Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
September 7, 2016
Health Canada has issued new restrictions concerning the use of isotretinoin. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Behaviour changes and suicidal thoughts: Some people taking this medication have experienced depression, including thoughts of suicide. If you experience any behaviour change or symptoms such as sad mood, hopelessness, feelings of guilt, loss of pleasure or interest in activities, changes in sleep pattern, irritability, or restlessness while taking this medication, contact your doctor immediately.
If you are at risk for developing depression or have a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Family members or caregivers of people who are taking this medication should contact the person's doctor immediately if they notice unusual behaviour changes.
Blood donation: You should not give blood during treatment with isotretinoin and for one month after stopping treatment in case the blood is given to a pregnant woman.
Bones and joints: Isotretinoin may cause some minor bone changes. Talk to your doctor if you notice aches or pains in the bones or joints, or have difficulty moving. Your doctor may monitor you for bone changes while you are taking this medication.
Cholesterol: Isotretinoin can cause increases in cholesterol and other lipids in the blood. If you are already at an increased risk of developing high cholesterol, for example if you have a family history of high cholesterol, diabetes, are overweight, or have an increased alcohol intake, you are more likely to experience this.
If you are at any increased risk of developing increased blood lipids, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Diabetes: Isotretinoin may cause a loss of control of blood sugar levels for people with diabetes. If you have diabetes, or anyone in your family has diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to check your blood glucose levels more often.
Inflammatory Bowel Disease: This medication may cause irritation in the digestive system. If you experience stomach pain, rectal bleeding or diarrhea, contact your doctor immediately.
Liver disease: Several cases of hepatitis (inflammation of the liver) have been reported that are considered to be possibly or probably related to isotretinoin therapy.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Neurologic: Isotretinoin has been linked to causing intracranial hypertension, also known as pseudotumor cerebri. Early symptoms of this condition include headache, nausea, vomiting, and visual disturbances. If you have these symptoms call your doctor immediately.
Night vision: Decreased night vision has been reported during isotretinoin therapy. Because some patients experience sudden onset of vision problems, use caution when driving or operating any vehicle at night. Report any vision changes to your doctor.
Pancreatitis: Isotretinoin can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Report signs of pancreatitis such as abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, or swollen abdomen to your doctor immediately.
If you have a history of pancreatitis, gallstones, alcoholism, or high triglycerides, you may be more at risk of experiencing this.
Skin care: Isotretinoin causes irritated, dry skin and lips. Ask your doctor or pharmacist for appropriate moisturizers and lip balms to use to prevent severe dryness. While you are taking isotretinoin, avoid exfoliators, waxing and dermabrasion, or laser procedures.
Sun sensitivity: Isotretinoin may make you more likely to burn in the sun. Use appropriate measures to prevent excessive exposure to the sun. These include wearing a hat and sunglasses when out in the sun, using a sunscreen that provides an SPF of 15 or more, and avoiding going out in the sun between 10 am and 2 pm when the sun is at its strongest.
Vitamin supplements: You should not take vitamin supplements containing vitamin A if you also take isotretinoin as this may increase the side effects of vitamin A. Talk to your doctor or pharmacist if you are not sure which of your supplements might contain vitamin A.
Pregnancy: Isotretinoin causes severe birth defects in an extremely high percentage of infants born to women who take this medication even for a short period of time during pregnancy.
Isotretinoin must not be used during pregnancy. Women must not become pregnant while taking isotretinoin or for at least one month after stopping the medication. Your doctor may routinely perform pregnancy tests while you are taking isotretinoin to confirm the safety of continuing to take this medication.
Women who may become pregnant must not be given isotretinoin until pregnancy is excluded. A pregnancy test must be performed within 11 days of starting treatment. Isotretinoin treatment should start on the second or third day of the next normal menstrual period following this negative pregnancy test. Effective birth control must be used for at least one month before starting isotretinoin treatment, during the treatment, and for at least one month following the discontinuation of treatment.
Two reliable forms of birth control should be used at the same time during treatment unless abstinence is the chosen method.
Breast-feeding: It is not known if isotretinoin passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Because of the potential for side effects, women should consider not breast-feeding if they take isotretinoin.
Children: The long-term safety of using this medication have not been established for children under 12 years of age.
Seniors: The use of isotretinoin by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from this medication.