A USA Today article reports on a serious "drug drought" for pregnant women with no real relief in sight.
There have been only a handful of drugs approved for use by pregnant women over the last twenty years. Looking ahead, there are likely to be no new drugs for pregnant women developed in the next ten years.
In the United States alone, according to the FDA, there are over 9 million women of reproductive age who live with chronic asthma, hypertension, epilepsy and many other chronic conditions that require episodic or ongoing treatment with medication. That means that many millions of women who become pregnant require some sort of medication to maintain their health during pregnancy.
The FDA does currently house a list of "pregnancy exposure registries" run by drug companies where pregnant women who take particular medications can volunteer to take part in an observational study. The FDA collects the data in order to gain a better understanding of drug effects on fetal health.
In his study on "the poverty of new drugs in maternal health" Nicholas Fisk, an obstetrician-gynecologist and director of the University of Queensland Centre for Clinical Research in Australia, shares a frightening reality with a future that seems cloudy at best for the child-bearing women of the world.
Almost no one is developing drugs that will improve the lives and health of pregnant women and their babies around the world. There are currently only 17 new medications in the process of being developed worldwide for maternal health. The study reports, "only three new drugs… have been licensed over the last two decades in the United Kingdom for obstetric indications, two of which are only used after delivery. In the US, no licensed drug is available for use in preterm labour. No new classes of drug have been developed for the big diseases of preeclampsia, fetal growth restriction, postpartum haemorrhage, and miscarriage."
In many cases, says Fisk, doctors are resorting to delivering babies early in order to avoid serious health risks for the mother – a trade-off that seems heart-wrenching for the parents of the baby: compromise the health of the baby in order to save the life or health of the mother or the other way around?
As I reported a couple of weeks ago, a new report recently released, showed that the rising number of C-sections were the number one cause of preterm birth in the United States. But if obstetricians are delivering babies purposefully early in order to protect the health of the mother, progress seems out of reach.
Women who suffer from pre-eclampsia, for example, a condition that raises a woman’s blood pressure to dangerous levels when she’s pregnant, can find no cure from medication. USA Today reports on Leslie Candy, a pregnant woman suffering from pre-eclampsia whose condition prompted doctors to offer her this sole option after bed-rest and IV medicine did not work: perform an emergency C-section.
They delivered her son in January, seven weeks before his due date. He spent 21⁄2 weeks in neonatal intensive care. Candy says she wishes doctors were working on a cure for pre-eclampsia.
Of course, companies are wary of testing drugs on pregnant women because of the potential (and unknown) effects on the fetus. According to Medical News Today, 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
According to the CDC, some drugs are tested on pregnant animals to identify potential problems. If the drug is "cleared" it is then given to humans in clinical trials to test for how effective it is in combating the medical condition and for potential side effects. Pregnant women generally do not take part in these trials. However, the CDC notes that pregnant women "…can have effects that
pregnant animals don’t have. In addition, over-the-counter drugs, vitamins,
and other dietary or herbal supplements are not regularly tested on
There is certainly a frightening, if not legendary, history surrounding medication for pregnant women.
Remember DES? The drug prescribed to pregnant women for a period of almost thirty years – from the 1940’s to the 1970’s – was ultimately found to cause cancer in the daughters of women who took it. Thalidomide, another medication which was used to combat morning sickness and prescribed to women in the 1950s through 1961 around the world, caused horrendous birth defects in thousands of babies.
Are we doomed to repeat history?
Because of the world’s lack of investment in developing drugs known to be safe for use by pregnant women, we are still sending generations of mothers and their children into the virtual unknown.
According to the USA Today article, doctors admit that they do not know the effect particular kinds of medication may have on a fetus, whether the medication is to treat depression, anxiety or a physical condition that may cause miscarriage if left untreated, such as Crohn’s disease.
Thus, an astronomically high percentage of pregnant women are taking medication "for which safety data are unavailable." Seventy-five percent of pregnant women around the world are taking at least one drug with unknown risks to their, or their babies’, health. This is not a judgment or a condemnation. This is a statement that tells a simple story – pregnant women and their fetuses are being put at risk by a society that refuses to invest in their health and lives.
It’s not that there isn’t intention among the world’s governments. The Millennium Development Goals (MDGs), developed by the United Nations, is comprised of eight goals – or targets – for the countries of the world to meet by 2015. The goals include reducing maternal and infant mortality. By 2015, the fifth MDG seeks to reduce the maternal mortality ratio by ¾ through universal access to reproductive health. The 4th MDG focuses on reducing the mortality rate among children under five by 2/3.
But with such a poor investment in drug development for pregnancy-related conditions by the pharmaceutical industry, we’re unlikely to see those goals met by the stated date.
Fisk and his co-author are quick to point out that while "pregnancy has become a virtual pharma-free zone" there are ways to address the problem – particularly the economics or market issues – by making a case for the numbers of women who will need medication during pregnancy, the "untapped developed world market," and working to address the current gaps in the system for regulating drugs. USA Today reports that there are tax breaks to be had for companies that make drugs for rare diseases, as well as other governmental incentive possibilities as well.
The authors of the study also suggest setting up agencies to help raise awareness of the importance of funding sorely needed research and development for obstetric medications.
Finally, as the Daily Women’s Health Policy Report noted last week, the FDA has proposed rule changes to require that the risks of certain drugs for pregnant and breast feeding women be added to the drug labels. This FDA policy has not been updated since 1979.
There exists potential side effects and risks for any new medication – most especially feared when the drug is taken during pregnancy – and there is always the danger of leaning too far in the other direction, pharmaceutically medicating more than might be necessary. The fact remains that there is no assuredly effective and safe way to treat the most common maternal and infant health conditions including pre-eclampsia, preterm labor and miscarriage to this day, let alone ensuring the safety to mother and fetus from the effects of medication for more common disorders like depression, epilepsy or asthma.