FDA launches investigation of antipsychotic Zyprexa Relprevv following two deaths

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by John Chapman

The Food and Drug Administration has launched an investigation into the schizophrenia medication Zyprexa Relprevv following the deaths of two patients who were injected with the drug. According to a warning issued by the FDA, the two patients died several days after being injected with Zyprexa Relprevv, despite receiving what the agency calls “an appropriate dose” of the drug.

Zyprexa Relprevv is an injectable version of the antipsychotic drug Zyprexa and was approved for sale by the FDA in 2009. In addition to being used to treat patients with schizophrenia, Zyprexa and Zyprexa Relprevv can also be prescribed for the treatment of bipolar disorders, depression, manic episodes, and aggression.

The FDA’s safety investigation of Zyprexa Relprevv is not the first time that the agency has raised concerns about the drug’s safety. The warning label for Zyprexa Relprevv already contains a black box warning for a condition known as post-injection delirium sedation syndrome (PDSS). PDSS occurs when Zyprexa Relprevv enters the blood too quickly after an injection, causing high levels of the medication in the patient’s bloodstream. Patients who develop PDSS after being treated with Zyprexa Relprevv may experience serious complications, including cardiac arrest, heart rhythm problems, delirium, sedation or coma.

The two deaths that launched the FDA’s investigation of Zyprexa Relprevv are not the first that have been reported with the drug. According to Eli Lilly, the manufacturer of Zyprexa and Zyprexa Relprevv, at least 82 deaths have been reported among patients who were treated with Zyprexa Relprevv. So far, the cause of these deaths is unknown. AN FDA spokesperson said that the agency launched its investigation of Zyprexa Relprevv because of the unusual circumstances surrounding the two deaths, including an unclear cause of death and “very high” postmortem blood levels of the drug despite the normal doses received by both patients.

Clinical trials for Zyprexa Relprevv found that cases of PSDD occurred in patients who had been injected with the antipsychotic drug within three hours of treatment. The warning label for the drug states that patients must remain at their doctor’s office for at least three hours after their injection so that they can be monitored for symptoms of PSDD. Both of the deceased patients who were treated with Zyprexa Relprevv died three to four days after receiving their injection.

Zyprexa Relprevv is a longer acting version of Zyprexa, which was prescribed to patients in pill form. Zyprexa was once Eli Lilly’s largest selling product until it lost patent protection in 2011 and began facing generic competition. Representatives from the FDA and Eli Lilly were silent on questions of whether the new injectable delivery method of Zyprexa Relprevv could be linked to the dozens of deaths that have been observed with the drug.

Medical experts have observed cases in which switching an older drug to a new delivery method has created an increased risk of side effects and placed the health of patients at risk. In 2002, Ortho-McNeil began selling a birth control patch called Ortho Evra that used a combination of hormones which had been used safely in several older birth control pills. However, subsequent research found that because the patch delivered these hormones directly through the skin and into the bloodstream, patients received a significantly higher hormone dose than with older medications. Studies found that Ortho Evra patients were twice as likely to develop blood clots as users of older birth control pills, placing them at risk of other serious side effects.

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