A Brief History Of Celebrex

Exactly 10 weeks after Merck & Co. pulled their top-selling arthritis drug Vioxx from the shelves, Pfizer’s Celebrex was also found to increase the risk for heart attacks and strokes in a person. Pfizer, the world’s largest drug maker was conducting a study on Celebrex in preventing cancerous colorectal polyps with the National Cancer Institute, when these findings came to light. Celebrex is one of Pfizer’s biggest products with sales of $1.9 billion in 2003. More than 27 million Americans have been prescribed this medication since its FDA approval in 1998.

Celebrex like Vioxx belongs to a class of drugs known as cox-2 inhibitors. They work by blocking inflammation causing proteins called cox-2. Given below is a short summary of what has happened so far in this Celebrex controversy.

December, 1998 – Celebrex is approved by the FDA.

December, 1999 – Charges are made that the product labeling of Celebrex includes contraindications with the anticoagulant drug Warfarin.

April, 2000 – The FDA issues a warning to Pfizer for misrepresenting Celebrex.

2001 – Sakai et al from the Molecular Human Reproduction Journal in the European Society of Human Reproduction and Embryology determines that Celebrex narrows the ductus arteriosus. The ductus arteriosus is a short broad vessel in the fetus that allows blood bypass circulation to the lungs.

2002 – FDA determined that Celebrex should include in its product insert its CLASS clinical trial data.

September 30, 2004 – Merck & Co. pulls its painkiller Vioxx from the market, after studies showed that people who took Vioxx for a period of 18 months had an increased risk for developing cardiovascular disease including heart attacks and strokes.

October 1, 2004 – As both Vioxx and Celebrex are Cox-2 inhibitors, Pfizer releases data showing that Celebrex has no negative long term effects or “significant safety issues”.

October 7, 2004 – The New England Journal of Medicine raises questions in its editorial about the working of Cox-2 inhibitors in general and advises caution.

October 18, 2004 – Pfizer says it will evaluate the effects of Celebrex on patients with osteoarthritis who have a high risk for heart disease.

December 8, 2004 – Pfizer defends Celebrex, saying it is perfectly safe.

December 17, 2004 – Pfizer issues a statement that in one clinical trial for colonic polyps; Celebrex increased a persons risk for cardiovascular disease over a placebo. While in the other no greater cardiovascular risk was observed.

December 17, 2004 – The FDA issues a press release over the findings of the Pfizer-National Cancer Institute clinical study. It states that while these are only preliminary results, the FDA will conduct further testing and in the mean time advises caution over its use. The FDA also advises the use of the lowest effective dose of Celebrex.

December 17, 2004 – Pfizer issues another statement stating it will not withdraw Celebrex from the market.

December 18, 2004 – The FDA asks Pfizer to limit its direct marketing campaign and Pfizer agrees.

December 20, 2004 – Pfizer agrees to no longer advertise Celebrex to consumers.

December 21, 2004 – Pfizer says new study by the National Institute of Health is consistent with evidence supporting cardiovascular safety of Celebrex.

December 23, 2004 – U.S. health regulators recommend doctors limit their prescription of Celebrex, with evidence supporting an increased risk for heart attacks and strokes among its users. The FDA issues a public health advisory limiting the use of all Cox-2 inhibitors.