FDA Alerts

FDA Drug Safety Communication: FDA Recommends Against the Continued Use of Meridia (sibutramine)

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Meridia

Safety Announcement 
[10-8-2010] The U.S. Food and Drug Administration (FDA) is recommending against continued prescribing and use of Meridia (sibutramine) because this drug may pose unnecessary cardiovascular risks to patients. FDA has requested that Abbott Laboratories—the manufacturer of Meridia—voluntarily withdraw this drug product from the United States market. Abbott has agreed to voluntarily stop marketing of Meridia in the United States.

Meridia was FDA-approved in November 1997 for weight loss and maintenance of weight loss in patients with a body mass index (BMI) greater than or equal to 30 (≥30) kg/m2 or for patients with a BMI ≥27 kg/m2 who have other cardiovascular risk factors. BMI is a measure of body fat in adults that is based on height and weight. Patients with a BMI ≥30 kg/m2 are considered obese.

FDA’s recommendation is based on new data from the Sibutramine Cardiovascular Outcomes (SCOUT) trial, which demonstrated a 16% increase in risk of major adverse cardiovascular events (a composite of non-fatal heart attack, non-fatal stroke, resuscitation after cardiac arrest and cardiovascular death) in patients treated with Meridia compared to patients taking a placebo (see Data Summary below). At the end of the trial (60 months), patients in the Meridia group lost a small amount of body weight compared to patients in the placebo group. FDA has concluded that the risk for an adverse cardiovascular event from Meridia in the population studied outweighed any benefit from the modest weight loss observed with the drug.

In November 2009, and January 2010, FDA announced it was reviewing clinical trial data about a potentially serious effect on the heart from the use of Meridia. The links to these communications are listed below: 

 Additional Information for Patients 
If you currently take Meridia, you should:

  • Stop taking Meridia and talk to your healthcare professional about alternative weight loss and weight loss management programs.

  • Talk to your healthcare professional if you have any concerns about Meridia.

  • Contact your healthcare professional right away if you experience pain in the chest, heart palpitations, abnormal heart rate or rhythm, or other symptoms including dizziness and lightheadedness.

  • Dispose of unused Meridia in your household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines:

    • Take your Meridia out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter. The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.

    • Put the medication in a sealable bag, empty can, or other container to prevent it from breaking out of a garbage bag.

  • Report any side effects with Meridia to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

Additional Information for Healthcare Professionals 
FDA recommends that healthcare professionals:

  • Stop prescribing and dispensing Meridia to patients.
  • Contact patients currently taking Meridia and ask them to stop taking the medication.

  • Inform patients of the risks associated with Meridia.

  • Discuss alternative weight loss strategies other than Meridia with your patients.

  • Be aware of the possible risk of major adverse cardiovascular events with patients taking Meridia and assess patients for these events if they present with any signs or symptoms of cardiovascular disease.

  • Report any side effects with Meridia to FDA's MedWatch program using the information at the bottom of the page in the "Contact Us" box.

 

FDA NEWS RELEASE

For Immediate Release: Oct. 8, 2010

Abbott Laboratories agrees to withdraw its obesity drug Meridia
Abbott Laboratories has agreed to voluntarily withdraw its obesity drug Meridia (sibutramine) from the U.S. market because of clinical trial data indicating an increased risk of heart attack and stroke, the U.S. Food and Drug Administration announced today.

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER). “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.”

Meridia was approved by the FDA in 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 lost at least 5 percent of their body weight than people on placebo who relied on diet and exercise alone.

The FDA requested the market withdrawal after reviewing data from the Sibutramine Cardiovascular Outcomes Trial (SCOUT). SCOUT was initiated as part of a postmarket requirement to look at cardiovascular safety of sibutramine after the European approval of this 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 compared to another given placebo. There was a small difference in weight loss between the placebo group and the group that received sibutramine.

“The patients in the European SCOUT trial did not have the same characteristics as the patients for the approved indication in the United States; however, these results, combined with other available safety data raised serious questions about Meridia’s safety for all patient groups,” said Gerald Dal Pan, M.D., M.H.S., director of the Office of Surveillance and Epidemiology in CDER.

The agency’s analysis of SCOUT was the subject of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 15.

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Scott has been involved in numerous and diverse settlements and verdicts throughout his 18 year legal career.  He prides himself on taking care of the injured people he represents.  Scott has represented individuals from almost every state in the country and can point to settlements involving millions of dollars. Whether it be a faulty medical device, a flawed manufacturing process, a failed prescription drug or some other issue that has caused personal injury, Scott has the experience, determination and the integrity to represent a client’s interests aggressively and see that justice is served. The following examples are but a few of recent notable accomplishments:

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Most recently, Scott began working on Paxil birth defect cases. Paxil is an antidepressant still used by millions of Americans daily.  In recent years, however, it has been associated with significant heart defects when ingested by women during the first trimester of a pregnancy.  Scott has been actively prosecuting these cases against GSK, maker of the drug. One of his cases was the first to be set for trial.  The case was resolved in favor of Scott’s client.

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