FDA Investigates Zyprexa Patient Deaths

Dangerous drug lawyers at Pintas & Mullins Law Firm highlight a recent investigation initiated by the FDA concerning the death of two patients injected with the schizophrenia drug Zyprexa Relprevv. The patients died three to four days after receiving appropriate doses of the treatment.

Zyprexa Relprevv is manufactured by Eli Lilly, to which it brought profits of about $1.3 billion in 2012. The drug was approved in 2009, and patients are supposed to be closely monitored for at least three hours after receiving the treatment.

It comes with a “black box warning,” the most serious warning for any pharmaceutical, alerting patients that side effects include post-injection delirium sedation syndrome (PDSS). During this condition the drug enters the bloodstream too quickly after an injection, causing greatly increased – potentially lethal – levels of the drug in the bloodstream. It is not yet clear if the two patients died from PDSS.

High doses of Zyprexa Relprevv can also cause cardiopulmonary arrest, heart rhythm issues, coma, and sedation. Zyprexa Relprevv is a follow-up to Eli’s blockbuster antipsychotic Zyprexa, which itself has been under much FDA and legal scrutiny.

Our nursing home abuse lawyers recently reported on the excessive and dangerous use of antipsychotics, such as Zyprexa, in nursing homes. As a direct and devastating result of understaffing, budget cuts, and corporate greed, nursing home employees are increasingly depending on pharmaceutical restraints to sedate “unruly” residents. Oftentimes, these residents have dementia, a cognitive disorder that significantly increases the risk of death and stroke when combined with antipsychotics.

Zyprexa also comes with other, less serious side effects, such as weigh gain and metabolic issues. Eli Lilly was subject to thousands of Zyprexa lawsuits in recent years from patients claiming the drug caused them to gain so much weight they developed diabetes. The company ultimately settled with the majority of them in a mass $1.2 billion agreement.

The U.S. Department of Justice also opened an investigation into Zyprexa, from which Eli ended up shelling out more than $1.4 billion to resolve. The investigation stemmed from the fraudulent, often misleading marketing practices associated with Zyprexa. At the time (2009), it was the largest criminal fine for an individual corporation ever imposed in a U.S. criminal prosecution.

Among the allegations brought to light at trail were that Eli Lilly pushed Zyprexa for use in children and for elderly dementia patients, both off-label groups. It was also accused of specifically marketing Zyprexa in long-term care facilities and nursing homes, in attempt to make Zyprexa a primary care drug (meaning it could be used to treat a wide array of ailments). In reality, it was approved by the FDA for only two uses: schizophrenia and bipolar disorder.

Eli Lilly ultimately pled guilty to a misdemeanor misbranding charge for its Zyprexa marketing practices, which occurred between 1999 and 2001. Similarly, Johnson & Johnson has reportedly set aside an undisclosed amount of money – undoubtedly ranging in the billions – to settle claims of illegally marketing its antipsychotic, Risperdal, for uses not mentioned on its label.

Eli Lilly ultimately pled guilty to a misdemeanor misbranding charge for its Zyprexa marketing practices, which occurred between 1999 and 2001. Similarly, Johnson & Johnson has reportedly set aside an undisclosed amount of money – undoubtedly ranging in the billions – to settle claims of illegally marketing its antipsychotic, Risperdal, for uses not mentioned on its label.

The abuse of antipsychotics in nursing homes and recovery centers became so abundant that, in 2011, the Centers for Medicare and Medicaid Services started tracking their use. Beginning in July 2012, that information was made public on the Nursing Home Compare website. As of that date, the national average for the percentage of long-term residents receiving an antipsychotic medication was nearly 24%.

Dangerous drug lawyers at Pintas & Mullins Law Firm will continue to report on updates, reports and alerts relating to antipsychotic drug use and side effects. If you or a loved one was administered an antipsychotic for reasons other than bipolar or schizophrenia, you have important legal rights, and may be entitled to significant compensation for your suffering.

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