Accutane® (Isotretinoin) A-detailing Presentation

 

Accutane® (Isotretinoin)

 

 

  Content:

SIDE EFFECTS, SAFETY AND RISKS

 

 

Common Side-Effects

  • Dry Lips and Skin
  • Dry Eyes and Vision
  • Nasal Dryness
  • Thinning Hair:
  • Photosensitivity:
  • Fatigue (15-20%)
  • Headaches (5-16%)

Organs That May Be Affected

  • Neurologic
  • Hepatic
  • Bones
  • Lipids
  • Muscloskeletal
  • Leukopenia

Dry Itchy Eyes

  • Common problem (blepharoconjunctivitis)
  • Loss of visual acuity uncommon.
  • Rare night blindness which may be permanent

Management Options

  • Stop wearing lenses
  • Frequent use of artificial tears
  • If possible loss of visual acuity or night vision changes
  • Opthalmological opinion should be sought

Dry Skin and Lips

  • Dry lips:
    • Almost all patients have very dry lips. The lack of dryness raises the possibility of the patient either not taking the medication or not ingesting the drug with food.
    • Secondary bacterial infection is common
  • Dry Skin:
    • The face and backs of the hands and forearms are usually the driest. 87% of patients
    • There is often a low grade dermatitis present.
    • Look out for secondary staph infection.

Management Options

  • Dry Lips:
    • Frequent use of vaseline and lip balm containing sunscreen.
    • Antibiotic ointments if inflammation or crusting
  • Dry Skin:
    • Avoid drying cleansers
    • Regular moisturizing

Uncommon Eye Side Effects

  • Corneal opacities which do not impair vision and have been show o disappear after discontinuation of drug
  • Cataracts have been reported in adults
  • Retinal changes leading to night blindness. Rarely these changes can be permanent

Other Side-effects

  • Tetracyclines – may increase risk of pseudotumour cerebri – avoid concomitant use
  • Pancreatitis – rare
  • in patients with normal or elevated triglycerides
  • d/c drug
  • also d/c if triglycerides cannot be controlled due to increase risk of pancreatitis
  • Hepatoxicity - increased lfts, usually resolve if continue with therapy
  • Inflammatory bowel disease -d/c drug
  • may or may not result in resolution of sx
  • Rhabdomyolysis – rare
  • CVS: palipitations, tachycardia, stroke
  • Endocrine: altered blood sugars
  • Heme: anemia, thrombocytopenia rare
  • Cuts that take longer to heal
  • Facial redness, flushing – more common .in fair haired people

Pregnancy

  • This drug is teratogenic and causes fetal abnormalities.

Bones

  • Hyperostosis, osteophytes (bony spurs) may develop, but are usually of little consequence.
  • There is a possible risk of osteoporosis, osteopena, bone #, increased risks with high does, long-term, multiple courses.

Neurological

  • A pseudotumor in the cerebrum can occur, which can cause increased brain fluid pressure, headaches, vomiting, and visual disturbances.
  • Depression and suicidal thoughts have been reported in some patients.
 

Lipids

  • Cholesterol/ triglyceride levels may increase, a short-term increase in cholesterol, though this is not thought to be very significant. The increase is dose related.
  • Usually reversible with D/C therapy. Full impact on lipids seen in about 4 weeks following therapy
  • Incidence of hypertriglyceridemia is 1 in 4
  • Pancreatitis is a risk if your triglycerides rise quickly.
  • This may be a marker for familial hyperlipidaemia. And may be an indication to check lipid levels in 1st degree relatives

CNS Risks

Product Monograph

  • A pseudotumor in the cerebrum can occur, which can cause increased brain fluid pressure, headaches, and vomiting.
  • Tinnitus, hearing impairment has been reported
  • Visual disturbances, corneal opacities usually resolve on stopping the drug
  • Decreased night vision may or may not resolve with cessation of therapy
  • Dizzy spells, drowsy, seizure, lethargy, malaise, nervousness may occur

Clinical Experience

  • Headaches persist with benign intracranial hypertension and are present on waking. May lift as the day progresses, nausea, vomiting and visual changes are warning signs.
  • Opthalmologic exam is required. Refer to Neurologist if in doubt.

Depression caused by Isotretinoin?

  • Anxiety and depression and decrease quality of life is associated with acne.
  • Depression and suicide is relatively common in the teenage population.
  • Accutane packet insert warns of possible psychiatric side effects including aggressive and violent behaviour.
  • Mood swings, depressive symptoms and suicidal thoughts may be a very uncommon idoisyncratic reaction for those on Isotretinoin.
  • A causal relationship has not been firmly established.
  • Awareness of mood changes in all teenagers with acne is important.
  • Close monitoring of mood in all patients on Isotretinoin is prudent.
  • Clinical experience shows that depressive symptoms, if they occur, disappear quickly in the vast majority on discontinuation of the drug.

Publications About Psyche and Isotretinoin

  • Arch Dermatol 2000 oct;136(10):1231-6 - “No evidence.”
  • Clin Exp Dermatol 1991 may;16(30:210-1 - Psych benefit of Isotretinoin use.
  • J Am Acad Dermatol 2001 nov;45(5):s168-75 - be aware of risk factors for suicide and monitor for depressive symptoms.
  • J Am Acad Dermatol 1987 jul;17(10:25-32 - Reduced anxiety and depression from Isotretinoin use.
  • Australasian J Dermatol.2002 nov;43(4):262-8 - No link with Isotretinoin and depression apart from being a rare, unpredictable idiosyncratic side-effect.
  • Austral N Z J Psychiatry 2003 feb;37(1):78-84 - Causal relationship for depression not clearly established. A positive psychological effect in the majority.Depression may occur as an idiosyncratic side-effect and requires detection and treatment.

Monitoring

  • CBC, Cholesterol, Trigycerides
  • ALT, AST
  • LFTS During Use:
    • Repeat in 4 weeks. If ALT is 2-3 times baseline repeat testing in 3 weeks and reduce the dose.
    • If the levels climb higher d/c the drug and retest in 3 weeks
  • Pregnancy Testing:
    • Two negative urine tests prior to initiating therapy.
    • Repeat monthly prior to renewal of prescription.
  • Lipids:
    • Fasting Lipids at baseline then every 1-2 weeks until response is established.
    • Monitoring of Lipids next slide
    • Triglyceride elevation during Isotretinoin use may be a marker of familial combined hyperlipidemia
    • See Ann Inter Med 2002:136:582-589
    • Trigycerides and cholesterol elevation of the triglycerides above 7 may be associated with pancreatitis.
    • Cholesterol elevation during therapy may not pose a short term threat.
    • Familial combined hyperlipidemia is associated with a risk of hyperlipidemia, diabetes, hypertension and obesity in later life
    • Check lipids of first degree relatives of Isotretinoin patients who have elevated triglycerides

Next:   Cost of Treatment

 

 

    More Presentations: