::: Meridia Advocate  


Ron C. Eddins
Waters & Kraus
3219 McKinney Ave.
Suite 3000
Dallas, TX 75204

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In 2000, Americans spent $1.8 billion in diet pills. Despite a 95% weight loss failure, consumers anxiously awaited the next "miracle pill" for weight loss. Pharmaceutical companies have been able to capitalize on the large market of dieting Americans even despite the numerous deaths and serious adverse health conditions that resulted from the use of different weight loss solutions. In 1997, a breakthrough in weight loss pills, called fen phen was withdrawn from the market after an estimated 6-7 million Americans took the prescription drug. The drug was linked to serious and life-threatening conditions, including heart valve disease and primary pulmonary hypertension (PPH).

When Meridia was released following fen phen's ban, manufacturer Abbott Laboratories was quick to market the new weight loss drug as a preemptive strike against any diet drug skeptics by saying fen phen and Meridia were very different. The death of 29 Meridia patients and hundreds of serious Meridia side effects leave experts wondering if this could have been prevented. One year before the FDA approval of Meridia, the FDA advisory committee voted 5-4 that the health benefits of Meridia did not outweigh the serious risks. The FDA medical officer who reviewed Meridia recommended it not be approved because the research indicated the potential heart problems that now affect a growing number of Meridia patients.

In March, the consumer advocacy group Public Citizen filed a petition to the FDA asking Meridia to be immediately banned from the market. Public Citizen is also pushing for a raise in FDA standard for the approval of diet drugs and to require drug makers to show actual health benefits rather that relying on short-term studies. If you or a family member is suffering adverse health effects from Meridia, we have provided contact information as well as comprehensive information to better educate patients of the importance of better weight loss drug safety standards.

About Meridia
Since the introduction of Meridia there have been 29 deaths, including 19 due to adverse cardiovascular effects associated to the weight loss pill. First approved in 1997, one year after the FDA advisory committee voted 5-4 that the benefits of Meridia did not outweigh the risks Meridia is available in 70 countries and have been used by 8.5 million people worldwide. Meridia had received a review from an FDA medical officer concluding that a non-approval was recommended due to the significant increase in blood pressure and heart rate in many people. Despite the opposition from the FDA's own advisory committee and medical officer, Meridia is still being sold.
read more about Meridia . . .

Meridia Side Effects
Meridia has been associated to potentially fatal and serious conditions like primary pulmonary hypertension (PPH), cardiac valve dysfunction, and heart valve disease. These serious Meridia side effects are listed on Abbott Laboratories' patient information. Since the FDA approval of Meridia, there have been 29 deaths and hundred of serious adverse reactions occur in Meridia patients. These adverse health effects that are being linked to the use of Meridia are serious and life threatening.
read more about the side effects of
Meridia . . .

Reporting Adverse Meridia Events
The FDA has a program for consumers to report serious reactions and problems with medical products, including Meridia weight loss pill side effects, called MedWatch. If you, or a family member, have suffered the serious and potentially deadly Meridia side effects, it is encouraged for you to report it to help prevent any unnecessary future health complications from occurring.
read more on reporting adverse Meridia events . . .




Meridia News Stories

BREAKING NEWS!!
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).
Read Full Article..

Public Citizen Urges Criminal Charges Against Meridia Manufacturer Abbott Laboratories
-May 21, 2002

Public Citizen has already petitioned the FDA for the immediate removal of Meridia weight loss pill, and on May 21, 2002, the group said they had obtained a report of an FDA inspection of Abbott facilities in Abbott Park, Illinois. Read More here...

Abbott Laboratories assures safety of Meridia
-March 20, 2002
After Public Citizen issued a petition to the FDA remove Meridia from the U.S. market, Abbott Laboratories, Meridia's maker, 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 and that removal of Meridia from the market would be a large disfavor to every American that suffers from obesity.


Read more Meridia news stories . . .

March 19, 2002 Public Citizen files a petition asking the FDA to immediately ban Meridia weight loss pills from the market.

March 19, 2002 Public Citizen's petition concluding the benefits of Meridia does not outweigh the risks.

Notable Meridia Quotes
"For simply across-the-board use, I think that you can't endorse it, but for use in an appropriately screened populations of people, absolutely, but more information is really going to be needed."
(CNN, 9-26-96)
-Dr. John Flack, FDA consultant after Meridia was sent back for more research in 1996

"We still have some concerns."
(Detroit News, 11-29-97)
-FDA's Dr. James Bilstand at the time of the 1997 FDA approval of Meridia

"As we saw with Redux, there's a tremendous pent-up market in weight loss. I think- I hope the public has learned there is a danger in prescribing this to individuals who do not fit the criteria."
(AP, 2-13-98)
-Morgan Downey, executive director of the American Obesity Association

"Based on 50 reports of adverse events during treatment, the Pharmaceutical Commission decided that the beneficial effects of the drug must be re-evaluated." (Yahoo, 3-7-02).
-Italy's Pharmaceutical Commission recommending the suspension of sibutramine

"The drug should have never been put on the market- the advisory committee and the physician in charge of the drug both recommended against approval. This is a mistake that is being corrected. The drug is just not going to survive much longer."
(ABC News, 3-19-02)

-Sidney Wolfe, Public Citizen Director

 
 
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