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FDA refuses to pull Abbott obesity drug

August 17, 2005

WASHINGTON (Reuters) – The U.S. Food and Drug
Administration rejected a consumer group’s petition to withdraw
Abbott Laboratories Inc.’s obesity drug Meridia but said it
would continue to watch for safety problems, according to
documents released on Wednesday.

Consumer advocacy group Public Citizen had twice called on
the agency to pull the drug — also known as sibutramine —
from the market, citing deaths from cardiovascular problems in
people using the drug.

But the FDA concluded that “sibutramine’s overall
risk-benefit profile supports it remaining available as a
prescription drug for the treatment of appropriately selected
obese patients,” wrote Steven Galson, head of the agency’s drug
division.

Galson added that the agency had worked with Abbott to
educate doctors about appropriate patients and to change the
drug’s label, adding the need to monitor patients’ blood
pressure.

Meridia is an appetite suppressant approved in 72 countries
to treat obese adults along with dieting, according to the FDA.
It can cause side effects ranging from headaches and
constipation to higher blood pressure and a faster heart rate.

Public Citizen’s Health Research Group Director Sidney
Wolfe said the 50 heart-related deaths reported since the
drug’s approval still warrant its removal. While Meridia use
has dropped, “many people are still getting this dangerous but
not very effective drug,” said Wolfe, whose group petitioned
for the ban in 2002 and again in 2003.

Abbott, in a statement, criticized Public Citizen’s
analysis and said Meridia had repeatedly been proven safe and
effective.

Long term effects of the drug on obesity-related death is
still unknown, according to the drug’s label.

Weight-loss drugs are a growing market and have added to
the debate over whether obesity is itself a disease and how to
treat it. Nearly two-thirds of Americans are overweight or
obese, which can raise the risk of diabetes, heart disease,
certain types of cancer, and other diseases.

Some advocates say many patients cannot shed pounds without
medicine. But critics say the benefits of small weight loss
through these drugs are not worth the risks, which can include
heart problems, nausea and vomiting.

Meridia is one of five approved drugs that FDA veteran
scientist David Graham said should be scrutinized when he spoke
at a congressional hearing last year.

On Wednesday, Graham said the FDA and the company were
“relying on statistics” to keep the drug on the market. While
studies show Meridia can help patients lose some pounds, the
loss is not enough to improve patients’ health, he said.

“What’s the health benefit of losing 15 pounds if you weigh
300 pounds? There is none,” Graham said. Because of the side
effects, he said a study he did three years ago showed most
patients stayed on the drug for less than a month.




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