Meridia Weight Loss Drug

BREAKING NEWS!!
Abbott’s Meridia continues to be plagued with deadly and dangerous side effects : October 1, 2003

Meridia has continued to receive negative press regarding the serious and deadly side effects that have been reported. Public Citizen already renewed the call for federal regulators to ban Meridia in the beginning of September. According to the consumer advocacy group, since March 2002 when it initially petitioned the FDA to ban Meridia, it had found an additional 30 cardiovascular deaths in Meridia patients.

The Meridia side effects only added to the already cited 49 Meridia deaths and 124 Meridia hospitalizations due to serious heart and cardiovascular problems. All Meridia patients must be closely monitored for increased heart rate and blood pressure. If discontinuing Meridia use, any lost weight will be regained.

Most of the Meridia deaths have occurred in patients under 50 years of age and the result are considered too minimal considering the drug’s risks according to Meridia critics. The FDA spokeswoman has said in response to Public Citizen’s renewed Meridia ban request that the agency had already begun after the actual Meridia petition an additional review comparing adverse event reports for Meridia.

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

Meridia weight loss pill still popular: May 12, 2003
Despite the fen phen recall in 1997, reports show that diet pills are still as popular as when fen phen was first introduced to the market. Serious and fatal side effects of the diet pills did not deter dieting Americans from seeking slimming effects from other drugs like Meridia. A disease prevention expert at Stanford University points out that people looking for a quick and easy was to lose weight will not be found with a fad drug and should refrain from seeking fast results with diet pills like Meridia when they do not yet understand the potential downsides.

Meridia side effects still concerning: April 22, 2003
University of Pennsylvania researchers have said that the increases in blood pressure and pulse rate in participating Meridia patients make it necessary for close monitoring. Linked to at least 29 U.S. deaths, Public Citizen consumer group asked the FDA to ban Meridia from the market in March 2002.

Meridia still dangerous for adolescents: April 8, 2003
Meridia has been controversial due to the 29 reported deaths occurring with Meridia patients, most of them the result of cardiovascular events. After being approved in 1998 despite the 5-4 votes by the FDA advisory committee concerned with elevated blood pressure and increased pulse rate, Meridia received high amounts of opposition, especially from Public Citizen consumer group.

The group petitioned in 2002 for the immediate ban of Meridia, however Meridia has remained on the market for adult use only. A new study on Meridia has shown that despite the weight loss results Meridia can provide, the weight loss drug is still not safe for adolescents to use. The Meridia study showed there were increases in pulse rate and blood pressure and Meridia studies should continue to be performed, especially regarding Meridia use for adolescents and children.

Breaking Meridia News: May 21, 2002
The Public Citizen Health Research Group sent a letter calling for criminal charges against Abbott Laboratories, manufacturer of Meridia weight loss drug. Already associated to 29 U.S. deaths, Public Citizen petitioned the FDA In March 2002 for the immediate removal of Meridia. 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 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 weight loss drug has been linked to 29 U.S. deaths. To read the entire letter, urging criminal charges be brought against Abbott Laboratories regarding Meridia weight loss drug, click here.

Health Canada Investigates Meridia
Meridia weight loss 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 weight loss drug. Nine thousand Canadians use Meridia weight loss 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 remove Meridia weight loss 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 weight loss drug would be a large disfavor to every American that suffers from obesity

Meridia Safety In Question
The FDA has been asked to ban Meridia weight loss drug (sibutramine) due to the 29 deaths and hundreds of serious Meridia weight loss drug side effects. Abbott Laboratories has admitted at least 32 Meridia weight loss 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 weight loss drug to almost 400 serious and bad reactions from February 1998- September 2001.

Studies performed on Meridia weight loss 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 weight and gain the entire weight back if stopping drug use. There is also evidence that Meridia 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 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 weight loss drug was approved, the FDA advisory committee voted 5-4 against approving it. One year later, the FDA overruled the committee and Meridia weight loss drug was approved. While Abbott states they are very confident their Meridia weight loss drug will not be taken off the market, Wolfe predicts otherwise.

(March 22, 2002, WebMD)

March 19, 20002, USA Today
Sibutramine, marketed under the name Meridia, is a weight loss drug that has come under fire due to the Meridia side effects directly linked to it. Public Citizen has petitioned the FDA to ban the prescription diet drug because its association with the 29 deaths, including 19 due to cardiovascular causes like heart attacks. The Meridia weight loss drug complication follows the fen-phen ordeal that was withdrawn over heart valve problems in 1997.

The average weight loss from using Meridia 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 sibutramine increases blood pressure in some patients and substantially increases it in others. The Public Citizen director Sidney Wolfe thinks that the Meridia weight loss drug “is a drug with no evidence of long-term benefit and significant evidence of short-term risk, including death.”

March 19, 20002, ABC News
The Public Citizen director Sidney Wolfe believes Meridia weight loss 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 sibutramine 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 weight loss 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 weight loss drug labels warn against potentially serious cardiovascular side effects. The label warns against individuals with already elevated blood pressure taking Meridia because of the risk of elevating blood pressure and heart rate. There have been questions of whether or not the Meridia weight loss drug side effects that 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 Meridia weight loss drug side effects are acceptable or if the safety issues outweigh the benefits.

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.

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.

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 weight loss drug, 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 weight loss 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. Meridia’s marketing strategy began as a preemptive strike to critics by saying that the drugs are very different from fen phen. Meridia weight loss 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 weight loss 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 weight loss 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 can cater to.

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 weight loss 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 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 weight loss 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
A new diet drug Meridia poses health risks. An FDA advisory committee concluded that while Meridia weight loss 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 weight loss drug 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 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.