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Starting Accutane

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Starting Accutane

Posted by Calvin on February 14, 2003 at 21:41:00:

Hi,
After battling acne for five years, I've decided it's time to subject my body to the wrath of Accutane. I'm currently 18, and not done growing, but I basically cannot take it anymore. I've done almost every drug in the book- Tetracycline, Clindamiyacin, Benzoyl Peroxide, Tazerac, Retin-A......the list goes on. NOTHING worked at all. Not even one pimple went away. My acne in eighth grade (13 years old) was just mild type 1, even though I was extremely stressed-out. I had almost gotten expelled from my old school, and switched to a new one. I really doubt that stress had made my acne any worse. I hit puberty right about then, and I think that the new hormones are the reason it started in the first place. By Freshmen year, it was about the same, and I was on the swim team that year. I had a few zits on my back, but mostly on my face, and the chlorine only irritated my face more. As soon as swimming was over, I broke out on my back. Stress definetely had nothing to do with that, because I was very happy with all my new free time. By sophomore year, it got worse, especially on my face. I mainly had type 2 acne, and some cystic on my back.
Now it's Senior year, and while my face isn't any worse than before, my back is horrible. I have hundreds of zits on it, and at least a dozen are cystic (sure to leave deep scars). I also have developed acne on my neck, chest, and upper arms. It has completely ruined my life in every way. Girls will not go out with me, and even if I could find one that would, I'm sure she'd break up with me after seeing my back. People tell me it's no big deal, but that's a load of crap (the people saying that have never had a zit in their lives). It's a huge deal, because in America, we're raised to care about how people look from day one. I've taken the attitude of not caring about what anyone thinks, but that has made me extremely depressed, to the point of thinking about suicide. Acne is the reason why I have never had a girlfriend, and the reason for my depression. I haven't been in a pool for three years, and I used to love swimming. I'm ready to say goodbye to acne, and from what I've read, Accutane is pretty effective. The derm gave me a low dose of 20mg a day, because I'm still developing. I'm still really scared though. I'm really scared it could seal my growth plates and make my hair fall out. I'm 5'10" tall, but I'm supposed to be 6'0", and I don't know if I want to give up those two inches. Does anyone know how common it is for Accutane to seal the growth plates or cause hair loss? I really would like some answers if there are any. I agree that stress is the reason for ADULT acne, but I highly doubt mine was caused by that. I think I just have puberty-related acne, because it's been bad even when I've had little stress. No one else in my family has had acne. My doctor says at 18, I'm almost done growing anyway, but he also said there's no way to really know for sure. I've always been a late bloomer when it comes to bone development, and I have never had a growth spurt. The most I've ever grown in a year is two inches. Is every male supposed to get a growth spurt? What should I do?- Take Accutane and risk all the bad side effects, or just ride it out and risk some bad scarring? I need some advice and opinions.



Re: Starting Accutane

Posted by Mary on February 15, 2003 at 00:04:24:

In Reply to: Starting Accutane posted by Calvin on February 14, 2003 at 21:41:00:

Calvin,
I know it seems tough right now that you don't have girls liking you. However, it is not worth risking long-term problems due to Accutane. It is a horrible drug with many side effects. I think you need to try following the wellness program outlined on this site first. Give it a year and if the acne is still there, then try the accutane.



Re: Starting Accutane

Posted by Walt Stoll on February 15, 2003 at 07:52:48:

In Reply to: Starting Accutane posted by Calvin on February 14, 2003 at 21:41:00:

Hi, Calvin.

The one thing I KNOW you have not done is what is recommended in the acne archives. Wellness. Go to the glossary for any unfamiliar terms. See the acne archives for testimonials.

If you just have to take something start the B5 and the EFAs described in the acne archives.

Let us know how you do.

Walt

Follow Ups:


Re: Starting Accutane

Posted by
Beth on February 15, 2003 at 08:27:34:

In Reply to: Starting Accutane posted by Calvin on February 14, 2003 at 21:41:00:

Hi Calvin,

I had the same trouble with acne and nothing worked. Mine got worse when I got older, I'm 22 and went on Accutane. I did a 6 month course of 60mg a day, and did it ever work! I've been off it now for 5 months, and every now and then I might get a small pimple, but not the quantity that I got before. There were side effects, your whole body dries out and becomes itchy and flakes; it's great though, you can go a few days without washing your hair! I lost some hair too, mainly when I'd wash or brush my hair, but don't worry it didn't leave any bald spots. Don't drink alcohol in any large amounts, if you want to have a liver left when you're finished. For me it worked really well and I was freaked out by all of the side effects at first too. I would recommend Accutane, but as long as you feel comfortable and are aware that the side effects can be different in each person. If you want some more advice feel free to email me. I hope this helps!

