Pfizer Inc. wants to put its second-generation COX-2 drug Bextra back on the market but lawyers for patients who contend they were harmed by the drug warn it was approved too hastily in the first place.
The pharmaceutical giant voluntarily suspended sales of the $1 billion-a-year anti-inflammatory painkiller April 7, one day after a 19-page Food and Drug Administration memo raised concerns of possible health risks of COX-2 inhibitors, the class of painkillers touted as being easier on the stomach lining than aspirin. Bextra, Pfizers second generation COX-2 after the success of Celebrex, was prescribed for treatment of arthritis, rheumatism and menstrual pain.
Pharmacists no longer are allowed to fill prescriptions for Bextra and people who think they have suffered harm by taking the drug are filing personal injury lawsuits.
Pfizer Chief Executive Officer Hank McKinnell hopes Bextra gets FDA re-approval for at least limited use. He told the Boston Globe FDA reviewers saw unpredictable skin reactions in Bextra users but had not seen increased cardiovascular risk, the problem seen with Mercks Vioxx, which was pulled from the market last fall.
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, the company said in a statement released last week.
Should FDA reintroduce the drug, patients likely would have to sign consent forms before filling a prescription.
FDA placed its strongest black box safety warning for risk of cardiovascular events on Celebrex last month and recommended pulling Bextra after seeing at least seven reports of people dying from severe skin reactions.
Stevens Johnson Syndrome and Toxic Epidermal Necrolysis are the most severe skin rashes triggered by full-blown allergic reactions to NSAIDs and sulfonamides. Both diseases are rare and life-threatening. SJD causes skin to burn from the inside and TENS occurs when the damage covers more than 30 percent of the body.
FDA have said Bextra, Celebrex and Vioxx and possibly all nonsteroidal anti-inflammatory drugs drugs come with an increased risk of serious adverse cardiovascular events. Vioxx was shown to double the risk of heart attack and stroke among patients in a clinical study who took the medication for longer than 18 months.
A Dec. 23, 2004, public health advisory on NSAIDs warned long-term use of naproxen sold as Aleve, Naprosyn and other trade names may also be associated with an increased cardiovascular risk.
Pfizer said Bextra, however, does not have the same heart-related risk as Vioxx.
Two studies released in January suggested combining Bextra with aspirin could increase risk of blood clots leading to heart attack or stroke. FDA asked makers of all NSAIDs to revise labels to warn of potential cardiovascular events, as well as serious stomach ulcer bleeding.
A study involving 6,000 people in clinical trials presented at the American Heart Associations annual conference in November found Bextra doubled risk of heart attack or stroke.
The fact is they introduced a drug that was studied no longer than 12 months and then got a NDA (new drug approval) in 10 months, said Michael A. Galpern, a civil trial attorney in Cherry Hill, N.J.
Bextra was marketed as a kind of non-sulfa Celebrex. Critics branded it a COX-2 me-too possibly rushed to market because of Vioxx’s popularity. Bextra sales increased 355 percent worldwide in a single year.
This was a drug that according to Pfizer’s own admission was not studied in any clinical trial over 12 months duration, Galpern told United Press International. And they knew that there was a huge market for these drugs so that there would be a patient population taking these drugs. I think that they saw the incredible early success of Vioxx and they wanted a share of that.
The Alabama law firm Beasley, Allen, Crow, Methvin, Portis & Miles has filed more than 161 Bextra, Celebrex and Vioxx cases and is leading efforts to take all COX-2 drugs off the market. Several attorneys are pushing for consolidation of Bextra cases in Louisiana.
All of the cases involving Vioxx have been transferred to the federal court in New Orleans and it would be appropriate if the Bextra/Celebrex litigation were here also, Richard J. Arsenault of Neblett, Beard & Arsenault of Alexandra, La., said in a statement. We need to make sure that people who have taken Bextra or Celebrex and suffered a serious side effect are heard and that the drug manufacturer is held responsible.