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Precautions and Warnings With Isotretinoin

Talk to your healthcare provider about precautions and warnings with isotretinoin before starting treatment to discuss possible side effects or complications that may occur. For example, make sure your healthcare provider is aware of any other medical conditions you may have (such as depression or liver disease), as they may become worse with isotretinoin. Warnings and precautions also include potential drug interactions and allergic reactions.

What Should I Tell My Healthcare Provider Before Taking Isotretinoin?

You should talk with your healthcare provider prior to taking isotretinoin (Accutane®, Absorica™, Amnesteem™, Claravis™, Sotret®) if you have:
 
Also, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
     
Make sure to tell your healthcare provider about any other medicines you are taking, including prescription and non-prescription medicines, vitamins, and herbal supplements.
 

Specific Precautions and Warnings With Isotretinoin

Some warnings and precautions to be aware of prior to taking isotretinoin include the following:
 
  • This medication is likely to cause severe birth defects if it is taken during pregnancy. It is absolutely essential that you not take isotretinoin while pregnant, and you should not get pregnant while taking it (or for one month after stopping the medication). Isotretinoin may also increase the risk of miscarriages and premature birth (see Accutane and Pregnancy or Absorica and Pregnancy for more information).
     
  • There are strict rules for isotretinoin prescriptions, especially for women of childbearing potential. Such women must use two reliable forms of birth control and must have a negative pregnancy test (done at a lab) every month. No one (male or female) can get more than 30 days' worth of isotretinoin at a time, and you must sign consent forms. Each prescription must be authorized using the iPLEDGE program (your healthcare provider will do this for you) before your pharmacy can fill it, and you must get your prescription within seven days of the authorization.
     
  • Isotretinoin can cause depression, psychosis, or suicidal behavior. Make sure to let your healthcare provider know if you have had such problems in the past, or even if any of your family members has had such problems. It is important for you and those around you to watch for any mood or mental changes that could indicate a problem, such as:
 
    • A sad mood
    • Hopelessness
    • Feelings of guilt, worthlessness, or helplessness
    • Loss of pleasure or interest in activities
    • Fatigue
    • Difficulty concentrating
    • Changes in sleep pattern
    • Changes in weight or appetite
    • Suicidal thoughts or attempts
    • Restlessness or irritability
    • Acting on dangerous impulses
    • Hallucinations or delusions.
 
  • Isotretinoin can cause pseudotumor cerebri, a condition involving high pressure inside the cranium. This seems to occur mostly when the medication is combined with tetracycline antibiotics (see Drug Interactions With Isotretinoin for more information). Let your healthcare provider know if you develop signs of this condition, such as:
 
 
  • Sometimes, isotretinoin causes high triglycerides, which could possibly increase your risk of heart disease, although this is not known for sure. Also, high triglycerides can increase your risk of pancreatitis, a dangerous condition of the pancreas. Your healthcare provider should test your triglycerides before you start taking this medication and periodically during the first month of treatment. If you cannot get your triglycerides under control, you will need to stop taking isotretinoin.
     
  • Some people have experienced hearing problems possibly due to isotretinoin. In some cases, these problems did not go away when the medication was stopped. Let your healthcare provider know right away if you develop any hearing changes.
     
  • Isotretinoin can cause hepatitis. High liver enzymes (found using a simple blood test) can be a sign of this problem. However, as many as 15 percent of people who take the medication will develop high liver enzymes, which often goes away during treatment, and high liver enzymes do not necessarily indicate a problem.
     
  • This medication may cause inflammatory bowel disease (ulcerative colitis or Crohn's disease). Let your healthcare provider know if you develop signs of these problems, such as:
 
 
  • In certain clinical trials, isotretinoin seemed to cause skeletal hyperostosis, a type of degenerative arthritis. If you develop back or joint pain while taking this drug, let your healthcare provider know.
     
  • Isotretinoin has been shown to decrease bone mineral density. This may increase the risk of osteoporosis, broken bones, and slow bone healing. This problem seems more common in people who take more than one course of isotretinoin.
     
  • If you experience vision changes while taking isotretinoin, you should stop taking the medication, get an eye exam, and let your healthcare provider know. This medication can cause poor night vision. While you don't need to stop taking isotretinoin for this problem, you may need to limit night driving.
     
  • Isotretinoin can potentially interact with a few other medications (see Drug Interactions With Isotretinoin).
     
  • You cannot donate blood or blood products while taking isotretinoin, or for one month after stopping the medication.

 

  • In rare cases, potentially life-threatening problems known as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) have been reported with isotretinoin. Let your healthcare provider know right away if you have signs or symptoms of such problems, such as a rash with blisters or with sores in the mouth or throat, especially if skin peeling occurs. 

 

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