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Meridia Side Effects

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Meridia weight loss pill information

In 1998, the FDA approved the Meridia weight loss pill for the treatment of obesity. The approval of Meridia came at a time when the diet pill market was hungry for the next "miracle" drug after the highly publicized ban of Fen Phen, which had been taken by an estimated 6 to 7 million Americans. Fen Phen was found to cause heart valve damage in some patients, and was linked to PPH (primary pulmonary hypertension). A settled class action lawsuit followed.

Meridia Heart Attack Risk Revealed

Initially marketed as the safe alternative to Fen Phen, Meridia was recalled October 8, 2010. It wasn't long after Meridia weight loss pill hit the market that it became under fire for being both ineffective and hazardous to its patients.

Timeline of Events Leading up to Meridia Recall

On March 19, 2002, the Public Citizen consumer advocacy group petitioned the FDA for an immediate Meridia recall, citing the 397 serious adverse reactions to Meridia reported to the FDA, including 29 Meridia deaths.

"There is a 10 to 100-fold underreporting of adverse events. What gets reported to the FDA is just a tiny fraction of what is going on," Sidney Wolfe, Public Citizen Director (ABC News, 3-19-02).

Public Citizen re-petitioned the FDA to recall Meridia in December 2009 because of heart risks. Sibutramine Cardiovascular OUTcomes (SCOUT) trial links Meridia to dangerous cardiac risk including heart attack and stroke.

In January 2010, the FDA requests that Abbott update Meridia's label, stating the drug should not be used by patients with a history of cardiovascular disease, including coronary artery disease, stroke or transient ischemic attack (TIA), congestive heart failure, heart arrhythmias or uncontrolled hypertension.

In September 2010, the FDA debates whether to withdrawal the diet pill from the market. The panel was split. Eight members argued for a Meridia recall. Eight others requested stricter warnings and restrictions.

A voluntary Meridia recall was announced October 8, 2010.


Public Citizen Says FDA Took Too Long to Recall Meridia - October 8, 2010

Since Meridia was first approved as a weight loss pill, Public Citizen has been trying to get it banned. The public advocacy group has petitioned the FDA multiple times to withdrawal the diet drug due to serious heart risks.

Abbott Laboratories finally issued a Meridia recall Oct. 8, 2010 after a request from the FDA. The diet pill has been used by numerous patients and has been linked to more than a 15 percent increased risk of both fatal and non-fatal cardiac problems.

Public Citizen says the recall took too long. Its first petition to the FDA was in 2002. Since then, more than 3 million people have been prescribed Meridia for obesity. The group re-petitioned a Meridia diet drug ban in 2009. Since then approximately 160,000 prescriptions have been filled in the U.S.

Public Citizen petitions the FDA to recall Meridia- March 19, 2002

Despite the FDA's approval, there have been hundreds of serious Meridia side effects reported to the FDA, including 29 deaths. Prior to approval, when asked if the benefits of sibutramine outweighed the risks, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 5 to 4 against Meridia's approval. Since 1996, the Health Research Group of Public Citizen has petitioned for the removal of four other drugs previously approved by the FDA. Three of the drugs are now banned, and the fourth is severely restricted. Public Citizen finds Meridia to be both ineffective and unsafe.

View the entire Public Citizen petition. Click Here...

 

 

Public Citizen Calls For Criminal Charges To Be Filed Against Meridia Manufacturers

On May 22, 2001, the consumer advocacy group Public Citizen called on the US government to bring criminal charges against Abbott Laboratories, the manufacturers of Meridia for allegedly withholding information about adverse events and 8 patient deaths related to Meridia.  These allegations are based on an FDA inspection of an Abbott plant in Illinois conducted in late March and early April.

View the entire Public Citizen letter. Click Here...

Abbott's Response to the Petition To Ban Meridia

Every year, an estimated 300,000 Americans die from obesity-related illnesses costing the United States an estimated $117 billion annually. With insurers increasingly willing to pay for preventative treatments, pharmaceutical companies are under increasing pressure to develop a new miracle weight-loss drug, which could potentially generate an enormous profit.

Abbott Laboratories disputes the validity of the FDA's statistics that link patient deaths to Meridia, and also argues that obese people are already at risk for heart problems and high blood pressure. Abbott maintains that Meridia is an effective weight loss treatment in obese patients, is safe when used as indicated, and has strong support throughout the world.

Spokespersons for Abbott have also stated that possible side effects are clearly listed for doctors and patients.

To read Abbott Laboratories' entire Press Release regarding Meridia weight loss pill, Click Here...




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Meridia Side Effects

Sibutramine Cardiovascular OUTcomes (SCOUT) shows a 16 percent increased risk of heart problems in Meridia users.

Oct. 8, 2010
Abbott recalls Meridia because of the risk of heart attack, stroke, cardiac death and other dangerous heart problems.

September 2010
FDA meets to determine if Meridia should be pulled of the market.

January 2010
FDA requires stricter warning on the label of diet drug. Warning states diet pill should not be used by people with a history of cardiovascular disease.

December 2009
Public Citizen sends a letter to re-petition the FDA to pull Meridia diet pill from the market.

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