The Consumer Justice Foundation Alerts the Public of Continued Growth of Cadila's Market Share for Generic Depakote Despite FDA Warning Regarding Depakote Birth Defects

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The Consumer Justice Foundation, a for-profit corporation that’s comprised of a team of professional consumer advocates who build and maintain free online resources for consumers designed to inform the public of dangers of pharmaceutical drug use, which can be found at http://www.depakotebirthinjury.com, hereby discusses an announcement by Cadila Pharmaceuticals, Ltd. regarding its continued growth in its market share of generic Depakote despite a public FDA warning regarding the potential link between the use of valproate products including Depakote by pregnant women and children who are born with cognitive defects.

“The benefits and the risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.”

The Consumer Justice Foundation, a team of professional consumer advocates who serve the public by providing free online educational and informational resources regarding the potential dangers of pharmaceutical drug use hereby discuss the announcement by Cadila Pharmaceuticals, Ltd. of its continued growth in the market share for generic Depakote despite a public warning issued by the United States Food and Drug Administration regarding the dangers of using valproate products including the potential for Depakote side effects by pregnant women and children born with cognitive defects. The CJF hereby warns the public of the dangers of the use of Depakote and its equivalents in hopes that more awareness will be achieved and potential dangers avoided.

Cadila Pharmaceuticals, Ltd., announced that its market share for its generic form of Depakote as of the end of August 2011 had grown to 25.3 percent of the overall market reach. This growth was announced despite a preceding public warning issued by the FDA regarding the potential link between the use of Depakote while pregnant and children being born with cognitive defects and signifies a troubling lack of awareness of the potential dangers of using this medication.

Specifically, the FDA published this warning on June 30, 2011, and the warning specifically stated that women who use valproate-containing medications such as Depakote during the early stages of pregnancy are at a higher risk of having children who are born with cognitive defects than women who do not take these medications. Cognitive defects have long been alleged to be Depakote birth defects.

Depakote and other valproate medications are known as anticonvulsant medications, and they are used to treat the symptoms of epilepsy and migraine headaches. The FDA took the step of issuing a public warning regarding the dangers of using these medications after reviewing available evidence regarding the risk of lower cognitive test scores in children whose mothers used these anticonvulsant medications during the early stages of pregnancy.

As a result, the FDA stated that the “benefits and the risks of valproate sodium and related products should be carefully weighed when prescribing these drugs to women of childbearing age, particularly for conditions not usually associated with permanent injury or death.” The FDA has also taken the step of adding this information to the product labels of valproate medication including Depakote. Despite these warnings, the use of Depakote and its equivalents continues to advance, and consumers need to be aware of the risks they could be facing.

About the Consumer Justice Foundation

The Consumer Justice Foundation, whose Web site is located at http://www.depakotebirthinjury.com, is a public resource that’s been built and maintained by a group of concerned professionals who want to provide general information for consumers regarding the potential dangers involved with the use of Depakote while pregnant. This resource is not to be considered as medical or legal advice, which should only be dispensed by a licensed medical doctor or a Depakote lawyer.

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Faith Anderson
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