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Thursday 27th October 2016

Call for pregnancy drugs trials

30th June 2008

Fears around the involvement of pregnant women in clinical trials of new medicines are having an impact on maternal health, especially in the developing world.


Of the estimated 536,000 maternal deaths worldwide during 2005, 99% were in developing countries where maternal and perinatal conditions are a major contributor to the global burden of disease.

A team of tropical medicine experts based in Bangkok, Thailand, said in a recent study that the pipeline of new drugs specifically for maternal health is alarmingly small, putting the lack of newly developed drugs in maternal health down to fears left over from the thalidomide disaster 50 years ago.

However, the rightful caution on the part of the medical profession has left a dangerous Catch 22 situation for pregnant mothers, they write in the online open access journal, PLoS Medicine.

Pregnant women face being treated with inferior drugs for potentially fatal illnesses because of fears of hypothetical risks to the unborn child, and liabilities arising from any side-effects.

Pharmaceutical companies were holding back from recommending their drugs to pregnant women, doctors were holding back from prescribing them, and the result has been a lack of reliable information about the effects of drugs, especially in the treatment of tropical infections.

For example, malaria, which is present in about 5% of the global population, is particularly problematic in pregnancy, reducing birth weight, and carrying a higher risk of severe illness.

In spite of this, few studies have been carried out on the effects of antimalarial drugs in pregnancy, leading to pregnant women being denied treatments, or to their being given doses that are too low to be effective.

However, clinical trials in nearly 1,000 women in the second and third trimesters of pregnancy have led to artemisinin-based combination treatments now being recommended in the second and third trimesters, although there are still concerns about embryotoxicity in the first trimester.

In spite of this, most pregnant women with severe malaria are still prescribed quinine, in spite of a 35% increased risk of both mother and baby dying from severe cases.

As yet, no studies exist of the use of artesunate in pregnancy which could guide recommendations for dosage levels, which may still be too low.

The problem, the writers suggest, is that the pharmaceutical industry is rarely willing to underwrite studies of new drugs in pregnant women, particularly in the tropics.

They call for further funding from international agencies and funders into antimalarial, antitrypanosomal, and antileishmanial drugs.


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