Top NSAID Litigation Attorney James Barber Praises FDA Action on Bextra and Agency's Requirement That Warning Labels Be Placed on OTC Children's Advil and Children's Motrin; Urges Fast FDA Action To Get Labels on Products.

DALLAS -- One of the country's top non-steroidal anti-inflammatory (NSAID) drug litigation attorneys who has fought and received settlements from the makers of Bextra and Children's Motrin on behalf of his injured clients praised the U.S. Food and Drug Administration (FDA) for its recent action on Bextra, but urged the FDA to act quickly in requiring warnings about serious skin reactions on Children's Motrin and Children's Advil.

James Barber, of the Law Offices of James C. Barber and the first attorney in the United States to have settled a drug product liability lawsuit involving Stevens Johnson Syndrome (SJS) with the markers of Bextra, called the withdrawal of Bextra appropriate.

"Although our case involved oxaprozin, a sister drug to Bextra, it was only after we settled our lawsuit against Pharmacia and Pfizer, that the company issued a 'Dear Doctor' letter and later changed its package labeling to warn about the risk of SJS and Toxic Epidermal Necrolysis (TEN) associated with Bextra," said Barber. "The action taken last week by the FDA took our efforts one step further and recognized that Bextra and other NSAIDs had serious side effects that required they be removed from the market. It was an appropriate action."

Barber also praised the FDA for including in its announcement last week that over-the-counter (OTC) drugs, such as Children's Advil and Children's Motrin, have new product warnings that warn against serious skin reactions of those two drugs.

"We have been advocating the need for these warnings on behalf of our clients for several years in the lawsuits we have filed against McNeil and Wyeth," said Barber. "Our law firm joined with four respected scientists from across the country and several families whose lives have been significantly impacted and drastically changed by the side effects their children experienced from taking Children's Advil or Motrin, to file what is formally called a Citizens Petition with the FDA this past February. This petition asked the FDA to review the mounting scientific evidence that shows that the risk of SJS and TEN associated with these OTC products is substantial and that there should be stronger consumer warnings about SJS and TEN on those products," said Barber.

"The FDA's action last week validates our point that stronger label warnings were needed on over-the-counter products such as Children's Advil and Children's Motrin," said Barber. "We respectfully urge the FDA to move fast in requiring these warning labels. Parents and families need to know this information now, not next month, or next year."

Barber also asked the FDA to move quickly in its review of the Petition. "While the FDA referenced the Citizens Petition in its official announcement last week and indicated they still had it under advisement, we hope the FDA after its review will strengthen last week's action by specifically including references to SJS and TEN on the product labels," said Barber. "Just last week, a 19 month-old baby died from TEN caused by Children's Motrin. Prompt FDA action on the Petition can help prevent more needless deaths by requiring these additional warnings on OTC NSAID products."

The Law Offices of James C. Barber, in partnership with the firm of Waters and Kraus, also located in Dallas, is a nationally known plaintiffs' firm that specializes in product liability cases involving adverse reactions from drug products. It has successfully litigated cases against several NSAID manufacturers, including the makers of Bextra and Children's Motrin. It currently has lawsuits pending against the makers of Children's Advil, and the NSAID diflunisal (Dolobid), as well as the antibiotics Zithromax and Amoxicillin, a synthetic penicillin.