Contraindicated: on being human while breastfeeding
Also on male doctors, r/breastfeeding, and having to figure it out our goddamn selves
I recently got my period for the first time in 23 months. As lovely as it was to not buy tampons for two years, the respite from menstruation was symptomatic of other burdens borne by my body during this phase—the conception, gestation, and sustenance of a baby. That has meant having to think twice before consuming whatever it is I want or need or a given day, be it a spicy tuna roll or NyQuil.
What’s difficult about having to engage in a constant cost-benefit analysis as a pregnant or breastfeeding person is that the risks to your child are mostly uncertain—particularly when it comes to medication. While Emily Oster has helped the millennial parent attempt to make sense of the data associated with conventional pregnancy wisdom, there is limited data available to guide decisions regarding medication use during pregnancy or lactation. Historically, pregnant and lactating people have been excluded from clinical drug trials, for fear of causing harm to the baby. But as reported by the Coalition to Advance Maternal Therapeutics, more than 90% of pregnant people report taking medication during pregnancy. It often feels like we’re making decisions in the dark.
If you’ve ever read a drug or supplement label, you know that virtually all of them advise consulting a doctor before using if pregnant or breastfeeding. But even if you can afford to wait 48 hours for your doctor to respond to your MyChart message, the answers aren’t always clear. While I made an intentional and informed decision with my psychiatrist to remain on Lexapro during pregnancy, many other decisions involving medication were made on the fly, e.g., while walking in circles around the Duane Reade on Lafayette and Spring waiting for a response from my midwife, as I Googled “Naphcon A eyedrops pregnancy,” and gouged at my itchy eyes during our April babymoon in New York. The Mullein herbs I always took to break up a phlegmy cough? I couldn’t find any data, so I’ve avoided. Antiviral medication when I came down with shingles, days after conceiving, before I could even know for certain whether I was pregnant? (“Is there any chance you could be pregnant?” my dermatologist mother-in-law asked me, before writing me a script.) A necessary risk. The Chilean equivalent of DayQuil last January when I had Covid and needed to survive a travel day with a four-month-old? Okay, according to a Chilean pharmacist, but not according to the Internet, which told me that its decongestive component could harm my milk supply.
Efforts are slowly underway to standardize and improve the information available to pregnant and breastfeeding people and their clinicians. In 2015, the FDA issued the “Pregnancy and Lactation Labeling Rule” or “PLLR,” to ensure drug labels “provide what is known in a way that enables decisions for treatment.”1 The rule superseded the FDA’s previous regimen, which classified the safety of medications during pregnancy and lactation into letter categories A, B, C, D, and X. (Many of you who have been pregnant since 1979 may recall your doctor advising you that a particular drug was “Category B” or “Category C.”2) The issue with the letter categories, according to those who lobbied for the change, was that they oversimplified available data without actually identifying any known risks. The FDA found that providers misinterpreted and misused the letter categories, by making prescribing decisions based on the letter category rather than the underlying information.3 The goal of the PLLR was to provide prescribers with more information to allow for better decision-making, such as clearer statements of the known risks based on available data, the contextualization of animal data, the consideration of medical/disease factors, and explicit statements when no data is available.4 All of this feels like common sense. What also feels like common sense is the PLLR’s requirement that drug labels separately discuss risks during pregnancy, risks during lactation, and risks to men and women of reproductive potential.
Particularly of interest to me is the information that the PLLR requires a drug label to identify risks during lactation. There are different kinds of risks during lactation depending on whether the drug is absorbed systemically—which the label is required to state. If it is absorbed systemically, the risk summary section of the label must address the presence of the drug in the mother’s milk, the effects of the drug on the breastfed infant, and the effects of the drug on milk production. If any of these things are unknown, the label must so state! The label must also include a risk/benefit statement.5 For example, a label might state “Because of the potential for serious adverse reactions, including . . ., advise patients that breastfeeding is not recommended during treatment with TRADENAME.” Alternatively, a label might advise clinicians to balance the benefits of breastfeeding and the mother’s clinical need for the drug against any potential adverse effects on the breastfed child.
You’re probably seeing where this is going—a situation where I needed medication and had to consider the risks to my daughter and my milk supply.
