Nobody who lived through the thalidomide scare of the 1960s will ever forget it.

Babies around the world were born with mutilated and even missing limbs after their mothers took this dangerous morning sickness drug.

But now we may be on the verge of a birth defects crisis even worse than what we saw half a century ago.

A morning sickness pill called Diclegis is being handed out to expecting mothers as a “new” way to prevent the nausea and vomiting of morning sickness.

But this drug has a frightening back story that you need to hear, especially if you have a daughter, granddaughter or other loved one expecting a child.

Because Diclegis might just be an alias for a dangerous corporate cousin of thalidomide. One that was pulled from the market 30 years ago after leaving countless deformed babies in its wake.

A new alias for an old villain

been two years since the FDA approved Diclegis for pregnant women. But the marketing campaign is now starting in full swing.

Its brochures are popping up in doctors’ offices around the country, and celebrities like reality TV star Kim Kardashian are endorsing the drug. Well, I wouldn’t take advice from Kardashian on eyelashes let alone a medical decision.

Because Diclegis isn’t a new breakthrough for moms-to-be. It’s just a return of a drug from the fifties that numerous parents believed to be the cause of scores of horrible birth defects.

You see, in 1956 the FDA approved a morning sickness pill called Bendectin from drug giant Merrell. It was a combination of doxylamine and pyridoxine — the very same duo used in Diclegis.

If you haven’t heard of (or don’t remember) Bendectin, I don’t blame you. Just three years after it launched Bendectin, Merrell added thalidomide to its morning sickness line and it became a top-selling drug — and major scandal — in several countries.

But as the shocking thalidomide stories unfolded during the early 1960s, the FDA began researching other drugs that might be causing similar birth defects. And it uncovered terrifying reports of moms who took Bendectin and gave birth to children with missing or deformed fingers, arms and bones.

And years later, lawsuits over kids like Jeffrey Blum, who was born with clubfeet causing him to have 11 operations during his first 12 years, uncovered more hidden scandalous facts. We even learned that Merrell concealed data from its animal studies showing birth defects and cherry-picked which research it sent to the FDA for 30 years.

In fact, an FDA official testified in the Blum case that women who took doxylamine — one of the same drugs found in both Bendectin and Diclegis — were twice as likely to have babies born with clubfeet.

The FDA should have banned Bendectin in America. But instead, the agency let Merrell keep selling the drug until the company voluntarily withdrew it in 1983.

And that’s because Merrell was spending as much defending itself from hundreds of Bendectin lawsuits as it was making from the pill.

But because the FDA never pulled Bendectin from the market, Canadian drug company Duchesnay had no trouble reintroducing it under its new name — Diclegis.

It’s being handed out like candy right now, because it’s the only FDA-approved anti-nausea med for pregnant women. And it’s even been declared safe for expecting mothers during the first trimester — exactly when Bendectin used to be prescribed.

But what about all that bad press that Diclegis’ predecessor Bendectin received? Well, Duchesnay claims doctors likely don’t remember any of that. Or if they do, “they can relate very strongly and very positively to Bendectin.”

Unfortunately, lots of mothers — and their babies — aren’t going to feel the same way.

Sources:

“Spotlight-savvy Kim Kardashian adds Duchesnay med to her talking points” Emily Wasserman, July 22, 2015, Fierce PharmaMarketing, fiercepharmamarketing.com

“Controversy surrounds Kim Kardashian’s pregnancy drug promotion” Esther Crain, July 21, 2015, Yahoo Parenting, yahoo.com


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Allan Spreen, M.D.
Dr. Allan Spreen, Chief Medical Advisor

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