Is a Morning Sickness Pill by any Other Name – Still Dangerous?

Holy Hormones Journal: Dr. Michael Platt, wrote a blog post in August of this year warning pregnant women of the re-introduction of yet another highly controversial morning sickness

Researchers linked use of the SSRIs paroxetine and fluoxetine in early pregnancy with greater risk of birth defects, but no such association was found with maternal use of other SSRIs

pill that has been approved by the FDA. The pill was formerly known as Bendectin – which was removed from the market after causing birth defects in children. How many times have we seen this? Case in point, this summer when a twice-failed antidepressant was repackaged and branded as the first pink Viagra pill for women.

Listen up folks – it costs too much money for a pharmaceutical company to just throw a drug away… they have to re-create and re-package it. Maybe tweak the patented ingredients just a tad – do another short-term study on a small group of innocent people – and voilà they are back in front of the FDA saying their drug is now safe.

Taking any drug during pregnancy – including the flu vaccine – endangers the life of your child – PERIOD.

Dr. Platt, who is the author of “Adrenaline Dominance” – and who is the next guest on my Holy Hormones Honey! podcast points us all in the right direction. According to his work and research women who have constant morning sickness…. and many experience this throughout the entire nine months of pregnancy – are actually suffering from excess adrenaline – from an overworked – over burdened – endocrine system which in turn affects the neuro-endocrine-immune system.

All the hormones addressed in this book (Adrenal Dominance – A Revolutionary Approach to Wellness), adrenaline, progesterone, cortisol, and insulin – have a strong effect on neurotransmitters, which are responsible for how the brain cells communicate with each other. ~ Dr. Michael Platt

If neurological communication systems are thwarted/distorted those messages will be sent throughout the maternal body and will and can affect fetal health. I think we can see this with the high rates of autism and ADHD and chronic illness in our children.

Fetal health begins with maternal health. Maternal health begins with a healthy endocrine system. Drugs and vaccines will only interfere and breakdown the already damaged endocrine glands. In addition, not living with circadian rhythms – the clock of the universe – the bodily rhythm that is the foundation of women’s health and mental well being is the cause behind excess or diminished hormone secretion.

In between Dr. Platt’s informative article I have taken the liberty to insert some history on the two drugs mentioned: Bendectin and Diclegis. If you are going to be an informed consumer you have to understand the history behind the drug. The lawsuits behind the drug.

BTW – I was doing a search for images of Bendectin and found another book about the drug – with the subtitle “The Challenges of Mass Toxic Substance Litigation.” Need we say more?

The “New” Morning Sickness Pill

by D. Michael Platt
Platt Wellness Center
August 12, 2015

Many people probably remember thalidomide which was a popular sleeping pill prescribed for pregnant women starting in the 1940’s because it was touted to help with morning 10.14.15 Adrenal Dominancesickness. It was eventually removed from the market after it had resulted in thousands of babies being born with skeletal abnormalities such as only having hands  without arms attached to their shoulders (a condition called focomyelia).

In 1956, a drug was introduced called Bendectin, and again used for morning sickness. It was a combination of two drugs, doxylamine and pyridoxine. Unfortunately, this drug resulted in many, if not more, of the same side effects as thalidomide. It should have been removed by the FDA, but they allowed it to be marketed until it was voluntarily recalled by its manufacturer, Merrell Pharmaceuticals, in 1983. It seems that the multiple law suits involved with this drug ate into their profits in a large way.

The Genesis

Bendectin was developed in the mid-1950s by the Wm. S. Merrell Company of Cincinnati, Ohio, from pharmaceutical ingredients that had been individually marketed for many years. It was indicated specifically for nausea and vomiting of pregnancy. The product was approved by the FDA in 1956.

The original drug formulation contained three ingredients: doxylamine succinate (an antihistamine), which has antinauseant and antiemetic properties, pyridoxine hydrochloride (Vitamin B6) and dicyclomine hydrochloride (an antispasmodic).

