The original patent for Accutane expired in 2002. Held by Hoffmann-LaRoche until that time, it is perhaps now better known by its common name, isotretinoin, although over 100 trade names for the compound now exist. Isotretinoin was originally developed to treat cystic acne, and today this is still its primary use despite several more modern applications of the drug, including a treatment for pancreatic and brain cancers.

Isotretinoin is the 9-cis isomer of retinoic acid, a close relative of retinol, or vitamin A. First shown to be an effective treatment for acne in 1982, its development stemmed from advances in knowledge of the effects of vitamin A to reduce or eliminate sebum production. Since that time, however, several instances of deleterious effects became well known, most notably birth defects arising from the use of isotretinoin.
Accutane was removed from distribution by Roche in 2009 after several lawsuits had been filed alleging damages due to side effects, especially in young adult males due to inflammatory bowel disease (IBD).

Use

The primary use of Accutane (isotretinoin) was the treatment of acne. Its use as an acne treatment is generally limited to severe cases where lesions are at least 5mm in diameter and appear suppurative or hemorrhagic, or for inflammatory acne and acne conglobata. Less severe acne may be treated with isotretinoin if the patient has a history of dyspigmentation or scarring due to acne. Isotretinoin is generally a last course of treatment in these cases after all other routes have been explored. 

Additional uses for Accutane (isotretinoin) include treatments for keratinization such as lamellar ichthyosis, and keratosis follicularis (Darier’s disease) in addition to palmoplantar keratoderma and pityriasis rubra pilaris. It is also an effective treatment for severe rosacea and gram-negative folliculitis, and to treat hidradenitis suppurative.

 Interestingly, isotretinoin has been shown to significantly reduce inflammation associated with adjuvant arthritis in rats, although this has not been verified to be the case in humans.

Mechanism of Toxicity 

Direct studies focused on the environmental fate of Accutane (isotretinoin) are rare in the literature. The pure compound is insoluble in water, and highly lipophilic. Powders do not aerosolize readily, and volatilization is extremely low. Isotretinoin released into the environment would not be expected to have high mobility in water or soil, and will most likely become deposited in organic materials. 

Bioaccumulation is possible, but isotretinoin is readily oxidized to form other retinoids or metabolites that are expected to be mitigated via natural biological pathways.

Side effects

Isotretinoin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

red, cracked, and sore lips

dry skin, eyes, mouth, or nose

nosebleeds

changes in skin color

peeling skin on the palms of the hands and soles of the feet

changes in the nails

slowed healing of cuts or sores

bleeding or swollen gums

hair loss or unwanted hair growth

sweating

flushing

voice changes

tiredness

cold symptoms

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, stop taking isotretinoin and call your doctor or get emergency medical treatment immediately:

headache

blurred vision

dizziness

nausea

vomiting

seizures

slow or difficult speech

weakness or numbness of one part or side of the body

stomach pain

chest pain

difficulty swallowing or pain when swallowing

new or worsening heartburn

diarrhea

rectal bleeding

yellowing of the skin or eyes

dark colored urine

back, bone, joint or muscle pain

muscle weakness

difficulty hearing

ringing in the ears

vision problems

painful or constant dryness of the eyes

unusual thirst

frequent urination

trouble breathing

fainting

fast or pounding heartbeat

red, swollen, itchy, or teary eyes

fever

rash

peeling or blistering skin, especially on the legs, arms, or face

sores in the mouth, throat, nose, or eyes

red patches or bruises on the legs

swelling of the eyes, face, lips, tongue, throat, arms, hands, feet, ankles, or lower legs

difficulty swallowing or pain when swallowing

Isotretinoin may cause the bones to stop growing too soon in teenagers. Talk to your child's doctor about the risks of giving this medication to your child.

Isotretinoin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.