With Bextra off the market, are there effective alternative ways to treat pain?

The latest drug recalls of prodects like Bextra and Vioxx and drug warnings on drugs such as Celebrex have left millions of people wondering what to use for relief. A new study suggests over-the-counter heat wraps may help people trying to manage arthritis and other chronic pain. A study funded by Procter and Gamble, the makers of ThermaCare heat wraps, looked at 110 men and women with osteoarthritis of the knee. Given either acetaminophen, ibuprofen or a placebo, and wearing a wrap with no heat or a ThermaCare heat wrap for eight hours a day, researchers found that those receiving the heat treatment had significantly less pain, a better range of motion and more reduced disability than those treated with any of the other options.

What prompted the recall of Bextra?

Bextra warning statements regarding cardiovascular safety follow the recent Vioxx recall that occurred on September 30, 2004. The recall was prompted by research findings indicating that patients taking Vioxx for eighteen months double their risk of suffering from a serious heart attack or stroke. Because Bextra, like Vioxx, is a COX-2 selective nonsteroidal anti-inflammatory drugs and because it is so similar to Bextra in its actions on the body, warnings were raised regarding the safety of Bextra and all other COX-2 selective NSAIDs.

How has Pfizer reacted to claims that Bextra is unsafe?

Pfizer, the manufacturer of Bextra, claims that no substantive evidence of Bextra cardiovascular side effects was discovered in clinical trials. The earliest Bextra warning statements were made at an American Heart Association meeting in early November 2004. They cited studies showing an increase of cardiovascular side effects for Bextra users who underwent cardiac bypass surgery. Later, a New York Times article appeared stating that Bextra may have adverse effects on cardiovascular health. Pfizer retorted by stating that none of these findings are substantiated and that the company intends on initiating long term studies on the long term effects of Bextra on cardiovascular health. The FDA also plans on conducting studies on the effects of all COX-2 selective on cardiovascular health.

Filing Bexra lawsuits

The matter of intent does not figure in claims against Pfizer, makers of Bextra. Regardless of whether there was an intentional withholding of information or the warnings were simply overlooked, drug companies have a responsibility to warn consumers of any potential dangerous consequence of medication usage. It's important for victimized consumers to stand up to drug makers before the statutes of limitations expire.

What is the consensus of the medical community regarding Bextra?

Studies suggesting possible dangerous side effects of COX-2 inhibitors such as Bextra remain inconclusive and even contradictory. However, there is enough evidence that the FDA has made the following interim recommendations: Physicians prescribing Celebrex or Bextra , should consider this information when weighing the benefits against risks for individual patients. Patients who are at a high risk of gastrointestinal bleeding, have a history of intolerance to non-selective nonsteroidal anti-inflammatory drugs (NSAIDs), or are not doing well on non-selective NSAIDs may be appropriate candidates for COX-2 selective agents. Risk for cardiovascular events and other risks commonly associated with NSAIDs should be taken into account on an individual basis.

What are the alternatives for people who no longer have access to Bextra?

Both Vioxx and Bextra have been taken off the market, leaving arthritis patients confused about how to safely get effective pain relief while protecting their hearts and stomachs. According to a new study, the majority of arthritis patients may be advised to use a combination of two drugs - a non-COX-2 pain reliever like Aleve, Advil or Motrin and a gastro-protective medicine like Prilosec or Nexium. Some experts believe this drug combination may have always been the best solution.

Bextra and the FDA

FDA announced in December of 2004 that it is requiring evaluation of all prevention studies that involve the Cox-2 selective agents such as Bextra to ensure that adequate precautions are implemented in the studies and that local Institutional Review Boards reevaluate them in light of the new evidence that these drugs may increase the risk of heart attack and stroke. A prevention trial is one in which healthy people are given medicine to prevent a disease or condition. The FDA issued the advisory because of recently released data from controlled clinical trials showing that the COX-2 selective agents (Vioxx, Celebrex, and Bextra) may be associated with an increased risk of serious cardiovascular events (heart attack and stroke) especially when they are used for long periods of time or in very high risk settings, such as immediately after heart surgery.

I took Bextra. What should I do?

If you are one of the millions who took Bextra, contact your doctor immediately. The side effects of the medication may take some time to appear and the earlier that treatment is given, the better the outcome for the patient. If you feel that you've been a victim of these types of side effects, contact an experienced Bextra lawyer who can help you fight for what you deserve.

How does Bextra work?

Relieving the pain of inflammation traditionally involved targeting chemical messengers that cause tissue to inflame. One very important chemical messenger is an enzyme called cyclooxygenase-2 or COX-2 for short. Unfortunately, it is very similar in chemical makeup to the Cyclooxygenase-1 (COX-1) which plays an important role in protecting the lining of the lower stomach. Traditional anti-inflammation drugs like asprin or ibuprofen indiscriminantly block both COX enzymes, so one could get relief from inflammation, but at a cost to the health of one's stomach. New COX-2 inhibitor drugs like Bextra were designed to target the COX-2 enzyme, but not the COX-1 enzyme. This would allow patients who could not tolerate traditional anti-inflammatory medications to get relief for arthritis pain.

Does Bextra come with warning information?

Bextra warning statements have already been included in Bextra labeling information. Bextra causes rare but serious skin diseases in some patients who take it. Bextra warning statements indicate that Bextra side effects may include Stevens-Johnson syndrome, a rare skin condition characterized by a severe inflammatory eruption of the skin and mucous membranes. Toxic epidermal necrolysis is also a potential side effect of taking Bextra. This skin condition causes large portions of the skin to become red and peel in the manner similar to a second degree burn. Bextra warnings also caution that Bextra can cause severe allergic reactions in some patients, including anaphylactic shock.