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FDA Opts For Safer Diabetes Drugs

After months of internal debate, the Food and Drug Administration decided to pull the controversial diabetes drug Rezulin from pharmacy shelves after it received the latest data on two newer diabetes drugs, Avandia and Actos.

CBS News Correspondent Sharyl Attkisson reports that with safer drugs available, the FDA decided there's no longer any reason for patients to take Rezulin.

The agency said it requested that the drug no longer be sold and that its manufacturer, Park-Davis /Warner Lambert, had agreed.

"The data show that the potential for causing serious liver damage is greater with Rezulin than with the other two," said Dr. Murray Lumpkin, of the FDA's Center for Drug Evaluation and Research.

Since CBS News' first report on the drug a month ago, the number of liver deaths linked to Rezulin has risen from 58 to 63.

However, even though Warner-Lambert agreed to take it off the market, the company still insists Rezulin's benefits outweigh the risks.

In a statement explaining its decision to cooperate with the FDA , the company said, "repeated media reports sensationalizing the risks...have created an environment in which patients and physicians are unable to make well-informed decisions."

But Rezulin's withdrawal comes months later than it should have, according to FDA scientist Dr. Robert Misbin and several of his colleagues who told CBS News FDA management ignored their warnings about Rezulin.

Warner-Lambert's Statement
March 21 release from Warner-Lambert:

Warner-Lambert Company announced today that it is voluntarily discontinuing the sale of REZULIN (troglitazone) Tablets, its therapy for the treatment of type 2 diabetes, although the Company continues to believe that the benefits of the drug outweigh its associated risks.

Patients taking REZULIN should consult with their physicians as soon as possible to discuss alternative therapies.

Warner-Lambert will work closely with the Food and Drug Administration and other constituencies to assure a safe and efficient transition for patients as they switch to alternative therapies.

The Company has always believed that it is essential for patients and physicians to receive accurate and objective information regarding the benefits and risks of REZUIN. It was for this reason that Warner-Lambert requested a public meeting of the FDA's expert Advisory Committee.

However, repeated media reports sensationalizing the risks associated with REZULIN therapy have created an environment in which patients and physicians are simply unable to make well-informed decisions regarding the safety and efficacy of Rezulin.

Under these circumstances, and after discussions this evening with the FDA, we have decided it is in the best interests of patients to discontinue marketing REZULIN at this time.

Misbin wrote Congressman Henry Waxman, D.-Calif., to complain, "I have been frustrated in my efforts to convince my superiors that the time has come to remove Rezulin from the market."

He and another FDA whistleblower, Dr. Leo Lutwak, were summoned by that agency's Internal Affairs division for questioning on leaking information to the media.

"There is something wrong, in my humble opinion, about professional after professional medical officers at the FDA giving a recommendation and their recommendation being overturned by people above them who are not really experts in this drug," said former FDA medical reviewer Dr. John Gueriguian, the first to clash with FDA management over Rezulin; it was approved over his objections.

"I think that there's been an awful lot of pressure brought on by the media and by events, by lawsuits, et cetera, et cetera, so that at some point the FDA decided it was time to change course and move on," Gueriguian told CBS News' The Early Show on Wednesday.

Asked about complaints by FDA scientists, Lumpkin said the allegations of a cover up were "just totally untrue."

"It is not uncommon at all here for us to have differences of opinion, have honest differences of scientific opinion," Lumpkin said.

While the new drugs, Avandia and Actos, appear far safer, the FDA says they haven't been out long enough for scientists to know for sure whether there will be serious problems in the long term with these drugs.

The FDA today cautioned in rare cases Avandia and Actos may also cause severe liver problems.

Rezulin, a drug used to treat type II diabetes, was introduced in the United States in 1997.

CBS News has previously reported that two researchers who conducted clinical trials of the drug for manufacturer Warner-Lambert claim the company told them to downplay problems with the drug.

CBS News also reported that FDA documents show tests of the drug found liver enzyme levels six times the normal levels, even though Warner-Lambert reported levels of "2 to 3 times...normal," a figure the company later acknowledge to the FDA was "not correct."


Links to other Rezulin stories:

Rezulin: A Chronology

Rushing Drugs To Market

Drug Linked To Liver Damage

Drug Maker Wants Rezulin Review

Did Manufacturer See Rezulin Danger?

FDA Whistleblower Faces Probe

Another FDA Whistleblower Speaks