Premarin

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Subj: [HEALTHE] Drug company sued for not disclosing side effects

Date: 2/11/99 11:47:39 PM CST

From: UncleWolf@... ( Gach)

Sender: HEALTHE@... (Health and Environment Resource Center)

Reply-to: HEALTHE@...HEALTHE@... (Health and Environment Resource Center)

To: HEALTHE@...

FYI: Wyeth-Ayerst, the drug company sued for failing to disclose that

its diet drug has caused pulmonary hypertension and heart valve damage

is also the maker of Premarin, an estrogen supplement obtained from

horse urine. [AG]

=================================================

Lawyers say fenfluramine maker withheld side effects information

Associated Press, - DALLAS , February 11, 1999

By JAY JORDEN

The maker of the now-recalled diet drug fenfluramine withheld

information about instances of potentially fatal side effects and

delayed stronger warning labels until it had rolled out another

weight-loss drug, say lawyers suing the pharmaceutical company.

Fenfluramine - which was half of the diet-drug combination fen-phen and

was sold by the drug company Wyeth-Ayerst as Pondimin - carried labels

starting in 1988 warning that in rare instances, it caused pulmonary

hypertension, a potentiallly fatal illness.

In June 1994, Wyeth's medical monitor, doctor Frederick , told

executives that he knew of 37 PPH cases, even though Wyeth-Ayerst had

notified federal regulators of only four, according to internal

documents acquired by Kip Petroff, a lawyer for 100 people suing

Wyeth-Ayerst.

" In view of this, as well as other case reports ... revision of the

current labeling should be considered, " wrote in a memo.

Petroff said it took Wyeth-Ayerst two years to get the warning label to

list more cases. He said that Wyeth-Ayerst was obligated by federal law

to amend the labeling immediately and could do so without FDA

permission.

Wyeth-Ayerst has been hit with hundreds of lawsuits over fenfluramine

and another recalled Wyeth-Ayerst diet drug, Redux. The first case is

scheduled to go to trial on March 16 in Fort Worth.

Wyeth-Ayerst spokesman Doug Petkus insisted that the FDA knew about the

additional PPH cases while it was reviewing the new application for

Redux and that the cases were discussed publicly by FDA advisory

committee members twice in 1995.

Petroff represents clients in the Dallas-Fort Worth area and Arkansas

who are suing Wyeth-Ayerst for unspecified damges for heart valve

injuries, pulmonary hypertension and other ailments.

Pondimin and Redux were pulled from shelves in 1997 when the Mayo Clinic

warned of heart-valve damage risks unrelated to PPH. The other half of

fen-phen, phentermine, is still on the market.

Evidence in the lawsuit includes an internal document calling for

additional warnings. According to Petroff, such warnings were delayed by

a June 1995 note from doctor Marc Deitch, Wyeth medical affairs

director. He wrote that officials " need to discuss implication re:

dexfenfluramine before proceeding. "

Dexfenfluramine, marketed as Redux, went on the market in 1996. The

labeling change on Pondimin became effective weeks later.

" We believe that what was done in this case was putting profits in front

of patients' lives, " Kisselburgh, Petroff's law partner, said

Thursday. " It was in the company's economic interest to get Redux

approved. It was worth millions of dollars to them. "

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Date: Thu, 11 Feb 1999 09:35:01 -0800

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Subject: [HEALTHE] Drug company sued for not disclosing side effects

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