New Drug Development For Pregnancy-Related Conditions Lagging, Experts Say

Main Category: Pregnancy / Obstetrics
Article Date: 07 Jun 2008 - 0:00 PDT

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A recent review found that only 17 medications for maternal health are in development worldwide, and many advocates say that the "drought" of new medications to treat pregnant women is unlikely to change any time soon, USA Today reports.

The review was written by Nicholas Fisk, an ob-gyn and director of the University of Queensland Centre for Clinical Research in Australia, and published in the January issue of PLoS Medicine. It found that no new classes of drugs have been approved for conditions such as preterm labor in the past 20 years and that none are currently being tested in clinical trials. Fisk said that there are so few effective drugs for pregnancy complications that in some cases, the only option to save the life of a pregnant woman is for her doctor to deliver the infant early. He added that most of the medications physicians give pregnant women are prescribed "off label." Fisk said, "We're not going to have a new drug in the next 10 years."

Alan Goldhammer, deputy vice president of regulatory affairs for Pharmaceutical Research and Manufacturers of America, said that although drug makers would like to develop drugs for pregnancy complications, the companies have to take into consideration the potential harmful effects that experimental drugs could have on a fetus. According to USA Today, some researchers said that past issues involving testing drugs on pregnant women have cause them to be cautious. The drug thalidomide was used to treat morning sickness in the late 1950s and early 1960s but later was found to cause severe limb deformities in infants. Another drug -- diethylstilbestrol, or DES -- was prescribed from the 1940s through the early 1970s but was found to cause cancer in the daughters of women who took it.

Jennifer Niebyl, head of obstetrics and gynecology at the University of Iowa Hospitals and Clinics, said she believes the lack of new drugs is primarily because of financial reasons. According to USA Today, "[r]elatively few" women develop pregnancy-related conditions that need medication, and women who develop the conditions only need treatment for a few weeks or months.

Fisk said that the government could provide incentives for companies to study pregnancy-related medications, including longer patents and tax breaks. FDA officials in May proposed overhauling the ways drugs are labeled for use during pregnancy and breastfeeding, with the aim of providing women and their doctors with better information about risks and benefits.

Sandra Kweder, deputy director of FDA's Office of New Drugs, said the agency is also working to perform more studies using a database that will include 100 million patients by 2012. She added that recent legislation also gives FDA the power to require companies to study drugs used by pregnant women and other "vulnerable populations" that have not been well-researched. Karen Feibus, medical team leader of FDA's maternal health unit, said that the agency is working with drug companies to create drug registries to study approved medications (Szabo, USA Today, 6/4).

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