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Acne vulgaris is a chronic inflammatory condition affecting the pilosebaceous unit. It is the most prevalent skin disorder, impacting nearly 85% of individuals aged between 12 and 14 years. Although acne vulgaris tends to resolve on its own over time, treatment is important to prevent scarring and potential psychological issues. Accutane, which received FDA approval in 1982, has long been considered the most effective therapy for severe acne. It is unique in its ability to suppress sebum production, offer long-term remission, and target all major factors involved in acne pathogenesis.
The standard recommended dosage for Accutane ranges from 0.5 to 1 mg/kg/day over the first 16 to 32 weeks, aiming for a cumulative dose of 120 mg/kg. While the side effects of Accutane are well-documented, there is limited data regarding their correlation with age, gender, and dosage. The objective of this study was to identify common side effects of Accutane and examine their associations with patient age, sex, and drug dosage.
Patients and their families were informed about potential side effects prior to treatment initiation. Throughout the treatment period, patients were evaluated monthly for possible side effects, and any new symptoms were discussed with them. The initial daily dose of Accutane was set at less than 0.5 mg/kg. During follow-up, 39 patients (27.7%) received doses under 0.5 mg/kg/day, while 102 patients (72.3%) were administered doses between 0.5 and 1.0 mg/kg/day. The goal for all patients was to achieve a cumulative dose of at least 120 mg/kg.
Before starting treatment, all patients underwent routine biochemistry, lipid profile, and hemogram tests, while female patients were additionally tested for beta-human chorionic gonadotropin. Patients with normal baseline blood tests were re-evaluated every two months, whereas those with abnormal initial results were tested monthly.
The study included 149 patients in total. Treatment was discontinued in two cases—one due to sacroiliitis and the other because of elevated liver enzymes. Additionally, six patients chose to stop treatment due to concerns about side effects, including epistaxis (2 cases), elevated liver enzymes (1 case), high lipid levels (1 case), severe dryness (1 case), and irritability (1 case). The remaining 141 patients continued treatment with regular monitoring until completion.
Of the 141 patients who completed the treatment, 106 (75.2%) were female and 35 (24.8%) were male. The patients’ ages ranged from 14 to 34 years, with an average of 20.9±4.7 years. Among them, 60 (42.6%) had acne localized only on the face, 69 (48.9%) had involvement of both the face and body, and 10 (7.1%) had acne affecting the face, body, and scalp. Additionally, 26 (18.4%) of the patients had a first-degree relative with a history of Accutane use.
During the six-month follow-up, complete recovery was observed in 127 (90.1%) patients, while 14 (9.9%) showed partial recovery, necessitating prolonged treatment. Since Accutane (13-cis-retinoic acid) is a vitamin A (retinol) analogue, many of its side effects resemble symptoms of hypervitaminosis A. Accutane has a half-life of 22 hours and a bioavailability of 25%, with plasma concentrations increasing when taken with food. To minimize side effects, it is recommended to administer the drug twice daily.
Side effects are generally categorized into mucocutaneous and systemic groups. Their frequency and severity, aside from teratogenic effects, are dose-dependent and can often be managed with supplementary treatments. These side effects usually reverse upon discontinuation of the medication. In cases of severe side effects, lower doses may be prescribed, though this approach requires a longer treatment duration to reach the cumulative dose goal. In our study, the daily dose was split into two administrations to reduce side effects, and the medication was given with meals to enhance absorption, as recommended.
Although 14 patients experienced only partial recovery, all others achieved complete remission. Among those with partial recovery, 11 had received higher doses (>0.5 mg/kg/day) of Accutane. Xeroderma and mucosal dryness were common, affecting more than half of the cases. Previous studies have reported xeroderma rates between 47% and 85%. In our study, xeroderma occurred in 66% of patients, with higher prevalence in those on higher doses. It was more common during winter and improved with the use of moisturizers and topical corticosteroids.
Symptoms such as burning and stinging sensations in the eyes, nasal dryness, nosebleeds, and dry mouth were frequently reported during Accutane treatment. In comparison to Gökalp’s findings, where 41.3% of patients experienced mucosal dryness and 28.7% had nosebleeds, our study found xerophthalmia and nosebleeds in 36.9% and 42.6% of patients, respectively. Xerophthalmia improved with artificial tears, while mild nosebleeds were managed with moisturizers. In male patients, reducing the dose to less than 0.5 mg/kg/day during summer appeared to improve treatment tolerance.
Approximately 6-8% of patients may experience an initial worsening of acne within the first six weeks of Accutane therapy, possibly due to the release of Propionibacterium acnes. In our study, 44% of patients experienced an initial flare, typically within the first 45 days of treatment. These episodes were generally mild and short-lived, and we did not adjust the drug dosage. In some cases, adding topical antibiotics helped alleviate symptoms.
Photosensitivity, particularly erythema on the face, may occur when treatment is administered during the summer. Çıkım and Seyhan reported a photosensitivity rate of 35.1% in their study. Our results showed photosensitivity in 44.7% of patients, especially those treated in the summer. These patients were advised to use sunscreen regularly to mitigate this side effect.
Arthralgia and myalgia are more common in patients taking Accutane, especially those engaging in intense physical activity. These symptoms are generally manageable with analgesic medications. Arthralgia, particularly back pain, is frequently reported. While acute arthritis may also occur, it is typically reversible; however, rare cases have been documented where symptoms persist for years after discontinuing treatment. Previous studies have often categorized back pain under arthralgia, but in our study, back pain was assessed separately. We found back pain in 41.1% of patients, arthralgia in 19.1%, and myalgia in 29.1%, with myalgia being more prevalent among female patients.
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Comparing patients on lower (<0.5 mg/kg/day) versus higher (≥0.5 mg/kg/day) doses, myalgia was more frequent in those on higher doses. Additionally, patients aged 21 and older experienced higher rates of myalgia compared to younger patients. To enhance tolerance, particularly in athletic individuals or those engaged in vigorous exercise, maintaining a lower drug dose is advisable.
Mild to moderate elevations in liver function tests have been observed in approximately 15% of patients. Hyperlipidemia is the most common laboratory abnormality associated with Accutane, occurring in up to 35% of cases. After completing cheap Accutane therapy, liver function tests and lipid levels generally return to normal within a few months. Routine blood tests are recommended before starting treatment and should be repeated every 1-2 months.
A reduction in dosage is advised if liver enzyme levels rise to 2-3 times the upper normal limit. If levels do not normalize despite dose reduction, discontinuation of the drug may be necessary. In our study, elevated total cholesterol and/or triglyceride levels were observed in 29 patients (20.6%). Only one patient experienced triglyceride levels more than double the normal range, which normalized after lowering the dose. Treatment was discontinued for one patient due to persistently elevated liver enzymes that did not improve with dose reduction. Mild liver enzyme elevations were noted in 11 patients (7.8%), and these cases were monitored more frequently. Ultimately, liver enzyme levels normalized following temporary dose adjustments.