In 1975, the efficacy of each ingredient of multi-ingredient medications marketed between 1938 and 1962 had to be re-evaluated to ascertain that the drugs meet the efficacy requirement contained in the amended Food, Drug, and Cosmetic Act. Consequently Bendectin was submitted to this retrospective review – known as the DESI process (Drug Effectiveness Study Implementation) – which was conducted by the National Academy of Sciences and the FDA). Following an 8-way study, Bendectin was reformulated in 1976 to contain only the two active ingredients (doxylamine, pyridoxine) that demonstrated efficacy to treat NVP. Therefore the third ingredient, (dicyclomine, for which no benefits were observed), was removed from the original formulation.

The Litigation

Bendectin’s legal saga started in the USA in the late 1970s with the first allegations regarding possible teratogenicity with Bendectin. The first case that received wide publicity was the Mekdeci case, which alleged that Bendectin resulted in a birth defect called Poland syndrome (a deficit in the pectoralis muscle) was filed in 1977.

Some studies had emerged in the late 1970s and early 1980s, which associated Bendectin to some specific malformations.Following an article published in the National Enquirer (1979) which stated  that Bendectin could cause birth defects, many women wanted to abort their pregnancies. Following this article, the FDA issued a FDA talk paper on Bendectin, which was helpful to physicians and patients by stating that “the current physicians labelling for the drug reflects the FDA’s evaluation that there is no adequate evidence linking Bendectin with an increased risk of birth defects.”A series of lawsuits involving the safety of Bendectin in pregnancy followed throughout the 1980s, which again attracted widespread media and public attention.

A number of large epidemiological studies, many of which were reviewed in a 1983 article and in two meta-analyses have exonerated Bendectin and found no measurable teratogenic effect.

Two years ago, the FDA, who is supposed to be concerned about patient safety, allowed a Canadian drug company called Duchesnay, to have their drug called Diclegis  approved for treating morning sickness. This drug has exactly the same formula as Bendectin. They got away with re-introducing it because the FDA never took it off the market like they should have.

Not surprisingly, Kim Kardashian was brought in to market this toxic drug. The problem with this multimillion dollar campaign is that she failed to mention the potential side effects, so that the ads featuring Kardashian were pulled for the time being. Frankly, it would appear that considering the history of this drug, any doctor prescribing Diclegis is putting themselves on the same level of knowledge displayed by Kim Kardashian.

TUESDAY, April 9 2013 (HealthDay News) — A morning-sickness medication that was withdrawn from the market 30 years ago has won U.S. Food and Drug Administration approval under a new name.

In its new form, the drug — formerly called Bendectin and now renamed Diclegis — is the only medication specifically approved to treat the stomach upset many women suffer from during pregnancy.

In the intervening decades between the drug’s withdrawal from the market and its re-approval on Tuesday, the medicine has undergone rigorous scrutiny and is now deemed safe by the FDA.

Obstetricians welcomed the announcement.

“The nausea and vomiting of early pregnancy can range from mild to debilitating,” said Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City. “Patients will welcome more options for treatment with the reintroduction of Bendectin.”

So what should women do to eliminate morning sickness? Those of you who have followed my blogs realize that my approach to conditions is to treat the underlying cause. Well the underlying cause of morning sickness during the first trimester is always estrogen. So would it not make sense to block the effects of estrogen? This is achieved with the use of a natural bio-identical progesterone cream – a hormone that not only will eliminate morning sickness, but at the same time is extremely beneficial and healthful to the fetus.

While on the subject of morning sickness, please be aware that there are some women who vomit throughout their entire pregnancy – a condition called hyperemesis gravidarum. Interestingly, it is only found in women with creative minds. It is caused by excess adrenaline, and creative people have the most adrenaline. This situation is also treated by progesterone, in conjunction with a meal plan to lower adrenaline.

I strongly recommend that women who do have this problem read my latest book called “Adrenaline Dominance.” Not just for their own benefit, but also for the benefit of their offspring who will likely have the same hormonal challenges.

For those women who are looking for a therapeutic strength of progesterone, you can order Platt Pro 5% from my website. It provides 50 mg per pump, the strongest progesterone cream available without a prescription. It can also be found in a number of health food stores under the name Pro Max 5%. My website is: http://www.plattwellness.com.

 

Source:

The “New” Morning Sickness Pill

Bendectin History

FDA Allows Return of Drug for Morning Sickness

 

Related Article

My Baby Died While I Was Prescribed Bendectin, Now The FDA Brings It Back

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.