Beth


Follow Ups:


from the accutane info sheet

Posted by researcher on February 15, 2003 at 13:06:08:

In Reply to: Starting Accutane posted by Calvin on February 14, 2003 at 21:41:00:

INDICATIONS AND USAGE: Severe Recalcitrant Nodular Acne: Accutane is indicated for
the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a
diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. “Severe,” by
definition,2 means “many” as opposed to “few or several” nodules. Because of significant
adverse effects associated with its use, Accutane should be reserved for patients with severe
nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. In
addition, Accutane is indicated only for those females who are not pregnant, because Accutane
can cause severe birth defects (see boxed CONTRAINDICATIONS AND WARNINGS).
A single course of therapy for 15 to 20 weeks has been shown to result in complete and
prolonged remission of disease in many patients.1,3,4 If a second course of therapy is needed, it
should not be initiated until at least 8 weeks after completion of the first course, because
experience has shown that patients may continue to improve while off Accutane. The optimal
interval before retreatment has not been defined for patients who have not completed skeletal
growth (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature
Epiphyseal Closure).
CONTRAINDICATIONS: Pregnancy: Category X. See boxed CONTRAINDICATIONS
AND WARNINGS.
Allergic Reactions: Accutane is contraindicated in patients who are hypersensitive to this
medication or to any of its components. Accutane should not be given to patients who are
sensitive to parabens, which are used as preservatives in the gelatin capsule (see
PRECAUTIONS: Hypersensitivity).
WARNINGS: Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely,
suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.
Discontinuation of Accutane therapy may be insufficient; further evaluation may be
necessary. No mechanism of action has been established for these events (see ADVERSE
REACTIONS: Psychiatric). Prescribers should read the brochure, Recognizing Psychiatric
Disorders in Adolescents and Young Adults: A Guide for Prescribers of Accutane
(isotretinoin).
Pseudotumor Cerebri: Accutane use has been associated with a number of cases of
pseudotumor cerebri (benign intracranial hypertension), some of which involved
concomitant use of tetracyclines. Concomitant treatment with tetracyclines should
therefore be avoided. Early signs and symptoms of pseudotumor cerebri include
papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these
symptoms should be screened for papilledema and, if present, they should be told to
discontinue Accutane immediately and be referred to a neurologist for further diagnosis
and care (see ADVERSE REACTIONS: Neurological).
Pancreatitis: Acute pancreatitis has been reported in patients with either elevated or normal
serum triglyceride levels. In rare instances, fatal hemorrhagic pancreatitis has been
reported. Accutane should be stopped if hypertriglyceridemia cannot be controlled at an
acceptable level or if symptoms of pancreatitis occur.
Lipids: Elevations of serum triglycerides have been reported in patients treated with Accutane.
Marked elevations of serum triglycerides in excess of 800 mg/dL were reported in approximately
25% of patients receiving Accutane in clinical trials. In addition, approximately 15% developed
a decrease in high-density lipoproteins and about 7% showed an increase in cholesterol levels.
In clinical trials, the effects on triglycerides, HDL, and cholesterol were reversible upon
cessation of Accutane therapy. Some patients have been able to reverse triglyceride elevation by
reduction in weight, restriction of dietary fat and alcohol, and reduction in dose while continuing
Accutane.5
Blood lipid determinations should be performed before Accutane is given and then at intervals
until the lipid response to Accutane is established, which usually occurs within 4 weeks.
Especially careful consideration must be given to risk/benefit for patients who may be at high
risk during Accutane therapy (patients with diabetes, obesity, increased alcohol intake, lipid
metabolism disorder or familial history of lipid metabolism disorder). If Accutane therapy is
instituted, more frequent checks of serum values for lipids and/or blood sugar are recommended
(see PRECAUTIONS: Laboratory Tests).
The cardiovascular consequences of hypertriglyceridemia associated with Accutane are
unknown. Animal Studies: In rats given 8 or 32 mg/kg/day of isotretinoin (1.3 to 5.3 times the
recommended clinical dose of 1.0 mg/kg/day after normalization for total body surface area) for
18 months or longer, the incidences of focal calcification, fibrosis and inflammation of the
myocardium, calcification of coronary, pulmonary and mesenteric arteries, and metastatic
calcification of the gastric mucosa were greater than in control rats of similar age. Focal
endocardial and myocardial calcifications associated with calcification of the coronary arteries
were observed in two dogs after approximately 6 to 7 months of treatment with isotretinoin at a
dosage of 60 to 120 mg/kg/day (30 to 60 times the recommended clinical dose of 1.0 mg/kg/day,
respectively, after normalization for total body surface area).
Hearing Impairment: Impaired hearing has been reported in patients taking Accutane; in some
cases, the hearing impairment has been reported to persist after therapy has been discontinued.
Mechanism(s) and causality for this event have not been established. Patients who experience
