"A US Food and Drug Administration (FDA) advisory panel has backed a new biologic for psoriasis, though the panelists recommended strong warnings about the potential for suicide and self-injurious behavior (SIB) with the drug.
Soriatane Consumer (continued)
You may experience more redness, itching, skin scaling, peeling and dry skin the first several weeks as your body adjusts to the medication. Dry eyes, eye irritation, crusting of the eye lids, increased sensitivity to sunlight, dry mouth, peeling of the skin of fingertips, palms or soles of feet, chapped lips, runny nose, thirst, taste changes and hair loss may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Contact lens wearers may be uncomfortable while taking this drug because it causes dry eyes.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: decreased night vision, fever, chills, dizziness, aches and pain in the bones or joints, muscle pain/tenderness/weakness, difficulty moving, swelling, sudden weight gain, change in the amount of urine.
Get medical help right away if you have any very serious side effects, including: mood changes (e.g., depression, aggressive or violent behavior, and in rare cases thoughts of suicide).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Soriatane (acitretin) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking acitretin, tell your doctor or pharmacist if you are allergic to it; or to vitamin A-related drugs (other retinoids such as isotretinoin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, heart disease, diabetes, receive phototherapy.
Do not donate blood while taking this drug and for at least 3 years after stopping therapy. This will prevent the possibility of your blood being given to a pregnant woman.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Acitretin may cause vision changes, including decreased night vision. Do not drive, use machinery, or do any activity that requires clear vision (especially at night) until you are sure you can perform such activities safely.
Avoid drinking alcohol while taking this medication and for 2 months after stopping it.
This drug must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug should not be used if you are planning to become pregnant during treatment or within 3 years after use has stopped.
Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.
Use 2 effective forms of birth control starting 1 month before and during treatment and at least 3 years after use has stopped. If you are unsure which types of birth control are effective, consult your doctor, pharmacist, or Medication Guide.
Semen may pose a risk to a pregnant woman if a male is using this drug. Consult your doctor.
It is not known if this drug is excreted into breast milk. Breast-feeding is not recommended while using this medication and for at least three years after the medication has been stopped.
Additional Soriatane Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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