Meridia Diet Drug

Meridia side effects have resulted in the deaths of 29 people. The weight loss pill considered to be only “minimally effective” has caused a significant increase in blood pressure and heart rate in many people. To learn more about your rights regarding the dangerous Meridia side effects, CONTACT US.

Meridia side effects can include:

• PPH, or primary pulmonary hypertension
• Stroke
• Seizures
• Increase in blood pressure
• Heart disease
• Increase in heart rate
• Mental impairments
• Increased sweating
• Headaches
• Dry Mouth
• Anorexia
• Constipation
• Insomnia

Meridia Diet Drug

Public Citizen Issues Public Statement Criticizing FDA’s Failure to Ban Meridia
-September 3, 2003
The Public Citizen consumer group has called upon the FDA once again for the immediate ban of Meridia diet pill from the market. Originally calling upon the agency to ban Meridia in a March 2002 petition, the watchdog group has been critical of the failure to take adequate safety actions. With “new evidence of a rapidly growing number of deaths and serious adverse reactions” linked to Meridia, Public Citizen believes there is “no justification in continuing to market a drug that provides minimal weight reduction while increasing the likelihood of injury and death” (citizen.org 9/3/03).

The group added that the original 2002 petition did not address the effect Meridia can have on a developing fetus. According to new analysis, Meridia has been linked to spontaneous abortions, stillbirths, and congenital malformations, including heart and central nervous system in the fetus when Meridia is used with pregnant women. During animal studies before Meridia was approved, the same link between Meridia use and developing fetus impacts were witnessed.

The FDA has sufficient evidence for a Meridia ban to be issued already, according to the group, based on dangerous increases in blood pressure. Before Meridia approval an FDA advisory committee voted in 1997 against the approval of Meridia because of safety concerns. The allowance of Meridia to remain on the market is troubling because “the number of victims is rising rapidly and the effectiveness in treating obesity is meager” according to Public Citizen Health Research Group director.

For more information on Meridia side effects contact us to confer with a Meridia lawyer.

Public Citizen Sends Criminal Charges Letter Against Meridia Manufacturers
-May 21, 2002
The Public Citizen Health Research Group sent a letter calling for criminal charges against Abbott Laboratories, manufacturer of Meridia diet drug. Already associated to 29 U.S. deaths, Public Citizen petitioned the FDA in March 2002 for the immediate removal of Meridia diet drug. The Public Citizen letter sent to the secretary of Department of Health and Human Services, Tommy Thompson, was to “strongly urge you to bring criminal charges against Abbott Laboratories for illegally withholding from the FDA important information concerning eight deaths and other adverse effects of their big-selling obesity drug, sibutramine (Meridia), a drug we asked you to ban in March of this year.”

Public Citizen director, Dr. Sidney Wolfe, found that a recent FDA inspection report of the Abbott Laboratories plan in Abbott Park, Ill. showed that the adverse Meridia diet drug information reported to FDA was either not accurate, not supported by source data, or was missing additional information found in the source data. FDA inspectors also found that “complete case files containing any documentation as to follow-up investigations conducted an information obtained therein concerning deaths associated with Meridia were missing.” In addition, the FDA charged that “records relating to all adverse drug experiences known to you (Abbott), including raw data and any correspondence, have not been maintained for the required ( )* year period.”

Approved in 1998 as a weight loss pill to combat obesity, Meridia diet drug has been linked to 29 U.S. deaths. To read the entire letter, urging criminal charges be brought against Abbott Laboratories regarding their Meridia diet drug, click here.

Health Canada Investigates Meridia
-March 28, 2002

Meridia diet drug (sibutramine) was temporarily pulled from the market in Italy after two deaths and at least 28 other deaths around the world and is now under review by European regulators. The FDA is currently reviewing the safety of Meridia diet drug. Nine thousand Canadians use Meridia diet drug for severely overweight or obese people, but with the recent fatalities possibly linked to the diet drug, the Canadian government is reviewing the safety implications of the drug.

(CBC News, 3-28-02).

