FDA investigates deaths of patients on antipsychotic drug

FDA investigates deaths of patients on antipsychotic drug
Following the deaths of two patients three to four days after receiving a dose of Zyprexa Relprevv (olanzapine pamoate) via intramuscular injection, the U.S. Food and Drug Administration is conducting an investigation into the possible cause.

(HealthDay)—Following the deaths of two patients three to four days after receiving a dose of Zyprexa Relprevv (olanzapine pamoate) via intramuscular injection, the U.S. Food and Drug Administration is conducting an investigation into the possible cause.

The patients were well outside the three-hour window of monitoring required by the antipsychotic drug's Risk Evaluation and Mitigation Strategy (REMS), but were found to have very high blood levels of after death.

In addition to the three-hour monitoring period, REMS protocol requires patients to receive injections only at REMS-certified facilities and to be accompanied home after the monitoring period. The drug's label warns against possible post-injection delirium sedation syndrome, in which the agent enters the blood too quickly and causes heavy sedation (possibly coma) and/or delirium.

According to the agency, "FDA is providing this information to while it continues its investigation. If therapy with Zyprexa Relprevv is started or continued in patients, health care professionals should follow the REMS requirements and drug label recommendations. Patients and caregivers should talk to their health care professional(s) about any questions or concerns."

More information: More Information

add to favorites email to friend print save as pdf

Related Stories

FDA encourages opioid prescribers to pursue training

Mar 12, 2013

(HealthDay)—Prescribers of extended-release/long-acting (ER/LA) opioid analgesics are encouraged to participate in continuing medical education (CME) provided by manufacturers of these analgesics, according ...

FDA reports Samsca may cause liver damage

May 02, 2013

(HealthDay)—After reviewing data from recent large clinical trials, the U.S. Food and Drug Administration has determined that Samsca (tolvaptan) should not be used for longer than 30 days and should not ...

FDA to decide on Qnexa obesity drug in July

Apr 10, 2012

US regulators will decide in July whether to approve Qnexa, the first obesity drug in more than a decade, extending the initial deadline by three months, the California-based drug-maker VIVUS said.

FDA: Omontys injection pulled from market

Feb 26, 2013

(HealthDay)—Affymax Inc. of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited of Deerfield, Ill., have voluntarily recalled all lots of Omontys Injection, used to treat anemia in adult dialysis ...

Recommended for you

FDA OKs Cubist antibiotic for serious infections

Dec 20, 2014

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.