Opioids and Birth Defects

Opioid medications are strong pain relievers, often used in combination with such other analgesics as aspirin or acetaminophen and sometimes in prescription cough suppressants.  Recent studies reported in the American Journal of Obstetrics and Gynecology have indicated that birth defects may occur more frequently when the mother was exposed to these medications in the first trimester, suggesting the safest course would be to avoid these substances in the month before and the first few months of pregnancy.  Considering the fact that many pregnancies are not planned, it would be ideal for all women of reproductive years to use caution with these substances.  Risk and benefits must be considered and about 3% of all live births in the U.S. are effected by birth defects, so a slight increase due to opioid use may not represent a large number increase. 

Examples (from WebMD)

Generic Name	Brand Name
buprenorphine	Buprenex
butorphanol	Stadol
codeine	Tylenol with codeine
fentanyl	Duragesic
hydrocodone	Vicodin
hydromorphone	Dilaudid
methadone	Dolophine
morphine	Astramorph
oxycodone	OxyContin
propoxyphene	Darvon

Prevent Birth Defects

January is national birth defects prevention month. Click here for 10 things you should know about birth defects. Want more information? Click here.

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).

What;'s Safe to Take?

WebMD has an excellent article on this subject with a table listing many "safe" medications - those considered to be safe in pregnancy.

Because we don't do the usual testing of drugs in pregnancy and lactation, we do not have the usual data confirming safety and the manufacturer of the medications must not claim such safety due to the regulations of the FDA regarding testing. However, we have learned much about this because after thousands of women have exposures during pregnancy, either because they didn't know they were pregnant or because their condition warranted the medication in consideration of the risks and benefits, we have good resources. Organizations like OTIS (Organization for Teratology Information Services) and our local Pregnancy Risk Line gather information and are available to inform women about the medication they are considering and whether or not it is likely to increase the risk of having a child with a birth defect. Few drugs have actually been shown definitively to cause defects, such as Accutane (isotretinoin) and thalidimide.

PRL number is (801) 328-2229 (328-BABY) or (800) 822-2229 (822-BABY). These experts are available for questions about specific medication or other exposures in pregnancy or while breastfeeding. If you don't get through, leave a message and they will return your call.

The safe course is always to avoid any unnecessary exposures in pregnancy since it is impossible to know every possible concern - either for the mother or the baby - and you should always discuss medications, supplements, and herbal treatments with your doctor or nurse midwife.