As a defective drug attorney, I’ve written here several times about the issue of using atypical antipsychotic drugs for off-label treatment of dementia patients. The FDA has not approved this class of drugs for dementia; they are approved for mental illness, and include name brands such as Risperdal (risperidone), Zyprexa (olanzapine) and Seroquel (quetiapine). However, despite a growing body of research showing they have dangerous side effects, particularly in the elderly, and a black box warning on the subject, they have become widely used to control the behavior of dementia patients. Now, a report from the Department of Health and Human Services has found that the vast majority of atypical antipsychotic prescriptions filled under Medicare — 88 percent — are for off-label use with dementia.
According to a May 11 story from NPR’s Shots blog, HHS’s Inspector General’s office reviewed Medicare data to reach that conclusion. The Inspector General also found that 14 percent of nursing home residents made claims for atypical antipsychotics. That’s a legal problem because a little more than half of the claims should not have been covered in the first place, wrote the Inspector General in a May 9 opinion piece. Medicare rules require that drugs be approved only for medically accepted indications and documented as actually provided to the patients. Furthermore, one in five patients received the drugs in ways that violated Medicare rules, including doses that were too high or medication courses that went on too long.
But perhaps even more important, the Inspector General noted, is the fact that atypical antipsychotics have dangerous metabolic side effects that are particularly pronounced in the elderly dementia patients who frequently get the drugs. Among other things, the drugs raise the risk of stroke, cardiovascular disease and metabolic disorders including diabetes and insulin resistance. This has led the FDA to order a black box warning stating saying atypical antipsychotics are associated with an increased risk of death in dementia patients. However, the article said, their use is still widespread, in part because manufacturers of these drugs have illegally but aggressively marketed them for off-label purposes. Multiple manufacturers have pleaded guilty or settled with the government over these charges, including one that intentionally withheld evidence that Seroquel causes diabetes.
These results concern me as a dangerous drug lawyer because they show how many dementia patients are still getting inappropriate and potentially dangerous drugs — on the federal government’s dime. Scientists have known for several years that atypical antipsychotics pose unacceptable risk of death in dementia patients, and at least one study showed prescriptions falling as a result. However, this report suggests that Medicare providers have not gotten the message, particularly those in nursing homes. Nursing homes like antipsychotics even though they’re inappropriate because they sedate dementia patients, who can be hard to control. But however convenient this is for caregivers, it poses an unacceptable risk of killing the patient.


Based in St. Louis and Belleville, Ill., Carey, Danis & Lowe represents clients who were sickened or injured by taking a drug that was supposed to make them feel better. In addition to relatively new drugs like these atypical antipsychotics, that includes any other prescription or over-the-counter drug that had an unexpected and dangerous effect when used as directed. Our pharmaceutical liability attorneys have extensive experience representing clients who have been hurt by medications with serious safety defects, in individual lawsuits as well as part of class actions. We help clients collect the money they need to treat the conditions the dangerous drugs caused, replace lost wages and compensate their fairly for their personal losses, a death in the family, pain and more.
If you developed an illness or injury that you believe was caused by a drug you thought you could trust, you should call Carey, Danis & Lowe for help. You can reach us through our website or call 1-877-678-3400 for a free, confidential consultation.