Nothing In The Oven For Pregnancy Complications

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pregnantLeslie Candy was expecting her first baby when she developed pre-eclampsia, dangerously high blood pressure that can cause seizures or strokes if not controlled. So her docs ordered bed rest and gave Candy, 38, intravenous meds to lower her blood pressure. But there are no effective drugs for pre-eclampsia and her condition worsened after she was hospitalized, USA Today writes.

After two days, her docs said the only way to treat the condition was to perform an emergency C-section and delivered her son seven weeks before his due date. He spent more than two weeks in neonatal intensive care.

Although 4 million American women give birth each year, almost no one is developing meds for pregnancy complications, including conditions that threaten the lives of mothers and children, Nicholas Fisk, an obstetrician-gynecologist and director of the University of Queensland Centre for Clinical Research in Australia, tells the paper. He adds there are so few effective drugs for pregnancy-related conditions that, in many cases, docs can save their patients only by delivering babies early.

Researchers also rarely test drugs for common conditions such as depression on pregnant women, says Fisk, whose review of drugs under development was published in January in PloS, the paper writes. And no new classes of drugs have been approved for conditions of pregnancy such as pre-term labor or a liver condition called cholestasis in the past two decades, he tells USA Today.

The absence leaves obstetricians to use decades-old meds, making obstetrics “a specialty stuck in a time warp,” he tells the paper, adding that mMost of the meds taken during pregnancy are prescribed “off label” for unapproved use.

Alan Goldhammer, deputy vp of regulatory affairs for PhRMA, says drugmakers want to help pregnant women, but must consider the risks of exposing a developing fetus to experimental chemicals. Given those concerns, experts says the “drug drought” isn’t likely to end any time soon, the paper writes.

Worldwide, scientists are actively developing only 17 meds for maternal health, Fisk tells the paper. This is less than 3 percent of the 660 drugs being developed for heart disease and half as many being researched for Lou Gehrig’s disease, which affects only 5,600 new patients a year, the paper writes.

No new drugs made primarily for pregnant women are in clinical trials, which is the final phase of testing, Fisk tells USA Today. On average, only about one drug in 10 makes it from early tests to final approval a process that takes about a decade. “We’re not going to have a new drug in the next 10 years,” he tells the paper.

Here’s the rest of the story

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  1. While acknowledging the problem, I have to say a drug company would be C-R-A-Z-Y to investigate a product in pregnant women in today’s litigation-friendly environment.

  2. No one wants to deal with pregnant patients after thalidomide catastrophe.

  3. That risk would have been way too huge for most companies to consider years ago - now it would be absolute suicide.

    Geez even OB/GYNs are giving up obstetrics in droves.

  4. And getting accurate information on meds used during pregnancy is next to impossible in this country, due to HIPAA. Docs can’t register patients in a registry–the patient has to do it and often just won’t take the time.

  5. Is it only me but don’t the symptoms of pre-eclampsia sound like ergotism, and didn’t the FDA issue an advisory last year on increased risk of Pulmonary Arterial Hypertension in infants born to mothers on Paxil, a SSRI, and aren’t all the new drug classes for a lot of different diseases or their side effects based on some variation of effecting serotonin receptors.

    Now with FDA preemption, and allowing off-label promotion, based on review articles, and all the recent FDA stuff on pregnancy and breast feeding do you think that there’s something FDA and Pharma isn’t telling us?

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