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Re: ziprasidone- Chris

Posted by Sunnely on July 29, 2000, at 12:56:21

In reply to Re: ziprasidone- Chris, posted by AndrewB on July 29, 2000, at 9:54:33

> Can anybody verify that it has approval?

The Psychopharmacological Drugs Advisory Committee to the US FDA recently voted to recommend that the agency approve Pfizer's Zeldoz (ziprasidone) for the treatment of schizophrenia. Almost always the FDA goes along with the recommendation of the Advisory Committee, so Zeldoz should be out in the market fairly soon.

Pfizer and the FDA need to iron out some kinks, yet, particularly related to the drug's potential to cause an electrocardiogram abnormality termed "prolongation of the QT." When the QT is corrected for heart rate, it is termed "QTc." This ECG abnormality can lead to potentially serious heart rhythm irregularity called "torsades de pointes" which in turn can lead to an even more serious heart rhythm irregularity such as ventricular fibrillation and sudden cardiac death.

The FDA is more particularly cautious about approving drugs with potential to cause prolongation of QTc. Drugs known to cause this ECG abnormality such as Seldane and Hismanal (both nonsedating antihistamines), and Propulsid (for GERD), have been removed from the pharmacy shelves due to several reports of sudden cardiac deaths. (Over 100 sudden cardiac deaths linked to Seldane and Hismanal; about 80 deaths to Propulsid.)

Check with your physician or pharmacist regarding drug-drug interactions with Zeldox before taking it. It is possible that other psychotropic such as the antidepressants and nonpsychotropic drugs such as certain antibiotics may raise Zeldox's blood level. Also, it is possible that grapefruit juice may raise Zeldox's blood level (not sure about this). If you have a pre-existing heart condition, this drug may not be right for you. Whether ECG before and periodic ECG during treatment will be required while on Zeldox is not known, yet.


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