Seroquel Manufacturer Knew of Risks in 2000
Company documents publicized in federal court demonstrate that AstraZeneca Plc. knew about the risks associated with Seroquel as far back as 2000. Currently, AstraZenca Plc. facing more than 15,000 consumer claims alleging the antipsychotic drug Seroquel causes diabetes.
AstraZeneca Global Safety Officer Wayne Geller concluded there was “reasonable evidence to suggest Seroquel therapy can cause” diabetes and related conditions, according to documents presented in federal court in Tampa, Florida. Geller drew his conclusions following a review of available studies and internal trials, according to the documents.
The internal documents were shown publicly for the first time during a hearing over the qualifications of expert witnesses the plaintiffs plan to use at trial. They are to testify in a lawsuit over the drug’s effects when the proceeding begins in February. While portions of the documents were shown in court, the filings remain sealed at the request of the London-based pharmaceutical company.
Seroquel, used to treat bipolar disorder, brought in $4.03 billion last year, making it AstraZeneca’s second-biggest seller after its ulcer treatment Nexium. The company is trying to broaden the medicine’s use to offset revenue lost as pricing pressure in the U.S. reduces demand for Nexium.
AstraZeneca is facing claims over the drug in state and federal courts in the U.S. The company has had an additional 2,243 cases dismissed or dropped. The initial trial, set to begin Feb. 2, is based on a complaint filed by a plaintiff in Florida.
Developed Diabetes
The plaintiff claims she developed diabetes after taking Seroquel. The drug is part a class of newer antipsychotic drugs including Eli Lilly & Co.’s Zyprexa and Johnson & Johnson’s Risperdal. Thousands of consumers have sued the companies claiming they hid the risks of the drugs and marketed them for unapproved purposes. Lilly has paid $1.2 billion to settle 31,000 claims by individuals.
The FDA, in a Jan. 8 letter, asked AstraZeneca to provide an analysis of all its clinical trials relating to Seroquel. AstraZeneca responded June 26 with an analysis that showed 2.4 percent of people who began treatment with normal levels of sugar in the blood became technically diabetic after 52 weeks. Normal levels are less than 100 milligrams per 10 deciliters. Someone is labeled diabetic with a reading of 126 milligrams, said Laura Massey Plunkett, a human risk assessment specialist, who read in court from the company report.
1.4 Percent
That result, compared to 1.4 percent of patients given a placebo who showed the same increase in blood-sugar levels, Plunkett testified, makes it almost 70 percent more likely that people taking Seroquel would develop diabetes than people who weren’t taking the drug.
“It’s clear this compound Seroquel can cause diabetes,” she said. “I don’t think there is any real controversy about that.”
AstraZeneca lawyer Jane Thorpe said that was just a part of the company’s analysis and data showed no significant increases when all people who had a sugar reading of less than 125 milligrams were included.
Thorpe also questioned Plunkett’s conclusions, saying she relied only on studies that supported her views and ignored those that didn’t show an increased tendency for people taking Seroquel to develop diabetes.
Studies have shown that Seroquel and similar medications known as atypical antipsychotics are associated with an increased risk of diabetes. These studies prompted the FDA to require AstraZeneca and other drugmakers to warn doctors of the risks in September 2003. AstraZeneca doesn’t intend to settle these lawsuits, company spokesman Tony Jewell said in an interview.
“We intend to litigate these cases on the merits,” he said.
