Celebrex Benefits May Have Been More Hype, Not Enough Substance

No matter how impressive a new drug may appear, it can take years on the market and millions of patients before possible risks and side effects begin to surface.

(PRWEB) March 2, 2005 -- Celebrex was deemed a “super aspirin” when it was released in 1999. The COX-2 inhibitor drug class, which includes Pfizer’s Celebrex and Bextra and Merck’s Vioxx, had one advantage over aspirin and other time tested pain medicines, which was to leave the stomach lining less vulnerable to damage.

Both Pfizer and Merck took part in aggressive advertising campaigns. The emergence of COX-2 drugs was shortly after the FDA relaxed television advertising rules in 1997. In 2004 alone, Pfizer spent $118 million in advertising on Celebrex, while Merck spent $71.8 million for Vioxx ads, according to Nielsen Monitor-Plus.   

Celebrex and other COX-2 drugs were intended for a certain group of patients at high risk for stomach bleeding, but the “super aspirin” label, alongside the widespread advertisement exposure, quickly allowed both Celebrex and Vioxx to reach blockbuster status, making billions of dollars in sales annually. A study published in January by Stanford University scientists estimate 25 million patients with no high risk of stomach bleeding were on COX-2 inhibitors by 2002.

The entire class of COX-2 drugs was questioned for the increased risks of heart attacks and stroke (http://www.onlinelawyersource.com/celebrex/side-effects.html) that resulted in Vioxx’s withdrawal from the market last September. Last week, an advisory panel of the FDA voted to allow Celebrex and Bextra to remain on the market, in addition to allowing a possible return of Vioxx provided it carries a black box warning on its label about cardiovascular risks, and patients who take the drug sign consent forms.

The panel also recommended Celebrex and Bextra carry a black box warning on their labels. Critics hoped the panel would recommend consumer ads be completely banned, but the FDA is not expected to take such an extreme measure. In the past, Pfizer faced regulatory action for misleading safety claims and omitted risk information about Celebrex and Bextra, and the company discontinued consumer advertising for Celebrex after the Vioxx recall in response to an FDA request.

The FDA’s acting commissioner, Lester Crawford, has pledged to aggressively monitor ads that make unrealistic promises with little mention of risks, but the public still remains weary. In addition to having no advantage from taking Celebrex and other COX-2 drugs, the price of the drugs is significantly more expensive than aspirin and other alternatives and carries a risk of heart problems.

Patients, alongside their doctors, are now left weighing the pros and cons of COX-2 drugs, as well as their alternatives, but one lesson is clear. No matter how impressive a new drug may appear, it can take years on the market and millions of patients before possible risks and side effects begin to surface. Although a new drug has the ability to dramatically improve one’s condition, many Celebrex and other COX-2 users could have easily benefited from older drugs, at a small percentage of the cost, without suffering an increased risk of heart attacks and stroke.