Showing posts with label Risk. Show all posts
Showing posts with label Risk. Show all posts

Thursday, July 29, 2010

Pregnancy Risk Line


Medication Questions & the PRL

Questions always arise about taking medications in pregnancy or while breastfeeding. In Utah we have a wonderful resource in the Pregnancy Risk Line. Trained and experienced medical consultants with the Utah Department of Health answer your calls for any kind of exposure question in pregnancy and lactation. They can be reached at (801) 328-2229 in the Salt Lake valley or (800) 822-2229 outside (the last 4 digits spell BABY). Their hours are Monday through Thursday from 8:00 AM to 6:00 PM. mountain time.

Medication Labeling & Tracking

It is important to understand the labeling on medications as they relate to pregnancy and breastfeeding. It can be scary to read, "do not take if you are pregnant..." because that sounds like it is dangerous. In truth, that is the way they label because we don't do the normal kind of testing the FDA requires to indicate safety in the drug literature. It just would not be right to experiment on moms and babies!

But in many cases women become pregnant while taking medications that they need and sometimes they don't even know they are pregnant. By pooling information resources throughout the country (and other countries as well), data is obtained after the exposure and they are able to track, stratify and determine if there appears to be a risk to the fetus or nursing baby through exposure to the medication.

Usual Risks

This is not a perfect system because about 3% of babies are born with birth defects independent of any exposures. The only thing we can do is try to determine if there is a greater risk when exposed to a drug or other substance. Even if there was exposure, that does not necessarily mean it was caused by that drug - it could be that it was just one of the 3%. In addition, there are other factors that could be going on with the mother and baby such as other underlying disease apart from the drug or even the reason the drug is needed. If a baby has a defect, was it because of the medication the mother was taking or the underlying disease that required the medication such as with seizure disorders? These confounding factors make it difficult to determine actual causes.

If there appears to be a pattern that points to increased risk as they analyze the data, the teratology organizations such as the PRL have access to that information and can help advise women in making their decisions. Most medications to not pose a risk to the baby but since information is limited, a good rule of thumb is to only take meds when the benefits outweigh the risks and in consultation with your doctor or midwife. Often the medication is important for the mother's health, and therefore the baby's health as well. For this reason it is not good to just
assume all meds are risky and stop taking them.

One common practice is to stop taking antidepressants such as Prozac, Zoloft, Celexa, Paxil, etc. when one learns of pregnancy, sometimes because this is not seen as a real medical condition. This can pose a risk to the mother because we know that depression causes problems in pregnancy and motherhood, while any risks to the newborn appear to be very small and easily controlled. These meds should not be stopped suddenly and only under the direction of your prescribing physician. If your depression is mild, you may be fine to stop taking the meds but please do so under the care of your provider to avoid the complications of rebound depression.

Sometimes people cut their dose in half, thinking this will reduce any risk. In truth it will still expose you and the baby while possibly not doing the good you need. If the medication is needed, it should be taken in a dose that actually does the job. So, it is important that any tapering be done with close observation as to the effects. If you don't get enough to do the job, there wouldn't be much point in taking the medication.

Another example is medication for asthma. It is very important that you are able to breathe and get oxygen so medications to help you breathe can be critical to the health of you and your baby. If you assume all meds are bad, you could put yourself and your baby at risk.

There are very few medications which have been clearly associated with birth defects and these must always be avoided. Included here would be Accutane ((isotretinoin) used for severe and cystic acne and Thalidomide (rarely used).

Animal Studies

Another point to consider is animal studies. Sometimes an exposure will appear to cause problems in laboratory animals. The trouble with this is that we are not animals and there has not been reliable comparisons between animals and people - we just don't respond the same way to exposures, the studies usually use huge amounts by comparison to what humans would consume, and we just haven't found these to be indicative of human response. So, even if a drug has been shown to cause defects in animals, it does not mean that will happen in the human. As an example, animal studies did not alert scientists to the risk of Thalidomide. The problem didn't occur in the animals, but did occur in humans.

OTIS

Another online resource is OTIS Pregnancy (Organization of Teratology Information Specialists). They have created some helpful information sheets that can be viewed and/or printed on various exposure sources.

Bottom Line

Use the PRL and/or OTIS to help you to be informed about your use of medications in pregnancy. Often the benefits of the med are important and the risk very low. But, don't take meds that aren't needed, avoid recreational drugs and known dangerous substances such as tobacco and alcohol. Use common sense, talk to your doctor or midwife, and consult with the experts at the PRL (even after you have spoken with your provider). Spread the word about this valuable resource. Best Blogger Tips

Monday, December 7, 2009

New FDA Warning ~ Drug/Birth Defect Connection

Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects (12/3/09)

There are not a lot of products that have actually been shown to cause birth defects. Since we don't test in the usual way on pregnant women, most medications fall in the category of "not enough information to determine safety." The manufacturer cannot claim safety because FDA guidelines require certain testing to be able to make the claim. That does not mean that a product with a warning not to use in pregnancy unless advised by a doctor is unsafe. So, it's best to check with a teratology agency such as Utah's Pregnancy Risk Line or Otispregnancy.org for information on product safety. If there has been shown to be some problem with the medication, affecting the baby in the form of a birth defect, or affecting the mom (such as raising blood pressure), they will know about it. You can call them at (800) 822-2229 or (801) 328-2229.

There is a new warning from the FDA about a medication sometimes used for migraine headaches, seizures and other disorders. Information is below. Or, click on the post title to be taken to the FDA site directly. Sometimes the need for the medication is greater than the risk to the baby (all babies are not adversely affected) so your doctor will need to make the call here. If you have questions talk to your provider.
The FDA notified health care professionals and patients about the increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products (valproic acid and divalproex sodium) during pregnancy. Healthcare practitioners should inform women of childbearing potential about these risks, and consider alternative therapies, especially if using valproate to treat migraines or other conditions not usually considered life-threatening.
Women of childbearing potential should only use valproate if it is essential to manage their medical condition. Those who are not actively planning a pregnancy should use effective contraception, as birth defect risks are particularly high during the first trimester, before many women know they are pregnant. A valproate Medication Guide, provided with each outpatient prescription, will explain the benefits and risks of valproate and encourage patients to discuss options with their healthcare professional.
Pregnant women using valproate or other AEDs should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334; www.aedpregnancyregistry.org).
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