Isotretinoin - Side Effects That Need Medical Monitoring By Your Physician

Certain Isotretinoin (AccutaneŽ) side effects will not be as apparent to you and will need to be monitored by your doctor during your acne treatment. These include effects on your bones, lipids, liver and pregnancy status.

Pregnancy:

• This drug is teratogenic and causes fetal abnormalities, birth defects, miscarriages, infant death and premature birth.
• YOU CANNOT RISK BECOMING PREGNANT. YOU MUST AVOID PREGNANCY 1 MONTH BEFORE, DURING, AND 1 MONTH AFTER USE OF THIS DRUG.
• If you do get pregnant, stop taking AccutaneŽ right away and call your doctor.
• Pregnancy prevention programs such as the iPLEDGE program, are offered to ensure that you avoid getting pregnant.
• Doctors and patients should report all cases of pregnancy to:
  
  
  • FDA MedWatch at 1-800-FDA-1088, and
  • the iPLEDGE pregnancy registry at 1-866-495-0654

Depression:

• There are reports that Isotretinion may cause depression and mood changes.
• It is wise to look out for suspicious changes in mood although a direct causal relationship has not been established.
• Clinical experience suggests that some patients become moody on this drug.
• An increase risks of suicide has received much press but has not been substantiated.
• It is prudent to be aware and closely observe patients that might be at risk.

Bones:

• Hyperostosis, osteophytes (bony spurs) may develop, but are usually of little consequence
• There is a possible risk that your bones will become thinner (osteoporosis)
• (however, more work needs to be done, as studies have been inconclusive)
• Premature closure of bony epiphyses can occur in children, which may reduce long bone growth

Musculoskeletal:

• There is a risk of inflammation around joints, and tendonitis.
• Aches and pains around joints, and lower back pain are common.
• Tell your doctor if you plan hard physical activity during treatment with isotretinoin.
• Tell your doctor if you develop back pain or joint pain.
• Stop AccutaneŽ and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
• AccutaneŽ may stop long bone growth in teenagers who are still growing.

Lipids:

• Cholesterol/ triglyceride levels may increase, this must be followed by your doctor
• You may experience a short-term increase in cholesterol, though this is not thought to be very significant
• Pancreatitis is a risk if your triglycerides rise quickly and the level becomes high, this is very rare, however

Gastrointestinal:

Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas, bowel (intestines), and esophagus. Stop taking AccutaneŽ and call your doctor if you have:

• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine

If your organs are damaged, they may not get better even after you stop taking AccutaneŽ.

Liver:

• May be mildly irritating to your liver

Blood tests occasionally show changes but they are usually of little consequence. It is rare to have to discontinue AccutaneŽ because of liver abnormalities. Drug induced hepatitis has been reported.

Neurologic:

• A pseudotumor in the cerebrum can occur, which can cause increased brain fluid pressure, headaches, vomiting, and visual disturbances.
• You may experience headaches.
• AccutaneŽ can increase the pressure in your brain, which can lead to permanent loss of eyesight and, in rare cases, death. Stop taking this drug and call your doctor immediately if you get any of these signs of increased brain pressure:
  
  • bad headache
  • blurred vision
  • dizziness
  • nausea or vomiting
  • seizures (convulsions)
  • stroke

Hearing

Stop using AccutaneŽ and call your doctor if your hearing gets worse or if you have ringing in your ears. Any hearing loss caused by this drug may be permanent.

Vision Problems

AccutaneŽ may affect your ability to see in the dark. This condition usually clears up after you stop taking this drug, but it may be permanent. Other serious eye effects can also occur. Stop taking AccutaneŽ and call your doctor right away if you have any problems with your vision, or dryness of the eyes that is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking AccutaneŽ even after concluding treatment.

Muscloskeletal:

• There is a risk of inflammation around joints, and tendonitis
• Aches and pains around joints, and lower back pain are common

These symptoms do not produce permanent damage in the joints and often taking anti-inflammatory painkillers can give you relief.

Blood:

• Your ability to produce red and white blood cells may be diminished. However, this is rare. Call your doctor if you have trouble breathing, or fee faint, or weak.
• Isotretion may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.

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