Antipsychotic Seroquel Facing Further Scrutiny, Lawsuits

Seroquel, the antipsychotic, will have a further safety review by advisers brought in by the FDA.  AstraZeneca Plc’s drug is increasingly used off-label in youngsters to treat ADHD and in the elderly population to quiet anxiety.

AstraZeneca would like to expand use to include the treatment of adult depression and anxiety. Seroquel is approved to treat bipolar disorder and schizophrenia.

Blockbuster Drug

Last year sales of Seroquel generated $4.45 billion for AstraZeneca. Seroquel XR is the newest version which offers a time release of the drug and will increase the length of the patent.  Only Nexium outsells Seroquel for AstraZeneca. 

Problems

The drug is known to produce symptoms of tardive dyskinesia, a metabolic effect that causes involuntary movements, lip smacking, and grimacing. The panel will be gathered April 8, reports Reuters.

Ongoing Litigation

While AstraZeneca Plc knew of the possible links of Seroquel to diabetes and warned Japanese physicians of such, the sales force in the U.S. was told to downplay the diabetes and weight gain link.

That information is emerging from internal documents produced by AstraZeneca facing consolidated lawsuits filed by 9,000 who claim they were harmed by Seroquel. While the first two cases have been dismissed, the remainder will be heard in Orlando and in Delaware.   

In a letter issued November 2002, the company warned Japanese doctors that it had received a dozen reports of high blood-sugar levels with the use of Seroquel.  But three years later AstraZeneca sales managers were told to tell U.S. doctors that, “the available data has not established a causal link between diabetes and Seroquel.”

That was contained in a voice-mail unsealed last week, reports Bloomberg, which helped secure some of the documents now being used in litigation against AstraZeneca.

The Wall Street Journal reports that AstraZeneca employee Christine Ney’s transcript of the call says “Our objective is to neutralize customer objections to Seroquel’s weight and diabetes profile.” Sales managers were told to “refocus the call” away from the diabetes issue to how well patients tolerated Seroquel. 

Public Citizen’s Sidney Wolfe, a member of the FDA’s drug safety committee, calls AstraZeneca’s actions, “irresponsible”.  

In its defense, AstraZeneca notes that among 130,000 patients on Seroquel through September 2002, 12 cases of diabetes emerged, amounting to 0.009 percent of the population to report diabetes-related problems. #