Celebrex Heart Disease Safety – Part 2

Then, in December 2004, the NIH (National Institute of Health) suspended a colon cancer prevention trial when the findings suggested that Celebrex more than doubled the heart deaths, heart attacks and strokes in people enrolled in the study determining there was concern for Celebrex heart disease safety.

This particular study, called the Adenoma Prevention with Celecoxib (APC) trial, was stopped by an independent Data Safety and Monitoring Board. The APC trial was a study of more than 2,000 people who had a precancerous growth removed and who were randomized for Celecoxib to determine if it would prevent the growth of colon cancer. After the removal of Vioxx from the market in September 2004, additional cardiovascular expertise was added to the monitoring committee. Even though the study began in 2000, and was scheduled to be completed Spring 2005, it was immediately suspended in December 2004.

Another ongoing trial, PreSAP, using Celebrex and the same heart measures and safety monitoring board found no increased risk of heart attack or stroke in patients. The opposing findings of both studies was concerning, as was the fact that no previous studies linked Celebrex to heart attacks or stroke.

Then, in April 2005, Bextra was removed from the market by request of the FDA because the skin disease and risk of heart attack and stroke outweighed any benefits of the medication. The drug company disagreed with the FDA ruling but complied. Bextra was Pfizer’s second leading seller in 2004 at $1.3 billion dollars led only by Celebrex at $3.3 billion dollars.

Today, concerns for Celebrex heart disease safety has led to increased warnings to physicians and screening of patients who are prescribed the medication.

Resources:

FDA: Cardiovascular Safety of Celebrex

http://www.fda.gov/ohrms/dockets/dockets/04n0559/04N-0559_emc-000002-01.pdf

Consumer Reports: Should you still take Celebrex

http://www.consumerreports.org/cro/2012/05/should-you-still-take-celebrex/index.htm

RxList: Celebrex

http://www.rxlist.com/celebrex-drug/warnings-precautions.htm

Pfizer: Celebrex Important Safety Information

http://www.pfizerpro.com/hcp/celebrex

Drugs: Celebrex

http://www.drugs.com/pro/celebrex.html

LawInfo: Celebrex Side Effects