Deaths Prompt FDA Alert on Schizophrenia Drug

Anyone who takes or knows someone who takes the drug Zyprexa Relprevv to treat schizophrenia should know that the FDA has issued a safety alert and is investigating the cases of two schizophrenia patients who died after injecting the drug.

Various versions of Zyprexa also are used to treat aggression, depression, manic episodes and bipolar disorders.

Schizophrenia can be devilishly difficult to treat, partly because people who suffer from it often fail to maintain a regular medication schedule; many complain that side effects from many schizophrenia drugs leave them dull and lethargic, cause them to gain weight gain and experience sexual problems. Zyprexa Relprevv was developed to offer weeks of schizophrenia symptom control with a single dose, relieving patients of the need to take meds on shorter schedules.

According to Reuters.com, both cases the FDA is investigating involved “appropriate” doses of the long-acting medicine, but the patients had very high levels of it in their bloodstreams three to four days after the injections.

The drug was developed by the Eli Lilly and Co. as after its oral drug, Zyprexa, began to have more competition when less expensive generic versions came on the market in 2011. At that point, according to Reuters, it was the company’s star product. Zyprexa Relprevv has no generic competition.

The information in its packaging includes a so-called “black box” warning. That signifies the severity of the risks associated with a drug; in this case they included post-injection delirium sedation syndrome (PDSS). That condition results from the drug entering the blood too fast, leaving dangerously elevated levels in the bloodstream. Risks associated with high doses of the drug -which is not what the two cases used-are delirium, cardiopulmonary arrest, heart rhythm problems, sedation and coma.

The danger of Zyprexa Relprevv emerged during the clinical trials; some cases of PDSS occurred within three hours of taking the drug, but none resulted in death, according to the FDA. The federal agency approved it in 2009, but warned that patients receiving the treatment should stay at the doctor’s office for at least three hours in order to be monitored for side effects. Administration of the drug is tightly controlled and doctors, patients and health facilities must be approved and enrolled in the Zyprexa Relprevv Patient Care Program to use it.

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