Europe Moves to Ban Sibutramine (MERIDIA): FDA Should Ban Weight-Loss Drug

The European Medicines Agency (EMEA), the European Union’s equivalent of the Food and Drug Administration (FDA), said Jan. 21 that the benefits of sibutramine (MERIDIA) do not outweigh its risks, and recommended that the drug be banned throughout Europe.

The EMEA’s recommendation is the result of the agency’s inves­tigation into the drug’s effects that began in late 2009. The decision is based on preliminary results of the Sibutramine Cardiovascular Out­comes study, nicknamed SCOUT, a large pharmaceutical industry-funded study.

SCOUT included 10,000 obese patients, of whom half were given sibutramine and half were given a placebo. Results from this study provide evidence of a statistically significantly increased chance of a stroke, heart attack, resuscitated cardiac arrest or death in patients taking sibutramine, compared to those taking a placebo.

Despite these results, the FDA has decided to leave the drug on the market in the U.S., strengthen the warning label and consider the results of SCOUT at an advisory committee meeting in September 2010. With 294,000 prescriptions filled in the U.S. for the drug in 2009, the FDA’s sluggishness can only be viewed as a reckless, patient-indifferent decision which will harm patients in this country (a sharp contrast to the patient-protective decision made in Europe).

Public Citizen petitions to ban drug – twice

We first petitioned the FDA to ban sibutramine in 2002 because the FDA physician who researched the drug before its approval said it should not be approved, as did FDA’s advisory committee who studied the drug. These conclusions were based on increased blood pres­sure, pulse and arrhythmias in pa­tients getting the drug. In addition, from the drug’s approval in 1997 until 2002, it had been associated with the deaths of 29 people, many quite young.

In 2005, the FDA denied our petition, stating:

An unbiased, objective assessment of sibutramine’s cardiovascular safety profile, particularly when used in obese patients with known or occult cardiovascular disease, can best be made through analyses of data from a large, randomized, controlled trial. The Sibutramine Cardiovascular Outcomes, or SCOUT study, is such a trial.

Thus, the FDA was waiting for the results of SCOUT to further assess the drug.

In Dec. 2009, using the same pre­liminary results the EMEA used to decide that the drug should not be marketed, we re-petitioned the FDA to ban the drug, based on this study.

When we filed the second petition to ban the drug, we stated in a letter to FDA Commissioner Margaret Hamburg:

If the agency decides not to ban this drug and, instead, chooses to merely increase the warn­ings, as it has previously done for two other drugs whose risks also substantially outweigh their benefits – propoxyphene (as in DARVOCET) and rosiglitazone (AVANDIA), you will be presid­ing over an expanding mockery of your [earlier published] statement: “Some benefits are not worth the risk” and “the public must trust the agency to base its decisions on science.”

It is our opinion that if the FDA truly intends to operate as a pub­lic health agency, then it should acknowledge that the continued approval of this drug cannot be justified based on science. The FDA should therefore tell manufacturer Abbott to pull sibutramine from the market immediately.