What is the most important information I should know about Accutane?
Accutane (isotretinoin) is a powerful drug that can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy . Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain.
Never use Accutane if you are pregnant. Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking Accutane. Unless you have had a total hysterectomy or have been in menopause for at least a year, you are considered to be of child-bearing potential.
Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign agreements to use birth control and undergo pregnancy testing as required by the program. Read all program brochures and agreements carefully.
It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication. If you or a loved one have been the victim of this dangerous drug contact our experienced legal staff.
What is Accutane?
Accutane is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly. Accutane is used to treat severe nodular acne. It is usually given after other acne medicines or antibiotics have been tried without successful treatment of symptoms. Accutane may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking Accutane?
Accutane is available only under a special program called iPLEDGE. You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program.
Read all of the iPLEDGE program brochures and agreements carefully. Ask your doctor or call the drug maker if you have questions about the program or the written requirements.
It is dangerous to try and purchase Accutane on the Internet or from vendors outside of the United States. The sale and distribution of Accutane outside of the iPLEDGE program violates the regulations of the U.S. Food and Drug Administration for the safe use of this medication.
Do not use this medication if you are allergic to Accutane or to parabens, or if you are pregnant or may become pregnant.
Before taking Accutane, tell your doctor if you are allergic to any foods or drugs, or if you have:
- a personal or family history of depression or mental illness
- heart disease, high cholesterol, or triglycerides
- osteoporosis or other bone disorders
- an eating disorder (e.g., anorexia nervosa)
- liver disease
If you have any of these conditions, you may not be able to use Accutane, or you may need a dosage adjustment or special tests during treatment.
Accutane can cause severe, life-threatening birth defects if the mother takes the medication during pregnancy. Even one dose of Accutane can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use Accutane if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. Even women who have had their tubes tied are required to use birth control while taking Accutane.
You must have a negative pregnancy test 30 days before you start taking Accutane. A pregnancy test is also required before each prescription is refilled, right after you take your last dose of Accutane, and again 30 days later.
All pregnancy testing is required by the iPLEDGE program. You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking Accutane and ending 30 days after you stop taking it. Both a primary and a secondary form of birth control must be used together.
Primary forms of birth control include:
- tubal legation (tubes tied)
- vasectomy of the male sexual partner
- an IUD (intrauterine device)
- estrogen-containing birth control pills (not mini-pills)
- hormonal birth control patches, implants, injections, or vaginal ring
Secondary forms of birth control include:
- a male latex condom plus spermicidal foam or gel
- a diaphragm plus spermicidal foam or gel
- a cervical cap plus spermicidal foam or gel
- a vaginal sponge containing spermicidal
Do not take St. John's wort, an herbal supplement, if you are using any type of hormonal birth control, including pills, patches, implants, injections, or a vaginal ring. Breakthrough bleeding may occur.
Stop using Accutane and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant.
It is not known whether Accutane passes into breast milk. Do not take Accutane without first talking to your doctor if you are breast-feeding a baby.
How should I take Accutane?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Each prescription of Accutane must be filled within 7 days of the date it was prescribed by your doctor. You will receive no more than a 30-day supply of Accutane at one time.
Always take Accutane with a full glass of water to prevent the capsule from melting in your esophagus (food pipe), causing irritation. Do not chew or suck on the capsule. Swallow it as quickly as possible. Take Accutane with food or milk.
Take this medication for the entire length of time prescribed by your doctor. Your acne may seem to get worse at first, but should then begin to improve.
To be sure this medication is not causing harmful effects; your blood may need to be tested on a regular basis. Your liver function may also need to be tested.
Do not miss any scheduled visits to your doctor.
Never share this medicine with another person, even if they have the same symptoms you have.
What happens if I miss a dose?
Skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an Accutane overdose include headache, dizziness, vomiting, stomach pain, warmth or tingling under the skin, swelling of the lips, and loss of balance or coordination.
What should I avoid while taking Accutane?
- Do not take vitamin supplements containing vitamin A while you are taking Accutane.
- Accutane can weaken bones. Avoid sports or activities that may result in injury or bone fracture.
- Do not donate blood while taking Accutane and for at least 30 days after you stop taking it. Donated blood that is later given to pregnant woman could lead to birth defects in her baby if the blood contains any level of Accutane.
- Do not use wax hair removers or have dermabrasion or laser skin treatments while you are taking Accutane and for at least 6 months after you stop taking it. Scarring may result.
- Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Accutane can make your skin more sensitive to sunlight and sunburn may result.
- Be careful if you must drive or do anything that requires you to see clearly. Accutane can cause side effects that may impair your vision, especially at night.
What are the possible side effects of Accutane?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Accutane 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
- joint stiffness, bone pain or fracture
Continue taking Accutane and talk to your doctor if you have any of these less serious side effects:
- discomfort with contact lenses
- joint pain, back pain
- feeling dizzy, drowsy, or nervous
- dryness of the lips, mouth, nose, or skin
- cracking or peeling skin, itching, rash, changes in your fingernails or toenails
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect Accutane?
Before taking Accutane, tell your doctor if you are also taking:
- steroids (prednisone and others)
- seizure medications such phenytoin (Dilantin)
- a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Minocin), or tetracycline (Brodspec, Sumycin, Tetracap)
If you are using any of these drugs, you may not be able to use Accutane, or you may need dosage adjustments or special tests during treatment. There may be other drugs not listed that can affect Accutane.
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.
Where can I get more information?
Your pharmacist has information about Accutane written for health professionals that you may read.
What does my medication look like?
Isotretinoin is available with a prescription under the brand name Accutane. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
To date, thousands of patients have experienced severe side effects and have filed lawsuits against Roche Pharmaceuticals, the manufacturer of name-brand Accutane. To find out if you may also have a valid claim, contact us today.