Meridia Lawsuit News

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.

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.

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.

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Meridia weight loss pill safety 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.

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Meridia requested to be immediately removed from the U.S. market
-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.

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FDA urged to 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.

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Public Citizen Petition to FDA ban 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.

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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.”

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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.

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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.

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.

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 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.

Interesting Facts

- In 1997, prior to FDA approval, an FDA advisory committee voted 5-4 that the benefits of Meridia weight loss pill did not outweigh the risks for potential heart problems.

- Public Citizen obtained data through a Freedom of Information Act request that shows after Meridia was introduced in February 1998-September 30, 2001, there were almost 400 serious adverse reactions in Meridia patients. Nineteen of these were cardiac deaths, with 10 in people under the age of 50 and three in women under 30.

- The average weight loss during one year on a standard dose of Meridia was only 6.5 pounds more than individuals taking a placebo.

- According to Abbott Laboratories, Meridia is sold in 70 countries and has been used by 8.5 million people worldwide.

- In the U.S., there have been 29 deaths linked to the use of Meridia.