Vioxx Post... resent for those who couldn't open

[Guest guest]

Here is the article from Medscape about Vioxx..

FDA Serves Merck With a Warning Letter for Vioxx Promotions

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WASHINGTON (Reuters Health) Sept 24 - The US Food and Drug Administration has

issued Merck & Co. Inc. a warning letter with regard to its promotion of

Vioxx (rofecoxib), the company's blockbuster COX-2 inhibitor.

According to documents released on Monday, the FDA cited Merck for a

misleading press release and several promotional audio conferences conducted

on behalf of the company by Dr. Holt, chief of gastroenterology at St.

Luke's-Roosevelt Hospital Center in New York City.

These promotional campaigns minimized potentially serious cardiovascular

findings from the Vioxx Gastrointestinal Outcomes Research (VIGOR) clinical

trial, the FDA said. The VIGOR trial was designed to compare the side effects

of Vioxx versus the non-steroidal anti-inflammatory drug Naprosyn (naproxen)

in patients with rheumatoid arthritis.

In specific, the FDA said that the promotional activities discounted the fact

that patients on Vioxx were observed to have a four- to five-fold increase in

strokes compared with those on Naprosyn.

The FDA also said that Dr. Holt minimized the risk of drug interactions, such

as interaction of Vioxx and Coumadin (warfarin); failed to present other

significant risks; made unsubstantiated claims of Vioxx's superiority to all

NSAIDs; and promoted unapproved uses. " Your minimizing these potential risks

and misrepresenting the safety profile for Vioxx raise significant public

health concerns, " the FDA said.

The FDA demanded that to remedy these violations, Merck must immediately

cease its promotional activities, issue a " Dear Doctor " letter to correct any

misperceptions, and provide the agency with a written plan on how it intends

to comply with its demands.

The FDA said that the written plan is necessary because it previously cited

Merck for similar violations in December 1999, just a few months after Vioxx

initially was approved for the management of acute pain and relief of

osteoarthritis.

Merck is now in the process of providing that response and expects to have an

answer to the FDA by the October deadline, Merck spokesperson Fanelle

told Reuters Health. " We continue to stand behind the overall safety of

Vioxx, " she added.

Under federal regulations, the FDA could now slap Merck with a fine and/or

place a hold on its pending new drug applications (NDAs) if the issue remains

unresolved. But most warning letters are resolved with no further action.

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[Guest guest]

Here is the article from Medscape about Vioxx..

FDA Serves Merck With a Warning Letter for Vioxx Promotions

------------------------------------------------------------------------------

--

WASHINGTON (Reuters Health) Sept 24 - The US Food and Drug Administration has

issued Merck & Co. Inc. a warning letter with regard to its promotion of

Vioxx (rofecoxib), the company's blockbuster COX-2 inhibitor.

According to documents released on Monday, the FDA cited Merck for a

misleading press release and several promotional audio conferences conducted

on behalf of the company by Dr. Holt, chief of gastroenterology at St.

Luke's-Roosevelt Hospital Center in New York City.

These promotional campaigns minimized potentially serious cardiovascular

findings from the Vioxx Gastrointestinal Outcomes Research (VIGOR) clinical

trial, the FDA said. The VIGOR trial was designed to compare the side effects

of Vioxx versus the non-steroidal anti-inflammatory drug Naprosyn (naproxen)

in patients with rheumatoid arthritis.

In specific, the FDA said that the promotional activities discounted the fact

that patients on Vioxx were observed to have a four- to five-fold increase in

strokes compared with those on Naprosyn.

The FDA also said that Dr. Holt minimized the risk of drug interactions, such

as interaction of Vioxx and Coumadin (warfarin); failed to present other

significant risks; made unsubstantiated claims of Vioxx's superiority to all

NSAIDs; and promoted unapproved uses. " Your minimizing these potential risks

and misrepresenting the safety profile for Vioxx raise significant public

health concerns, " the FDA said.

The FDA demanded that to remedy these violations, Merck must immediately

cease its promotional activities, issue a " Dear Doctor " letter to correct any

misperceptions, and provide the agency with a written plan on how it intends

to comply with its demands.

The FDA said that the written plan is necessary because it previously cited

Merck for similar violations in December 1999, just a few months after Vioxx

initially was approved for the management of acute pain and relief of

osteoarthritis.

Merck is now in the process of providing that response and expects to have an

answer to the FDA by the October deadline, Merck spokesperson Fanelle

told Reuters Health. " We continue to stand behind the overall safety of

Vioxx, " she added.

Under federal regulations, the FDA could now slap Merck with a fine and/or

place a hold on its pending new drug applications (NDAs) if the issue remains

unresolved. But most warning letters are resolved with no further action.

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