Meridia Risks - High Blood Pressure and Deaths related to Cardiovascular Events

The weight-loss drug Meridia has been the subject of a great deal of controversy. After many deaths and serious side effects, the FDA (Federal Drug Administration) has acted slowly in requiring the manufacturer, Abbott Laboratories, to inform health care professionals and the public about the dangers of this drug.

Concerns about Meridia first surfaced in 2002. In March of that year the Italian Ministry of Health suspended sales of the drug in Italy because of deaths related to cardiovascular events. The consumer-protection group Public Citizen filed a petition with the FDA asking that Meridia be banned in the U.S., because the risk of use was greater than the benefit. At that point, concerns were raised about fetal toxicity. In spite of that, the EU regulatory agency recommended that marketing be reinstated in Europe.

The Public Citizen 2002 petition was supplemented in September 2003, but the FDA took no action. In November 2004 David Graham, a safety expert with the FDA, testified at a Congressional hearing. In the course of his testimony he named 5 drugs that the FDA allowed to be marketed in spite of safety concerns. Meridia was one of the drugs named. In August 2005, the FDA finally responded to the Public Citizen petition in a letter that underplayed the risks of Meridia.

In December of 2004 and April 2005 Abbott Laboratories sent letters to health care professionals and pharmacists about the need to monitor blood pressure in patients using Meridia and methods for risk management. The current warnings on Meridia include:

  • Substantial increases in blood pressure occur in some patients.
  • Blood pressure should be monitored in all patients using Meridia.
  • Meridia should not be used in patients with a history of CAD, stroke, arrhythmia, or CHF.
  • Meridia is not recommended for use by pregnant women.

China's Macau’s Health Bureau banned all products in 2005 containing sibutramine, the generic name for Meridia.

Check out the following articles for more information about Meridia, filing a Meridia lawsuit and finding a Meridia attorney: