Pfizer PainKiller Bextra withdrawn from market, New Boxed Warnings for Celebrex

Thu, 07 Apr 2005

Pfizer’s withdrawal of the COX-2 pain reliever, Bextra, from the market because of potentially lethal side effects, including increased risk of cardiovascular malfunction and severe rash, validates Dr. David Graham’s analysis. This FDA medical expert became a whistleblower rather than keep silent about FDA approved drugs that are killing people–among these, Vioxx. Dr. Graham’s recommendations–which were based on the evidence– were rejected by his bosses at the FDA and by FDA’s expert advisory committee, which voted to allow the continued marketing of painkiller drugs that were shown to induce fatal heart attacks and strokes, in February, 2005. The New York Times reported that 10 of those 32 panelists on FDA’s advisory committee who swung the votes had ties with those drugs’ manufacturers – Pfizer and Merck. It was later revealed by Merril Goozner, of The Center for Science in the Public Interest, that, in fact, 27 of the 32 panelists had financial ties to drug manufacturers.

The suppression of evidence about concealed lethal drug side-effects has led doctors to prescribe medicines that kill.

A Citizens Petition was submitted May 2004, requesting the FDA to issue a Black Box warning and Dear doctor letter to warn physicians and the public about the suicide risk of Pfizer’s drug Neurontin. The drug is widely sold for pain relief and psychiatric conditions without FDA approval. So far the FDA has received 258 reports about fatal suicides and thousands of reports linking the drug to suicide attempts. Each day that passes without prominent warnings increases the number of preventable deaths and injuries. The petition is collecting dust–it will be posted within a day or two at: www.ahrp.org.

Hundreds of thousands of preventable human casualties in the US occur annually as a result of adverse drug reactions. The systemic failure to prevent drug-induced tragedies is a clear demonstration of a system corrupted by the influence of the pharmaceutical industry. Both the FDA and its advisory panels routinely set aside safety concerns to promote sales.

“The FDA has become an agent of industry. I have been to many, many internal meetings and, as soon as a company says it is not going to do something, the FDA backs down. The way it talks about industry is ‘our colleagues in industry’… it is rather because the body is entirely geared towards concentrating on approving drugs, doing little once they are on the market.”

See: Griffiths K; The Interview – Drug tsar who took on the system: David Graham, FDA whistleblower. The Independent, 12 February 2005

The British are, once again, ahead of the curve on drug safety issues–the British Parliament Health Committee has just released a landmark report following a 7 month investigation. The US government continue to drag its feet. See: http://www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf

Contact: Vera Hassner Sharav
212-595-8974

New FDA Labeling for Pfizer’s Celebrex and All Other NSAIDs to Reflect
Similar Cardiovascular Profile
April 07, 2005 09:20:00 AM ET

Pfizer Separately Agrees to Suspend Sales of Bextra Due to FDA Evaluation of Risks of Rare But Serious Skin Reactions

NEW YORK, April 7 /PRNewswire/ — Pfizer said today it will work with the U.S. Food and Drug Administration (FDA) to add expanded risk information in the Celebrex label following an FDA decision announced this morning to require boxed warnings of potential cardiovascular risk for all COX-2 pain relievers and all NSAIDs, including older non-specific drugs such as ibuprofen and naproxen.

The boxed warning for all non-steroidal anti-inflammatory drugs (NSAIDs), including Celebrex, will also contain information regarding gastrointestinal risk that is already included elsewhere in their current labels.

In addition, the FDA is asking manufacturers of all over-the-counter NSAIDs to revise their labeling to include more information on the cardiovascular and gastrointestinal risks as well as a warning about potential skin reactions.

Pfizer and the FDA plan further discussions regarding the precise content of the Celebrex label. Pfizer has accumulated extensive Celebrex clinical data over the past 10 years involving more than 40,000 patients. Pfizer also reaffirmed its commitment to conduct additional long-term clinical studies evaluating the benefits and risks of Celebrex.

Pfizer also said it will work closely with the FDA to develop a guide to assist patients and their healthcare professionals in making the best decisions for treating their arthritis pain.

Regarding Bextra, Pfizer’s other oral Cox-2 inhibitor, the FDA informed Pfizer late yesterday that, in the agency’s view, Bextra’s cardiovascular risk could not be differentiated from other NSAIDs. However, the agency has concluded that the additional, increased risk of rare but serious skin reactions associated with Bextra, already described in its label, warrants its withdrawal from the market.

Pfizer respectfully disagrees with FDA’s position regarding the overall risk/benefit profile of Bextra. However, in deference to the agency’s views, the company has agreed to suspend sales of the medicine pending further discussions with the FDA. Pfizer said it will explore options with the agency under which the company might be permitted to resume making Bextra available to physicians and patients. For now, patients should stop taking Bextra and contact their physicians about appropriate treatment options.

In addition, at the request of European regulators, Pfizer will also suspend sales of Bextra in the European Union. The company is in contact with other regulatory agencies around the world and will take appropriate measures based on those discussions.

Pfizer was informed by the FDA of its conclusions regarding Celebrex and Bextra on Wednesday afternoon, one day after the company held a meeting with financial analysts. Pfizer received the request from the European regulators early Thursday morning. Pfizer said it is evaluating the operational and financial impact of these actions.

© 2005 PRNewswire

FAIR USE NOTICE: This may contain copyrighted (© ) material the use of which has not always been specifically authorized by the copyright owner. Such material is made available for educational purposes, to advance understanding of human rights, democracy, scientific, moral, ethical, and social justice issues, etc. It is believed that this constitutes a ‘fair use’ of any such copyrighted material as provided for in Title 17 U.S.C. section 107 of the US Copyright Law. This material is distributed without profit.