Skip to content
Business
Link copied to clipboard

Warning boosted on Seroquel label

ORLANDO - AstraZeneca P.L.C. made information about health risks of its antipsychotic drug Seroquel more prominent on the drug's label last month at the request of the government, a company lawyer said here yesterday.

ORLANDO - AstraZeneca P.L.C. made information about health risks of its antipsychotic drug Seroquel more prominent on the drug's label last month at the request of the government, a company lawyer said here yesterday.

The information about the label change surfaced at a federal court hearing on whether the London drug company would have to release documents from lawsuits filed by about 15,000 patients who say that taking Seroquel led them to gain weight and triggered diabetes.

Plaintiffs' attorneys and the company agreed yesterday to a release of all but 14 of 132 documents. The U.S. District Court here expects to make the documents available today. AstraZeneca's U.S. headquarters are in Wilmington.

The U.S. Food and Drug Administration has approved Seroquel to treat schizophrenia and depression, but AstraZeneca has applied for approval of an extended-release version to treat depression and anxiety.

Documents related to such applications are not typically public and will remain under seal.

Bloomberg News, another party asking for the Seroquel information, continued to push yesterday for the release of all 132 documents. Tom Julin, a lawyer representing Bloomberg, argued that Seroquel patients and the general public had a right to the information.

Judge David Baker did not rule on Bloomberg's request. He did express concern that the FDA might not be protecting the public well and noted that companies frequently suppressed negative studies about drugs.

"The court is not blind to the controversy that has enveloped the FDA," Baker said.

Under yesterday's agreement with the plaintiffs' attorneys, which involved lengthy and contentious negotiations with AstraZeneca, the documents to be released include company e-mails, parts of some depositions in the case, and others.

Chris Coutroulis, a lawyer representing AstraZeneca, said his client recognized the need to balance the public's right to know against the company's competitive interests. Company officials also have expressed concern that preliminary information about Seroquel in FDA documents could confuse patients.

Documents pertaining to two company studies on Seroquel will remain sealed, but AstraZeneca plans to release those results eventually.

Arthur Louis Lazarus, an AstraZeneca doctor who oversees Seroquel research, testified yesterday that releasing study data was "almost like exposing your playing cards to your competition."

The documents have stirred intense interest; plaintiffs' attorneys have argued that they contain information about whether AstraZeneca reported negative information about Seroquel in a timely way. The documents also contain e-mails that attorneys on both sides of the case said included "salacious" details about relationships between an AstraZeneca executive and women who researched and wrote Seroquel studies.

Stephen McConnell, a Dechert L.L.P. lawyer who is representing AstraZeneca, said plaintiffs' attorneys were drawing unfair comparisons to Zyprexa, an antipsychotic made by Eli Lilly & Co. Indianapolis-based Lilly settled similar claims involving Zyprexa, weight gain and diabetes for about $1.2 billion and paid $1.4 billion to the federal government for illegally marketing the drug for unapproved uses. "This is not Zyprexa," McConnell said. "This is a different story."

Attorneys for AstraZeneca said yesterday that plaintiffs' attorneys were pushing to unseal the documents to gain a public relations edge after losing the first two plaintiffs' cases filed by patients who claimed that taking Seroquel caused them to develop diabetes.

Plaintiffs' attorney Ed Blizzard said he was acting in the public interest.

The FDA's decision to move information about weight gain and changes in blood-sugar levels to the warning section of the label is just one example, he said.