Vioxx

[Guest guest]

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.

----

This is from Medscape. There's also an article in the September 3 issue

of Newsweek about arthritis that talks about it.

Barbara in Fla