Let's Talk about Off Label Use, Cytotec and You

So you're pregnant. Congratulations! Guess what? Parenting starts now. It doesn't begin after you bring your baby home or even the moment your baby is in your arms. No, your role as protector and nurturer begins from the moment you first realized you were pregnant. You will have a larger role in your child's life than anyone else. You will know your child better than anyone else. You will make more decisions for your child than anyone else and those decisions are more likely to be purely out of a desire to do what is best for your child than anyone else. Being a responsible parent starts now.

What does this have to do with off label use of medications? This has to do with the protector part of your parental responsibilities. So here we go. As I explained in my previous post, "More on Why Women Need to Question Authority" a doctor can legally prescribe a medication for a use for which it has never been tested, in other words no FDA approval. This is called off label use. Apparently this practice is surprisingly common in the medical world.

So what would you do if your doctor came to you when you were pregnant and said, "I want to use drug X on you. It has never been tested for safety in pregnant women or their babies but there is some evidence that it may be effective for your situation." Unless your medical situation was dire most women would say, "Are you kidding? No way!"

What if you went to a prenatal appointment and your doctor or midwife said, "There is a new drug, X, which they are starting to test for FDA approval that might help with keeping blood pressure down during pregnancy. I'd like to sign you and your baby up to be part of the drug trial. Are you interested?" It is hard for me to imagine the mom who would answer, "Sure sign us up!"

So how do they find out if a drug is effective and safe during pregnancy, labor and birth? By doing an end run around you and the safeguards that are in place to protect us from unsafe medications. They go off label. Most medications we commonly use in pregnancy and birth were originally given experimentally on women without their real understanding or consent to the process. Then they collect data in hindsight and try to figure out what is truly OK to be using on us.

Marilyn talks about an example familiar to many of us in her comment on my earlier piece,
"I totally agree with you Jennifer. My mother was given thalidomide for nausea in the 60's and subsequently had three miscarriages and was never able to conceive again."
Most of us have heard about thalidomide babies but we make the mistake of assuming nothing like that could be happening now. That was the kind of thing they used to do in the past before women were treated as equals, right?

Now you are ready to talk about Cytotec. Do you remember the questions I posed in my earlier post?
"Are you seeing a doctor that will induce you if you go past a certain calendar date? Are you worried about being induced? Concerned about ending up on the dreaded "pit drip"? What if your doctor whom you trust said, "don't worry. We're not going to use Pitocin. We're going to use this little tiny pill instead. You won't even need to be hooked to an IV and it is perfectly safe for you and your baby." What would you think? What would you do?"

If facing a labor induction most women would say yes to their doctor or midwife. Their fear of a Pitocin induced labor, which they have heard plenty of bad things about from sisters, mothers and friends, coupled with their fear of ending up with a c-section, added to their trust in their care provider to never do anything to harm them or their babies, and their assumption this pill has been FDA tested for safety in labor, will lead most of them to say yes to their doctor. You have just become an unwitting lab rat.

The truth about Cytotec also known as Misoprostol:

From Wikipedia
In August 2000, Searle—the manufacturer of misoprostol—distributed a letter warning against the use of misoprostol in pregnant women. The letter cited reports of uterine rupture and death associated with using misoprostol to induce labor. Other rare complications include amniotic fluid embolism (a very rare complication which usually results in maternal and fetal death) It is difficult to determine if misoprostol causes a higher risk than do other cervical ripening agents. One estimate is that it would require approximately 61,000 patients enrolled in randomized controlled trials to detect a clinically significant difference in serious fetal complications and approximately 155,000 patients to detect a clinically significant difference in serious maternal complications.

Enter the lab rats. Where on earth are they going to get 155,000 pregnant women to sign up for their experiment? So instead they use Cytotec off label on many more women than 155,000. They have to use many more lab rats because no one is writing down the data. No one is setting up a control group. No one is following up! It takes much more momentum of bad outcomes for moms and babies before the collective consciousness of the medical community realizes the mistake they made.

So how did we get here with Cytotec? When they were testing this drug for it's intended use as an ulcer medication they discovered it was an abortifacient, in other words it caused women to go into labor and miscarry or abort. Someone had the bright idea to use it at the end of pregnancy to cause women to go into labor and birth their babies.

Since there had been no testing for dosing levels for labor induction they needed to wing it. Cytotec is a small white pill. It is only sold in 100ug tablets. They began placing it inside women up against their cervix's where it would slowly be absorbed into the blood stream. Through trial and error they have learned that the best dose is one quarter of one pill or 25ug. Searle the drug manufacturer continues to not sell it in 25ug because they don't want to be legally responsible for what may happen next to you and your baby.

Here comes the tricky part, Pitocin can also cause uterine hyperstimulation which left unchecked can lead to uterine rupture. Here is the difference in what I have seen with my clients. When Cytotec is used they place the pill and wait. With some of my moms absolutely nothing happens, nada, zippo, no contractions at all. Then we all have to wait many hours before they can either try placing a second dose or transfer over to Pitocin. With some moms it works like a charm. They start into strong labor and birth their baby. But what happens to the third group of moms? They get into trouble. Their contractions are coming too strong and too close together. Their baby begins to go into fetal distress. The nurse and doctor have no way of retrieving the pill. They have no way of turning it down or turning it off. With Pitocin they try to find the level of medication which will be strong enough to cause you to contract effectively enough to dilate while not causing contractions so strong they can rupture your uterus or that your baby can't handle. I have seen this dance many times with Pitocin. With Cytotec there is only one way to "rescue" the situation they have created; perform a surgical birth. The mom is rushed down to the OR and she is cut open. Voila! What a lucky thing you had your baby in the hospital otherwise who knows what would have happened!

The American College of Obstetricians and Gynecologists holds that substantial evidence supports the use of misoprostol for induction of labor, a position it reaffirmed in 2000 in response to the Searle drug company disclaimer letter.

When you google Cytotec up come all the law firms preparing cases for grieving families.

Remember Marilyn whose mom took thalidomide? Here's what she had to say as a conscientious parent, "Good rule of thumb - don't take ANYTHING while you're pregnant and before you agree to anything after your child is born - conduct a full spectrum of medical professionals - talk to top homeopathic practitioners, and SEVERAL medical practitioners before you make any decisions. You owe it to yourself and your child to do your homework - don't take anything doctors tell you at face value."