Arthritis pain reliever may lead to heart trouble

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Arthritis pain reliever may lead to heart trouble

 

Maker to keep Celebrex on market pending further

clinical studies

 

From wire reports

 

http://www.aberdeennews.com/mld/aberdeennews/10448211.htm

 

 

PHILADELPHIA - Pfizer

Inc. said Friday that its popular pain-reliever Celebrex may double the

risk of heart attack at high doses, triggering a torrent of new

warnings about an entire class of drugs used by millions.

New York-based Pfizer said it would not withdraw Celebrex, its third

best-selling drug behind Lipitor and Zoloft, and urged all patients to

consult with a doctor before changing their medication.

But its disclosure, similar to one about the related drug Vioxx

recalled three months ago by Merck & Co. Inc., rattled markets.

"People should go back to aspirin," said Herman Saftlas, a

pharmaceutical analyst at Standard & Poor's, which began advising

investors to sell Pfizer stocks Friday. The Celebrex-style drugs are

"under scrutiny and doctors will be very reluctant to prescribe them

for anybody with any hint of cardiovascular problem."

Other warnings: Pfizer's surprise announcement was coupled with

announcements from two other drug companies Friday, AstraZeneca P.L.C.

and Eli Lilly & Co.

AstraZeneca reported its lung cancer drug Iressa failed a key

clinical trial. The drug had been shown to be ineffective in prolonging

survival of patients with non-small cell lung cancer in the

manufacturer's clinical trial. The drug was approved in 2003 under an

accelerated review process that required the company to continue

conducting trials after it came on the market. The FDA recommended that

patients using Iressa consult with their doctors about further

treatment.

Lilly said it is warning doctors to stop using its attention deficit

disorder drug Strattera in patients with jaundice or laboratory

evidence of liver injury. Lilly said it was putting a boldface warning

in the prescribing information that it gives doctors about the drug

after two patients on the medication developed liver problems.

Stronger medications: The Cox-2 inhibitors such as Celebrex, Vioxx

and Bextra operate on a different process from pain-relievers like

ibuprofen and have become popular in treating arthritis, pain and other

inflammatory ailments.

Nearly 55 million prescriptions for Cox-2 drugs were written

worldwide in 2003, generating U.S. sales of $5.3 billion, according to

IMS Health, an industry monitoring firm.

Celebrex was a best-seller among them, with 27 million prescriptions

and U.S. sales of $2.6 billion in 2003.

The recommended dose is 100 mg to 200 mg daily to treat

osteoarthritis and 200 mg to 400 mg to treat rheumatoid arthritis.

Celebrex is also approved at doses up to 800 mg a day for familial

adenomatous polyposis,'' a rare colon cancer predisposition syndrome,

Pfizer said.

The National Cancer Institute, which was conducting the study for

Pfizer, suspended use of the drug after finding that patients taking

400mg to 800mg of Celebrex daily had a 2.5 times greater risk of major

heart problems than those who were not. A separate cancer study found

no increased heart risk with patients taking 400mg of Celebrex per day.

Pervious drug troubles: Vioxx, which had 20 million users and

worldwide sales of $2.5 billion, was withdrawn by Merck voluntarily on

Sept. 30 after a company-sponsored clinical trial showed increased risk

of heart attack and stroke in some patients after 18 months.

The Vioxx withdrawal came after the company had dismissed several

studies indicating a problem with its Cox-2 drug. Now, the New

Jersey-based Merck faces legal bills projected to run into the billions

of dollars.

The Food & Drug Administration also has come under scrutiny over

its actions related to Vioxx and other drug approvals. It has scheduled

hearings in February on the Cox-2 drugs, which operate by blocking a

protein believed to be associated with inflammation.

Scientists have long debated whether the same protein is also

responsible for preventing heart problems. The latest study supports

the theory that any Cox-2 inhibitor, no matter what its specific

chemical design or dosage, may have some effect on the heart.

A nonpartisan watchdog group, Public Citizen, reiterated its call

for a ban on Celebrex and another Pfizer painkiller, Bextra, in the

same class. Earlier this month, the Food and Drug Administration said

it was adding a warning to the labels of another Pfizer drug, Bextra,

warning of potential heart problems associated with the use of that

drug in people who recently had heart-bypass surgery.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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