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Bextra Lawsuits as Pfizer Pulls Defective Drug for Harmful Side Effects

April 19, 2005 – Attorneys in the New Jersey law firm of Pellettieri, Rabstein & Altman who have represented plaintiffs in other defective drug and pharmaceutical litigations such as Vioxx, Baycol, and Phen-Fen have decided to represent seriously injured victims of Bextra.

The Food and Drug Administration forced Pfizer Inc. to pull its drug Bextra off the market on April 7, 2005. The Pfizer drug, a cox-2 inhibitor, has already been linked to an increase risk for cardiovascular problems and now may be linked to an increased risk for Stevens-Johnson Syndrome, a rare and potentially fatal skin disease, and coronary artery bypass surgery infections and sternal wound complications.

“Americans pay higher prices, we are told, to ensure drug safety; so Americans must hold drug companies responsible for the promised drug safety.” asserts Joseph Gorman, Esq., an attorney practicing class action and mass tort litigation at Pellettieri, Rabstein & Altman.

“Through victim lawsuits the judicial process helps the agencies of our administrative branch of government enforce patient safety laws.” explains Arthur Penn, Esq., currently chairman of the Pellettieri, Rabstein & Altman class action and mass tort litigation department and formerly Director of the Division of Public Interest Advocacy for the New Jersey Department of the Public Advocate (1974-1978), Assistant Commissioner in the New Jersey Department of Public Advocate (1979-1981) and Member of the New Jersey Supreme Court Committee on Civil Procedure (1978-1981). “When drug companies face the expense and publicity of widespread victim lawsuits, they learn to recalculate the cost-benefit analyses to include more extensive, responsible testing into the side effects of future drugs. You will limit defective drug lawsuits by reducing the number of defective drug victims, and that will only happen by preventing defective drugs from coming to and remaining on the market.”

In related action, the Food and Drug Administration also issued its strongest “black box” warnings for other non-steroidal, anti-inflammatory drugs (NSAID). These medications include Celebrex and over-the-counter products such as Advil, Aleve and Motrin. The warning will indicate that these drugs carry an increased risk of gastric bleeding and heart attacks. Patients, hopefully, will seriously consider these newly indicated side effects.

Bexta is a nonsteroidal anti-inflammatory drug (NSAID), which was approved for use by the FDA in November 2001. It was prescribed for relief of the signs and symptoms of osteoarthritis, adult rheumatoaid arthritis and primary dysmenorrhea (pain associated with menstruation). The recommended dose for the signs and symptoms of arthritis was 10 mg once daily; the recommended dosage for primary dysmenorrhea was 20 mg twice daily, as needed.

A recent meeting by the American Heart Association discussed the possible side effects of Bextra on the heart. It was claimed that Bextra patients undergoing heart surgery could be at increased risk.

The cox-2 inhibitors have been embroiled in controversy since Merck & Co. voluntarily withdrew its blockbuster drug Vioxx from the market last September, after a study showed it doubled patients' risk of heart attack and strokes.

Another study by WellPoint Inc., linked the painkillers (Vioxx, Celebrex and Bextra) to increased cardiovascular risk, further reinforcing findings of other trials that already have sparked concern over the safety of the popular category of drugs.

That study indicated that Vioxx increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent.

A study submitted by Pfizer to the FDA on November 5, 2004, which included over 1,500 patients treated after undergoing coronary artery bypass graft (CABG), showed increased risk in patients treated with Bextra, compared with those treated with a placebo, of cardiovascular events such as myocardial infarction (heart attack), cerebrovascular incident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung).

However deep surgical infections and sternal wound complications following coronary artery bypass surgery are also a serious Bextra concern.

In a December 10, 2004 letter from the Vice President and Medical Director of Pfizer Canada to “health care professionals”, the maker of Bextra revised their product monograph (a drug’s clinical profile) to warn doctors that Bextra has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications. Pfizer Canada, after discussions with Health Canada, the Canadian government agency responsible for drug safety, now officially advises Canadian doctors and pharmacists that Bextra is contraindicated (not recommended) for the treatment of patients for pain following coronary artery bypass surgery (CABG) due to surgical infections and sternal wound complications, as well as heart attacks, strokes and blood clot embolisms.

The FDA advised patients to seek their doctors' advice and emphasized that short-term use of over-the-counter strength versions of the NSAID medicines does not appear to pose the same risks.

“When patients “self-dispense”, or purchase medicines over-the-counter, they may not sufficiently review or may not fully understand the side effects. They are in pain and totally focused on relief. If physicians are more aware of their patients’ use of over-the-counter NSAIDs, or other over-the-counter medicines, they can explain the nature of and monitor these side effects. They can help patients make more informed choices. Just because a drug is offered in over-the-counter strength does not mean that it has no potentially harmful side effects,” says Connie Bowen, RN, a registered nurse working with Pellettieri, Rabstein & Altman.

Lawyers pursuing Bextra victim lawsuits, such as the Pellettieri, Rabstein & Altman lawyers, are working with recognized medical experts in the field, as well as the patients’ own physicians.

Additional information about the FDA’s announcements is available on its Web site at www.fda.gov/cder. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).

To reach attorneys Arthur Penn, Esq. or Joseph Gorman, Esq., or other New Jersey lawyers at Pellettieri, Rabstein & Altman, call 1-800-432-LAWS (5297) or visit www.pralaw.com.

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