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 Clarus (Isotretinoin).
HEALTH CANADA ADVISORY
September 7, 2016
Health Canada has issued new restrictions concerning the use of Clarus (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 Clarus (Isotretinoin) 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 Clarus (Isotretinoin), contact your doctor immediately.
If you are at risk for developing depression or have a history of depression, discuss with your doctor how Clarus (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clarus (Isotretinoin), and whether any special monitoring is needed.
Family members or caregivers of people who are taking Clarus (Isotretinoin) should contact the person's doctor immediately if they notice unusual behaviour changes.
Birth Control: Clarus (Isotretinoin) causes birth defects in a large percentage of babies born to women who take Clarus (Isotretinoin) during pregnancy. Clarus (Isotretinoin) interacts with hormonal birth control (i.e., birth control pills), making it very important that women of childbearing age use an additional type of birth control.
Two reliable forms of birth control should be used at the same time during treatment unless abstinence is the chosen method.
Blood donation: You should not give blood during treatment with Clarus (Isotretinoin) and for one month after stopping treatment in case the blood is given to a pregnant woman.
Bones and joints: Clarus (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 Clarus (Isotretinoin).
Cholesterol: Clarus (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 Clarus (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clarus (Isotretinoin), and whether any special monitoring is needed.
Diabetes: Clarus (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 Clarus (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clarus (Isotretinoin), and whether any special monitoring is needed. You may need to check your blood glucose levels more often.
Inflammatory Bowel Disease: Clarus (Isotretinoin) 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 Clarus (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: Clarus (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 Clarus (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: Clarus (Isotretinoin) can cause the pancreas to become inflamed. If you have a history of pancreatitis, discuss with your doctor how Clarus (Isotretinoin) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Clarus (Isotretinoin), 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: Clarus (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 Clarus (Isotretinoin), avoid exfoliators, waxing and dermabrasion, or laser procedures.
Skin rash: Clarus (Isotretinoin) may cause skin rash or itchiness. Rarely, people taking Clarus (Isotretinoin) experience a severe skin reaction that can be life threatening. If you experience a rash that gets worse, or develops into blisters, sores on the lips or eyes, or covers a large area of the body, contact your doctor immediately.
Sun sensitivity: Clarus (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 Clarus (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: Clarus (Isotretinoin) causes severe birth defects in an extremely high percentage of infants born to women who take Clarus (Isotretinoin) even for a short period of time during pregnancy.
Clarus (Isotretinoin) must not be used during pregnancy. Women must not become pregnant while taking Clarus (Isotretinoin) or for at least one month after stopping the medication. Your doctor will perform monthly pregnancy tests while you are taking Clarus (Isotretinoin) to confirm the safety of continuing to take Clarus (Isotretinoin).
Women who may become pregnant must not be given Clarus (Isotretinoin) until pregnancy is excluded. A pregnancy test should be performed when you first see your doctor. A second pregnancy test must be performed within 11 days of starting treatment. Clarus (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 Clarus (Isotretinoin) treatment, during the treatment, and for at least one month following the discontinuation of treatment.
Breast-feeding: It is not known if Clarus (Isotretinoin) passes into breast milk. If you are a breast-feeding mother and are taking Clarus (Isotretinoin), 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 Clarus (Isotretinoin).
Children: The long-term safety of using Clarus (Isotretinoin) have not been established for children less than 12 years of age.
Seniors: The use of Clarus (Isotretinoin) by seniors has not been well studied. It is likely that seniors would be at an increased risk for side effects from Clarus (Isotretinoin).
