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FDA Warning on Celebrex Adds to Pfizer's Woes

Posted on: Tuesday, 21 December 2004, 21:00 CST

Dec. 19--Pfizer, the world's biggest drug maker, and the rest of the pharmaceutical sector will come under renewed pressure this week after the Food and Drug Administration (FDA) warned doctors to consider alternatives to the company's popular arthritis drug Celebrex on safety grounds.

The FDA's stark warning came hours after Pfizer issued a statement on Friday saying a study of Celebrex's effectiveness as a cancer treatment had thrown up new evidence that the drug doubled the risk of heart attacks and strokes.

Pfizer's admission led to more than $30 billion (43 billion euros, $57 billion) being wiped off its shares; the FDA's statement caused the shares to be active in after-hours trading.

The federal agency also said it may be forced to take other actions against Celebrex, including requiring stronger warnings or calling for the painkiller to be recalled. Viagra-maker Pfizer has given no indication that it would withdraw the drug, which is taken by 27 million Americans and has been available for five years.

In October, Merck's Vioxx, a drug from the same class of painkillers, was removed from the market.

The future of all Cox-2 inhibitors is now in question. On Friday, the National Institutes of Health ordered a review of more than 40 studies involving Cox-2 inhibitors. The FDA had planned to convene an advisory committee in February to discuss Cox-2 inhibitors; the agency may have to act sooner. On Friday the European Medicines Agency said it was reviewing data on the effects of Cox-2 inhibitors.

Friday was also a black day for AstraZeneca, which saw its shares drop 8.3 percent after the company said Iressa, the lung cancer drug approved in 2002, had not helped patients in a key clinical trial to live longer than they did without the drug.

Celebrex and other Cox-2 inhibitors were developed to be a stomach-friendly alternative to anti-inflammatory medicines such as aspirin, ibuprofen and naproxen. Taken long term, the older medicines can cause stomach bleeding and gastric problems.

The new Cox-2 inhibitors are moneyspinners because they are taken daily by millions of people. They sell for as much as $3 a pill; two Cox-2 drugs, Celebrex and Bextra, had been expected to account for $5 billion of Pfizer's estimated 2005 sales of $55 billion.

Some researchers suspected Cox-2 inhibitors may be reducing the body's production of a protein that prevents blood platelets from clumping together; this clumping could be the trigger for strokes and heart attacks.

Evidence of the risk in Celebrex surfaced in a Pfizer study conducted by the National Cancer Institute to determine if high doses of the drug could prevent formation of certain precancerous colon polyps.

The three-year study involved 2,000 patients. Some were given a placebo. Others were given 400 or 800 milligrams of Celebrex a day. The usual dose for arthritis patients (from 100 to 200 milligrams daily for those suffering from osteoarthritis) is much lower, accounting for why the side effects were not picked up previously.

Pfizer said the cancer study was out of step with other evidence showing Celebrex is safe.

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PFE, MRK, AZN,

Source: Sunday Business

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