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U.S. Department of Health and Human Services

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Geodon (ziprasidone HCl) Dear Healthcare Professional Letter, Mar 2002

 

This is the retyped text of a letter from Pfizer Laboratories. Contact the company for a copy of any referenced enclosures.

 


IMPORTANT PRESCRIBING INFORMATION

Geodon (ziprasidone HCl) Capsules were approved on February 5, 2001. Since Geodon's approval, 563,000 prescriptions have been written and 156,000 individual patients have received Geodon. The postmarketing experience has been consistent with the clinical database, and not unexpected in this patient population.

This communication is to inform healthcare professionals about clarifications to the labeling for Geodon capsules. The revisions, made in consultation with the Food and Drug Administration, clarify information that had already been included in the package insert. The Contraindications section included a list of seven drugs contraindicated with ziprasidone and stated that this list of drugs was "not a complete list". Not all physicians, pharmacists and pharmacy databases interpreted this language as intended. Some may have considered certain drugs excluded from the contraindication, while others believed that, irrespective of the level of documentation, any drug associated with QT-prolongation was contraindicated with ziprasidone. Pfizer and FDA agreed there was a need to provide greater clarity around the particular drugs or types of drugs that are contraindicated with Geodon.

The key sections that have been changed in the Geodon label are provided below, and the full prescribing information is enclosed.

CONTRAINDICATIONS

QT Prolongation Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with dofetilide, sotalol, quinidine, other Class Ia and III anti-arrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron mesylate, probucol, or tacrolimus. Ziprasidone is also contraindicated with drugs that have demonstrated QT prolongation as one of their pharmacodynamic effects and have this effect described in the full prescribing information as a contraindication or a boxed or bolded warning (see WARNINGS).


WARNINGS

QT Prolongation and Risk of Sudden Death

Ziprasidone use should be avoided in combination with other drugs that are known to prolong the QTc interval (see CONTRAINDICATIONS, and see Drug Interactions under PRECAUTIONS). Additionally, clinicians should be alert to the identification of other drugs that have been consistently observed to prolong the QTc interval. Such drugs should not be prescribed with ziprasidone. Ziprasidone should also be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias (see CONTRAINDICATIONS).

As previously mentioned, given that post-marketing experience with Geodon is consistent with the information generated during clinical trials, there are no other changes to the prescribing information.

We hope this information is useful in providing more specific guidance on the appropriate use of ziprasidone with other drugs.

Pfizer Inc.
235 East 42nd Street
New York, NY 10017-5755