Lack Of FDA Trial Authority, DTC Marketing Caused COX-2 Crisis – Topol
This article was originally published in The Tan Sheet
Executive Summary
Evaluation of naproxen safety should be postponed until final data from NIH's ADAPT trial is released, Cleveland Clinic cardiologist Eric Topol, MD, advocates
You may also be interested in...
Pfizer settles Celebrex litigation
Pfizer will pay $894 million to resolve more than 90 percent of personal injury claims involving its COX-2 inhibitors, consumer fraud class action claims and litigation by state attorneys general. The figure is less than half of the firm's annual Celebrex (celecoxib) sales, which totaled $2.3 billion in 2007. Pfizer has not returned Bextra (valdecoxib) to the market after withdrawing it in February 2005 at FDA's request following research showing increase cardiovascular risk at 40 mg. Plaintiffs sought to avoid the model Merck used to settle Vioxx (rofecoxib) litigation. Scott Nealey, a partner at Lieff Cabraser Heimann & Bernstein, which served as plaintiffs' liaison counsel, said the settlement will pay plaintiffs quickly. Pfizer restarted direct-to-consumer advertising for Celebrex in April 2007 after suspending it in January 2005 after a study showed an increased CV risk (1"The Tan Sheet" Jan. 10, 2005, p. 6 and 2"The Tan Sheet" April 23, 2007, In Brief). The new ads say Celebrex's CV risk is similar to that of ibuprofen and naproxen
Pfizer settles Celebrex litigation
Pfizer will pay $894 million to resolve more than 90 percent of personal injury claims involving its COX-2 inhibitors, consumer fraud class action claims and litigation by state attorneys general. The figure is less than half of the firm's annual Celebrex (celecoxib) sales, which totaled $2.3 billion in 2007. Pfizer has not returned Bextra (valdecoxib) to the market after withdrawing it in February 2005 at FDA's request following research showing increase cardiovascular risk at 40 mg. Plaintiffs sought to avoid the model Merck used to settle Vioxx (rofecoxib) litigation. Scott Nealey, a partner at Lieff Cabraser Heimann & Bernstein, which served as plaintiffs' liaison counsel, said the settlement will pay plaintiffs quickly. Pfizer restarted direct-to-consumer advertising for Celebrex in April 2007 after suspending it in January 2005 after a study showed an increased CV risk (1"The Tan Sheet" Jan. 10, 2005, p. 6 and 2"The Tan Sheet" April 23, 2007, In Brief). The new ads say Celebrex's CV risk is similar to that of ibuprofen and naproxen
Pfizer settles Celebrex litigation
Pfizer will pay $894 million to resolve more than 90 percent of personal injury claims involving its COX-2 inhibitors, consumer fraud class action claims and litigation by state attorneys general. The figure is less than half of the firm's annual Celebrex (celecoxib) sales, which totaled $2.3 billion in 2007. Pfizer has not returned Bextra (valdecoxib) to the market after withdrawing it in February 2005 at FDA's request following research showing increase cardiovascular risk at 40 mg. Plaintiffs sought to avoid the model Merck used to settle Vioxx (rofecoxib) litigation. Scott Nealey, a partner at Lieff Cabraser Heimann & Bernstein, which served as plaintiffs' liaison counsel, said the settlement will pay plaintiffs quickly. Pfizer restarted direct-to-consumer advertising for Celebrex in April 2007 after suspending it in January 2005 after a study showed an increased CV risk (1"The Tan Sheet" Jan. 10, 2005, p. 6 and 2"The Tan Sheet" April 23, 2007, In Brief). The new ads say Celebrex's CV risk is similar to that of ibuprofen and naproxen