Meridia Label Change Follows FDA Review Of Heart-Related Adverse Events In SCOUT Study

New Meridia Package Insert Will Now Show "Contraindication" For Patients With A History Of Cardiovascular Disease

UPDATE:  Meridia Recall By Abbott In October 2010 Follows FDA Request To Withdraw Drug From Market

Meridia recall in U.S. pursuant to FDA request in October 2010 due to increased risks of a stroke or cerebrovascular accident (CVA), heart attack or myocardial infarction (MI), sudden cardiac death, and other serious cardiovascular side effects caused by Meridia outweighing any benefit from use of this obesity drug.

On January 21, 2010 the FDA announced that Abbott Laboratories, Inc. will change the package insert, or label, for Meridia (sibutramine) to indicate that this weight-loss drug should not be taken by patients with a history of cardiovascular disease. This Meridia label change follows the FDA's review of additional data showing an increased risk of heart attack and stroke among that patient population.

From the "Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia", which was issued by the FDA on January 21, 2010:

The U.S. Food and Drug Administration (FDA) has reviewed additional data that indicate an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, marketed as the weight loss medication Meridia. The [Meridia (sibutramine)] drug label already includes warnings against the use of [Meridia] in patients with cardiovascular disease. However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the [Meridia] drug label.

The contraindication will state that [Meridia] is not to be used in patients with a history of cardiovascular disease, including:

- History of coronary artery disease (e.g., heart attack, angina)
- History of stroke or transient ischemic attack (TIA)

- History of heart arrhythmias

- History of congestive heart failure

- History of peripheral arterial disease

- Uncontrolled hypertension (e.g., > 145/90 mmHg)

As indicated by the title of the above January 2010 document, this recent review of Meridia began in November 2009 when the FDA issued an "Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)". The FDA took this earlier action after the agency received preliminary data from Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study suggesting that patients using Meridia had a higher risk for serious cardiovascular side effects such as stroke, heart attack, and sudden cardiac death.

Another development related to the November 2009 FDA Early Communication concerning the safety of Meridia was the "Petition to Ban Sibutramine (Meridia)" submitted to the FDA by the consumer group Public Citizen in December 2009.

Returning to the Meridia "Follow-Up" issued by the FDA in January 2010, we get this preview about future agency action regarding Abbott's obesity drug:

Once FDA completes its review of the full study report for SCOUT, which is expected to be submitted to the FDA by the sponsor in March 2010, and other relevant information related to [Meridia]’s potential benefits and risks, an open public advisory committee meeting will be convened to discuss [Meridia]’s benefit/risk profile and to determine if additional regulatory actions should be taken to ensure safe use of the medication.

Of course, this FDA advisory committee meeting regarding the safety of Meridia should be most interesting in light of the fact that Abbott suspended sales of Meridia (sibutramine) in Europe in January 2010 soon after European drug regulators recommended its marketing suspension on the basis of the increased cardiovascular (CV) events seen with Meridia in the SCOUT study.

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