When pharmaceutical companies market drugs, they must market the drug only for a specified use. Advertising unapproved uses to the public is illegal and misleading, but this is exactly what Abbott, the company marketing Depakote, has been accused of doing.
In addition, suits against Abbott state that the agency did not adequately warn patients about risks and side effects associated with the medication. The US Justice Department announced it will be taking over several claims filed against Abbott that originated from sales representative whistleblowers at the company.
Promoting off-label uses of Depakote is dangerous and irresponsible. According to the lawsuit, the FDA had not approved Depakote to treat the conditions listed by the company, including dementia, Alzheimer’s disease, and schizophrenia. Currently, the drug is intended to only treat disorders such as seizures, manic depression, and migraines.
It’s important to distinguish here between off-label use of a medication and off-label promotion. Doctors are free to prescribe a drug they think will help a particular condition (even if the drug is not typically given to patients for that reason), companies, on the other hand, are forbidden to advertise off-label uses of their products.
Depakote may also cause birth defects in the children of women who are pregnant and taking the drug. If you, or someone you love, suffered injurious side effects because of a misused drug, discuss this with a qualified personal injury lawyer as soon as possible.
IW