Drug Policy, Bendectin, and Frivolous Litigation
I was reading this article on the FDA's increasing sensitivity to safety concerns (via Instapundit) and I couldn't help myself. My version of the article's conclusion:
If America's [reproductive-age] population is to get the new [or any] drugs it needs, policy makers must make decisions based on data, and resist speculation and public pronouncements by special interests.
Of course, my position is that policy makers shouldn't make any drug-related decisions, period, but it's good to see wide support for science-based policy, and noninterference in medical matters by special interest groups. Oh, wait, my mistake! This only applies when it comes to America's aging population [and a few select other populations, *cough* males *cough*].
One thing of note from the article is the mention of Bendectin. Although the drug was long off the market when I started out, I must say, every single time I heard an attending who'd used Bendectin talk about it, it was in glowing terms. No wonder, considering what happened after its withdrawal:
The most widely prescribed drug for nausea and vomiting of pregnancy (NVP), Bendectin, was voluntarily withdrawn from the US market in 1982, after numerous, unsuccessful lawsuits alleged it had caused birth defects.
After its withdrawal, hospitalization rates for NVP doubled while solid evidence of Bendectin's safety continued to accumulate.
Here's more on the Bendectin story, and the treatment of NVP, in general.
And since we're on the subject of NVP, I cannot emphasis this strongly enough: nausea and vomiting are NOT an inevitable part of the pregnancy experience. Please don't feel like you have to suffer in silence. Untreated, this condition gets worst before it ever gets better. And for some it can get quite bad, indeed. Hospitalization and parenteral nutrition while pregnant are truly miserable experiences. Please talk to your physician and ask for treatment!
Last, but not least, no mention of Bendectin would be complete without a lawyerly perspective.







4 Comments:
For some reason, today I thought of the drug Bendectin after 41 years and decided to google it. This was a medication I was given in 1968 for " morning sickness" early on in my pregnancy. My baby was born 3 weeks early
with multiple congenital anomalies including polydactyly, enlarged kidneys, missing left ventricle of the heart, only one dwarfed lung, bowel malrotation, fetal hydrops, low set ears, and facial deformities .he lived one hour. this was my first baby and I was 19 years old. I subsequently had three
normal healthy full term pregnancies, the last at age 45.
After googling this drug I see that Merck spent $100,000.00
Combating lawsuits, and decided to withdraw the drug. Just today there was an article published on how they are trying to reintroduce this onto the US market. I would hate to think this devastating experience could happen again to an unsuspecting new mother. I had never pursued anything related to this prior to today because I had a healthy baby one year and one week after my first heartbreak. Now with the information age, I google whatever comes to mind. I wonder how many
Other women had similar experiences. I am now convinced that this drug caused myterribleisfprtune.
i also took bendectine during the early stage of my pregnancy. my daughter was born perfectly normal. she graduated from unc chapel hill with honors. she is now 36 with two children who are also normal and very intelligent too. i am sorry for your loss but the drug did not effect my normal exactly on due date birth.
I am so very sorry for your loss, and the agony you went through, Andrea, but Bendectin was not the culprit.. I took Bendectin for a full 8 months during my first pregnancy and my baby was 2 weeks overdue! He was perfectly healthy. I went on to have 3 more pregnancies in which I took those wonderful little white pills. Each one was healthy and resulted in a perfectly healthy baby. Except for minor childhood illnesses, they were healthy kids.. I hope they bring them back so that other women won't be as miserable as I was before I started taking them! They are wonderful.. not evil!
I took Bendectin for a short time in 1983. It was taken off the market while I was taking it and no one ever followed up with us to monitor any issues. My son went full term was born in the last day of 1983. He had surgery in Feb 1984 for pyloric stenosis. He has had other issues and I'd like to know the facts about the potential effects or connection with Bendectin.
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