Abstract
The available teratogenic risk classifications are ambiguous and are often difficult to interpret. There are no evidence-based clinical guidelines on risk/benefit assessment to help with decision-making when drug treatment is considered in pregnancy. Studies available in humans are limited, and at best may show an association between the drug and the undesirable effect. Specific changes have been made in the data sheets to improve information on the use of medicines in pregnancy, but it is not enough. The quality of studies in pregnant women has improved, but some training in epidemiology and statistics is required to interpret them. A personalised selection of the safest drug must take into account the risk/benefit ratio of the drug as well as and the expected outcome of an untreated disease.
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