Celebrex Heart Disease Safety – Part 1

Patients using Celebrex have questions about heart disease safety. And, they have good reason. A few weeks after September 2004, when Vioxx was withdrawn from the market, Bextra – a sister drug – was also found to increase the risk of heart disease. Drugs like Vioxx, Celebrex, and Bextra fall into the class of drugs commonly called NSAIDs or nonsteroidal anti-inflammatory drugs. And, these drugs belong to another subclass called Cox-2 inhibitors or second generation NSAIDs.

Cox-2 inhibitors work by reducing substances that cause inflammation, pain and fever in the body. Looking into Celebrex heart disease safety finds that it also is a Cox-2 inhibitor.

In September 2004, Merck (the company that manufactures Vioxx) withdrew Vioxx from the market after a clinical trial confirmed that the drug increased risk of heart attack and stroke in patients. Their decision was based on new data from a clinical trial called APPROVe. The purpose of this trial was to see if Vioxx was effective in preventing the recurrence of colon polyps. The trial was stopped after 18 months because patients taking Vioxx had rates of heart attack and stroke double that of those on the placebo. Merck took a $25 billion dollar hit to their market value in one day.

Fast forward several weeks and find that both Bextra and Celebrex were under scrutiny for the same effects. Pfizer produces both of the other medications. At this time, European regulators were launching a safety investigation into the entire category of Cox-2 inhibitors and Pfizer was considering clinical trials to test the safety of use in the long term. Not long afterwards, to comply with European regulators, Pfizer took Bextra and Celebrex off the market in Europe.

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