Meridia (sibutramine) is a weight loss drug which was prescribed to treat obesity by helping people lose weight and keep it off. Upon the request of the U.S. Food and Drug Administration (FDA), Abbott Laboratories withdrew Meridia from the U.S. market on October 8, 2010 due to risk of stroke, heart attack, and other dangerous cardiovascular events.

Meridia Uses

Meridia was approved by the FDA in 1997 to treat obesity. It may also have been prescribed off-label to treat people who were merely overweight. People with a body mass index (BMI) of 30 or greater are classified as obese.

Meridia is an appetite suppressant and was meant to be used in conjunction with a diet and exercise program during the weight loss phase and then could be taken to maintain weight loss.

Meridia affects the area of the brain that controls hunger. By inhibiting the reuptake of the neurotransmitters dopamine, norepinephrine, and serotonin, it makes you feel full and satisfied.

Meridia Dangers

Meridia side effects can include:

  • Heart attack
  • Stroke
  • Increased blood pressure
  • Rapid heart rate
  • Nervousness
  • Anxiety
  • Insomnia
  • Abdominal pain
  • Joint pain
  • Sore throat
  • Depression

Dangers Were Known

The dangers of Meridia were known to its maker and to the FDA when the drug was approved, in 1997, but the FDA says it believed that the benefits outweighed the risks.

The consumer advocacy organization Public Citizen petitioned the FDA to have Meridia banned in 2002, citing 29 deaths and hundreds of serious adverse reactions associated with Meridia use. In 2003, the group updated its petition, stating that 49 Meridia users had died of adverse cardiovascular events.

The FDA did not ban Meridia or request its withdrawal in response to the petition, but in 2004, it did required changes in the Meridia label warning of the risks of increased heart rate and blood pressure. The label change also included warning that Meridia should not be used in patients over 65 years old or those with a history of:

  • Stroke
  • Congestive heart failure
  • Coronary artery disease
  • Peripheral artery disease
  • Uncontrolled hypertension
  • Abnormal heart rhythm
  • Rapid pulse

SCOUT Leads to Withdrawal

The Sibutramine Cardiovascular Outcomes Trial (SCOUT) was a five year study of Meridia risks and efficacy, conducted from January 2003 to March 2009. SCOUT found an increased risk of heart attack, stroke, and death with Meridia use. It also found that the average weight difference between Meridia users and those taking a placebo was only about 2.5%

In January 2010, based on SCOUT data, the European Medicines Agency (EMEA) announced that the risks of the drug outweighed the benefits and took action to begin removing sibutramine from the European market.

Nearly nine months later, the FDA drew the same conclusion and asked Abbott Laboratories to voluntarily withdraw Meridia from the U.S. market.

If you have been injured by Meridia use or lost someone you loved to the defective drug, please talk to a Meridia injury lawyer in your area today.