© Dr. Michael D. Jacobson, D.O. Do not reproduce this article without permission.
Editor’s note: This information was published in the July 2018 issue of Heartfelt Magazine, CHM’s monthly magazine that provides CHM membership-related tips and tricks, medical advice from doctors, testimonies from CHM members, and more. Please refer to the CHM Guidelines and applicable web pages for the most up-to-date information regarding CHM membership, sharing eligibility, and ministry news. Read part 1 and part 2.
Isotretinoin is a synthetic (manufactured in a chemical laboratory) derivative of vitamin A (a group of vitamins collectively known as retinoids, including retinol, retinal, retinoic acid and retinyl esters) and therefore is named 13-cis-retinoic acid.
It’s used for severe, cystic (nodular) acne unresponsive to conservative treatment. It appears to work principally through regulating the proliferation of skin cells and by blocking sebaceous glands from thickening (keratinization) and producing sebum.
Supplied as a capsule and available in dosages ranging from 10 to 40 milligrams, isotretinoin is taken by mouth twice daily with meals. The treatment course usually lasts four to five months, but may be discontinued earlier if the total number of cysts has been reduced by at least 70 percent. In some cases a second course of therapy is necessary.
It’s extremely effective, which begs the question of why it’s only used as a “last resort” for severe acne. The answer: It is one of the most toxic drugs on the market.
As one of the relatively few medications in pregnancy category X, isotretinoin is a proven teratogen (it can cause severe birth defects) and is an abortifacient (it can end a pregnancy).
In fact, it’s so toxic that isotretinoin can only be marketed through a special, centralized and restricted risk management and distribution program. Known as iPLEDGE, this FDA-approved program is specifically designed “to help ensure that fetal exposure does not occur” through scrutinizing prescribers (who must be registered and activated) before they can prescribe isotretinoin.
Even then, doctors can only prescribe isotretinoin through iPLEDGE-registered pharmacies to patients who have registered with iPLEDGE and met all its requirements. iPLEDGE restricts prescriptions to a 30-day supply with no refills allowed for female patients until verifying that they aren’t pregnant and are taking contraception.
Breastfeeding mothers and children under age 13 aren’t permitted to take isotretinoin. Patients also cannot donate blood until at least one month after the drug was last ingested.
In addition to birth defects, isotretinoin has been associated with a number of other possible adverse effects:
- Depression, suicidal tendencies and other serious mental problems. Patients on isotretinoin have been known to become depressed and even take their own lives. However, it’s unclear if these effects are due to the medication itself or due to other factors, such as the social stigma and poor self-image that can be associated with severe acne.
- Pseudotumor cerebri, a condition caused by increased pressure on the brain (also associated with taking tetracycline), is accompanied by such symptoms as headache, nausea, vomiting and visual disturbances.
- Severe pancreatitis or hepatitis
- Abnormal, elevated cholesterol levels: Patients are at greater risk from a personal or family history of lipid disorders, obesity or diabetes.
- Inflammatory bowel disease
- Musculoskeletal problems including joint pains, bony deposits, early closure of bone growth plates (epiphyses), osteoporosis and osteopenia (thinning of the bone) and fractures. Therefore, participation in high- or repetitive-impact sports is discouraged while taking isotretinoin.
- Hearing impairment or tinnitus as well as opacities of the cornea (eye), cataracts, decreased night vision (therefore, caution should be exercised while driving at night) and increased eye irritation to contact lens wearers.
- Serious allergic reactions to either the drug or to paraben (present in some formulations)
- Sensitivity to sunlight
- Possible reduction in red blood cells (anemia), platelets (thrombocytopenia) or white blood cells (neutropenia)
- The most common, less serious, adverse events include dry skin, chapped lips, dry eyes and dry nose, which may lead to nosebleeds.
- Finally, isotretinoin can interact with a number of other drugs, including steroids, oral contraceptives, phenytoin (Dilantin), St. John’s wort, tetracyclines and vitamin A.
To summarize isotretinoin in two words, they are “effective” and “dangerous!”
Whether to use isotretinoin should be decided carefully and prayerfully. If it was me or my child, I might consider it if the skin condition was severe enough, but only after I had first exhausted every other reasonable option.*
Principal source: DynaMed [Internet]. Ipswich (MA): EBSCO Information Services. 1995 - 2017. Record No. 115279, Acne; [updated 2017 Jun 27, cited 2017 Dec 10]; [about 17 screens]. Available from http://search.ebscohost.com/login.aspx?direct=true&db=dnh&AN=115279&site=dynamed-live&scope=site. Registration and login required.
*CHM generally doesn’t share bills for acne treatment. For more information, see Guideline T.1.