Isotretinoin side effects

Acne Medication

Adverse drug reactions associated with isotretinoin include:

Common:

Mild acne flare
Dryness of skin lips
Cuticle infection – called paronychia, it is usually caused by a staph infection.
Cheilitis – inflammation of the lip.
Itchiness
Rosacea
Skin fragility
Skin peeling
Rash
Nose bleeds
Diffuse alopecia – seen in both men and women, it tends to affect the whole scalp and can occur at any age.
Areata – sometimes called spot baldness. It can affect some or all areas of the body, but most often the scalp.
Eye irritation
Conjunctivitis – commonly called pink eye. It is most commonly due to an allergic reaction or infection.
Reduced tolerance to contact lenses
Hyperlipidaemia – Includes a variety of conditions involving increased concentrations of lipids in plasma.
Permanently thinned skin
Headaches
Permanent hair thinning (This could start or continue after treatment)
Myalgia and/or arthralgia – muscle pain and joint pain.
Back pain

Infrequent:

Severe acne flare
Raised blood glucose level
Increased erythrocyte sedimentation rate (ESR)- a measure of inflammation.
Fatigue

Rare:

Impaired night vision
Cataracts – involve changes in clarity of the natural lens (behind the iris) that gradually degrade visual quality.
Optic neuritis – inflammation of the optic nerve that may cause a Partial or complete loss of vision.
Menstrual disturbances
Inflammatory bowel disease
Pancreatitis – inflammation of the pancreas.
Hepatitis – injury to the liver caused by inflammatory cells in the tissue of the organ.
Corneal opacities – similar to a cataract it impairs visual function and needs to be treated early and aggressively.
Papilloedema – optic disc swelling caused by increased intra-cranial pressure. It may progress to a blind spot, blurred vision, obscurations (temporary inability to see a part of the visual field) and ultimately total loss of vision.
Idiopathic intracranial hypertension – a neurological disorder that is characterized by increased intracranial pressure.
Skeletal hyperostosis – also called Forestier’s disease. It is considered a form of degenerative arthritis psychosis.
Depression – can occur although no conclusive evidence has been proven for this.

Adverse effects reported to persist, even after discontinuing therapy:

Alopecia (hair loss is experienced by about 13% of patients taking Accutane, the condition is usually temporary).
Arthralgias – joint pain
Decreased night vision
Inflammatory bowel disease
Degenerative disc disease
Keloids – acne scars
Bone disease
Rosacea – severe facial skin redness and irritation has been experienced in patients taking high doses.
Erectile dysfunction – has been reported by several patients in clinical studies. Impotence may have been caused by psychiatric side effects of this drug.

Patients receiving isotretinoin therapy are not permitted to donate blood during, and for at least a month following, discontinuation of treatment.

Getting a tattoo while on this medication could lead to scarring on the tattooed area, ink rejection can also occur.

Isotretinoin is a teratogen and is highly likely to cause birth defects if taken during pregnancy, including:

Hearing and visual impairment
Missing earlobes
Facial dysmorphism
Mental retardation

Several scientific studies have suggested the drug is a probable cause of ulcerative colitis and Crohn’s Disease in some individuals. Three cases have been successfully argued in the US, resulting in multi-million dollar judgments against the drug manufacturer. There are currently over 425 US cases pending.

A possible link between isotretinoin and clinical depression has been suggested from several studies. several successful lawsuits have been filed on this basis, they are partially responsible for the strict control of this medication in the United States.

The U.S. FDA’s Adverse Events Reporting System has had 431 Isotretinoin-related cases reported between 1982 and May 2001.
The majority of these reports involved depression, suicidal ideation, suicide attempt and suicide. 37 patients were known to have taken their lives while being treated with Isotretinoin. However, this rate is considered to be in line with national averages and no causal relationship has been established.

A US Congressman, Bart Stupak, has stated that total Accutane-related suicides may be upwards of 50,000 due to under-reporting and since it is used for other medical conditions including a form of brain cancer. The congressman’s son took his own life while taking Accutane for acne.

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