When I drove to urgent care a few weeks ago for a urinary tract infection that had come on fast and strong, I was expecting to see the same reserved middle-aged female doctor who had treated me for a UTI on Christmas Day in 2022, and who had excavated a lost tampon from some corner of my vagina a few months before that. “Oh dear,” a little voice inside me said, when a male doctor6 walked into the room and stayed standing, leaning against the sink across the room. “What’s going on?” he asked.
I quickly summarized my symptoms, using the buzz words like the UTI veteran I am. “Burning, frequency, since this morning,” I rattled off. “Urgency?” he asked. "A little. I took Azo to help,” I said, referring to the brandname for phenazopyridine, an over-the-counter analgesic that provides pain relief in the urinary tract.
“So your urine test doesn’t show any signs of an infection,” he said. “It hasn’t been that long since you started experiencing symptoms. So I’d like you to wait to start antibiotics until your culture comes back.”
I nodded, assuming the meek deference that always comes over me in a doctor’s office. But I remembered I needed to advocate for myself and tried to start to explain why I had come in at the first sign of symptoms—”I came in early because my husband is about to leave on a business trip and—”
He cut me off. I immediately hated myself for invoking my husband, his business trip, making myself sound like some sort of vintage housewife, when what I wanted to tell him was that I was going to be alone with a toddler, that I could’t deal with pain and urinating every 20 minutes with a child that I couldn’t leave alone for even a minute, who would manage to find razor blades in the time it took me to flush the toilet. “How about this?” he offered, as if he were doing me a favor. “I’ll write you a prescription for the pain, and I’ll write you a prescription for the antibiotics, but don’t start taking it until the culture comes back. How does that sound?” “Okay.” I said. “One sec,” he said, and walked out of the room.
I sat there wondering what antibiotic he was going to prescribe and whether I should ask about its compatibility with breastfeeding. I assumed the pain medication he was referring to was the prescription-strength phenazopyridine I had been prescribed in the past. I wondered how long it would take to get the culture back, given that it was a Sunday. But I didn’t have time to contemplate whether there were any more questions I should ask, because a nurse suddenly appeared with a printed copy of my after-visit summary and ushered me out of the room. I was taken aback—too taken aback to ask whether I could have another minute with the doctor to ask questions. Had he really walked out of the room without saying goodbye, without wishing me well, by saying “one sec”?
It gets worse.
When I got to CVS to pick up the prescriptions, I was surprised to learn that the only prescription that had been called in was an antibiotic. No pain medication. I called back to urgent care. “You were under the impression that you were going to get a prescription for a pain medication?” a nurse responded with unnecessary snark. “Yes,” I said. “The doctor wanted me to wait to start taking antibiotics until my culture came back.” “Let me check.” I was put on hold. “Hello?” she returned. “He didn’t write you a prescription for pain medication because it is contraindicated for breastfeeding.” What. the. fuck. I seethed, inwardly. Outwardly, I was passive aggressive. “It would have been nice if he had told me that himself.” I said. “I agree,” she said. We hadn’t even discussed breastfeeding! I had only mentioned it to the medical assistant who took my vitals in reference to the date of my last period, which at that point was still nearly two years ago. “So what about over the counter analgesics like Azo?” I asked, which at that point I didn’t know was the same active ingredient as what I had previously been prescribed. “I don’t know,” she said. “Ask the pharmacist.”
On the verge of rage tears while my urinary tract burned, I brought a box of Azo up to the pharmacy counter and asked to speak to the pharmacist. “Is this safe for breastfeeding?” I asked. “The advice nurse at urgent care wasn’t sure and said to ask you.” She glanced quickly at the box without picking it up. “That should be fine,” she said without an ounce of conviction. I quickly paid for my antibiotics and the Azo. I had to get home so that Ben could leave for the airport for his business trip.
When I got in the car, I glanced at the Azo packaging and immediately realized what I had missed in my frantic desperation for pain relief. Azo was just brand-name phenazopyridine - the CONTRAINDICATED drug that was apparently so contraindicated that it didn’t even merit a discussion of risks and benefits. I burst into tears. I had already taken it! Images of birth defects sprung to mind, notwithstanding the fact that my baby was already out of the womb. What possible risk had I posed to her?
