Abbott Laboratories gets a one-two safety punch today. First, the FDA issued a reminder warning about birth defects in babies born to pregnant women who take Depakote, the epilepsy drug that's also used in bipolar disorder and against maladies such as migraines. The drug and related versions, such as the injectable form Depacon, carry an increased risk of neural tube defects and other major birth defects such as craniofacial defects and cardiovascular malformations, the FDA statement says.
Doctors should consider alternative meds, "especially if using [these drugs] to treat migraines or other conditions not usually considered life-threatening," the agency advises. "Women of childbearing potential should only use valproate if it is essential to manage their medical condition." The agency says it will be working with drugmakers on changing the labels for Depakote and its relatives. Depakote already has a black box warning of the risk of birth defects.
As Pharmalot points out, the safety warning comes on the heels of disclosures that the Justice Department is investigating Abbott's sales and marketing of the drug. Among the government's concerns: Whether Abbott's marketing violated anti-kickback laws, FDA marketing rules, and/or the Federal False Claims Act.
Meanwhile, the consumer advocacy group Public Citizen is once again lobbying FDA to pull Abbott's weight loss drug Meridia. The group petitioned FDA, citing early results from a new, large study called Scout. "The fact that [Meridia] actually increased the number and percentage of cardiovascular events [in the study] ... should mandate its immediate removal" from the market, the group contends. Abbott maintains that the drug is safe when used as directed, and that "more than 90 percent of the patients" in the Scout study shouldn't have even used the drug.