FDA recommends alternatives following Celebrex scare
pharmafile | December 21, 2004 | News story | Sales and Marketing |
A new study linking Celebrex to the same increased risk of heart attacks and strokes as recently withdrawn Vioxx has plunged manufacturers Pfizer into crisis.
The Adenoma Prevention with Celecoxib (APC) study of the blockbuster painkiller has been halted after a new analysis has shown patients taking the drug suffered up to 3.4 times as many cardiovascular events as those taking a placebo.
The trial was a publicly funded, large-scale trial conducted by the US National Institutes of Health, and has reached a contrasting conclusion to a trial of similar size and duration sponsored by Pfizer, called PreSAP.
This study has shown no increased cardiovascular risk in patients, but the FDA is exercising extreme caution after the Vioxx controversy and is already advising doctors to consider switching patients to alternative treatments.
The FDA said: "Physicians should consider this evolving information in evaluating the risks and benefits of Celebrex in individual patients. FDA advises evaluating alternative therapy. At this time, if physicians determine that continued use is appropriate for individual patients, FDA advises the use of the lowest effective dose of Celebrex."
When the news broke, 11% was wiped off Pfizer's share price as investors feared the industry leader would have to withdraw its blockbuster, which will earn around $2 billion worldwide in 2004.
Pfizer chief executive Hank McKinnell was quick to defend Celebrex's safety profile, and said it had no plans to withdraw the drug. McKinnell revealed that he takes the drug himself and would continue to. Despite the manufacturer's confidence, the FDA says it is ruling nothing out at this stage.
"We're leaving open all regulatory decisions as we move forward. But we do not have a decision on the fate of the product," said Acting FDA Commissioner Lester Crawford. "We do have great concern about this product (Celebrex) and the class of products."
The increased risk was only uncovered because steering committees at the National Institutes of Health asked for specific analysis of cardiovascular risk in the trials following Vioxx withdrawal.
The Celebrex study was for exactly the same indication as the decisive Vioxx trial – the prevention of colorectal polyps. Pfizer's drug is already licensed as a treatment to reduce the number of polyps, which can eventually become malignant.
Dr Joseph Feczko, president of worldwide development for Pfizer was keen to stress that results from the APC trial had not been replicated in the PreSAP study or in the large body of data already accumulated since Celebrex's launch in 1998, even in higher doses than the top 400mg dose used.
Europe's regulator the EMEA says it is currently evaluating the new data, but has instructed doctors to follow existing guidance which advises particular caution and extra monitoring when prescribing the drug to patients with heart disease.
In the UK, the the Committee on Safety of Medicines is setting up an Expert Working Group to specifically examine the cardiovascular safety of all the COX-2 inhibitors and says it will play a leading role in a forthcoming Europe-wide safety review.
The British Society of Rheumatology, the UK professional body for specialists in the field said that for patients without a history of heart disease who had been taking the drug for less than a year it was unlikely they were at significant risk.
But Professor David Isenberg, president of BSR added: "However, it is important to realise that there are risks as well as gains associated with all forms of arthritis drugs. There are alternative treatment options available and I would recommend that anyone who is concerned about possible risks should discuss their situation with their GP or rheumatologist at the earliest opportunity."
Pfizer's drug has only benefited slightly from the withdrawal of Vioxx in the UK, with some patients switched to Celebrex after the withdrawal, but many others have switched to older NSAIDs or have come off medication entirely.
