Meridia Lawsuit

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).

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 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. This recent FDA report prompted the consumer advocacy group to urge criminal charges be brought against Abbott because the company illegally withheld information from regulators regarding eight deaths and other side effects in Meridia patients.

Required by law, all drug makers must report serious events that occur with the patients using their drugs. The report had indicated Abbott failed to report one death associated to Meridia weight loss pill and records regarding seven other deaths were inaccurate, unsupported, or incomplete. Public Citizen also stated that the FDA inspection found case files containing any documentation of follow-up investigations of Meridia associated deaths to be missing, as well as other records regarding Meridia adverse events had not been maintained for the required time period.

Public Citizen’s letter sent to Secretary Tommy Thompson at the Health and Human Services included that the FDA inspection “reveals an Abbott scheme to conceal important information that could establish the causal role of sibutramine in the deaths of specific patients using the drug.” To view the entire Public Citizen letter click here.

Health Canada Investigates Meridia
-March 28, 2002
Meridia (sibutramine) has been pulled from the market in Italy after being linked to two deaths and at least 28 other deaths around the world and is now under review by European regulators. Meridia has been on the U.S. market since 1998, but the FDA is currently studying the Meridia side effects. Nine thousand Canadians use Meridia for severely overweight or obese people, but with the recent fatalities possibly linked to the diet drug,

Public Citizen, the U.S. consumer advocacy group, finds Meridia to be extremely dangerous. According to the group's director, Dr. Sidney Wolf, "In the last year, the sales of it (Meridia) went up enormously….and as a result there were more problems, deaths, arythmias, cases of hypertension, and so forth" (CBC News, 3-28-02).

Abbott Laboratories, Meridia's maker, continues to claim the drug is effective and safe.

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.

Abbott has maintained that Meridia is an effective means for weight loss in obese patients, Meridia is safe when used as indicated, and Meridia has strong support throughout the world. Abbott finds Public Citizen's statements saying the effectiveness of lowering obesity is meager with Meridia to be untrue. To read Abbott Laboratories' entire Press Release regarding Meridia weight loss pill, click here.

top

Safety regarding Meridia weight loss pill in question

-March 22, 2002, WebMD
The FDA has been asked to ban the diet drug Meridia, or sibutramine, and to withdraw its approval to the drug due to the 29 deaths and hundreds of serious Meridia side effects attributed to it. Manufacturer Abbott Laboratories has admitted at least 32 Meridia 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 pill to almost 400 serious and bad reactions from February 1998- September 2001.

Studies performed on the diet drug Meridia show that there is an average 6.5 lbs 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, which is an especially serious side effect for obese patients, as well as increases a person's heart rate. While Abbott claims that any weight loss Meridia can provide an obese patient would be expected to decrease the risk of heart disease and death, 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 pill was approved, the FDA advisory committee voted 5-4 against approving it. One year later, the FDA overruled the committee and Meridia was approved. While Abbott states they are very confident their diet drug Meridia will not be taken off the market, Wolfe predicts otherwise.

top

Removal of Meridia from U.S. market wanted immediately

-March 19, 2002, Public Citizen
Public Citizen filed a petition telling the FDA to immediately remove Meridia weight loss pill because the link between 29 deaths and hundreds of serious Meridia side effects. Public Citizen claims the FDA knew that approval of the sibutramine drug would significantly increase blood pressure and heart rates with only minimal benefits.

top

Public Citizen wants FDA to immediately ban diet drug Meridia
-March 19, 2002, Public Citizen
Watchdog group Public Citizen has submitted a petition to the FDA to immediately ban Meridia weight loss pill, the brand name for sibutramine, due to the risks of heart complications that outweigh the "minimally effective" drug. Meridia side effects include increased blood pressure and heart rates. The diet drug was pulled off the Italian market after two deaths were associated to its use, and now other European governments are reviewing the serious and potentially fatal Meridia side effects. Public Citizen also supports an increased standard for FDA approval of diet drugs that requires drug manufacturers to display actual health benefits.

Before initial approval the FDA was already concerned with the safety of Meridia. In 1997, an FDA advisory committee had voted 5-4 against the approval of Meridia because they felt the benefits of the weight loss drug did not outweigh its risks. An FDA medical officer that was reviewing Meridia recommended it not be approved due to the potential heart problems that could result from its use. Data complied by Public Citizen through a Freedom of Information Act request shows that from February 1998-September 30, 2001 there were nearly 400 serious adverse Meridia reactions, including 19 cardiac deaths, with 10 of them involving people under 50 and three of them women under 30.

top

Public Citizen's Petition for an immediate FDA ban of diet drug Meridia

-March 19, 2002, Public Citizen
Public Citizen submitted a petition to Tommy Thompson, the Secretary to the Department of Health and Human Services on March 19, 2002. The conclusion of whether or not the effect of sibutramine, Meridia, benefits outweigh the risks Public Citizen stated:

The known serious risks of sibutramine might be acceptable if there were evidence that it prevented one stroke or heart attack or prolonged the life of a single patient. Such evidence is lacking for sibutramine as well as for other diet drugs, leaving patients with only the risk of injury from their use and expensive drug bills. This disproportionate risk compared to any known therapeutic benefit of sibutramine was seen by the FDA medical officer and the members of the Endocrinologic and Metabolic Drugs Advisory Committee who recommended against its approval.

Sibutramine is a drug that should never have been approved, and in the interest of the safety of the American public it must come off the market now. The FDA must reexamine the episode of Dr. Knox and fenfluramine and reject an approval standard for diet drugs that only requires short-term studies, which demonstrate the statistical superiority of a drug over a placebo.

To view the entire petition, click here.

top

March 19, 2002, USA Today
Sibutramine, manufactured by Abbott Laboratories and 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. The consumer advocacy group, Public Citizen, has petitioned the FDA to ban the prescription diet drug because their associations with 29 deaths including 19 due to cardiovascular causes like heart attacks. This diet 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 pill "is a drug with no evidence of long-term benefit and significant evidence of short-term risk, including death."

top

March 19, 2002, ABC News

The Public Citizen director Sidney Wolfe believes Meridia weight loss pill 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, the manufacturer of Meridia, 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. 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's diet pill labels warn against some potentially very serious cardiovascular side effects that have been identified. 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 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 side effects are acceptable or if the safety issues outweigh the benefits.

top

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. Italy's move led to a Europe-wide review of the diet pill, making Italy the first country to react to the drug's potential side effect since the 1997 approval. The commission found the decision to re-evaluate sibutramine a necessary move. This weight loss pill was first approved in Italy in April 2001, and Abbott said 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.

top

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.

top

February 13, 1998, Associated Press
Meridia weight loss pill 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 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 diet drug Meridia, 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 "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 diet drug Meridia, 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. 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.

top

September 26, 1996, CNN
A new diet drug Meridia poses health risks. An FDA advisory committee concluded that while Meridia 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 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.