Last week, I met with a woman who was planning pregnancy. She had a long history of generalized anxiety disorder and panic disorder and had done very well over the past 10 years on a regimen of citalopram (Celexa) and lorazepam (Ativan) as needed for sleep. She wanted to discuss alternative sleep medications because “my OB told me I couldn’t take Ativan because it’s a Category D medication”.
The Pregnancy and Lactation Labeling Rule
In 2015, the U.S. Food and Drug Administration (FDA) proposed major revisions to prescription drug labeling in order to provide more accurate and helpful information on the effects of medications used during pregnancy and breastfeeding. The system used by the FDA for the last 30 years classifies the reproductive safety of medications using five risk categories (A, B, C, D and X) based on data derived from human and animal studies. While widely used to make decisions regarding the use of medications during pregnancy, many have criticized this system of classification, indicating that this type of drug labeling is often not helpful and, even worse, may be misleading.
The Pregnancy and Lactation Labeling Rule or PLLR has abolished the letter categories and instead includes more comprehensive information discussing the potential risks and benefits to the mother and the fetus, and how these risks may change during the course of pregnancy.
Are Healthcare Providers Using the New System?
A recent study queried 1500 dermatologists about the PLLR. This may not be the most representative sample, as only 184 (12%) who received the survey via email actually completed the survey. However, the findings were concerning and worth noting. Less than half (46%) of the respondents were aware that the pregnancy letter category system had been replaced with a narrative summary. After reading the example of the PLLR, most of the respondents (68%) felt that the narrative summary was too long. Most of the respondents (95%) stated that they will continue to use the pregnancy letter category system to make prescribing decisions.
To the best of my knowledge, no other studies have assessed the use of the PLLR by obstetricians or other specialists. While we cannot make meaningful conclusions about the use of the PLLR by all healthcare providers, experience in our clinic suggests that the PLLR is not widely used.
But Where Do You Find This Information?
Finding information on the reproductive safety of medication is not that straightforward. Not so long ago, you could find the information continued within the product label in the Physician’s Desk Reference or PDR which was updated regularly and mailed to doctors’ offices every year. Now we go to the internet and find all kinds of stuff, much of it outdated or misleading.
Even when you try to make sure the information comes from a reputable source, the information can be misleading. For example, if you search for “lorazepam package insert”, the first listing is from the FDA, the governmental organization responsible for approving the language contained in package inserts. It seemed legitimate but I couldn’t find the date anywhere on the document. With a little bit of digging, I discovered that the document that came up first was outdated — from 2007. This most recent package insert was from 2016.
Don’t trust the internet.
Updated Information on DailyMed
On this journey, I happened to discover DailyMed. This is a useful website which is hosted by NIH and posts updated drug listings (package insert information) as submitted by the Food and Drug Administration (FDA). It’s relatively easy to use; my only gripe is that you have to expand the PRECAUTIONS section to find data on pregnancy and lactation safety.
While the information on the site is up-to-date, it feels a little sparse. Certainly the narrative summary provides more information than a single letter, but will providers find that the information is detailed enough to inform and simplify decision-making in pregnant and breastfeeding women? While it may help, I suspect that it is but one element that women need to make informed decisions regarding their care.
Ruta Nonacs, MD PhD
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