Impact of Cevimeline and Hydroxychloroquine on Pregnancy Outcomes - Internal Medicine

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Took CEVIMELINE and HYDROXYCHLOROQUINE SULFATE?


Hello Doctor, I have Sjögren's syndrome, and I was unaware that I was pregnant.
My current weight is 65 kg.
During this time, I have been taking Cevimeline and Hydroxychloroquine sulfate.
For the first three weeks of pregnancy, I took one Cevimeline 30 mg capsule and one Hydroxychloroquine sulfate 200 mg tablet daily.
From weeks three to six, I took one Cevimeline capsule every other day and one Hydroxychloroquine sulfate tablet daily.
I am now a little over seven weeks pregnant.
I have stopped taking Cevimeline.
Since both of these medications are classified as Category C drugs, will this have any teratogenic effects on the fetus?

Danxin de ren, 30~39 year old female. Ask Date: 2018/06/20

Dr. Gao Jiankai reply Internal Medicine


Hello, thank you for your question.
Although hydroxychloroquine and cevimeline are classified as Category C medications during pregnancy, the likelihood of these drugs causing adverse effects on the fetus is quite low.
Additionally, for some rheumatology patients with severe conditions that make it difficult to discontinue medication, we still recommend continuing these medications during pregnancy.
Therefore, the safety profile of these drugs is quite high, and since you are taking a lower dosage, there is no need for excessive concern.
However, Sjögren's syndrome is a relatively mild rheumatic disease, and it may be worth considering temporarily discontinuing the medication during pregnancy to reduce the potential risk of adverse effects on the fetus while also minimizing the chance of disease flare-ups.
It is advisable to discuss this with your physician.
Best regards from the Allergy, Immunology, and Rheumatology Department of Changhua Hospital, Ministry of Health and Welfare.

Reply Date: 2018/06/20

More Info


The use of Cevimeline and Hydroxychloroquine during pregnancy, particularly in the context of Sjögren's syndrome, raises important considerations regarding fetal safety and potential outcomes. Both medications are classified as Category C drugs by the FDA, which indicates that while animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans. This classification suggests that the potential benefits of using these medications may outweigh the risks, especially in cases where the mother's health is at stake.

Cevimeline is primarily used to treat dry mouth associated with Sjögren's syndrome. Its mechanism of action involves stimulating salivary gland secretion, which can alleviate symptoms significantly. Hydroxychloroquine, on the other hand, is an antimalarial drug that is also used to manage autoimmune conditions, including lupus and Sjögren's syndrome. It has anti-inflammatory properties and can help control disease activity.

Regarding the specific concern about teratogenic effects (the potential to cause birth defects), the available data suggest that the risk is relatively low. Studies have indicated that Hydroxychloroquine does not appear to significantly increase the risk of congenital malformations when used during pregnancy. In fact, many rheumatologists recommend continuing Hydroxychloroquine during pregnancy for women with autoimmune diseases, as it can help maintain disease control and potentially prevent flares that could harm both the mother and the fetus.

Cevimeline, while less studied in pregnant populations, is generally considered to have a favorable safety profile. The limited data available do not suggest a strong association with adverse fetal outcomes. However, as with any medication, the decision to continue or discontinue use during pregnancy should be made in consultation with a healthcare provider, considering the severity of the mother's condition and the potential risks to the fetus.

In your case, since you have been taking these medications without prior knowledge of your pregnancy, it is crucial to discuss your situation with your obstetrician or a maternal-fetal medicine specialist. They can provide personalized advice based on your health status, the severity of your Sjögren's syndrome, and the current stage of your pregnancy. It is also important to monitor the pregnancy closely for any potential complications.

In summary, while both Cevimeline and Hydroxychloroquine are Category C medications, the evidence suggests that they may not pose significant risks to fetal development when used appropriately. The benefits of managing your Sjögren's syndrome effectively during pregnancy may outweigh the potential risks associated with these medications. Always consult with your healthcare provider to make informed decisions tailored to your specific health needs and circumstances.

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