firm is pursuing 31,000 claims against the manufacturers of major NSAIDs Vioxx, Celebrex, Mobic, and Bextra.
The Public Citizen organization and worstpills.org web sites contain documentation of the efforts of one of the most effective advocacy groups in America and the results of their battles to make prescription drugs safer for consumers. Specific pharmaceuticals and their histories can be located by doing word searches on these sites.
Resource: Consumer Safety Vs. Multi-Million Dollar COX-2 Pain Pill Manufacturers
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