Advocacy Group Re-States Petition to Ban Meridia, Blasts FDA

May 29, 2010, 2:30AM. By Gordon Gibb

Washington, DCWhile various global health agencies have stepped up their opposition to Meridia sibutramine due to Meridia side effects, the consumer advocacy group Public Citizen (PC) has been railing against the diet drug since 2002. In March of that year, PC officially petitioned the US Food and Drug Administration (FDA) to ban the drug from pharmacy shelves.

This past December, Public Citizen—over the signature of longtime advocate Dr. Sidney Wolfe, re-petitioned the FDA to ban Meridia. And in March, on the eighth anniversary of its original petition to the FDA, Public Citizen brought the matter up again.

In a communiqué to Margaret Hamburg, MD, Commissioner, and Joshua Sharfstein, MD, Principal Deputy Commissioner of the FDA, Dr. Wolfe initially praised the two doctors for the "…welcome, increased focus and action to protect people from unsafe or possibly unsafe foods," citing the massive recall earlier that month of products containing hydrolyzed vegetable protein in spite of the fact no illnesses were known to be associated with salmonella bacterial contamination. The agency nonetheless was taking steps in an effort to insulate and protect the public.

However, Dr. Wolfe's praise was short-lived.

"In contrast to becoming more active and cautious in enhancing food safety by removing potentially dangerous products before they have caused harm, several FDA decisions in the past year regarding prescription drugs can only be described as reckless," Wolfe writes in a letter dated March 8, 2010 and posted on the Public Citizen web site.

He noted that Meridia (sibutramine) had been recommended for removal in the UK and in Europe.

"When it recommended the ban of sibutramine in January of this year," Dr. Wolfe writes, "the [European Medicines Agency] stated that 'the benefits of sibutramine-containing medicines do not outweigh their risks,' based on a 10,000 person study showing significantly increased heart attacks, strokes or cardiovascular deaths in people taking the drug compared with those who received a placebo.

"The FDA, in contrast, said that it had not yet analyzed the data from this same study but will strengthen the drug's warning label and have an advisory committee meeting in the fall."

In its re-submission of a petition to the FDA to ban Meridia this past December, Public Citizen referenced early results of the SCOUT study that found a "a significantly increased number of patients with heart attacks, strokes, resuscitated cardiac arrests or deaths in those who are obese and aged 55 or older with known or occult cardiovascular disease using sibutramine, compared with those given a placebo. Both groups were on the same weight management program.

"The FDA has reported that 11.4 percent of patients getting sibutramine vs. 10 percent of patients getting a placebo suffered a heart attack, stroke, resuscitated cardiac arrest or death, the primary pre-specified outcome of the study."

Dr. Wolfe used the December, 2009 re-petition to remind the FDA that as of June 30th, 2009—a little less than a year ago—there had been no fewer than 84 reports of deaths from cardiovascular causes in the FDA Adverse Event Reactions (AERS) database, including 30 individuals aged 50 or younger. Of those 30, 11 were age 30 or younger.

Wolfe reminded the FDA that in its original petition dated March 19th, 2002 Public Citizen noted that during the randomized placebo-controlled clinical trials conducted prior to sibutramine's approval in 1997, "the drug caused significant increases in blood pressure, pulse rate, and palpitations in patients taking the drug compared to patients using a placebo. In one study submitted by Knoll to the FDA, patients taking sibutramine were three times more likely to experience clinically significant ECG (electrocardiogram) changes than patients taking placebo.

"The FDA Medical Officer coordinating the review of the New Drug Application for sibutramine concluded on May 10, 1996 that, 'sibutramine has an unsatisfactory risk-benefit ratio, and therefore this Reviewer recommends non-approval of the original submission of NDA 20-632.' He also stated that 'the 10 and 15 mg doses of sibutramine satisfy the minimum weight-loss criteria and duration of study as defined in the Guidance, however, sibutramine does not improve, and in some cases it aggravates major obesity-related co-morbidities.'"

There is little doubt that Public Citizen will be carefully watching the FDA when the agency next addresses Meridia sibutramine and Meridia side effects for Meridia stroke, heart attack and other issues, come the fall.