Isotretinoin treats acne effectively, but the side effects can be serious.
Most acne treatments have little effect on severe acne, but isotretinoin can work when others fail.
One treatment typically lasts 4-5 months, after which about 85% of patients see permanent clearing.
However, isotretinoin can cause serious side effects, including teratogenicity, which causes birth defects, and hyperlipidemia, leading to liver problems.
Strict monitoring and regular lab tests
Before and during treatment with isotretinoin, patients must undergo a blood test, and women of childbearing age need two negative pregnancy tests before the drug can be prescribed.
In addition, the patient must agree to the strict terms of the iPLEDGE program, including seeing the dermatologist every 30 days and continuing to take regular medical and pregnancy tests to ensure safety.
The package insert for isotretinoin recommends repeated testing for lipids and liver function at weekly or biweekly intervals until "the response has been established."
Prior studies have looked at the usefulness of laboratory monitoring during isotretinoin therapy.
In this meta-analysis, Dr. Joslyn Kirby - of the Penn State Milton S. Hershey Medical Center in Hershey, PA - and coauthors estimated changes in laboratory tests during isotretinoin therapy. They evaluated results for lipid levels, liver function and complete blood cell counts.
Isotretinoin users not a high-risk group
The 26 studies, from around the world, reviewed clinicals trial from the period 1960-2013, involving doses of 40 mg/d or more of oral isotretinoin for at least 4 weeks; all the studies involved 10 or more participants, aged 9-35 years, with acne vulgaris. In total, there were 1,574 patients.
Results suggest that while isotretinoin was associated with a change in the average value of some laboratory tests - specifically white blood cell count and hepatic and lipid panels - the average change across a patient group did not meet the criteria for being high risk, and the proportion of patients with laboratory abnormalities was low.
The authors note some limitations, including not having access to specific information about patients or treatment, so that specific laboratory changes could not be correlated with doses or dose changes.
They conclude that "the evidence from this study does not support monthly laboratory testing for use of standard doses of oral isotretinoin for the standard patient with acne."
The team suggests that:
"Less frequent laboratory monitoring may be safe, with few missed high-risk laboratory changes, for many patients with acne who are receiving typical doses of isotretinoin."
This, they say, could help to decrease health care spending and blood sampling, which can cause anxiety.
Earlier this year, Medical News Today reported on research showing that many patients with acne fail to pick up their medications.