INDIANAPOLIS — Eli Lilly and Co. has changed the labeling on its antipsychotic Zyprexa to avoid confusion with Pfizer Inc.’s allergy medicine Zyrtec after some patients were given the wrong drug.
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Lilly said in a letter to psychiatrists and pharmacists that it has received 79 reports of such mix-ups since Zyprexa, which is used to treat schizophrenia and bipolar disorder, was introduced in 1996. The letter, dated Jan. 26, was posted Tuesday on the U.S. Food and Drug Administration’s Medwatch Web site.
Patients with psychological disorders who take Zyrtec instead of their regular Zyprexa could be at risk of relapse, but Lilly spokeswoman Heather Lusk said Wednesday that the company had not received any reports of such cases.
Sleepiness most frequent side effect
The most frequently reported effect from the mixed-up medication was excessive sleepiness, which is listed as a potential side effect for both drugs, Lusk said. Some cases required hospitalization, she said, though she did not know how many or details of the symptoms in those cases.
The mix-ups may have occurred because of similarities in the drugs’ names and dosage guidelines and the fact that they generally are stored close to each other on pharmacy shelves, Indianapolis-based Lilly said in the letter.
Lilly changed the labeling on Zyprexa from all capital letters to ZyPREXA and highlighted the lettering in yellow to reduce confusion. The company also said it has started direct mail and trade journal advertising and other measures to make pharmacists aware of the errors.
Those steps were taken before Lilly began working on the problem with the FDA, Lusk said.
Officials at New York-based Pfizer, the world’s largest drug company, were trying to determine whether they also should take any action, Pfizer spokesman Daniel Watts said.
“It’s important to get the medication correct,” he said.
Zyprexa is Lilly’s top seller, with sales of over $1 billion last year. Pfizer’s Zyrtec is the most prescribed antihistamine in the United States.
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