Bextra class action lawsuits being filed
The pharmaceutical firms produce often drugs that are not always tested for all the side effects, then these drugs are aggressively marketed (US is only one of the two countries in the world that allow direct-to-consumer marketing of prescription drugs), and when victims ask for damages, Americans are accused by drugmakers and politicians of raising insurance premiums. But what everyone forgets that Americans are the losers in this game. “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, Assistant Commissioner in the New Jersey Department of Public Advocate and Member of the New Jersey Supreme Court Committee on Civil Procedure. “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.”
The cox-2 inhibitors have been embroiled in controversy when in September of last year, Merck announced Vioxx recall but FDA had to force Pfizer to act on Bextra recall. Despite repeated calls for Celebrex recall from consumer rights groups, Pfizer has taken no action and on instructions from the FDA, the Celebrex merely carries a black box warning. (Related article: Black box warning on Celebrex)
The Food and Drug Administration also issued its strongest “black box” warnings for other non-steroidal, anti-inflammatory drugs (NSAID). These medications include 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.
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. 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, then physicians 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.
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posted by eCreativa Media | 11:14 AM
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