Diet Drug Causes Heart Attacks: Europe Bans & U.S. Issues Warning

by Heidi Stevenson

11 February 2010

A drug used for obesity, though it has always been known to have limited benefit and carries the risk of death from cardiovascular disease, is finally being banned in Europe, but the Food and Drug Administration (FDA) is merely putting a warning on it, a move known to have little effect on usage. Sibutramine is sold by Abbott pharmaceuticals as Meridia, Reductil, Sibutral, Reduxaid, Zelium, and Ectiva.

Known to carry grave risks prior to approval by the FDA, sibutramine has been widely prescribed for minor benefits. It's supposed to be used only in people with a body mass index (BMI) over 30. The average weight loss in a trial in which the subjects were also involved with a weight loss program was minimal. Subjects who took the drug lost about 15 pounds (6.8 kg). Those who took a placebo lost an average of 6.8 pounds (3.1 kg). The benefit gained by taking sibutramine was only 8.2 pounds (3.7 kg) over one year. Most trials actually showed even less benefit. (In fact, most trials showed even less benefit.)

For an expected benefit of, at most, only 8.2 pounds in weight loss, doctors have been prescribing a drug that causes heart attacks, congestive heart failure, anaphylactic shock, kidney disease, seizures, neuroleptic malignant syndrome, and psychosis—and that's just the beginning of known risks.

Sibutramine was first approved by the FDA in 1998. By 2002, 29 deaths had officially been associated with it. Italy banned it that year after two cardiovascular deaths. Public Citizen, an organization involved in health, safety, and environmental issues petitioned the FDA to withdraw sibutramine. In it, they stated:

...the effect of sibutramine in promoting weight loss is meager and it is not known if this drug, or any diet drug for that matter, can be taken safely for a long enough period of time to reduce the morbidity and mortality associated with obesity.
—and— More recently, the French medical journal, Prescrire International, concluded that "Sibutramine...has amphetamine-like side effects" and "In practice sibutramine currently has no place in the management of obesity."

Public Citizen's petition further noted that:

• Trials before submission documented an increase in blood pressure.
• "The FDA medical officer coordinating the review of the New Drug Application for sibutramine concluded on May 10, 1996 '...sibutramine has an unsatisfactory risk-benefit ratio, and therefore this Reviewer recommends non-approval of the original submission...'"
• One study showed that clinically-significant ECG changes were three times more likely to occur.
• "...the safety data [before approval] indicate a possible to probable drug-related risk for several serious adverse events cardiac arrhythmia, cerebrovascular accident, acute interstitial nephritis, thrombocytopenia, and bleeding disorders."

The petition gives more extensive documentation about why sibutramine should never have been approved, and identifies adverse effects documented since its approval. The FDA did nothing until this year, and, even now, all the agency has done is require that a warning be included stating that the sibutramine is contraindicated when the patient has prior heart disease.

Obesity of the sort defined by a BMI of 30 or more is virtually proof of cardiovascular problems. The heart is, without question, under increased stress by excess fat of that quantity. Obesity is noted as a predictor of heart disease. Obviously, a drug that increases the risk of death from heart disease is a poor choice in someone who's obese—and certainly makes no sense for obesity treatment, especially when its benefits are so limited.

Sibutramine is an SNRI (serotonin norepinephine reuptake inhibitor), a drug that interferes with brain chemistry. The history of this class of drugs is dismal. They were developed as a continuation of the SSRI (selective serotonin reuptake inhibitor) drugs, intended for use in depression. As has become more and more clear, they are not effective, cause suicide, and have a huge range of horrific effects, including the ones noted for sibutramine.

Yet, the FDA approved sibutramine, in spite of its own experts strongly advising against it. What possible reason could there be for approval of such a drug, if not for profits? The FDA's decision makers must have benefitted, either directly or through advantages gained later, such as cushy jobs in Big Pharma businesses—as happened recently when the former chief of the Centers for Disease Control (CDC) was hired to head Merck's vaccine division after she'd assured the CDC would strongly support their products for years to come through major upheavals in the agency.

All of this information has been available to doctors since sibutramine was first marketed. The question that must be asked is: Why have they prescribed sibutramine? Have they been blinded by the spin? Or have they been blinded by their own profits? Ignorance or greed—neither is comforting.

Surely, there has never been a legitimate reason for prescribing a drug with such limited benefit to the very people who are most likely to be harmed by it. Yet, sibutramine has been a very popular drug. It was approved without any concern for the people who would be harmed. It has been continued for years after its effects were obvious. People have clamored for it and doctors have prescribed it and Abbott has made enormous profits from it—and the agencies charged with protecting us from dangerous drugs have all failed us.

The European Medicine Evaluation Agency (EMEA), though it has finally banned sibutramine, allowed it to be sold and used for over a decade with clear information that the risks are far more significant than its limited benefits. Greece, though it was first to ban the drug, did allow its sale for about three years. And the FDA—words fail me. Even now, with the rest of the world banning it, the FDA has merely required that a warning be included in the package stating that people with preexisting heart conditions shouldn't take it.

I wonder who at the FDA is expecting a nice cushy job at Abbott?

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