Accutane

Millions of Americans took Accutane (isotretinoin) to treat severe acne. Roche withdrew the brand name drug from the United States market in 2003. As of January 2019, the drug was still available in generic forms and under other brand names. It carries a black box warning for birth defects, and women must prove they are not pregnant before a pharmacist will give them the drug.

Accutane pills
Accutane Facts
  1. Uses To Treat Recalcitrant acne
  2. Active Ingredient Isotretinoin
  3. Manufacturer Hoffman-LaRoche
  4. Black Box Warning Birth defects

American researchers first studied isotretinoin in 1975. Drug makers created it to treat cancer, and it later became a drug to treat severe acne that does not respond to other medications.

The acne it treats consists of nodules with a diameter of 5 mm or greater. Having this type of acne can be socially debilitating, so the potential of a cure can be life-changing.

Accutane is a form of vitamin A and is a part of the class of medications called retinoids. It works by:
  • Reducing the size of oils glands in the skin and the amount of oil produced
  • Reducing the amount of bacteria in the skin
  • Slowing down the production of skin cells inside pores, preventing clogging of pores
  • Reducing skin inflammation

The drug “should be considered in patients who have failed traditional therapies and those who have scarring — both physical scarring in the skin and emotional or psychosocial scarring,” Dr. Joshua Zeichner, an assistant professor of dermatology at Mount Sinai Hospital, told Dermatology Times.

Side Effects and Pregnancy Risks

Isotretinoin is extremely effective at treating acne. But it also comes with many side effects. Some common side effects of Accutane may subside after initial treatment.

Dry skin, lips and eyes are common in patients who take the medication. This dryness can lead to nosebleeds and cracked or peeling skin. Some patients say staying hydrated can help ward off some of these side effects.

Less serious side effects include:
  • 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

Patients should also keep their skin protected from the sun because the medication causes skin to be highly sensitive to the sun.

Serious side effects linked to Accutane are similar to those seen in patients taking high doses of vitamin A. These include rashes, drowsiness, nausea, abdominal pain, vomiting and headaches. Chronic toxicity can lead to liver or kidney damage. Patients who suffer these side effects should speak to their doctors immediately.

Some studies linked the drug to digestive problems such as Crohn’s disease, ulcerative colitis and pancreatitis. Patients who take the drug have been known to become depressed, aggressive or violent, and some users committed suicide, though it is unclear whether isotretinoin caused mental health problems.

The medication also carries a black box warning for birth defects. And it may cause pseudotumor cerebri, a condition caused by increased pressure on the brain. Side effects led some people to file lawsuits against Roche.

Certain serious side effects are more likely to occur with longer exposure to the medicine. An eHealthMe review of 30,934 people who took the drug found inflammatory bowel disease became more common in patients who used the acne medication for six months or more. These results were based on reports received by the FDA from 1997 to 2018.

iPledge Pregnancy Prevention Program

Isotretinoin carries a high risk of miscarriage and deformities. Any fetus exposed during pregnancy can potentially be affected, according to the FDA. Because of this, women must prove they are not pregnant before they can take isotretinoin.

Diagram showing that women shouldn’t get pregnant
Example of pregnancy warning on Accutane packaging.

The FDA worked with Roche to create programs to ensure that the medication’s users were not and would not become pregnant. In 2005, a computer-based system called iPLEDGE replaced the flagship program SMART.

“The iPLEDGE Program requires registration of all wholesalers distributing isotretinoin, all healthcare professionals prescribing isotretinoin, all pharmacies dispensing isotretinoin, and all male and female patients prescribed isotretinoin,” according to the program’s website.

Women must test negative for pregnancy through approved labs before they can receive the medication each month. Prescriptions only cover 30 days at a time, and women who use the drug must use two methods of birth control.

Accutane has a lengthy list of drug interactions. Some are more serious than others. The medication label lists the most important interactions.

Accutane may interact with the following medications:
  • Vitamin A
  • Tetracyclines
  • Micro-dosed progesterone preparations
  • Norethindrone/ethinyl estradiol
  • Combination of St. John’s Wort and birth control
  • Phenytoin
  • Systemic corticosteroids

Recommended Dosage

Generic versions of Accutane use the same dosage chart as the brand-name drug. Recommended doses of isotretinoin range from 0.5 mg/kg to 1.0 mg/kg body weight per day. It comes in capsules of 10 mg, 20 mg and 40 mg.

Doctors recommend patients take the pill with a high-fat meal. Most patients use the drug for 15 weeks to 20 weeks and may repeat the treatment course if acne returns.

Overdose

Patients who overdose on the drug should call the poison control helpline. Anyone who overdoses on isotretinoin should not donate blood for at least a month after the overdose. It increases the risk of birth defects in people who receive the donated blood.

“Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist.”

Source: U.S. Food and Drug Administration

Women who suffer an overdose should take two forms of birth control for one month after the overdose, and men should use condoms or avoid sexual contact if their partner may become pregnant.

Additionally, the FDA warns against buying isotretinoin on the internet.

“Isotretinoin is a potentially dangerous prescription medicine that should only be taken under the close supervision of your healthcare professional and pharmacist,” the FDA said on its website. “Buying this product over the Internet bypasses important procedures to ensure that patients can take this drug safely.”

Please seek the advice of a medical professional before making health care decisions.

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Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for seven years. She specializes in fluoroquinolone antibiotics and products that affect women’s health such as Essure birth control, transvaginal mesh and talcum powder. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • American Medical Writers Association (AMWA) Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine
Edited By

12 Cited Research Articles

  1. Acne.org. (2018, December 21). Accutane (isotretinoin). Retrieved from https://www.acne.org/accutane.html#HowDoesAccutaneWork
  2. eHealthMe. (2019, January 17). Accutane side effects - from FDA reports. Retrieved from https://www.ehealthme.com/drug/accutane/side-effects/
  3. Fletcher, J. (2018, November 9). Hypervitaminosis A: What to know. Retrieved from https://www.medicalnewstoday.com/articles/322238.php
  4. iPLEDGE. (2016). About iPLEDGE. Retrieved from https://www.ipledgeprogram.com/iPledgeUI/aboutProgram.u
  5. Kronemyer, B. (2017, April 10). Isotretinoin still the best drug for acne. Retrieved from https://www.dermatologytimes.com/dermatology/isotretinoin-still-best-drug-acne
  6. Reddy, D. et al. (2006). Possible association between Isotretinoin and inflammatory bowel disease. Retrieved from http://www.nature.com/ajg/journal/v101/n7/abs/ajg2006292a.html
  7. U.S. Food and Drug Administration. (2010, October 22). Isotretinoin (marketed as Accutane) Capsule Information. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/isotretinoin-marketed-accutane-capsule-information
  8. U.S. Food and Drug Administration. (2010, May 21). Accutane. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18662s051lbl.pdf
  9. U.S. Food and Drug Administration. (2018, March 15). Isotretinoin (marketed as Accutane) Capsule information. Retrieved from https://www.fda.gov/Drugs/DrugSafety/ucm094305.htm
  10. U.S. National Library of Medicine. (2008). Accutane (isotretinoin) capsule, liquid filled. Retrieved from https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=8655#section-10.6
  11. U.S. National Library of Medicine. (n.d.) Isotretinoin. Retrieved from https://medlineplus.gov/druginfo/meds/a681043.html
  12. Wysowski, D.K. et al. (2001, October). An analysis of reports of depression and suicide in patients treated with isotretinoin. Journal of the American Academy of Dermatology. Retrieved from https://www.jaad.org/article/S0190-9622%2801%2928089-X/abstract
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