Item #2

Beware of Meridia -- Italy Already Pulled it Off the Market

Italy' has suspended sales of anti-obesity drugs containing sibutramine after 50 reports of adverse events among people taking the medicines.

The decision follows a report from the General Directorate for the Evaluation of Drugs and Pharmacovigilance. All drugs that contain sibutramine, including Abbott's anti-obesity drug Reductil (called Meridia in the US), have been withdrawn from the market.

"Based on 50 reports of adverse events during treatment, the CUF (Drugs Committee) decided that the beneficial effects of the drug must be re-evaluated."

Sibutramine-based drugs have been on the Italian market since April 2001.

The ministry advises people currently using sibutramine to stop taking the medicines and seek advice from their doctor.

Dr. Eugene Sun, the vice president for pharmaceutical development at Abbott reported that the company has received reports of 32 deaths in people who were taking sibutramine, with 28 in the US, two in Italy, one in Switzerland, and one in South Africa.

About 20,000 Meridia prescriptions are filled in the US each week, according to the FDA. Abbott said that 8.5 million people worldwide have taken the drug.

The drug was approved for use in the US in 1997. A risk of increased blood pressure and heart rate have been reported in some patients taking it. 

Consumer advocacy group Public Citizen petitioned the agency last week to take Meridia off the market.  

Claiming that the US Food and Drug Administration (FDA) never should have approved Abbott Laboratories' weight-loss drug Meridia (sibutramine), consumer advocacy group Public Citizen petitioned the agency last week to take the drug off the market.

Spokesman, Sidney Wolfe, director of Public Citizen's health research group, stated that Meridia poses significant risks without much benefit. He claims that the average weight loss with the drug is six to 11 pounds, an insignificant amount for someone who is obese.

"Everything was against approving this drug," said Wolfe. He noted that an FDA advisory panel voted against approval in 1996 because of Meridia's tendency to elevate blood pressure. An FDA reviewer also recommended against approval, and during trials, obese patients taking Meridia had higher incidences of elevated heart rate and blood pressure and abnormal electrocardiograms than those taking a placebo, Wolfe said.

As more European countries take a closer look at deaths and adverse events in patients taking Abbott Laboratories' weight-loss drug sibutramine, the US Food and Drug Administration (FDA) said Friday it is monitoring reports related to the drug, but would not say if it has begun a formal investigation.

The FDA also said that it was monitoring the situation in the US. The agency said it had reports of 25 deaths in US sibutramine patients, 16 of which were due to cardiac events. Abbott said last week that it had reports of more than 30 deaths in sibutramine patients worldwide, but that the company believes the deaths do not appear to be linked to the drug.

Abbott spokeswoman Melissa Brotz said the company "was not surprised" by Public Citizen's petition, but added, "we don't necessarily see what they're doing with any credibility." And, "the bottom line is, the drug remains safe and effective," said Brotz,  noting that the apparent death rate in patients taking Meridia -- about two per 100,000 -- is far lower than the standard reported rate for the obese, 400 per 100,000 patients.

An FDA spokeswoman said the agency will review Public Citizen's petition and respond accordingly. She added that "FDA is concerned about the adverse events with Meridia" and is looking into the reports. But, she noted, "If the warnings are heeded and the drug is used according to labeling, we feel the drug is safe and effective."

Because Meridia has been associated with increases in heart rate and/or blood pressure, its label notes that it should not be used by patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. It also notes that the drug "substantially" increases blood pressure in some patients, and urges regular monitoring.

Denise Bruner, an Arlington, Virginia-based obesity specialist and president of the American Society of Bariatric Physicians, said the Society recommends strict monitoring of patients taking obesity drugs.  She also said that she believes Meridia can be used safely as long as physicians keep a close eye on patients. But, she noted, the drug does not produce meaningful weight loss for some patients, especially those who think Meridia alone will do the job. "To rely on the pill is setting yourself up for failure," said Bruner, noting that "it's meant as a facilitator to help you embark upon lifestyle changes."

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