From the Guidelines
Patients on Accutane (isotretinoin) should undergo regular laboratory monitoring, including lipid panels and liver function tests, with pregnancy tests for females of childbearing potential, as recommended by the most recent guidelines 1.
Laboratory Tests for Accutane Patients
The following laboratory tests are essential for patients on Accutane:
- Lipid panel, including cholesterol and triglycerides
- Liver function tests, including ALT and AST
- Pregnancy tests for females of childbearing potential These tests should be performed at baseline and repeated as necessary during treatment, typically monthly for the first two months and then every 3 months thereafter for lipid panels and liver function tests, and monthly for pregnancy tests.
Rationale for Laboratory Monitoring
Isotretinoin can cause significant elevations in triglycerides and cholesterol, potential liver toxicity, and is a known teratogen that causes severe birth defects 1. Therefore, regular laboratory monitoring is crucial to detect any potential adverse effects early and adjust treatment accordingly.
Additional Considerations
Some providers may also monitor complete blood count periodically, although this is not universally recommended 1. Blood glucose may occasionally be monitored as isotretinoin can rarely affect glucose metabolism.
Importance of Patient Compliance
Patients should be instructed to fast for 12 hours before lipid testing to ensure accurate results and to comply with the recommended laboratory monitoring schedule to minimize the risk of adverse effects and ensure the safe use of Accutane.
From the FDA Drug Label
Pregnancy Test - Patients who can become pregnant must have had two negative urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the initial isotretinoin prescription. Lipids Pretreatment and follow-up blood lipids should be obtained under fasting conditions. Liver Function Tests Since elevations of liver enzymes have been observed during clinical trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should be performed at weekly or biweekly intervals until the response to isotretinoin has been established Glucose Some patients receiving isotretinoin have experienced problems in the control of their blood sugar. CPK Some patients undergoing vigorous physical activity while on isotretinoin therapy have experienced elevated CPK levels;
The laboratory tests recommended for patients on Accutane (isotretinoin) include:
- Pregnancy tests: before starting treatment, and then monthly
- Lipid profiles: pretreatment and follow-up, under fasting conditions
- Liver function tests: pretreatment and follow-up, at weekly or biweekly intervals
- Glucose tests: to monitor blood sugar control
- CPK (creatine phosphokinase) tests: to monitor for muscle damage, especially in patients undergoing vigorous physical activity 2
From the Research
Laboratory Tests for Accutane Patients
The following laboratory tests are recommended for patients on Accutane (isotretinoin):
- Liver function tests, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3, 4, 5, 6
- Lipid profiles, including triglycerides and total cholesterol 3, 4, 5, 6
- Pregnancy tests for female patients 3
- Biotinidase activity, as isotretinoin may decrease biotinidase activity 7
- Complete blood count and coagulation profile, as part of a routine blood test 5
Frequency of Laboratory Monitoring
The frequency of laboratory monitoring for Accutane patients is variable among physicians, but studies suggest that:
- Monthly laboratory monitoring may not be necessary for all patients 6
- Patients with higher body weight may require more frequent laboratory monitoring due to a higher risk of laboratory abnormalities 6
- Patients with normal baseline labs may require less frequent laboratory monitoring 6
Laboratory Abnormalities
Studies have shown that Accutane can cause laboratory abnormalities, including: