Chemical
Name: Isotretinoin
Originally
developed by Hoffman-La Roche Pharmaceuticals, Inc.
First
developed as a treatment for severe forms of acne in the 1950’s in
Switzerland,
Accutane received FDA approval in May 1982.1
Generic
isotretinoin has been available since April 2003. Generic
brands include “Sotret,” “Claravis” and “Amnesteem.”
Written
January 2005
By
Jessica Galuska
References:
1.
Http://leda.law.harvard.edu/leda/data/594/Lee.htm
2.
“Medicine.net.” Accessed January 30, 2005.
http://www.medicinenet.com/isotretinoin/article.htm
3.
Roche,
USA. Accessed January 24, 2005. Www.rocheusa.com/products/accutane/pi/pdf
4.
“Generic
Accutane
faces potential delays - Pharmacy Watch - Hoffman-LaRoche files
citizen's
petition,” “Look Smart, Find Articles.” Accessed 01/30/05.
http://www.findarticles.com/p/articles/mi_m3374/is_4_24/ai_84237952
5.
March
of Dimes,
Medical References:Accutane and other Retinoids. Accessed 1/30/05.
www.marchofdimes.com
6.
Pharmacists
at
Ralph’s Thriftway and Walgreen’s Pharmacies.
What is
it for?
Isotretinoin
is used to
treat severe nodular (cystic) acne. It is a prescription drug that is
intended
only for severe, resistant acne and only after other treatments have
been found
to not work.
Seen as
a wonder drug, Accutane is a highly sought after drug and is being
prescribed
inappropriately in growing numbers.
Though it is effective for less severe cases of acne, the
related side
effects are severe enough that isotretinoin should only be used under
the close
care of a medical professional and only for severe cases of nodular
acne.
How it
works:
No one
has figured out how Isotretinoin works in the body.
The working theory is that Isotretinoin limits the amount of
sebum produced in the sebaceous glands and limits the size of the
sebaceous glands.
Less sebum theoretically leads to less inflammation, the supposed cause
of
acne.2
How
isotretinoin works on the sebaceous glands is unknown, but after 15-20
weeks of
treatment, acne is completely or almost completely gone in 90% of cases.
What is
the active ingredient?
The
active ingredient in Accutane and its generic variations is a retinoid
called
isotretinoin. Related to retinoic acid
and retinol (vitamin A), its chemical name is 13-cis-retinoic
acid.3
Plant
derivations:
The
closest naturally occurring substance to Isotretinoin is vitamin A.
Vitamin A
is used by the body to maintain healthy mucus membranes in the nose,
mouth, and
ears. It also plays a role in healthy skin and with night vision.
Though
a vital nutrient, vitamin A is toxic in large amounts. Beta carotene is
stored
by the body when it is consumed in large amounts, so it never reaches
toxic
levels. Because the liver converts beta carotene to vitamin A, people
concerned
about their intake of vitamin A could consider beta carotene as a safer
supplement to take.
Many of
the effects of excessive vitamin A
consumption are similar to the side effects associated with the
use of
isotretinoin, including birth defects. Isotretinoin can be considered a
hardcore version of vitamin A, with the benefits but also the potential
for
hugely negative side effects.
Administration
and Dosage:
Isotretinoin
is administered orally. It is available
in 10-mg, 20-mg, and 40-mg soft gelatin capsules. Dosages vary and
treatment
generally lasts about six months.
Cost:
Accutane
is an expensive pharmaceutical. By
2001, global sales of Accutane had reached $675 million.4 At least 5 million people in the United
States have been prescribed Accutane.2 The
arrival of generics has lowered costs dramatically, but it is
still a pricey drug. Thirty 20 mg
tablets of the generic, “Claravis,” cost $232.59 at Walgreen’s Pharmacy. The same amount of Accutane costs
$399.59. One pharmacist estimated that
even with generics, medication for a patient could cost $600 a month.
The high
price of isotretinoin means that it is a popular product on online,
discount
pharmacies. Unfortunately, that means that more people are finding
their way
around the strict controls that are placed around who is prescribed
this drug.
Contraindications:
Isotretinoin
causes birth defects, premature births,
and miscarriage. Women who are
capable of bearing children must have two negative pregnancy tests
prior to
beginning this medication. Monthly pregnancy tests are also required.
In addition,
women must use two forms of birth control while taking isotretinoin and
for the
month prior to and after treatment.
Interactions with hormonal birth control that would lessen their
effectiveness have not been ruled out. Women who are breastfeeding
should also
not use this medication because it is not known whether it will hurt
the baby.
This
drug has also been linked to mental
problems and personality changes; including depression and
aggressive/violent behavior. Suicidal
thoughts and suicides have occurred in people taking isotretinoin,
some
with histories of mental health issues and others with no prior
history. Over
500 reports of suicide, suicide attempt, and suicide ideation have been
recorded worldwide for Accutane.1
Other concerns to tell your prescriber
before taking isotretinoin: family history of mental problems, asthma,
liver
disease, diabetes, heart disease, osteoporosis, weak bones, anorexia
nervosa,
or other important health problems so that your well-being is
appropriately
monitored while taking this medication.
Concerns
about isotretinoin’s affect on bones is still in dispute. Reports of
stunted
growth, broken bones, and reduced healing of broken bones have been
reported.
Impact sports can increase the risk of bone fractures. 29% of pediatric
patients develop back pain.
What
are other possible side effects?
·
Dry and peeling skin
·
Temporary worsening of
acne
·
Thinning of hair
·
Difficulty wearing
contact lenses
·
Fatigue
·
Permanent damage to
liver, pancreas, bowel, and esophagus
·
Dry mouth, nose or eyes
·
Bone and muscle
problems
·
Hearing and vision
problems
·
Allergic reactions
·
Problems with fats and
cholesterol in the blood
·
Blood sugar problems