Astrazeneca Is Asked to Expand Warning, Lawyer Says
The U.S. Food and Drug Administration wants AstraZeneca, the U.K.s second-largest drugmaker, to highlight on Seroquels warning label that some users experienced “significant weight gain,” lawyers for consumers suing the company said in a court filing yesterday. The first trial over claims that Seroquel caused diabetes is set to begin Feb. 2 in Orlando, Florida.
Letters sent by regulators to the London-based company last month “reveal FDA directives to AstraZeneca” to expand Seroquels warning label, Richard Laminack, a lawyer for two former Seroquel users, said in the federal court filing.
AstraZeneca faces about 9,000 lawsuits with more than 15,000 plaintiffs in the U.S. over claims that Seroquel causes diabetes and other health problems. Seroquel, which generated sales of $4.03 billion in 2007, is the companys second-biggest seller after the ulcer treatment Nexium.
“This warning will reduce the attractiveness of using this drug, given the risk of developing a serious condition,” said Navid Malik, an analyst at London-based Matrix Corporate Capital LLP. He doesnt have a rating on the stock.
AstraZeneca Shares
AstraZeneca fell 115 pence, or 3.9 percent, to 2,832 pence in London trading, the biggest drop in two months. The companys American depositary receipts, each representing one ordinary share, declined 83 cents, or 2 percent, to $39.99 in New York Stock Exchange composite trading.
Johnson & Johnson, maker of the rival antipsychotic Risperdal, rose 99 cents, or 1.8 percent, to $57.54. Eli Lilly & Co., maker of the antipsychotic Zyprexa, rose $1.04, or 2.8 percent, to $38.61.
Seroquels label has “always provided accurate and appropriate information and warnings,” Tony Jewell, a spokesman for AstraZeneca in Wilmington, Delaware, said in an e-mailed statement. “We continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.”
Jewell declined to comment on whether the FDA had requested stronger Seroquel warnings and said communications with the agency were confidential.
Weight Gain
Studies linking Seroquel, Zyprexa and similar antipsychotic treatments to weight gain and diabetes prompted the FDA to require that all makers of such medicines warn doctors about risks in 2003 and 2004.
Evidence uncovered in pre-trial exchanges of information shows that FDA officials advised AstraZeneca executives in letters of Dec. 18 and Dec. 22 that the “significant weight gain” reference should be added to the labels “warnings and precautions section,” according to Laminacks filing. It had been listed under “vital signs” on the label, the lawyer said.
The FDA also wants “data for Seroquel-induced weight change and glucose changes” moved up into the labels warning section, according to the filing.
Karen Riley, an FDA spokeswoman, said she couldnt immediately comment on whether the agency had asked AstraZeneca to toughen Seroquels warning.
Expert Witnesses
The FDAs calls for stronger warnings “mirror” the contentions of consumers expert witnesses, who are seeking to testify in Linda Guinns trial, Laminack said in the filing. U.S. District Judge Anne Conway hasnt ruled whether jurors will be allowed to hear those experts.
“Seroquel and Zyprexa are among the worst offenders affecting hazardous weight gain and glucose changes,” Laminack claimed in the filing.
Lilly agreed to pay at least $1.2 billion to settle lawsuits filed by about 31,000 patients who used Zyprexa. The Indianapolis-based company said this month it would pay an additional $1.42 billion to resolve claims by state and federal officials that it marketed the drug for unapproved uses. Lilly also agreed to plead guilty to a criminal charge.