Abbott Laboratories responds to Public Citizen regarding the safety of Meridia
-March 20, 2002

After Public Citizen issued a petition to the FDA to remove Meridia diet drug from the U.S. market, Abbott Laboratories issued a statement claiming the petition was based on incorrect conclusions. Abbott believes that Public Citizen has not considered the serious medical condition that obesity poses. They think the removal of Meridia diet drug would be a large disfavor to every American that suffers from obesity.

Meridia’s safety in question
-March 22, 2002, WebMD

The FDA has been asked to ban Meridia diet drug (sibutramine) due to the 29 deaths and hundreds of serious Meridia side effects. Abbott Laboratories has admitted at least 32 Meridia diet drug patients have died while taking the weight loss drug, but is quick to show that around 9 million people have used the drug in the last five years, making the death rate very small. The director of Pubic Citizen Health Research Group, Sidney Wolfe, says FDA documents link Meridia diet drug to almost 400 serious and bad reactions from February 1998- September 2001.

Studies performed on Meridia diet drug show an average 6.5 lbs is lost in a year’s time, and during the second year the majority of people regain the entire weight back if stopping drug use. There is also evidence that Meridia diet drug increases blood pressure, an especially serious side effect for obese patients, as well as increases a person’s heart rate. Abbott claims that any weight loss Meridia diet drug can provide an obese patient would decrease the risk of heart disease and death, but Wolfe claims, “There is no evidence that this drug has prolonged the life of a single patient, or reduced the risks of strokes or heart attacks tied to obesity.”

Wolfe also points out that when Meridia diet drug was approved, the FDA advisory committee voted 5-4 against approving it. One year later, the FDA overruled the committee and Meridia diet drug was approved. While Abbott states they are very confident their Meridia diet drug will not be taken off the market, Wolfe predicts otherwise.

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March 19, 2002, USA Today

Sibutramine, marketed under the name Meridia, is a weight loss pill that has come under fire due to the Meridia side effects directly linked to it. Public Citizen has petitioned the FDA to ban Meridia diet drug because its association with the 29 deaths, including 19 due to cardiovascular causes like heart attacks. Meridia diet drug complication follows the fen-phen ordeal that was withdrawn over heart valve problems in 1997.

The average weight loss from using Meridia diet drug is 5-9% in four to six months, though when it was approved experts warned against people with heart disease taking the weight loss pill. Studies had indicated that Meridia diet drug increases blood pressure in some patients and substantially increases it in others. The Public Citizen director Sidney Wolfe thinks that the Meridia weight loss pill “is a drug with no evidence of long-term benefit and significant evidence of short-term risk, including death.”

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March 19, 2002, ABC News

The Public Citizen director Sidney Wolfe believes Meridia diet drug should have never been put on the market after the FDA advisory committee and physician in charge of Meridia recommended against the approval of the drug. Abbott Laboratories continues to believe that Meridia diet drug is safe despite the alleged fatalities that have been linked to the use of the weight loss drug. About 9 million people have taken sibutramine according to Abbott, marketed as Meridia diet drug. The VP of pharmaceutical development at Abbott does not see a link between the use of sibutramine and the deaths that have been linked to its use.

Meridia diet drug's labels warn against potentially serious cardiovascular side effects. The label warns against individuals with already elevated blood pressure taking Meridia diet drug because of the risk of elevating blood pressure and heart rate. There have been questions of whether or not the side effects of Meridia diet drug have been associated to the recent deaths are due to inappropriate patient selection, but others have found sibutramine causes increased blood pressure in patients who have normal blood pressure. The FDA will now be considering Public Citizen’s petition and determine if the side effects of Meridia diet drug are acceptable or if the safety issues outweigh the benefits.

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March 15, 2002, BBC News

In the UK, two patients have died and over 200 others have reported adverse side effects due to the use of sibutramine, marketed as Reductil in the UK. The continued use of the weight loss pill was under the opinion that the deaths were caused by a patient’s underlying medical condition. In Italy, sibutramine was suspended after reports of health problems surfaced and Italy’s Pharmaceutical Commission decided to re-evaluate the drugs benefits. French drug regulators also reported they had received 99 reports of sibutramine side effects, ten of them being very serious.

