Isotretinoin is the active ingredient in a prescription drug available under the brand names Sortret, Zenatane, Myorisane, Claravis, Amnesteem, and Absorica.
Doctors prescribe isotretinoin to treat a severe form of acne called recalcitrant nodular or cystic acne.
The Food and Drug Administration (FDA) originally approved isotretinoin as the brand name Accutane in 1982. Hoffmann La Roche manufactured it.
Hoffmann La Roche stopped making Accutane in 2009, partly due to numerous class action lawsuits filed against the company for birth defects caused by the drug.
Today, women and men must agree to follow guidelines in iPLEDGE program before taking isotretinoin.
iPLEDGE requires that you and your doctor and pharmacist follow certain detailed steps to ensure your safety and prevent pregnancy while you are being treated with the drug.
Although requirements vary according to your gender and stage of life, iPLEDGE requires that people who are able to reproduce use two forms of birth control while taking isotretinoin.
Your doctor will enroll you in the iPLEDGE program. Then, before filling your prescription, your pharmacist will verify your enrollment and make sure you meet the program's requirements.
One major side effect of isotretinoin is that it dries tissues, causing dry skin, cracked lips, dry mucous membranes, and dry scalp.
It may thin hair or cause it to become dry, brittle, and fragile.
This happens because isotretinoin slows down or blocks the production and secretion of the body's on own natural oils.
According to anecdotal reports, isotretinoin may not only thin hair on the head but also on the face, causing a loss of eyelashes and eyebrows.
Some people may become bald.
Although hair may regrow a few months after stopping isotretinoin, some people report that it took several years.
Others say isotretinoin caused permanent hair loss.
The FDA has issued two black-box warnings for isotretinoin.
One requires anyone taking it comply with the iPLEDGE program.
The second bans isotretinoin from being prescribed to women who are either pregnant or are able to become pregnant.
The FDA also cautions people who use isotretinoin that it can cause serious skin reactions, some of which can be life threatening.
You should not take isotretinoin if you are:
Talk to your doctor before taking isotretinoin if you have:
Isotretinoin can cause severe birth defects and miscarriages. It should never be taken during pregnancy.
Isotretinoin passes into breast milk, so it also isn't safe to take while breastfeeding.