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Cytotec: Testosterone Searle
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Searle, the manufacturer of Cytotec was so concerned about this off-label use that it issued a letter to physicians in August 2000. The letter acknowledged these complications and urged physicians to follow their approved prescribing instructions.
[T]hen there's the warning label: a very clear, very adamant, and very serious caution that Searle (the manufacturer) puts on every bottle of Cytotec. It warns against the administration of Cytotec to pregnant women because it can cause abortion, premature birth, birth defects, maternal death, or uterine rupture (just to name a few potential problems). Searle even followed this up with a detailed warning letter that they sent to all health care providers in the United States (see below). It is ... important to know that as this book goes to press, Cytotec has not been approved by the FDA for the use of inducing or augmenting labor.
Being fully aware of the facts cited by Gaskin, in August of 2001 Searle sent out a Drug Alert to all physicians warning of the risks of Cytotec and that it should not be used for induction of delivery. This was followed by a Safety Alert issued by the FDA reiterating the risks and prohibitions contained in the Searle letter.
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The uterotonic effect of cytotec is an inherent property of prostaglandin E1 (PGE1), of which Cytotec is a stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.
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