Seroquel and FDA

Seroquel is an oral drug containing quetiapine as main active ingredient. It is used for treatment of Schizophrenia in adults or children older tha
13 years. Doctors prescribe Seroquel for treatment of bipolar disorder or manic depression in children above 10 years and adults. It is also used with other antidepressant drugs. Doctors prescribe it for other purposes as well. It is manufactured by AstraZeneca. It was introduced for treatment of Schizophrenia in the market in 1997.

It has been linked to hyperglycemia in patients using this. Many studies have shown that it could cause high level of sugar in blood or diabetes, in patients using this drug. Reports about its association with these side effects started coming in since this drug came into circulation. FDA too issued safety alerts and warnings related to this drug.

In August 2003 an article in The Wall Street journal highlighted the increased risk of diabetes in patients using Seroquel. It forced FDA to come up with new warnings related to the drug. The FDA stated that hyperglycemia in some patients resolved on its own, even if the medicine was continued, but some patients need treatment for this condition, even they discontinue the drug.

In April 2004 FDA asked AstraZeneca to add new warnings related to increased risk of hyperglycemia and Diabetes with use of Seroquel, on the label of the drug. It asked other manufacturers, who manufacture antipsychotic drug to add these warnings on the drug’s label. AstraZeneca came with modified label of Seroquel warning consumers of increased risk of hyperglycemia and diabetes associated with use of Seroquel.

FDA approved use of Seroquel for treatment of depressive episodes in patients of bipolar disorder in October 2006. It was already approved for treatment of maniac episodes in patients of bipolar disorder. It was also approved for treatment of schizophrenia. It was the first antypsychotic drug to be approved for treatment of both maniac and depressive episodes in patients of bipolar disorder. Clinical trials proved that it reduced depressive symptoms faster than other such drugs.

FDA approval made Seroquel one medicine to treat both depressive and manic episodes in patients of bipolar disorder. It made treatment easy.

FDA continued with studies on Seroquel for different approved uses. The study was also focused on treatment of major depressive disorder and anxiety disorder by Seroquel and its effects on patients. It has been sold to millions of people around the globe. In 2005 it earned $2.8 billion for its manufacturer.

AstraZeneca was criticized for off label promotion of Seroquel. It was said to have suggested an unapproved use of Seroquel to a physician. In 2006, the FDA came out with a warning that stated that Seroquel and other atypical antipsychotic drugs could also increase risk of death when used to treat mental conditions caused by dementia. It stated that Seroquel was never approved for treatment of dementia related mental condition. It should be considered as an off-label use of the drug, if used for such treatment.

FDA issued a warning to AstraZeneca in November 2006. It stated that promotion material of Seroquel had some misleading information. It also said that Seroquel manufacturer AstraZeneca failed to highlight the risks associated with use of Seroquel.

It blamed company of not providing enough warning on risk of hyperglycemia and diabetes and omitting important data about neuroleptic malignant syndrome and other such conditions..
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