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Anti-inflammatory and immunosuppressive drugs and reproduction

DOI: 10.1186/ar1957

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Abstract:

The pregnancy categories of the United States Food and Drug Administration (FDA) in their present form are often not helpful for the clinician treating patients with active chronic disease during pregnancy and lactation. They combine risk assessment and benefit, and are for most products based on animal data. There is no requirement to update categories with human experience. Drug trials in pregnant or lactating mothers are not performed with new drugs. Therefore the only information on the safety of drugs during pregnancy and lactation is derived from experimental and preclinical animal studies. Human experience accumulates in most cases from inadvertent drug exposure during pregnancy and lactation. Because only drugs considered safe can be studied in pregnant or lactating women, the number of controlled studies is small. In the absence of controlled studies, reporting bias favours the reporting of negative experiences, particularly in case reports and small case series.An important aspect of exposure in utero to drugs is possible long-term effects that will become manifest later in life. Because a follow-up several decades after antenatal exposure is not easily performed, information on late harmful effects in offspring is not available for most drugs. However, as a result of increasing awareness, studies are planned or in progress addressing these important questions.Gonadotoxic effects of anti-inflammatory and immuno-suppressive drugs have only seldom been studied except for cytotoxic drugs and, in men, salazopyrine. However, there is an increasing awareness among patients that drugs may impair fertility or be mutagenic. Again, available information concerns mostly experimental and preclinical animal studies.Information on the excretion of drugs into breast milk is based mostly on single-dose or short-term treatment. Studies enrolling a large number of lactating women have not been performed. The effect of the drug on the nursing infant has in many cases not bee

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