Side Effects of Risperdal, Seroquel, Zyprexa Linked to Kidney Injury: Study

Side effects of a popular class of antipsychotic medications, which includes Risperdal, Seroquel and Zyprexa, may increase the risk of acute kidney injury among elderly patients, according to the findings of new research. 

In a study published this week in the Annals of Internal Medicine, researchers found that atypical antipsychotics more than double the risk of acute kidney injury (AKI) and death, and nearly double the risk of hypotension (dangerously low blood pressure) and acute urinary retention.

The drugs already pose a health concern for the elderly patients, because of their overuse in the nursing home setting. Critics have pointed out that the drugs are often used as a form chemical restraints on elderly patients who are considered hard to handle, despite a known increased risk of death associated with use of the medications among the elderly. When nursing homes use them as chemical restraints it is often considered a form of nursing home abuse.

In this latest study, researchers specifically looked at the side effects of Risperdal, Seroquel and Zyprexa, conducting a population-based cohort study among adults aged 65 years or older, who had received a new outpatient prescription for one of the medications from 2003 through 2012. The data was then compared with those who did not receive such a prescription. Data on nearly 98,000 elderly antipsychotic users were included in the study.

The findings suggest that the absolute increased risk for acute kidney injury on Risperdal, Zyprexa or Seroquel was 2.12 times higher than was seen among elderly patients who were not prescribed the antipsychotics. The risk of hospitalization was 73% higher.

However, a number of other health risks presented themselves during the study as well. The risk of all-cause mortality was 2.39 times higher for those taking Risperdal, Seroquel or Zyprexa than those who did not, appearing to confirm that the drugs carry an increased risk of death for the elderly. Researchers also found that the risk of hypotension was 1.91 times higher, and the risk of acute urinary retention was 1.98 times higher.

“The findings support current safety concerns about the use of these drugs in older adults,” the researchers concluded.

Risperdal Illegal Marketing

The drug Risperdal has particularly been a subject of concern among elderly patients, after the Department of Justice (DOJ) accused Johnson & Johnson of engaging in a kickback scheme to convince doctors to prescribe Risperdal to elderly nursing home patients, knowing that the drug was being used abusively and that it increased the patients’ risk of death.

In November 2013, Johnson & Johnson agreed to pay $2.2 billion to the federal government to settle its Risperdal illegal marketing claims.

Investigators say that the illegal marketing led to the unnecessary and risky use of drugs like Risperdal, potentially putting dementia patients’ lives at risk.

The DOJ began investigating Johnson & Johnson’s marketing of Risperdal in 2004, looking into an alleged kickback scheme between the drug maker and Omnicare, the nation’s largest provider of drugs to nursing homes.

In 2009, Omnicare reached a settlement with DOJ over kickback charges. DOJ investigators indicated that Johnson & Johnson paid Omnicare millions to push off-label use of Risperdal to nursing home doctors and hid the kickbacks as data fees, education fees and payments to attend Omnicare meetings.

In January 2010, the DOJ filed a civil False Claims Act complaint against J&J. Johnson & Johnson, which also accused the drug maker of illegally promoting Risperdal for use among children prior to obtaining FDA approval for such use. Concerns have also been raised about the potential side effects of Risperdal use by children increasing the risk of childhood diabetes.