Failure to prescribe correct dosage and duration
A 25-year-old man came to a dermatology practice for treatment of cystic acne on the face, back, and chest. The patient had a history of two isotretinoin treatments in the past 10 years.
Failure to prescribe correct dosage and duration
A 25-year-old man came to a dermatology practice for treatment of cystic acne on the face, back, and chest. The patient had a history of two isotretinoin treatments in the past 10 years.
Presentation
On January 20, a 25-year-old man came to a dermatology practice for treatment of cystic acne on the face, back, and chest. The patient weighed 130 pounds, had a history of two isotretinoin treatments in the past ten years, and had undergone a laser-assisted in situ keratomileusis (LASIK) procedure seven years earlier.
Physician action
Dermatologist A noted abnormal findings of acne vulgaris to the face and upper body, comedones, and inflammatory lesions. The physician prescribed sarecycline daily, topical adapalene and benzoyl peroxide topical in the morning, and tazarotene at night.
Two months later, on March 19, the patient returned for a follow-up appointment. Though his acne had improved, the patient expressed interest in starting isotretinoin therapy. Dermatologist A warned about it being a high-risk medication and educated the patient on the side effects and contraindications.
On April 15, the patient returned to the dermatology practice requesting isotretinoin treatment. Physician Assistant A documented that the patient had extensive scarring, comedones, and inflammatory lesions, and prescribed daily isotretinoin of 40 mg orally.
One month later, Physician Assistant B saw the patient for his first isotretinoin follow-up appointment. While his acne was improving, it remained on the face, chest, and back in the form of mild inflammatory papules. The patient reported dry lips and skin, and Physician Assistant B noted xerosis on the head and face. The patient’s lab results were within normal limits, other than a slightly elevated total cholesterol.
Physician Assistant A and Physician Assistant B continued to see the patient for his monthly follow-up appointments during which he reported dry lips and skin. His acne was improving and was now localized to the face only. The patient was instructed to continue the current prescription based on the lab results being within normal limits except for hemoglobin of 10.8 g/dL; total cholesterol of 215 mg/dL; and LDL cholesterol of 140 mg/dL.
The patient was advised that he could stop isotretinoin in month six or month nine, per his request. It was documented that the patient wanted to continue the medication. During the patient’s seven-month visit on December 14, he reported eye irritation and dryness as well as dry skin and lips. Isotretinoin was continued after lab results showed no significant changes.
During the following month’s appointment, isotretinoin was discontinued, post-isotretinoin instructions were given, and the patient did not return to the dermatology practice.
Later that year, the patient was seen by an ophthalmologist for treatment of dry eyes and ocular neuropathic pain.
Allegations
A lawsuit was filed against the dermatology practice alleging that the patient’s treatment duration and dosage of isotretinoin exceeded the manufacturer’s recommendations, causing subsequent chronic dry eye, meibomian gland dysfunction, dry eye syndrome of bilateral lacrimal glands, and corneal neuralgia.
Legal implications
The Prescribers’ Digital Reference recommends isotretinoin be administered orally at 0.5 to 1 mg per kilogram of weight, in two doses per day over 15 to 20 weeks or until the total cyst count decreases by 70 percent. It was noted that adult patients with severe scarring or acne may require dosages up to 2 mg per kilogram a day.1 While the patient’s dosage was calculated according to this formula, the plaintiff’s expert claimed that other variables such as the patient’s metabolic rate should be considered when deciding on the dosage.
Dermatologists who reviewed this case for the defense were supportive of the defendants’ actions. However, there was concern about whether the treatment duration was appropriate, with one dermatologist stating that treatment with isotretinoin therapy should be stopped after six months to evaluate the skin condition.
Dry eye is a known side effect of LASIK, which the patient had undergone a few years before his isotretinoin treatment. The patient’s treating ophthalmologist could not state definitively whether the patient’s dry eye condition was due to LASIK or isotretinoin. He suggested that the nerves could have been sensitized from LASIK, then the dryness caused by isotretinoin could have triggered neuropathic pain.
An ophthalmologist reviewing this case for the defense shared this opinion and added that chronic dry eye due to isotretinoin is very rare and that there are no scientific or peer-reviewed studies that associate isotretinoin with defects of lacrimal glands.
Disposition
The case was settled on behalf of the dermatology practice.
