Accutane Warnings and Precautions
Because of the potentially serious complications that can occur with Accutane, warnings and precautions for the drug should be reviewed before starting treatment. For instance, Accutane can cause birth defects if taken during pregnancy. This medication can also cause high triglycerides, high blood pressure in the head, and osteoporosis. Accutane warnings and precautions also include possible drug interactions and the risk of psychological problems.
What Should I Tell My Healthcare Provider Before Taking Accutane?You should talk with your healthcare provider prior to taking Accutane® (isotretinoin) if you have:
- Depression or any other mental illness
- High triglycerides
- Liver disease, such as liver failure, hepatitis, or cirrhosis
- Weak bones due to osteoporosis or other conditions
- Any allergies, including allergies to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
- Pregnant or thinking of becoming pregnant
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 Accutane Warnings and PrecautionsSome warnings and precautions to be aware of prior to taking Accutane include the following:
- This medication is likely to cause severe birth defects if it is taken during pregnancy. It is absolutely essential that you do not take Accutane while pregnant, and you should not get pregnant while taking the drug or for one month after stopping treatment. Accutane may also increase the risk of miscarriages and premature birth (see Accutane and Pregnancy for more information).
- There are strict rules for Accutane 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 Accutane 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.
- Accutane 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 have 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
- Feelings of guilt, worthlessness, or helplessness
- Loss of pleasure or interest in activities
- 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.
- This medication can cause pseudotumor cerebri, a condition involving high pressure inside the cranium. This seems to occur mostly when Accutane is combined with tetracycline antibiotics. Let your healthcare provider know if you develop signs of this condition, such as:
- Vision changes.
- Sometimes, Accutane 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 Accutane and periodically during the first month of treatment. If you cannot get your triglycerides under control, you will need to stop taking this drug.
- Some people have experienced hearing problems possibly due to Accutane. 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.
- Accutane 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 Accutane 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 rare cases, potentially life-threatening problems known as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) have been reported with Accutane. 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.
- In certain clinical trials, Accutane seemed to cause skeletal hyperostosis, a type of degenerative arthritis. If you develop back or joint pain during treatment, let your healthcare provider know.
- Accutane has been shown to decrease bone mineral density. This may increase the risk of osteoporosis, broken bones, and slow bone healing. This seems more common in people who take more than one course of Accutane.
- If you experience vision changes while taking Accutane, you should stop taking the medication, get an eye exam, and let your healthcare provider know. Accutane can cause poor night vision. While you don't need to stop taking the drug for this problem, you may need to limit night driving.
- Accutane can potentially interact with a few other medications (see Accutane Interactions).
- You cannot donate blood or blood products while taking Accutane, or for one month after stopping the medication.
- It is unknown if Accutane passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Accutane and Breastfeeding).