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FDA ups warnings on drug often prescribed for pregnant women

On Behalf of | May 22, 2013 | Birth Injuries

Birth injuries and medical malpractice claims associated with them often relate to clear errors made by one or more members of a hospital delivery team during childbirth. In the absence of such error and departure from the reasonable standard of care that is expected by both patients and within the medical industry, complications are rare events; doctors and other health care professionals going about their business in a duly competent manner can typically do so free of liability concerns.

The types of birth injuries that can result when medical negligence is manifest are many and broad-based. They include life-altering complications such as cerebral palsy, shoulder dystocia, fetal distress and hospital-acquired infections.

Birth injuries and defects can also owe to factors other than patent medical errors committed during delivery. A common cause of injury resides in medication error, most centrally medications that a doctor inappropriately prescribes for a pregnant woman.

Whether a drug was appropriately prescribed is indeed an arguable point in some cases. Arguing that it was, though, would unquestionably be a weakened proposition when undercut by strong regulatory warnings against prescribing it in certain cases, and when risk warnings associated with taking the drug for a particular use are elevated by health regulators.

That is now the case with the drug Depakote (with the active ingredient valproate), which is used by many pregnant women for migraine headaches. New and strong evidence has emerged indicating that use for that reason can result in the drop of a child’s IQ by up to 11 points.

Doctors have been apprised that the classification for Depakote is changing from a Category D (denoting its use as acceptable despite certain risks) to a Category X medication. That change signifies that regulators believe Depakote’s efficacy in resolving migraines in a pregnant woman is outweighed by health risks to the child she is carrying.

Doctors will certainly want to keep that in mind regarding the prescribing of Depakote in the future.

Source: Lawyers and Settlements, “FDA to issue new warnings over Depakote birth defects,” Gordon Gibb, May 19, 2013

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