Failure to Disclose Increased Risk to Leqembi and Kisunla Patients
Two Alzheimer’s drugs Leqembi and Kisunla were approved by the FDA to treat mild dementia or a pre-Alzheimer’s condition called mild cognitive impairment. Data had suggested that Leqembi could slow cognitive decline in Alzheimer’s patients by five months over a period of 18 months for patients who had only mild symptoms. Two thousand volunteers had agreed to test Leqembi in clinical studies. However, it turns out these drugs may also increase the risk for brain bleeds and swelling in patients with certain genetic profiles—and patients may not have been given enough information. If you suffered brain bleeds or swelling during a clinical trial for Leqembi or Kisunla, you may be able to recover compensation.
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Investigation shows that drug manufacturers Eisai and Eli Lilly may not have disclosed to certain people in their clinical trials that they were more vulnerable to brain bleeding or swelling. The clinical trial for Leqembi had 274 volunteers without the manufacturer alerting them that they were at especially high risk to develop brain injuries. Eli Lilly also failed to tell volunteers in its Kisunla studies of increased risks, and dozens of those volunteers suffered severe brain bleeding.
Patients in the clinical studies should have received adequate information about the increased risks they faced due to their genetic profiles. Generally, patients must give informed consent before they take a medication for the study; patients cannot give informed consent if they have not been told the risks of taking a medication. In both of the trials, the volunteers were required to sign consent forms that let them know people with certain profiles faced greater risk of brain injuries while taking the drugs and that while participants would be tested for those risks, they wouldn’t be told the results.