Special Alerts:
[Posted 10/06/2006] FDA and the iPLEDGE program notified healthcare professionals and patients of an update to iPLEDGE, a risk management program to reduce the risk of fetal exposure to isotretinoin, that will eliminate one element of the program, the 23 day lock-out period for males and females of non-child bearing potential. This change does not affect female patients of child-bearing potential. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2006/safety06.htm#Isotretinoin, http://www.fda.gov/medwatch/safety/2006/accutane_ipledge.pdf, http://www.fda.gov/cder/drug/infopage/accutane/default.htm and http://www.fda.gov/cder/drug/infopage/accutane/FAQ200610.pdf.
Before taking isotretinoin, tell your doctor if you are also taking:
steroids (prednisone and others);
seizure medication such phenytoin (Dilantin); or
a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap).
This list is not complete and there may be other drugs that can interact with isotretinoin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Get emergency medical help if you have any of these
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:
depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
sudden numbness or weakness, especially on one side of the body;
blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
hearing problems, hearing loss, or ringing in your ears;
seizure (convulsions);
severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding; or
joint stiffness, bone pain or fracture.
Less serious side effects may include:
discomfort with contact lenses;
joint pain, back pain;
feeling dizzy, drowsy, or nervous;
dryness of the lips, mouth, nose, or skin; or
cracking or peeling skin, itching, rash, changes in your fingernails or toenails.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
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