FDA Approves Pain-Killer Linked to Death

The U.S. Food and Drug Administration (FDA) recently approved the first generic version of Celebrex (celecoxib), a potent and potentially lethal pain-killer.  Celebrex was the lone survivor of the “big three” pain drugs (including Vioxx and Bextra) in the cox-2-inhibitor family of medicines prescribed for pain conditions like arthritis.  The health dangers of Vioxx and Bextra resulted in their removal from the market in the mid-2000s but it remains a mystery why Celebrex escaped a similar fate.

Perhaps the willingness of its maker, pharmaceutical giant Pfizer, to openly declare, “Important Information: Celebrex may increase the chance of a heart attack or stroke that can lead to death” as part of its advertising helped to keep it in the marketplace when its competition disappeared.  But how could the company, medical doctors, the government and even patients continue to support this product in this face of overwhelming evidence of its danger?

Now, the FDA has opened the door for Teva Pharmaceutical Industries to manufacture and sell celecoxib—the active ingredient also found in Celebrex—in strengths ranging between 50 milligrams and 400 milligrams.  A second company, Mylan Pharmaceuticals Inc., received approval to market 50 mg celecoxib capsules.  In 2008, a study found that people who take 400 milligrams of Celebrex twice a day have three times the risk of having heart attacks, other heart problems, strokes, or cardiovascular disease death, compared with people who don’t take the drug.  People who take 200 milligrams twice daily have double the risk. The research was funded by the National Cancer Institute and involved an analysis of six studies with Celebrex and a placebo in nearly 8,000 patients being treated for conditions other than arthritis.

What is the upside for patients when the FDA requires a death warning on a medicine?  Why would the government approve a generic version of this drug when it acknowledges the numerous cardiovascular, gastrointestinal and other health risks, many of which are far worse than the pain the drug-users are trying to suppress? These questions are best directed to the FDA.

Pain is a horrible experience. It can rob you of the joy in your life when it is chronic. Fortunately, many types of pain can be managed and greatly reduced with lifestyle and diet changes. Mother Nature has a complete arsenal of pain-killing food and herbs, many of which have been scientifically proven to reduce pain better than pharmaceuticals.  Plus, they taste great and have no life-threatening side effects.

For those of you still tempted to take this drug or other cox-2 inhibitors and non-steroidal anti-inflammatory drug (NSAIDS) pain-killers:  be careful, they can kill more than pain.

13 Foods that Fight Pain
5 Dangers of Over-the-Counter Pain Relievers

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Bruce S.
Bruce S.2 years ago

Continued Form Below:

with the 10 day use of the anticoagulant) use of Celebrex. The normal risk enhancement for heart attack of COX 2 inhibitors was mitigated by the simultaneous use of an injected anticoagulant. I am glad that option was available, and that the potential for dangerous misuse of COX 2 inhibitors hasn't tempted the FDA to make COX 2 inhibitors unavailable in all circumstances.

Bruce S.
Bruce S.2 years ago

The premise behind this article is that the FDA should not approve drugs with life threatening side effects, and that approving a drug with a warning of risk of death is irrational. I disagree. the use of any drug, especially those with life threatening side effects requires balancing the risks and benefits, as well as evaluating the applicability of the risk and using and/or recognizing mitigating circumstances where applicable. Cox 2 inhibitors certainly can be dangerous, but that is not a basis for denying access under all circumstances. The FDA's approach of requiring a severe but realistic warning, and leaving the ultimate decision to the doctor and patient, is totally reasonable and appropriate.

For example, about a year and a half ago I underwent a major surgery. The post-surgery risk of throwing blood clots was addressed by 10 day use of subcutaneous injections of a powerful anticoagulant. Post-surgery pain and inflammation treatment options were limited: most NSAIDs are contraindicated when using an anticoagulant because NSAIDs have substantial, but very time dependent (rapidly changing) additional anticoagulant properties. Narcotics have multiple detriments, including further disruption of digestive track inhibition already inhibited from a sedative included in the spinal block used for the surgery. Also, narcotics would have only addressed pain; they would not have addressed post-surgery inflammation. The best option was 10 day (coinciding with the 10 d

Magdalena J.
Past Member 2 years ago

Thank you!

Debbie Crowe
Debbie Crowe3 years ago

A friend of mine takes Celebrex, so I sent her this article!

Kimberly C.
Kimberly C3 years ago

Many drugs have serious, possibly fatal side effects, but the benefit may outweigh the risk. It's up to you and your physician to decide.

The choices for pain killers is abysmal. What is an arthritis or injury sufferer to do? Lifestyle changes are great, but they don't work for everything.

Aspirin can cause gastric bleeding and it isn't all that effective for many types of pain. The more you take, the more likely you'll wind up with an ulcer. Children can't take aspirin for fear of Reye's Syndrome.

NSAIDs (Cox-1 type like Motrin, Aleve, et al) cause gastric bleeding much quicker with a lesser dose than aspirin. Although effective, especially for inflammation related pain, the risk of gastric bleeding outweighs the benefit of pain reduction for many people. A perforated ulcer can kill you. Yet it is still sold OTC and gobbled up by millions.

NSAIDs (Cox-2 celebrex) is discussed above. It was developed to avoid the gastric implications of its Cox-1 cousin. Effective, but expensive and a risk of cardiac death.

Tylenol can destroy your liver and is not all that effective for many types of pain.

Narcotics are incompatible with a mentally healthy lifestyle and surely kills many who become addicted. It has the potential to kill innocent bystanders as well when people take them then go out and drive.

Until something better comes out, allowing Celebrex to go generic makes sense as long as the patients and their doctors understand the risk and take steps to minim

Magdalena J.
Past Member 3 years ago

Thank you!

Anna Undebeck
Anna Undebeck3 years ago

Thanks for the info. Its difficult though- most medicine/painkillers/drugs are linked to death. But absolutely agree with @Mari : Legalize Hemp and Marijuana , everywhere thanks. But before that will happen in Sweden, if it ever will, i will probably be dead by then. Thanks again.

Wendy H.
Wendy H3 years ago

Thank you...can't say I am surprised...

Arlette King
Arlette King3 years ago

frightening , I have been taking Celebrex since they took vioxx of the market.took vioxx till that came off market

Sheri K.
Sheri K3 years ago

I was taking celebrex for a short time, but all i got was the side effects. Glad i am not taking it anymore