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Isotretinoin Long Term Side Effects

isotretinoin long term side effects

Introduction

Accutane is a brand-name version of the drug isotretinoin. The brand is no longer available in the United States. However, the generic version of isotretinoin and other brand-name versions, such as Absorica, are still available.

Isotretinoin is used to treat a type of severe acne called nodular acne. Nodular acne causes red, swollen, tender lumps to form in the skin. If untreated, nodular acne can lead to permanent scarring.

Your doctor will only prescribe isotretinoin when other treatments, including antibiotics, haven’t helped your nodular acne. While isotretinoin can help treat nodular acne, it can also cause many side effects. Some of these effects can be serious, especially if the drug is taken during pregnancy.

What is isotretinoin?

Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.

Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.

Isotretinoin is available only from a certified pharmacy under a special program called iPLEDGE.

Isotretinoin may also be used for purposes not listed in this medication guide.

Important Information

Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use isotretinoin if you are pregnant or may become pregnant.

You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.

Before taking this medicine

Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.

You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.

Primary forms of birth control include:

  • tubal ligation (tubes tied);
  • vasectomy of the male sexual partner;
  • an IUD (intrauterine device);
  • estrogen-containing birth control pills (not mini-pills); and
  • hormonal birth control patches, implants, injections, or vaginal ring.

Pregnancy warning

If you’re a female who is pregnant or trying to become pregnant, you must avoid using isotretinoin. Taking isotretinoin during pregnancy carries an extremely high risk of severe birth defects. This is true if the drug is used in any amount and even for short periods of time.

If you become pregnant during treatment with isotretinoin, stop taking the drug right away. A gynecologist can then give you further evaluation and counseling.

Isotretinoin can cause birth defects such as:

  • abnormalities of the face, eyes, ears, and skull
  • problems with the central nervous system, cardiovascular system, and thymus and parathyroid glands
  • reduced IQ

Miscarriages and premature births have also been reported with use of isotretinoin.

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