Pharmaceutical Drug Litigation Updates

Is there such a thing as a safe diet drug?

Quoted from http://www.theglobeandmail.com/life/health/is-there-such-a-thing-as-a-safe-diet-drug/article1769521/

Is there such a thing as a safe diet drug?

CARLY WEEKS

10/25/10

Globe and Mail

A few years after it hit the market, the diet drug Meridia was being investigated by health authorities globally for links to more than two dozen deaths and hundreds of adverse reactions. But those authorities, including Health Canada, concluded that Meridia, the brand name of the drug sibutramine, was safe enough to remain on the market and be prescribed to treat obesity.

 

Seven years later, Abbott Laboratories, the company that sells Meridia, has voluntarily pulled it off the market in Canada and the U.S. after a major study published last month, funded by the company, found that it raises a patient’s risk of stroke, heart attack and cardiovascular death.

Two generic versions, called Apo-sibutramine and Nova-sibutramine, have also been pulled off Canadian shelves.

The study, which last more than three years, also found that patients lost, on average, less than 10 pounds on sibutramine, which acts on the serotonin system to make an individual feel full.

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Abbott Labs Withdraws Meridia From Market

Quoted from http://www.nytimes.com/2010/10/09/health/09drug.html

Abbott Labs Withdraws Meridia From the Market

By ANDREW POLLACK

Abbott Laboratories, the drug’s manufacturer, said on Friday that it was taking the action voluntarily but under pressure from the Food and Drug Administration.

“Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” Dr. John Jenkins, director of the office of new drugs at the F.D.A., said in a statement.

F.D.A. officials said the estimated 100,000 Americans using Meridia should stop taking the drug and consult with their doctors.

The withdrawal of Meridia, also known as sibutramine, is the latest setback in efforts to provide a safe medicine to treat obesity, one of the nation’s largest health problems. In 1997, part of the fen-phen diet pill combination was removed from the market after it was found to damage heart valves.

The withdrawal of Meridia is not expected to seriously hurt Abbott, though it could conceivably expose the company to lawsuits from patients.

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Diet pill Meridia should be pulled off market, half of FDA panel says

Quoted from http://www.usatoday.com/yourlife/health/medical/2010-09-16-meridia16_ST_N.htm

Diet pill Meridia should be pulled off market, half of FDA panel says

By Rita Rubin, USA TODAY Given several options, half of the 16 members on a Food and Drug Administration advisory committee recommended Wednesday that the agency take the weight-loss drug Meridia off the market. Six panelists recommended keeping the drug on the market, but only if two conditions were met: •Adding a boxed warning to its label — the strongest type of warning — about an increased risk for major heart problems and the need to closely monitor patients' blood pressure, pulse and body weight. •Restricting its use, such as allowing only specially trained doctors to prescribe it. Two panelists voted to allow continued, unrestricted use as long as the boxed warnings were added. None voted to allow continued marketing without label changes. The FDA, which approved Meridia in 1997, usually follows the advice of its expert panels, but it is unclear what the agency will do in this case because the voting was split. [Article continues at original source]

FDA to ask panel whether to ban Abbott diet drug

Quoted from http://www.reuters.com/article/idUSTRE68C38U20100913

FDA to ask panel whether to ban Abbott diet drug

By Susan Heavey

WASHINGTON | Mon Sep 13, 2010 11:15am EDT

WASHINGTON (Reuters) - U.S. health regulators could pull Abbott Laboratories controversial weight-loss drug Meridia off the market over heart problems, according to documents released on Monday.

In memos released ahead of a public meeting to discuss the diet pill on Wednesday, Food and Drug Administration officials said they planned to ask outside advisers whether to ban Meridia, take other regulatory action, or leave the prescription drug as is.

While the FDA will later make the final decision, it usually follows its advisers' advice.

Meridia was never a big seller for Abbott, and some analysts see little impact no matter what steps the FDA takes.

Analysts expect $101 million in global sales for Meridia this year and $90 million in 2014, according to Thomson Reuters data.

Meridia, which was approved in 1997, has drawn concern for years over potential cardiovascular risks, with consumer advocates calling for its withdrawal. Critics say the slight weight loss is not worth the risk.

