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FDA issues warning after Kim Kardashian illegally promotes pregnancy drug feared to cause birth defects


Kim Kardashian

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https://www.naturalnews.com/051025_Kim_Kardashian_birth_defects_FDA_violation.html
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(NaturalNews) When Kim Kardashian, who is five months pregnant, took to Instagram and Facebook to promote a morning sickness drug, she probably never thought her action would lead to a warning letter from the FDA.

However, that's exactly what happened, with the FDA warning that Kardashian's posts violated federal law by failing to mention the drug's side effects.

The drug in question, which is now marketed under the name Diclegis, was pulled from production in 1983 when the company that made it could no longer afford to defend itself against lawsuits alleging that the drug caused birth defects.

Concealing information on risks

Diclegis was approved by the FDA in 2013 for the treatment of nausea and vomiting in pregnant women. Its active ingredients are vitamin B6 mixed with the over-the-counter antihistamine doxylamine.

Kardashian, who has 42 million Instagram followers and 25 million Facebook followers, lauded Diclegis for its effectiveness and safety.

"I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor," her post read. "He prescribed me #Diclegis, and I felt a lot better and most importantly, it's been studied and there was no increased risk to the baby."

The post then linked to the website of the drug's manufacturer.

The FDA's letter noted that Kardashian's posts did not warn of the drug's side effects (such as drowsiness that can make it unsafe to drive) or that Diclegis should not be mixed with alcohol, sleeping drugs or certain painkillers. It also failed to mention that Diclegis has not been approved for the severe condition known as Hyperemesis gravidarum.

In 2013, the FDA rebuked the same company for failing to mention the drug's side effects in a promotional letter to doctors.

Not really proven safe

The question of how safe Diclegis is has a long and complex history. The drug was first introduced in 1956 under the trade name Bendectin, and approximately 33 million women around the world were given the drug before its withdrawal from the U.S. market in 1983.

In 1962, it was revealed that thalidomide, a drug marketed as a morning sickness drug safe for pregnant women, caused severe birth defects. In the following decades, women became rightfully concerned that the drugs they were being prescribed were not actually safe for their unborn children.

One effect of this increased awareness was a rash of lawsuits by women who had taken Bendectin and later given birth to children with developmental defects. By 1983, drug maker Merrell Dow could no longer afford the legal costs and voluntarily withdrew the drug.

According to the CDC, studies later showed no connection between Bendectin/Diclegis and birth defects. In fact, the drug is one of the few to have actually undergone clinical trials on pregnant women and been shown to not cause birth defects.

While two meta-analyses did find no connection between the drug and birth defects, Jill Escher of the Escher Fund for Autism has noted that these studies tested only for physical (somatic) defects. Hardly any testing has been conducted on any drug for effects on the developing germ cells (precursors to eggs and sperm), such as "epigenetic" effects that can change gene expression for multiple generations to come, even though it is well established that many foreign chemicals can and do cause such changes.

In a 2013 letter to the FDA urging them to reconsider the drug's approval, Escher notes that peak morning sickness corresponds precisely with the development of fetal germline cells.

"Yet, administration of Diclegis is expressly targeted at this known window of epigenetic susceptibility, and may wreak unknown and unmitigatable havoc on the germ cell programming," she wrote.

Sources for this article include:
Yahoo.com
FDA.gov
Newsday.com
PrenatalExposures.blogspot.com
ABCNews.go.com
WomensHealthMag.com

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