Healthy Skepticism Library item: 893

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Japsen B.
FDA weighs decision on Meridia: Health advisory likely for Abbott obesity drug
Chicago Tribune 2005 Mar 13

Full text:

The Food and Drug Administration is close to issuing a health advisory on Abbott Laboratories’ weight-loss drug Meridia, one of several prescriptions that have engulfed the agency in controversy over its safety monitoring of drugs on the market, a source close to the FDA said.

While the FDA stands by past statements that Meridia is safe and effective if used according to its label, the source said the FDA is expected to issue an advisory that could result in a stiffer warning, restricted use or something more minor such as updated prescription guidelines.

Meridia has been found to raise blood pressure and increase heart rate in some patients.

Such a move by the FDA would be similar to the agency’s action March 2 when it ordered the cholesterol-lowering drug Crestor to carry an additional warning about a potential rare muscle-damaging side effect.

The moves by the FDA to issue more detailed information about potential problems on drugs comes as the agency faces significant criticism from consumer groups and lawmakers for a lack of oversight of drugs once on the market.

FDA safety officer Dr. David Graham listed Crestor and Meridia among five potentially dangerous drugs the FDA needed to evaluate in Senate testimony last fall.

Graham was brought in to testify about the pain reliever Vioxx which its maker, Merck & Co., withdrew after a study showed it increased the risk of heart attacks.

But he also used his opportunity to tell a Senate committee the FDA had left the nation “virtually defenseless”—citing Meridia, Crestor, the painkiller Bextra, acne drug Accutane and asthma medicine Serevent as medications that need more scrutiny.

Since that hearing, the FDA or its advisory panels have formally addressed three of the five drugs.

In addition to Graham, other consumer advocates are pushing the FDA to address Meridia’s safety.

“It is long overdue for the FDA to at least warn consumers about the risks of Meridia,” said Diana Zuckerman, president of the public interest group National Research Center for Women & Families.

Almost three years have passed since the consumer group Public Citizen petitioned the U.S. government to pull Meridia off the shelves, alleging it caused dozens of deaths and more than 400 adverse patient reactions since its launch seven years ago.

However, reviews of Meridia by overseas regulators have been quicker and favor keeping the drug on the market. In addition, the U.S. court system has dismissed several suits against the drug’s maker.

Meridia, which Abbott acquired in a 2001 merger, is most often criticized for promoting limited weight loss in exchange for increased risk of high blood pressure, especially in the obese patients who are likely candidates of the drug.

Meridia’s FDA-approved labels tout weight loss potential of four pounds in the first month while eating a low-calorie diet. The company claims patients lose more weight over time.

“Four pounds sounds pathetic because the first five are usually the easiest,” Zuckerman said.

Some unsure of next step

The elevated noise level surrounding Meridia has confused doctors and their patients, some of whom have abandoned the drug.

And doctors who do prescribe the drug say they proceed with caution.

“I would recommend the FDA come out with a clear statement one way or another,” said Dr. Robert Kushner, an internist and medical director of the Wellness Institute at Northwestern Memorial Hospital in Chicago said of Meridia, which he prescribes for some patients. “You certainly don’t want medications on the market where controversy remains.”

The embattled FDA said it has started, and plans to continue, communicating more information on its post-marketing surveillance of drugs, to reduce such controversy.

In its March 2 announcement regarding Crestor, the FDA said it was providing “Americans with earlier access to emerging safety information about their medicines.”

About a week after Graham’s testimony, the FDA announced “the strengthening of the risk minimization action plan for Accutane,” to eliminate the possibility pregnant women will use the drug, which can cause birth defects.

And last month, a FDA advisory panel said Bextra, like similar Cox-2 arthritis drugs Vioxx and Celebrex “significantly increases” the risk of heart attack or stroke. Although Bextra and Vioxx were almost recommended for a ban by the panel, advisers recommended all three Cox-2s carry a so-called “black box” warning label, the agency’s stiffest warning. The drugs now await a formal ruling from the FDA, which typically follows the recommendations of its panels.

As for Meridia—which an advisory panel voted 5-4 against approving in 1996—Graham said the FDA should consider whether the drug’s benefits outweigh the risks of high blood pressure and stroke among those who take it, indicating patients didn’t stay on the drug because of such risks.

“With Meridia, I think seriously we have to consider whether there’s just a need for the product in the first place,” Graham told the panel.

Abbott sticks with product

But Abbott is standing by Meridia’s safety, pointing to clinical studies and research that support the drug as a treatment for obese patients.

The company said last week that it is unaware of any forthcoming advisory from the FDA.

And when patients do decide to stop taking Meridia, Abbott said it’s because health plans don’t generally cover the drug.

“Lack of insurance coverage for obesity meds is the reason patients do not stay on treatment,” Abbott spokeswoman Laureen Cassidy said.

So far, Abbott has been successful in defending other allegations about Meridia, one of only two prescription drugs approved in the United States as a long-term treatment for weight loss. The other is Xenical, sold by Roche AG.

In July of last year, for example, a federal judge in Ohio dismissed 113 cases against Abbott, saying plaintiffs failed to show sufficient evidence the drug harmed them. Abbott still faces four cases in state courts involving claims related to Meridia, the company said.

Furthermore, Abbott sales figures show Meridia sales have been growing outside the United States where the company satisfied some regulators who had concerns three years ago.

In 2002, European regulators deemed Meridia safe for the treatment of obesity following some reports in Italy that two patients had died after taking the drug. In those cases, no link between Abbott’s drug and the patients’ death was established.

The regulatory go-ahead in Europe has helped Meridia’s sales outside the U.S. rise 20 percent annually. Meridia sales outside the U.S. rose to $240 million last year from $200 million in 2003.

By comparison, Meridia sales in the U.S. have been largely flat over the last two years at $65 million, a figure Wall Street analysts blame on publicity surrounding lawsuits as well as the FDA’s delay.

Last year, in response to a Tribune inquiry, the FDA said the agency wanted to make sure it had the most “up-to-date adverse event data before responding [to Public Citizen’s petition], and because of internal procedural delays it held off an earlier response,” FDA spokeswoman Laura Alvey said at that time. “We have decided to make the adverse event data as up-to-date as possible, which is going to form the basis of our response.”

Many observers are also particularly surprised at the slow response to Meridia, particularly in the wake of fen-phen, the pill combination that was linked to heart valve damage and subsequently yanked from pharmacy shelves in 1997.

The FDA still cannot say when it will issue a formal response to Public Citizen’s petition regarding Meridia.