The FDA recently advised AstraZeneca to strengthen Seroquel’s (quetiapine) label about potential side effects which could lead to diabetes, according to court documents submitted as part of a lawsuit alleging that the antipsychotic causes the disease. The trial is slated to begin in Florida on February 2.

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In letters sent to AstraZeneca executives in December, agency officials said the product’s “warnings and precautions” section should be revised to include the risk of significant weight gain, according to a filing by the plaintiffs’ lawyer. The agency also wants “data for Seroquel-induced weight change and glucose changes” that are currently on the label to be moved into the warning section.

AstraZeneca spokesman Tony Jewell stated that the drug’s label has “always provided accurate and appropriate information and warnings…we continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.” Both Jewell and a spokesperson from the FDA declined to comment on whether the agency had asked for stronger warnings for the compound. Commenting on the news, Matrix Corporate Capital analyst Navid Malik remarked that “this warning will reduce the attractiveness of using this drug, given the risk of developing a serious condition.”

Source: FirstWord

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