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Meridia raises the risk of heart attack, stroke

Quoted from http://www.app.com/article/20100905/LIFE/100903150/Meridia-raises-the-risk-of-heart-attack-stroke

Meridia raises the risk of heart attack, stroke

By RITA RUBIN • USA TODAY • September 5, 2010

A company-sponsored study found that the weight-loss drug Meridia raised heart attack and stroke risk in patients with pre-existing heart disease, according to a recent report.

The publication comes just two weeks before the Food and Drug Administration is to convene an advisory panel of outside experts to discuss the fate of Meridia, which the agency approved in 1997.

"It is difficult to discern a credible rationale for keeping this medication on the market," concludes an accompanying editorial in The New England Journal of Medicine.

Based on preliminary data, the FDA's counterpart for the European Union suspended Meridia's marketing license in January, but the FDA only added stronger information on the label about use by patients with pre-existing cardiovascular disease.

"The label has always had a warning about people with cardiovascular disease," Abbott Laboratories spokesman Scott Davies said. The drug, which isn't actively marketed in the USA, is expected to have sales of only $30 million this year, Davies said.

Abbott will propose "risk-management activities" at the upcoming FDA advisory committee meeting, Davies said, but he declined to describe them.

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Study Sees Heart Risk in Meridia Diet Pill

Quoted from http://www.nytimes.com/2010/09/02/health/research/02diet.html

Study Sees Heart Risk in Meridia Diet Pill

By GARDINER HARRIS

Published: September 1, 2010

A clinical trial of Meridia, a controversial diet pill, in nearly 10,000 overweight or obese older patients over many years found that the drug increased the risks of heart attacks and strokes while doing little to slim their waists.

 

JB Reed/Bloomberg News

Abbott Laboratories financed a study of 10.000 overweight patients using its diet drug.

The study was paid for by Abbott Laboratories, Meridia’s maker, and published in The New England Journal of Medicine. And the authors of the study, three of whom are Abbott employees, concluded that the trial results did little more than show that patients with heart problems should not be prescribed Meridia — a restriction already included in Meridia’s label.

But in an unusual rebuke, The Journal’s top editors wrote an editorial concluding that the study actually showed that Meridia, also known as sibutramine, should be removed from the market.

“It wasn’t that we disagreed with the interpretation of the authors,” said Dr. Gregory D. Curfman, The Journal’s executive editor. “It’s just that we thought they didn’t quite go far enough.” Many patients, Dr. Curfman added, “have cardiovascular disease and don’t know it. How are you supposed to identify those patients who might be put at risk by putting them on drugs like sibutramine?”

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Abbott's weight-loss drug to be reviewed by FDA panel

Quoted from http://www.chicagobusiness.com/article/20100806/NEWS03/100809909/abbotts-weight-loss-drug-to-be-reviewed-by-fda-panel

Abbott's weight-loss drug to be reviewed by FDA panel

August 06, 2010 

(Reuters) — Abbott Laboratories' weight loss drug Meridia will be reviewed by an advisory panel to the U.S. Food and Drug Administration on September 15, the company said on Friday.

The meeting will take place a day before the Endocrinologic and Metabolic Drugs Advisory Committee is scheduled to review lorcaserin, an experimental obesity drug being developed by Arena Pharmaceuticals Inc. and Eisai Co Ltd.

Abbott suspended European sales of Meridia, or sibutramine, in January after a recommendation by regulators that heart-related risks made the prescription drug too dangerous.

Abbott spokesman Scott Davies said on Friday that Abbott reiterates its view of Meridia's "positive risk/benefit profile" when used in the patient population for which the drug is approved.

Meridia's global sales were about $300 million in 2009.

An FDA panel last month voted to recommend that a weight loss drug called Qnexa, being developed by Vivus Inc., not be approved by the agency due to concerns that it could cause depression, memory loss and potential birth defects if used among millions of overweight or obese Americans.

Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug

Quoted from http://www.nytimes.com/2010/01/23/business/23diet.html

Heart Patients Warned Against Using Meridia, an Anti-Obesity Drug

By NATASHA SINGER and ANDREW POLLACK

Published: January 22, 2010

European and American drug regulators had two starkly different reactions this week to data on an obesity drug. The raw data from the study indicated that people with certain health problems who took the prescription diet drug Meridia had more heart attacks, strokes and other cardiovascular problems than people getting a placebo.

The F.D.A. urged a stronger warning label on the diet drug Meridia after a study showed complications in some users.

On Thursday, the European Medicines Agency advised doctors and pharmacists to stop prescribing and dispensing European equivalents of Meridia. The Food and Drug Administration, looking at the same study data on Thursday, took a less forceful step and asked Abbott Laboratories, the maker of Meridia, to put a stronger warning on its label.

The F.D.A. said the new warning should indicate that the drug was not to be used by people who have a history of heart attacks or strokes, or who have uncontrolled high blood pressure.

Abbott, which sells Meridia in Europe under various brand names, including Reductil and Ectiva, indicated Friday that it would comply with the F.D.A.’s labeling request and with the European advisory by suspending sales of the drugs in Europe.

Meridia contains the ingredient sibutramine, which works by increasing neurotransmitter activity in the brain, helping people to feel full after a meal and thereby reducing their food intake. The company said the drug was safe and effective when used in appropriate patients.

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FDA adds heart attack warning to Meridia diet pill

Quoted from http://www.sfgate.com/cgi-bin/article.cgi?f=/n/a/2010/01/21/financial/f084034S80.DTL&type=health

FDA adds heart attack warning to Meridia diet pill

By MATTHEW PERRONE, AP Business Writer

Thursday, January 21, 2010

Abbott Laboratories on Thursday stopped marketing a weight loss pill in Europe after regulators there said the drug increases the risk of heart attack and stroke when used by heart disease patients.

The European Medicines Agency advised doctors and pharmacists to stop using sibutramine, saying "the risks of these medicines are greater than their benefits." The agency said Abbott's license to market the drug should be suspended, a recommendation European Union nations are expected to adopt.

"We believe there are many patients who benefit from sibutramine and respectfully disagree with the committee's opinion and the recommendation to suspend the medicine," said Abbott spokesman Kurt Ebenhoch.

Meanwhile, the U.S. Food and Drug Administration added new warnings to sibutramine, marketed here as Meridia, highlighting its increased risks for patients with a history of heart problems. The new label says the drug should not be taken by patients with heart failure, hypertension, irregular heart beats and other problems.

In a statement posted online, the FDA urged patients to talk to their doctors about whether they should continue taking the drug.

"Health care professionals should regularly monitor the blood pressure and heart rate of patients using" Meridia, the FDA stated.

Abbott agreed to add the FDA's contraindication language to its marketing. The company, based in North Chicago, stressed that the drug is only approved for patients with no previous history of heart disease.

Consumer advocacy group Public Citizen petitioned the FDA to pull Meridia off the market late last year, based on new data about heart risks.

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Alli and Meridia Diet Drugs Warnings

Quoted from http://blogs.wsj.com/health/2010/01/21/meridia-another-diet-drug-warning/

Meridia: Another Diet-Drug Warning

By Jacob Goldstein

• January 21, 2010, 4:32 PM ET

It’s been a tough week for diet drugs. First, there were warnings that some people going to online auction sites to buy GlaxoSmithKline’s Alli weren’t getting the real thing. Instead, they were getting a counterfeit version that actually used the active ingredient from another diet drug — Abbott’s Meridia.

Today, it’s Meridia’s turn for trouble. European regulators said the drug — known generically as sibutramine, and sold in the EU under the brand names Reductil, Reduxade and Zelium — should be pulled from the market. In the U.S., the FDA said the drug shouldn’t be taken by patients with a history of heart disease — a significant limitation for a diet drug, given the link between heart disease and obesity.

At issue is a study that suggested the drug increased the risk of cardiovascular events (heart attack, stroke, that sort of thing) for people who already had heart trouble. Overall, 11.4% of the patients in the study who took the drug had cardiovascular events, compared with 10% who took a placebo. You can see how the subgroups break out in the table at the bottom of this page.

 

Abbott wasn’t immediately available for comment, Dow Jones Newswires said.