Source
- Prescribers’ Digital Reference. Isotretinoin. Available at https://www.pdr.net/browse-by-drug-name?search=isotretinoin. Last accessed on August 28, 2026.
Risk management for dermatologists
Disclaimer
Presentation
On January 20, a 25-year-old man came to a dermatology practice for treatment of cystic acne on the face, back, and chest. The patient weighed 130 pounds, had a history of two isotretinoin treatments in the past ten years, and had undergone a laser-assisted in situ keratomileusis (LASIK) procedure seven years earlier.
Physician action
Dermatologist A noted abnormal findings of acne vulgaris to the face and upper body, comedones, and inflammatory lesions. The physician prescribed sarecycline daily, topical adapalene and benzoyl peroxide topical in the morning, and tazarotene at night.
Two months later, on March 19, the patient returned for a follow-up appointment. Though his acne had improved, the patient expressed interest in starting isotretinoin therapy. Dermatologist A warned about it being a high-risk medication and educated the patient on the side effects and contraindications.
On April 15, the patient returned to the dermatology practice requesting isotretinoin treatment. Physician Assistant A documented that the patient had extensive scarring, comedones, and inflammatory lesions, and prescribed daily isotretinoin of 40 mg orally.
One month later, Physician Assistant B saw the patient for his first isotretinoin follow-up appointment. While his acne was improving, it remained on the face, chest, and back in the form of mild inflammatory papules. The patient reported dry lips and skin, and Physician Assistant B noted xerosis on the head and face. The patient’s lab results were within normal limits, other than a slightly elevated total cholesterol.
Physician Assistant A and Physician Assistant B continued to see the patient for his monthly follow-up appointments during which he reported dry lips and skin. His acne was improving and was now localized to the face only. The patient was instructed to continue the current prescription based on the lab results being within normal limits except for hemoglobin of 10.8 g/dL; total cholesterol of 215 mg/dL; and LDL cholesterol of 140 mg/dL.
The patient was advised that he could stop isotretinoin in month six or month nine, per his request. It was documented that the patient wanted to continue the medication. During the patient’s seven-month visit on December 14, he reported eye irritation and dryness as well as dry skin and lips. Isotretinoin was continued after lab results showed no significant changes.
During the following month’s appointment, isotretinoin was discontinued, post-isotretinoin instructions were given, and the patient did not return to the dermatology practice.
Later that year, the patient was seen by an ophthalmologist for treatment of dry eyes and ocular neuropathic pain.
Allegations
A lawsuit was filed against the dermatology practice alleging that the patient’s treatment duration and dosage of isotretinoin exceeded the manufacturer’s recommendations, causing subsequent chronic dry eye, meibomian gland dysfunction, dry eye syndrome of bilateral lacrimal glands, and corneal neuralgia.
Legal implications
The Prescribers’ Digital Reference recommends isotretinoin be administered orally at 0.5 to 1 mg per kilogram of weight, in two doses per day over 15 to 20 weeks or until the total cyst count decreases by 70 percent. It was noted that adult patients with severe scarring or acne may require dosages up to 2 mg per kilogram a day.1 While the patient’s dosage was calculated according to this formula, the plaintiff’s expert claimed that other variables such as the patient’s metabolic rate should be considered when deciding on the dosage.
Dermatologists who reviewed this case for the defense were supportive of the defendants’ actions. However, there was concern about whether the treatment duration was appropriate, with one dermatologist stating that treatment with isotretinoin therapy should be stopped after six months to evaluate the skin condition.
Dry eye is a known side effect of LASIK, which the patient had undergone a few years before his isotretinoin treatment. The patient’s treating ophthalmologist could not state definitively whether the patient’s dry eye condition was due to LASIK or isotretinoin. He suggested that the nerves could have been sensitized from LASIK, then the dryness caused by isotretinoin could have triggered neuropathic pain.
An ophthalmologist reviewing this case for the defense shared this opinion and added that chronic dry eye due to isotretinoin is very rare and that there are no scientific or peer-reviewed studies that associate isotretinoin with defects of lacrimal glands.
Disposition
The case was settled on behalf of the dermatology practice.
Source
- Prescribers’ Digital Reference. Isotretinoin. Available at https://www.pdr.net/browse-by-drug-name?search=isotretinoin. Last accessed on August 28, 2026.
Risk management for dermatologists
Disclaimer
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