Bextra was removed from the market in 2005 due to
increased risk of cardiovascular problems related to
the drug. It is expected that there will be
many personal injury claims, both personal and class
action, tied to Bextra and seeking substantial
compensation for injury.
In 2005 the FDA issued an alert requesting that
Pfizer voluntarily remove Bexta from the U.S. market.
The Agency had determined that Bextra posed a risk to
users of potential serious cardiovascular adverse
events. Pfizer subsequently agreed to suspend sales
pending further review.
Below is a copy of the FDA Alert.
FDA Alert April 7, 2005:
FDA has requested that Pfizer voluntarily withdraw
Bextra from the United States market. Pfizer has agreed to suspend sales and marketing of Bextra in the United States, pending further discussion with the Agency
concerning personal injury. At this time, the Agency has concluded that the overall risk versus benefit profile of Bextra is unfavorable. This conclusion is based on the potential increased risk for serious cardiovascular (CV) adverse events, which appears to be a class effect of non-steroidal anti-inflammatory drugs (NSAIDs) (excluding aspirin), an increased risk of serious skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme) compared to other NSAIDs, and the fact that Bextra has not been shown to offer any unique advantages over the other available NSAIDs.
* FDA recommends that patients being treated with Bextra be switched to an alternative therapy.
* Bextra has been demonstrated to be associated with an increased risk of serious adverse CV events in two short-term trials in patients immediately post-operative from coronary artery bypass graft (CABG) surgery. Data are not available from long-term controlled clinical trials to evaluate the cardiovascular safety of Bextra following chronic use. FDA has concluded that it is reasonable to extrapolate the adverse CV risk information for Bextra from the short-term CABG trials to chronic use given the fact that other COX-2 selective NSAIDs have been shown in long-term controlled clinical trials to be associated with an increased risk of serious adverse CV events (e.g., death, MI, stroke), and the well described risk of serious, and often life-threatening gastrointestinal bleeding.
* Bextra is a sulfonamide and already carries a boxed warning in the package insert for serious and potentially life-threatening skin reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme). The reporting rate to FDA’s spontaneous reporting system for these serious skin reactions is significantly greater for Bextra than other COX-2 selective agents. The risk of these serious skin reactions in individual patients is unpredictable, occurring in patients with and without a history of sulfa allergy, and after both short- and long term use.
* To date, there have been no studies that demonstrate an advantage of Bextra over other NSAIDs that might offset the concern about these serious skin risks, such as studies that show a GI safety benefit, better efficacy compared to other products, or efficacy in a setting of patients who are refractory to treatment with other products.
* Extensive data related to the cardiovascular safety of Bextra and other COX-2 selective and non-selective NSAIDs were presented at the Joint Meeting on February 16, 17, and 18, 2005, of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. This information is available on the following website:
Personal Injury News
• This RSS Feed URL Is Deprecated
This RSS feed URL is deprecated, please update. New URLs can be found in the footers at https://news.google.com/news
• Paralyzed Woman In Colorado Awarded 14.9 Million In Malpractice Case Legal Info
Paralyzed Woman in Colorado Awarded 14.9 Million in Malpractice Case Legal Info In 2015 Leventhal amp Puga took the case which last month took place in Douglas County District Court. This verdict won39t restore Robbin39s ability to walk, said Bruce Braley an attorney from Leventhal amp Puga. But it will give Robbin and Ed the chance
• Litigation Funder Facing SEC Fraud Claims Made Bad Bets On Mass Torts Reuter...
Litigation funder facing SEC fraud claims made bad bets on mass torts Reuters Blogs blog The SEC39s order against RD Legal shows that mass tort and personal injury litigation is still considered a promising asset class for investors. At some point in the last couple of years the order does not specify when the funds sold 50 million of
• They Arenapost All Safe: Pharma Is Willing To Look AposUnscientificapos To Se...
AlterNet They Aren39t All Safe: Pharma Is Willing to Look 39Unscientific39 to Sell Vaccines AlterNet medical centers, hospital wings, universities and sometimes personal paychecks are funded by Pharma. The motive of progressive sites is less clear. But Pharma knows best rings false with a quick look at withdrawn drugs like Vioxx, Bextra
• Legal News Archive For October, 2017 Legal Info
Legal News Archive For October, 2017 Legal Info After concluding that State Representative Sergio Muoz Jr. ignored the fact of disclosing an affiliation to state District Judge Jesse Contreras during a case Muoz took in Contreras39 courtroom a federal judge charged Muoz to pay 3 million in
NOTICE: This webpage is
Copyrighted content. No portion of this page may be copied
to any other webpage, forum, blog or other domain page or
offline publication without written permission from
FactsOfLaw.com. Violators will be prosecuted to the fullest extent of the law.
The information provided by FactsOfLaw.com does not
constitute legal advice or any other type of advice and is
provided for educational purposes only without warranty of any
kind. FactsOfLaw.com has not reviewed the information on this
page for accuracy and is not responsible for any errors,
omissions or inaccuracies. For legal advice you should
consult a licensed attorney.