Decongestant while pregnant
I’m 5 weeks pregnant. My doctor prescribed the decongestant “Entex LA tablet SA”. Do you have any information regarding the safety/risks of taking this drug while pregnant?
I want to preface this by stating the testing of drugs in pregnancy. The best way to study a drug would be to find two identical groups of pregnant women and give one group the drug to be studied, and give the other a placebo. Very few studies are performed that way in pregnant women looking for side effects. Most of what is done is that a group of women on the drug are looked at to see if there is any increase in adverse outcomes, but because there isn’t an identical group to compare them to, these are less valid. Comparing them to the general population isn’t the same either. Unfortunately, that is the best data we have. Drugs are given a risk factor catagory A-D. A is where controlled studies (the one with two identical groups) have shown no demonstratable risk. As I stated, there are few studies of this nature. Cat B: either no animal studies or human studies have shown risk, or animal studies have shown risk, but human controlled studies haven’t confirmed this risk. This is one of the most common catagories. Many of the medications women take in pregnancy fall into this catagory. Cat C: either animal studies have shown a risk but no human studies are available, or studies in animals and humans are not available. Many medications are in this catagory. The FDA states that drugs in this catagory should only be given if the potential benefit justifies the potential risk. A lot of the drugs used to treat complications in pregnancy fall into this catagory. Cat D: there is positive evidence of fetal risk, but the benefits may be acceptable despite that risk. Such as a life-threatening situation or serious disease without any other option. If it is unsafe for the mom and fetus to not be on this medication then it should be given. There are many other confounding elements that make studying drugs in pregnancy difficult. For one, there is a 2-3% random chance of a defect for every pregnancy, so this makes it diffucult to determine if the drug in question was the culprit or nature. The best advice is to consult with your doctor the potential risks versus benefits of any medication. I went through all this detail because it will lay the foundation for the many questions I receive about the risks in pregnancy.
TThe antihistamine in Seldane (terfenadine) is a Cat C drug. No controlled studies have been performed, but there are no reports linking this antihistimine with any adverse outcomes.
For more information:
Go to the Pregnancy health topic.