Spoiler alert: I’m still not really sure. This question remains unanswered. Phenazopyridine is not an FDA-approved drug, and so its label isn’t required to comply with the PLLR. The Azo label says nothing more than “If pregnant or breastfeeding, ask a health professional before use.” In other words, go on Reddit (r/breastfeeding !) and see what other people have been told by their health professionals. But as I quickly learned on Reddit and via my own Googling, a health professional doesn’t have much to go on when advising a breastfeeding patient on Azo. When I checked LactMed, a database containing information on drugs and chemicals to which breastfeeding mothers may be exposed, I saw it said very little:
Now, I’m not a doctor, and I don’t know what methemoglobinemia or sulfhemoglobinemia or hemolytic anemia are. But was this it? Was this the only basis of the urgent care doctor’s conclusion that phenazopyridine is “contraindicated” for breastfeeding? Because this looked to me like there was basically no information on the drug, but that my healthy 14-month-old could probably handle me having taken one pill. The pediatrician friend whom I frantically texted from the parking lot of CVS agreed. She told me not to stress about it, and that it was probably fine given that she was older than one and didn’t have the deficiency mentioned on LactMed.
My most generous reading of the urgent care doctor’s clinical decision is that “reasonable minds can differ.” He likely read some version of this LactMed entry and saw a risk not worth taking. But a clinician with a more complete picture of my situation reached a different conclusion. But whichever way he read the LactMed entry, shouldn’t this have been … a conversation? Breastfeeding a 14 month old is totally different than breastfeeding a 6 week old. I could have pumped and dumped for a few days. I needed the pain medication. But some “breastfeeding” note in my chart was treated as a reductive binary, one that apparently precluded me from taking medication rather than one that necessitated caution before breastfeeding.
While efforts like the PLLR reflect a movement in the medical establishment to more explicitly weigh the risks to a woman of not treating her pain and suffering when considering the risks to her fetus or baby associated with treatment, progress is slow. And the urgent care doctor’s refusal to prescribe me pain medication reflected a paternalism that was also latent in my pediatrician’s refusal to recommend a formula brand to me before my baby’s birth—breast is best, no matter the cost to the mother. Both doctors made me feel like a host; both made a value judgment that my baby’s purported need for breast milk should take precedence over any need of my own and couched it as a clinical recommendation.
When instilled by authority figures like physicians, it’s hard to unlearn this value judgment and the insinuation that taking care of my own needs is selfish. Instead of taking Azo, pumping and dumping, and giving my daughter more bottles full of cow’s milk, I breastfed and went without pain meds until my culture came back positive 48 hours later. I’m no martyr. I love breastfeeding and hate pumping. But it’s hard for me to separate my love for breastfeeding from my desire to be a “good” mother, meaning one that breastfeeds and makes baby food from scratch and doesn’t unnecessarily expose her daughter to harm. I mean, listen to me! Suggesting that pain relief isn’t necessary! Internalizing shitty outdated messages from shitty male doctors despite working on a book with a goal of freeing moms from the shitty breastfeeding binary!
Sigh. I’m a work in progress.
For more information, check out the federal Task Force on Research Specific to Pregnant Women and Lactating Women.
U.S. Food & Drug Admin., The Pregnancy and Lactation Labeling Rule (PLLR), Presentation by Miriam Dinatale, Pediatric Advisory Committee Meeting (Sept. 14, 2016) at 6, available at https://www.fda.gov/media/100406/download (hereinafter “Sept. 14, 2016 PLLR Presentation)
Under the FDA’s 1979 regime, drugs were classified as “Category B” or “Category C” without any human data. A “Category B” drug was one for which animal studies failed to show any negative effect on the fetus, and a “Category C” drug was one for which animal studies showed an adverse effect on the fetus, or one for which no animal or human studies were available.
Sept. 14, 2016 PLLR Presentation at 10.
Sept. 14, 2016 PLLR Presentation at 22-23.
I’m trying to resist letting this become a rant against male doctors. (I know there are good ones out there, but I also know that the particular hellish sensation of a UTI—like getting shampoo in your eyes, but in your genitals— is about as foreign to a 40 year old man as bad menstrual cramps or a contraction.)