Sibutramine [Meridia]: Market Withdrawal Due to Risk of Serious Cardiovascular events
Last Updated on October 9, 2010 by Joseph Gut – thasso
October 08, 2010 – Today, we learn that Abbott Laboratories and FDA notified healthcare professionals and patients about the voluntary market withdrawal of Sibutramine [Meridia], an obesity drug, from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke.
BACKGROUND: Sibutramine [Meridia] was approved November 1997 for weight loss and maintenance of weight loss in obese people, as well as in certain overweight people with other risks for heart disease. The approval was based on clinical data showing that more people receiving Sibutramine [Meridia] lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone. FDA has now requested market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT is part of a postmarket requirement to look at cardiovascular safety of Sibutramine [Meridia] after the European approval of the drug. The trial demonstrated a 16 percent increase in the risk of serious heart events, including non-fatal heart attack, non-fatal stroke, the need to be resuscitated once the heart stopped, and death, in a group of patients given Sibutramine [Meridia] compared with another given placebo. There was a small difference in weight loss between the placebo group and the group that received Sibutramine [Meridia].
Physicians are advised to stop prescribing Meridia to their patients, and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs.
More information can be found at FDA Drug Safety Communications for Sibutramine [Meridia] and at FDA Questions and Answers concerning Sibutramine [Meridia].
Every year about 230,000 Americans die and 2.3 million spend time in a hospital as a result of adverse reactions to prescription and/or nonprescription drugs. The same side effects also generate annual healthcare costs in excess of $200 billion. These numbers may not be a surprise to some, but did you also know that well over 50% of all drugs entering the market have a severe adverse reaction that no one knows about other than, perhaps, the manufacturer marketing and selling the drug? You and I, and the rest of the American public, are effectively guinea pigs for the drug industry.
It has been estimated that Vioxx killed between 26,000 and 56,000 of its users before being removed from the market in September 2004. Records produced during litigation with Merck revealed that the company knew about the drug’s propensity to produce blood clots at least two years before it was approved by the FDA. Paxil was initially marketed in 1993 for the treatment of depression. But by 2004, postmarket studies were reporting that with many children and young adults the drug increased depression and was inducing suicidal thoughts, doubling the risk of suicide. But the real shocker occurred in 2008, when records produced by GlaxoSmithKline pursuant to court orders revealed that premarket studies with the drug had been manipulated – that the drug company had concealed the fact that studies going as far back as 1989 demonstrated an 8-fold increase in the risk of suicide.
The above facts are just two of many examples of why it is absolutely insane that the very studies which determine whether a drug is approved by the FDA for market ARE CONDUCTED AND CONTROLLED BY THE DRUG COMPANIES THEMSELVES. This is the way it has been since the FDA was formed 72 years ago in 1938. It is thus about time that we took the fox out of the henhouse and established an impartial and objective entity to oversee all premarket clinical studies of drugs. We also need to REMOVE THE 10-MONTH AND 6-MONTH ARBITRARY DEADLINES for standard and priority new drug reviews established by Congress at the behest of the drug industry in 1992, which has created an environment at the FDA where drugs are being rushed to market without an adequate opportunity to assess their safety and effectiveness.
I would thus encourage everyone to go to my website at http://www.FDAReformPetition.com and sign my petition to Congress demanding the above changes. Only as potential voters speaking in a unified voice will we ever have any hope of enhancing the safety of marketed drugs and slashing a huge chunk out of our future healthcare costs.
The FDA announcement that Abbott Laboratories would be withdrawing Meridia from the market was long over-due. Indeed, it follows the drug’s removal in Europe by 9 months. Meridia was approved in November 1997 for weight loss and maintenance of weight loss in obese and overweight patients. The recent study reported a 16% increased incidence of combined serious cardiovascular events, which included a 28% increased risk of non-fatal heart attacks and a 36% increased risk of non-fatal strokes. The average loss of weight in the Meridia group over the controls was only 2.5%. The FDA thus concluded that the benefits did not outweigh the risks and ordered withdrawal. My only question is – WHAT TOOK SO LONG?
Why should it take 13 years to determine that a drug, capable of causing heart attacks and strokes, cannot provide a meaningful loss of weight in return for taking on the risk? On May 10, 1996, the assigned FDA medical officer concluded that Meridia had an unsatisfactory risk-benefit ratio and recommended against approval of the drug. He observed that Meridia did not improve, but often aggravated the usual cardiovascular risks associated with being obese, including increases in blood pressure, heart rate and heart palpitations – with only a 5% loss of body weight. On September 26, 1996, an FDA advisory committee voted 5 to 4 against the drug’s approval and concluded that Meridia’s ability to cause an increase in high blood pressure was “clinically important.” The only justification for approving Meridia for market 13 years earlier would have been that it produced a reduced risk of cardiovascular disease. Loss of weight – by itself – should not have been enough. With all early indicators pointing to an increased risk – even a small one – the drug had no place on the American market. The original medical officer saw the problem in May 1996. An FDA advisory committee saw the problem in September 1996. But for the FDA brass…well, let’s say it took a bit longer before the fog cleared. http://www.DrugSafetyAdvice.com.