tinnitus or hearing impairment should discontinue Accutane treatment and be referred for
specialized care for further evaluation (see ADVERSE REACTIONS: Special Senses).
Hepatotoxicity: Clinical hepatitis considered to be possibly or probably related to Accutane
therapy has been reported. Additionally, mild to moderate elevations of liver enzymes have been
observed in approximately 15% of individuals treated during clinical trials, some of which
normalized with dosage reduction or continued administration of the drug. If normalization does
not readily occur or if hepatitis is suspected during treatment with Accutane, the drug should be
discontinued and the etiology further investigated.
Inflammatory Bowel Disease: Accutane has been associated with inflammatory bowel disease
(including regional ileitis) in patients without a prior history of intestinal disorders. In some
instances, symptoms have been reported to persist after Accutane treatment has been stopped.
Patients experiencing abdominal pain, rectal bleeding or severe diarrhea should discontinue
Accutane immediately (see ADVERSE REACTIONS: Gastrointestinal).
Skeletal: Bone Mineral Density: Effects of multiple courses of Accutane on the developing
musculoskeletal system are unknown. There is some evidence that long-term, high-dose, or
multiple courses of therapy with isotretinoin have more of an effect than a single course of
therapy on the musculoskeletal system. In an open-label clinical trial (N=217) of a single course
of therapy with Accutane for severe recalcitrant nodular acne, bone density measurements at
several skeletal sites were not significantly decreased (lumbar spine change >-4% and total hip
change >-5%) or were increased in the majority of patients. One patient had a decrease in
lumbar spine bone mineral density >4% based on unadjusted data. Sixteen (7.9%) patients had
decreases in lumbar spine bone mineral density >4%, and all the other patients (92%) did not
have significant decreases or had increases (adjusted for body mass index). Nine patients (4.5%)
had a decrease in total hip bone mineral density >5% based on unadjusted data. Twenty-one
(10.6%) patients had decreases in total hip bone mineral density >5%, and all the other patients
(89%) did not have significant decreases or had increases (adjusted for body mass index).
Follow-up studies performed in 8 of the patients with decreased bone mineral density for up to
11 months thereafter demonstrated increasing bone density in 5 patients at the lumbar spine,
while the other 3 patients had lumbar spine bone density measurements below baseline values.
Total hip bone mineral densities remained below baseline (range –1.6% to -7.6%) in 5 of 8
patients (62.5%).
In a separate open-label extension study of 10 patients, ages 13-18 years, who started a second
course of Accutane 4 months after the first course, two patients showed a decrease in mean
lumbar spine bone mineral density up to 3.25% (adjusted for body mass index).
Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone
fractures have been seen in the Accutane population. While causality to Accutane has not been
established, an effect cannot be ruled out. Longer term effects have not been studied. It is
important that Accutane be given at the recommended doses for no longer than the recommended
duration.
Hyperostosis: A high prevalence of skeletal hyperostosis was noted in clinical trials for disorders
of keratinization with a mean dose of 2.24 mg/kg/day. Additionally, skeletal hyperostosis was
noted in 6 of 8 patients in a prospective study of disorders of keratinization.6 Minimal skeletal
hyperostosis and calcification of ligaments and tendons have also been observed by x-ray in
prospective studies of nodular acne patients treated with a single course of therapy at
recommended doses. The skeletal effects of multiple Accutane treatment courses for acne are
unknown.
In a clinical study of 217 pediatric patients (12 to 17 years) with severe recalcitrant nodular acne,
hyperostosis was not observed after 16 to 20 weeks of treatment with approximately 1 mg/kg/day
of Accutane given in two divided doses. Hyperostosis may require a longer time frame to
appear. The clinical course and significance remain unknown.
Premature Epiphyseal Closure: There are spontaneous reports of premature epiphyseal closure
in acne patients receiving recommended doses of Accutane. The effect of multiple courses of
Accutane on epiphyseal closure is unknown.
Vision Impairment: Visual problems should be carefully monitored. All Accutane patients
experiencing visual difficulties should discontinue Accutane treatment and have an
ophthalmological examination (see ADVERSE REACTIONS: Special Senses).
Corneal Opacities: Corneal opacities have occurred in patients receiving Accutane for acne and
more frequently when higher drug dosages were used in patients with disorders of keratinization.
The corneal opacities that have been observed in clinical trial patients treated with Accutane
have either completely resolved or were resolving at follow-up 6 to 7 weeks after discontinuation
of the drug (see ADVERSE REACTIONS: Special Senses).
Decreased Night Vision: Decreased night vision has been reported during Accutane therapy and
in some instances the event has persisted after therapy was discontinued. Because the onset in
some patients was sudden, patients should be advised of this potential problem and warned to be
cautious when driving or operating any vehicle at night.
PRECAUTIONS: The Accutane Pregnancy Prevention and Risk Management Programs consist
