Seroquel - Warnings & Precautions

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In nearly all cases, cessation of SEROQUEL treatment was associated with a reversal of the effects on total and free T4, irrespective of the duration of treatment. About 0.4% (10/ 2386) of SEROQUEL patients did experience TSH increases. Six of the patients with TSH increases needed replacement thyroid

treatment.

Cholesterol and Triglyceride Elevations

In a pool of 3-to 6-week placebo-controlled trials, SEROQUEL-treated patients had increases from baseline in cholesterol and triglyceride of 11% and 17%, respectively, compared to slight decreases for placebo patients. These changes were only weakly related to the increases in weight observed in SEROQUEL-treated patients.

Hyperprolactinemia

Although an elevation of prolactin levels was not demonstrated in clinical trials with SEROQUEL, increased prolactin levels were observed in rat studies with this compound, and were associated with an increase in mammary gland neoplasia in rats (see Carcinogenesis).

Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating compounds, the clinical significance of elevated serum prolactin levels is unknown for most patients. Neither clinical studies nor epidemiologic studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans; the available evidence is considered too limited to be conclusive at this time.

Transaminase Elevations

Asymptomatic, transient and reversible elevations in serum transaminases (primarily ALT) have been reported. The proportions of patients with transaminase elevations of > 3 times the upper limits of the normal reference range in a pool of 3-to 6-week placebo-controlled trials were approximately 6% for SEROQUEL compared to 1% for placebo. These hepatic enzyme elevations usually occurred within the first 3 weeks of drug treatment and promptly returned to pre-study levels with ongoing treatment with SEROQUEL.