PHILADELPHIA—As rheumatologists, we care for patients who may or may not want to become pregnant. We aren’t obstetricians or gynecologists, but several of the drugs we prescribe for active rheumatic disease can negatively affect pregnancy outcomes. It’s imperative we understand how to effectively counsel our patients with rheumatic disease on the risks and benefits of different medications and contraceptive methods, especially in the post-Dobbs v. Jackson Women’s Health era.
Dobbs v. Jackson is the June 2022 U.S. Supreme Court decision in which the court held that the U.S. Constitution does not protect a right to abortion. The ruling gives individual states the power to regulate any aspect of abortion not preempted by federal law.1
Dr. Edens
At ACR Convergence 2022, Cuoghi Edens, MD, FAAP, assistant professor of medicine and pediatrics, University of Chicago Medicine, and Mehret Birru Talabi, MD, PhD, assistant professor of medicine, University of Pittsburgh, shared practical information on the risks of teratogens and contraception options for people with rheumatic disease. Additionally, Greer Donley, JD, associate professor of law, Center for Bioethics and Health Law, University of Pittsburgh, provided a high-level overview of the legal risks facing rheumatologists in today’s new landscape.
Teratogens
Dr. Edens kicked off the session, providing an excellent overview of the teratogenic potential of common rheumatology medications. A teratogen is any agent that can cause a congenital malformation or miscarriage. These agents are concerning to patients and providers alike, but it’s important to put their risks into context.
“In the general population, there’s about a 3% risk of congenital malformations regardless of medications, and one in four women has a miscarriage,” Dr. Edens said.2,3
The 2020 ACR Guideline for the Management of Reproductive Health in Rheumatic and Musculoskeletal Diseases offers guidance on the safety of many medications used to treat RMD.4
“MotherToBaby.org is also a great resource [to learn about] teratogens not covered by these guidelines,” Dr. Edens said.
Contraception
Dr. Talabi continued the presentation with an overview of contraception for patients with rheumatic disease. “At the bare minimum,” she said, “we need to be prepared to advise our patients on contraceptive options, safety and efficacy.”
Dr. Talabi
In general, rheumatologists need to be aware of two major safety considerations when recommending contraceptive methods to patients with rheumatic disease:
- Estrogens increase the risk of thrombosis. Therefore, use should be avoided in patients with positive antiphospholipid antibodies (aPL) or prothrombotic states (i.e., history of clot); and
- Estrogens at high doses may stimulate systemic lupus erythematosus (SLE) activity.
The safest and most effective contraceptive methods for all women with rheumatic disease include tubal ligation, vasectomy for their male partners and subdermal implants and intrauterine devices, both copper and hormonal. This holds true for women with SLE and positive aPL. The Minipill (progestin-only) is also safe for all patients, but less effective.
“These are only moderately effective because we’re now introducing human error,” Dr. Talabi said. “People need to remember to take the Minipill on time and daily. With the old version of the Minipill, users could be no more than three hours late in taking it or lose [its] contraceptive benefit. There’s a new version of the Minipill that is more forgiving and allows for someone to be 24 hours late in taking their pill without the loss of contraceptive benefit, but this particular version of the pill must be requested directly from a pharmacy.”
Estrogen-containing methods, such as combination oral contraceptive pills, the ring and the patch, are not safe for people with aPL or who have a high clot risk. These methods should also be avoided in patients with high SLE disease activity. Low estrogen, combined oral contraceptives are safe to use for people with SLE who don’t have aPL.
Of note, emergency contraception (i.e., intrauterine devices and emergency contraception pills) is safe for all patients with rheumatic disease.
Excellent handouts to help patients and providers select appropriate contraception are available from the ACR and Duke Repro Rheum (see sidebar below).
Legal Implications
Dr. Greer Donley
Prof. Donley concluded the session with valuable information about the legal risks facing practicing rheumatologists in the post-Dobbs v. Jackson era.
“It’s important to note that in this new reality, no lawyer can tell you that any of [what I’ll discuss today] is 100% safe if you live in a state that bans abortion,” Prof. Donley began. “In some circumstances, the risk of liability will be so low that altering practice is likely unwarranted, but in other circumstances the risk is higher.”
Of note, if you live in a state that permits abortion, there’s no reason to change your practice because the legal risks remain unchanged. Prof. Donley touched on three theoretical legal risks.
1. Prescribing Abortifacients
“If you accidentally cause an abortion by prescribing an abortifacient (e.g., methotrexate) for another use in a person who is unknowingly pregnant or later becomes pregnant, are you criminally liable under abortion bans?” Prof. Donley asked.
Thankfully, prescribing methotrexate for another use (e.g., arthritis, not abortion) in states that ban abortion is a low risk activity because abortion is typically defined with reference to intent, she said. Thus, when you prescribe methotrexate for a purpose other than abortion, you aren’t performing an abortion under law.
“Of note, the risk increases substantially if you prescribe methotrexate to a patient who you know is pregnant [because] intent to abort could be inferred,” she said.
2. Counseling on Abortion
“If a pregnant patient’s health deteriorates, their fetus has an anomaly or they otherwise want an abortion, are you illegally ‘aiding and abetting’ an abortion if you provide counseling on abortion options?” Prof. Donley asked.
Unfortunately, this situation could be a higher-risk activity depending on a particular state’s laws unless an abortion exception is met. Example: Providers may be liable for counseling patients on abortion in Texas.5
“More states are likely to follow suit,” she said.
3. Prescribing Teratogens
“Does prescribing teratogens to women of reproductive age who may become pregnant and can no longer access abortion care increase your liability if the fetus is born with an anomaly?” Prof. Donley asked.
Abortion bans don’t change the medical malpractice risk associated with prescribing teratogens, but they may increase the likelihood that your patient won’t be able to access abortion and subsequently have a child with a disability. To reduce liability risks before prescribing a teratogen, Prof. Donley recommended counseling the patient on the risks of fetal anomalies associated with the drug and the importance of effective contraception. If your patient wants to become pregnant or becomes pregnant, immediately replace their medication with a safer option when possible.
In conclusion, Prof. Donley spoke to the fact that, sometimes, the law may create a legal risk that asks you to violate your ethical duties to your patient or your conscience. In situations such as these, “It’s important to consider that, practically speaking, rheumatologists aren’t the target of the anti-abortion movement,” Prof. Donley said. “Rather, prosecutors are laser focused on ‘repeat offenders’—abortion funds and organizations that are helping thousands of women find an out-of-state clinic or buy medication online [to induce an] abortion. The practical risks here are fairly low, and for many, the ethical duties will outweigh the legal risks in this context.”
Samantha C. Shapiro, MD, is the executive editor of Harrison’s Principles of Internal Medicine. As a clinician educator, she practices telerheumatology and writes for both medical and lay audiences.
References
- Dobbs, State Health Officer of the Mississippi Department of Health, et al. v. Jackson Women’s Health Organization et al. U.S. Supreme Court. 2022 Jun 24.
- Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. Arthritis Rheumatol. 2020 Apr;72(4):529–556.
- Data & statistics on birth defects. Centers for Disease Control and Prevention. 2020 Oct 26 (last reviewed).
- Dugas C, Slane VH. Miscarriage. [Updated 2022 Jun 27]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan.
- Arey W, Lerma K, Beasley A, et al. A preview of the dangerous future of abortion bans—Texas Senate Bill 8. N Engl J Med. 2022 Aug 4;387(5):388–390.
