The long-acting form of the popular drug Zyprexa - Zyprexa RelPrevv - recently caused the death of two patients. Despite the clear link between injection of the drug and their deaths, the FDA decided not to change the drug's label warnings. Zyprexa lawyers at Pintas & Mullins warn patients of the dangers of this powerful antipsychotic.
Zyprexa RelPrevv is the long-acting version of the top-selling drug Zyprexa, which is prescribed to treat schizophrenia. Zyprexa RelPrevv must be injected by a certified health care facility with access to ER services, and patients must be continuously monitored by the facility for several hours after injection.
The patients injected with fatal doses of this drug died three to four days after receiving the drug. Both patients had extremely high levels of Zyprexa RelPrevv in their blood at time of death. The FDA launched an investigation into the issue to determine the cause of the high blood levels. Unfortunately, the FDA concluded its study with "inconclusive" results.
The agency did confirm, however, that it was unable to exclude the possibility that the deaths were caused by entry of Zyprexa RelPrevv into the bloodstream. The agency suggests that the drug level increase could have occurred after death, though it is not certain.
Zyprexa RelPrevv already comes with the FDA's most serious warning - a Black Box Warning - informing patients that the drug can cause post-injection delirium sedation (PDSS). This syndrome is suggestive of drug overdose, and is likely caused by unintended injection of the drug into veins or blood vessels, instead of into muscle tissue as it is intended.
If the drug is accidentally injected, even partially, into blood vessels, higher than intended drug concentrations are produced, causing potential overdose. These accidental injections can occur even with proper injection technique by a trained professional.
Zyprexa belongs to a class of drugs known as atypical antipsychotics, which are approved to treat schizophrenia and bipolar disorder. Other drugs in this class include: Abilify, Geodon, Risperdal, Seroquel, and Symbyax.
These drugs make billions of dollars per year for their manufacturers, primarily due to their "off-label" marketing tactics. Prescribing a drug off-label, meaning for uses not approved by the FDA, is not illegal for doctors. It is illegal for drug companies to market the drugs for any uses not approved by the FDA, because they have not been proven to be safe nor effective.
For this reason, a large number of criminal lawsuits have been filed against atypical antipsychotic manufacturers for unlawful marketing. In 2009, Zyprexa's manufacturer agreed to pay $1.4 billion to resolve criminal allegations that it marketed the drug for off-label uses. The settlement included a $515 million criminal fine, the largest ever in a health care case and the largest criminal fine for a single company ever imposed in an American criminal prosecution of any kind. More on this case can be found here.
In this lawsuit Zyprexa's manufacturer was accused of promoting the drug for patients with dementia, including elderly patients in nursing homes with Alzheimer's disease. The company expended significant resources to promote Zyprexa in nursing homes. This is not only illegal but is unconscionable, as Zyprexa carries a serious warning of premature death if used in elderly patients with dementia.
Despite this fatal warning, Zyprexa was given to nursing home patients suffering from dementia to treat behavioral problems such as aggression, agitation, and hostility. Nursing homes in the United States are chronically understaffed, and employees are often tempted to dose uncooperative residents with powerful drugs, like Zyprexa, to subdue them. This is a practice known as chemical restraints, which is a severe form of nursing home abuse. More information on chemical restraints in nursing homes can be found here, on our Nursing Home website.