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Drug maker cited for illegal off label promotions in Virginia

On Aug. 14, two counties in the commonwealth of Virginia received settlements totaling $1.3 million from Abbott Laboratories, the manufacturer of the prescription medication Depakote. The settlement was based on an accusation that Abbott Laboratories promoted the medication for uses not approved by the Food and Drug Administration. The counties involved in the settlement were Smyth and Tazewell.

According to a statement released by the commonwealth attorney general's office following the settlement, Abbott Laboratories engaged in what is known as "off-label" promotion of the medication. Specifically, the company allegedly marketed the medication to older patients with dementia and downplayed side effects and risks associated with the drug in the process.

The FDA initially approved Depakene, which is valproic acid, in 1978. Depakote is related to Depakene. The drugs are based on the same basic chemical substance. Initially, the medications were approved to treat epilepsy. Ultimately, the FDA approved the drugs for treatment of migraine headaches and bipolar disorder. According to the press release from the office of the commonwealth attorney general, Depakote has never been approved for the treatment of dementia. In fact, Abbott Laboratories actually discontinued a clinical trial testing Depakote as a dementia medication in 1999.

If a Virginia consumer is harmed by a defective productdefective product, a products liability lawsuit may be the proper course of action. A Virginia personal injury attorney may assist in determining not only what type of legal action is appropriate in a particular case but may assist in preparing a filing a lawsuit as well. This includes potentially assisting with cases involving injuries associated with prescription medications.

Source: Medical Daily, "Depakote Drug Settlement: Abbott Gives 2 Virginia Counties $1.3M Payout For Illegal Promotion Of Seizure Drug", Susan Scutti , August 16, 2013

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