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March 15, 2002, Reuters

According to the Department of Health two patients died in Britain after taking sibutramine and over 200 others have adverse reactions. As of March 13, 2002 reported adverse effects due to sibutramine use had been received in Britain, with 93 considered very serious and two fatalities.

March 7, 2002, Yahoo

Italy took weight loss pill sibutramine off the shelves after 50 reports of health related problems were made, leading to a Europe-wide review of the diet pill. Italy’s sibutramine suspension was the first action taken since the 1997 approval. Abbott responding by saying they would work with the Italian and European authorities to confirm the safeness of their product market under the name of Meridia in the U.S.

Last December, Britain’s Drug and Therapeutics Bulletin that is published by the Consumers’ Association, had warned the drug had limited benefits and unwanted side effects, including raised heart rates and blood pressure. The bulletin also noted sibutramine should not be taken with patients who have coronary artery disease, congestive heart failure, and high blood pressure.

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January 3, 2001, ABC News

The FDA sends out roughly 100 letters to drug companies to demand changes be made in their advertising and promotional materials. These demands are based on the premise that the FDA feels the drug companies make promises suggesting their product can be more effective than evidence suggests. One of the FDA’s targets was Abbott Laboratories, the makers of Meridia, and the drug company refused requests for interviews by ABC News. Dr. Sharon Levine, of RX Alliance, thinks that the companies are “leaving an impression on people’s minds- and this is intentional- that the drugs can deliver more than they actually do.” Dr. Bradford Pontz advises patients to be wary of advertisements and what a drug can really provide a person.

February 13, 1998, Associated Press

Meridia diet drug is now on the shelves after the last diet drugs were recalled. This is the first prescription anti-obesity drug since fen phen was recalled after the drug was linked to fatal heart valve damage. The market for diet drugs is a large one, and many people have been looking forward to the drug’s release. The marketing strategy for Meridia diet drug began as a preemptive strike to critics by saying that the drugs are very different from fen phen. Meridia diet drug was approved despite the safety concerns that their own scientific advisers objected to. The FDA warns that there are increases in blood pressure and pulse rates that endanger patients with hypertension or certain heart conditions.

November 25, 1997, The Detroit News

The FDA approved Meridia diet drug, the first obesity drug to follow the ban of two popular diet pills that left Americans with severe and deadly conditions. The FDA called Meridia diet drug “moderately effective” at helping patients shed pounds, but sibutramine comes with serious risks as well. This drug is expected to be popular due to the large market of 58 million Americans considered overweight that Meridia diet drug can cater to.

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September 25, 1997, Associated Press

The FDA approved the first obesity drug following the fen phen recall, but this weight loss drug causes serious risks as well. The new Meridia diet drug, manufactured by Abbott Laboratories is only “moderately effective” at helping patients lose weight. The FDA’s Dr. James Bilstad urged doctors to actively check patient’s blood pressure and pulse with any Meridia diet drug patients, “we still have some concern.” Anyone with poorly controlled hypertension, heart disease, or irregular heartbeat, or who has survived a stroke is cautioned by the FDA to avoid Meridia diet drug. Meridia is chemically called sibutramine and the diet drug slows the body’s dissipation of the serotonin it naturally produces. It is not known why the diet drug causes blood pressure to rise.

September 26, 1996, CNN

The new weight loss pill, Meridia diet drug poses health risks. An FDA advisory committee concluded that while Meridia diet drug works it should not be approved because of the elevated blood pressure the diet drug causes amongst the general population. An FDA consultant, Dr. John Flack thinks, “more information is really going to be needed.” Meridia had been studied for a year in 4,200 U.S., United Kingdom, and France and has shown to cause the elevated blood levels, as well as inducing dry mouth, insomnia, and constipation. Meridia diet drug may still gain approval according to the panel because the company may be able to work with the FDA to resolve some of the concerns.

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