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A dangerous "catch-22" situation exists that prevents the health community from knowing whether new drugs, including new malaria drugs, are effective and safe in pregnancy, says Nicholas J. White and colleagues from the Mahidol–Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine at Mahidol University in Bangkok, Thailand.
"Since the disaster of thalidomide 50 years ago," they say, "the medical profession has been rightfully very cautious about giving newly developed drugs to pregnant women, for fear that they might damage the unborn baby," says White.
The result has been that new medicines often carry a prescribing warning that they not be used in pregnancy. In fact, there may have been no worrying results from reproductive toxicology testing to warrant this caution—simply insufficient clinical information in pregnancy.
Pregnant women with potentially fatal illnesses may thus be treated with inferior drugs to avoid a hypothetical risk to the unborn child, and the consequent liability.
Dangerous catch-22
This situation in turn leads to a "dangerous catch-22": new medicines that might be life-saving are not prescribed in pregnancy, and since they are not prescribed it is impossible to know whether they are effective and safe. Recognising this catch-22, regulatory authorities in developed countries have begun to encourage pharmaceutical companies to gather information on the use of new drugs in pregnancy.
But in the developing world, there are few or no studies in pregnancy on most drugs used for treating tropical infections such as malaria — and so there are often no recommendations for treating these infections based on good medical research.
Establishing the efficacy and safety of new malaria medicines in pregnancy should be an urgent priority, argue White and colleagues: "International agencies and funders need to provide adequate support for quality studies in pregnancy and, in an increasingly litigious climate, to underwrite the liabilities." - (EurekAlert!)
Source: PLoS Medicine
Read more:
Pregnant women risk malaria
Malaria Centre
June 2008
