Pfizer Disagrees with the FDA Decision to Ban the Drug

Pfizer was asked by Food and Drug Administration (FDA) to halt the sales of Bextra in 2005. Sale of Bextra was suspended because FDA suggested that consumption of bextra causes serious side effects. It was found that more than 7 million people were prescribed with bextra in 2004. Bextra is a COX 2 selective Non-Steroidal Anti-Inflammatory Drug (NSAID).

Bextra was withdrawn from the market because reports suggested that the use of this drug increases the risk of heart attack, fatal skin disease, strokes and Stevens Johnson Syndrome. At that time FDA decided to issue stronger safety warnings on all NSAIDs including Aleve, Celebrex, Motrin and Mobic.

Bextra belongs to the group of Merck & Co’s drug Vioxx, COX 2 inhibitor for pain relief. It was also withdrawn from the market in 2004 when it was found that the use of this drug caused strokes and heart attacks in the patients taking it.

In a response to media, Pfizer issued the statement given below in May, 2005:

“As previously communicated, Pfizer has suspended sales of Bextra (valdecoxib) pending further discussions with the U.S. Food and Drug Administration (FDA). Pfizer continues to believe that Bextra could be an important treatment option for certain patient populations. In the future, the company plans to discuss options with the FDA under which Bextra might be made available to those patients”.

In information given to Pfizer by FDA, it stated that there is no difference in the cardiovascular risks caused by the use of Baxter and other NSAIDs. But the agency added that bextra is associated with a rare skin disease, Stevens Johnson Syndrome, which led to its removal from the market. It is a life threatening disease caused by bextra.
Symptoms of Stevens Johnson Syndrome are inflammation of the membranes in the intestinal tract, eyes, mouth, genital tract and throat. Ulcers inside the mouth cause irritation and inflammation to the lips, tongue and gum. This irritation and inflammation may extend to the throat. Patients affected from the SJS may also have blisters, skin lesions and bleeding in the nasal passage, eyes, genital areas, mouth and lips. Patients suffering from SJS are treated in the burn unit of a hospital. Infected skin lesions and lesions in the lungs may even cause death.

Bextra was initially given to the patients suffering from arthritis in order to relieve the symptoms of   rheumatoid arthritis and osteoarthritis. It was also given to women to relieve their pin during menstrual cycle and PMS. According to a study conducted in November 2004, patients who consumed bextra were at an increased risk of suffering from early strokes and cardiac arrest as compared to non users. The study was conducted on almost 6000 patients who were given bextra and placebo. Many COX 2 inhibitors have been banned till date due to increased risk of stomach ulcers, severe stomach reactions, stroke, liver damage and heart attack.

Some patients are always at an increased risk of suffering from complications and side effects of bextra. This includes post operative patients who have undergone cardiovascular bypass surgery (CABG) and people who suffered from cerebrovascular disease or coronary artery disease and patients suffering from stroke and stomach ulcers. It has been recommended that patients who are prescribed Bextra should consult a doctor even if they are not experiencing any of the side effects..

Pfizer Settlement for the Use of Unsafe Drugs

On October 17, 2008, Pfizer declared that a deal has been finalized with 33 states to resolve the investigation related with the promotion of two painkillers Bextra and Celebrex. The company will pay $ 60 million as settlement because they promoted the drugs for the disease that were not meant to treat.  This deal is a part of $ 745 million that Pfizer is paying to the people who filed personal injury lawsuit against the company for the side effects caused by the use of Bextra and Celebrex.

In 2004, Merck pharmaceuticals voluntary remove Vioxx from the market. This led to the legal trouble for many other pharmaceutical companies. Moreover, questions were raised on the safety and effectiveness of these drugs. One year after the withdrawal of Vioxx in 2004, Bextra was taken off the shelves and from the market in 2005. In addition to main functions, doctors can prescribe these drugs for other purpose also. However, companies cannot advertise their drugs or medicines in this way.  Many health care professionals and doctors have linked Bextra and Vioxx with severe side effects including the following:

• Stomach ulcers
• Risk of blood clots
• Liver damage
• Cardiac arrest
• Kidney damage
• Increased risk of stroke

These side effects and complications are commonly associated with COX 2 inhibitors, namely Celebrex, Vioxx and Bextra. Pfizer expects that the settlement money will be adequate to resolve all the present and future lawsuits related to the use Bextra and Vioxx.

If you believe that you are suffering from the side effects of taking Celebrex, than you should seek the advice of an experienced attorney who will help you in filing a lawsuit against the company.