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2005 Safety Alert: ZyPREXA (olanzapine)

Jan 26, 2005 | www.fda.gov

Eli Lilly and Company
Lilly Corporate Center
Indianapolis, Indiana 46285
U.S.A.

January 26, 2005

Dear Healthcare Professional:

Eli Lilly and Company has received reports of medication dispensing or prescribing errors between our atypical antipsychotic ZyPREXA (olanzapine) and the antihistamine ZYRTEC (cetirizine HCI) marketed by Pfizer. These reports include instances where Zyprexa was incorrectly dispensed for Zyrtec and vice versa, leading to various adverse events in some instances. These errors could result in unnecessary adverse events or potential relapse in patients suffering from schizophrenia or bipolar disorder.

The FDA-approved indications for each of these drugs differ considerably. Zyprexa is indicated for the short-term and maintenance treatment of schizophrenia and is also indicated for the short-term treatment of acute mixed or manic episodes associated with Bipolar I Disorder and as a maintenance treatment in bipolar disorder (normal dose 5 to 20 mg/day), while Zyrtec is indicated for the treatment of allergic rhinitis or chronic urticaria (normal dose 5 to 10 mg/day). However, many similarities do exist that could contribute to medication errors, including names starting with the same 2 letters, the availability of same dose strengths (5 mg and 10 mg tablets), the same dosing interval (once daily) and the fact that these two products are generally stored near each other on pharmacy shelves. It is these similarities that likely contribute to errors in dispensing or prescribing.

The ZYPREXA 2.5 mg, 5 mg, 7.5 mg, and 10 mg tablets are white, round, and imprinted in blue ink with LILLY and tablet number. The 15 mg tablets are elliptical, blue, and embossed with LILLY and tablet number. The 20 mg tablets are elliptical, pink, and embossed with LILLY and tablet number.

ZYRTEC tablets are white, film-coated, rounded-off rectangular shaped containing 5 mg or 10 mg cetirizine hydrochloride engraved with "ZYRTEC" on one side and dose strength on the other.

Lilly is committed to the safety of patients and helping to increase the likelihood that the correct medications are being dispensed. Some of the measures that Lilly has taken or will be taking to help reduce the potential for future errors include:

Changes to label on the 10 mg bottles from ZYPREXA to ZyPREXA, for easier identification,

Launch awareness direct mail campaign to pharmacists,

Sponsor medication error prevention continuing education,

Journal ads focusing on this dispensing error potential, with emphasis on good prescribing and good dispensing practices

The Institute for Safe Medication Practices (ISMP) recommends that products with reports of medication errors, such as Zyprexa and Zyrtec, be stored in different locations. The ISMP also recommends that prescribers print both the brand and generic names of medication on all prescriptions. Furthermore, they recommend that healthcare professionals remember to discuss medications, their indications, and their proper use when counseling patients.

Additional information on medication errors and good prescribing and dispensing practices in various healthcare settings can be found at the ISMP website, www.ismp.org.

Sincerely,

Dr. Paul Eisenberg
Vice President, Global Drug Safety
Eli Lilly and Company


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