of the System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) and the Accutane
Pregnancy Prevention Program (PPP). S.M.A.R.T. should be followed for prescribing Accutane
with the goal of preventing fetal exposure to isotretinoin. It consists of: 1) reading the booklet
entitled System to Manage Accutane Related Teratogenicity (S.M.A.R.T.) Guide to Best
Practices, 2) signing and returning the completed S.M.A.R.T. Letter of Understanding
containing the Prescriber Checklist, 3) a yellow self-adhesive Accutane Qualification Sticker to
be affixed to the prescription page. In addition, the patient educational material, Be Smart, Be
Safe, Be Sure, should be used with each patient.
The following further describes each component:
1) The S.M.A.R.T. Guide to Best Practices includes: Accutane teratogenic potential,
information on pregnancy testing, specific information about effective contraception, the
limitations of contraceptive methods and behaviors associated with an increased risk of
contraceptive failure and pregnancy, the methods to evaluate pregnancy risk, and the method
to complete a qualified Accutane prescription.
2) The S.M.A.R.T. Letter of Understanding attests that Accutane prescribers understand that
Accutane is a teratogen, have read the S.M.A.R.T. Guide to Best Practices, understand their
responsibilities in preventing exposure of pregnant females to Accutane and the procedures
for qualifying female patients as defined in the boxed CONTRAINDICATIONS AND
WARNINGS.
The Prescriber Checklist attests that Accutane prescribers know the risk and severity of
injury/birth defects from Accutane; know how to diagnose and treat the various presentations
of acne; know the risk factors for unplanned pregnancy and the effective measures for
avoidance; will refer the patient for, or provide, detailed pregnancy prevention counseling to
help the patient have knowledge and tools needed to fulfill their ultimate responsibility to
avoid becoming pregnant; understand and properly use throughout the Accutane treatment
course, the revised risk management procedures, including monthly pregnancy avoidance
counseling, pregnancy testing, and use of qualified prescriptions with the yellow selfadhesive
Accutane Qualification Sticker.
3) The yellow self-adhesive Accutane Qualification Sticker is used as documentation that the
prescriber has qualified the female patient according to the qualification criteria (see boxed
CONTRAINDICATIONS AND WARNINGS).
4) Accutane Pregnancy Prevention Program (PPP) is a systematic approach to comprehensive
patient education about their responsibilities and includes education for contraception
compliance and reinforcement of educational messages. The PPP includes information on the
risks and benefits of Accutane which is linked to the Accutane Medication Guide dispensed
by pharmacists with each prescription.
Male and female patients are provided with separate booklets. Each booklet contains
information on Accutane therapy, including precautions and warnings, an Informed
Consent/Patient Agreement form, and a toll-free line which provides Accutane information in
13 languages.
The booklet for male patients, Be Smart, Be Safe, Be Sure, Accutane Risk Management
Program for Men, also includes information about male reproduction, a warning not to share
Accutane with others or to donate blood during Accutane therapy and for 1 month following
discontinuation of Accutane.
The booklet for female patients, Be Smart, Be Safe, Be Sure, Accutane Pregnancy Prevention
and Risk Management Program for Women, also includes a referral program that offers
females free contraception counseling, reimbursed by the manufacturer, by a reproductive
specialist; a second Patient Information/Consent form concerning birth defects, obtaining her
consent to be treated within this agreement; an enrollment form for the Accutane Survey; and
a qualification checklist affirming the conditions under which female patients may receive
Accutane. In addition, there is information on the types of contraceptive methods, the
selection and use of appropriate, effective contraception, and the rates of possible
contraceptive failure; a toll-free contraception counseling line; and a video about the most
common reasons for unplanned pregnancies.
General: Although an effect of Accutane on bone loss is not established, physicians should use
caution when prescribing Accutane to patients with a genetic predisposition for age-related
osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of
bone metabolism. This would include patients diagnosed with anorexia nervosa and those who
are on chronic drug therapy that causes drug-induced osteoporosis/osteomalacia and/or affects
vitamin D metabolism, such as systemic corticosteroids and any anticonvulsant.
Patients may be at increased risk when participating in sports with repetitive impact where the
risks of spondylolisthesis with and without pars fractures and hip growth plate injuries in early
and late adolescence are known. There are spontaneous reports of fractures and/or delayed
healing in patients while on treatment with Accutane or following cessation of treatment with
Accutane while involved in these activities. While causality to Accutane has not been
established, an effect cannot be ruled out.
Information for Patients and Prescribers:
• Patients should be instructed to read the Medication Guide supplied as required by law when
Accutane is dispensed. The complete text of the Medication Guide is reprinted at the end of
this document. For additional information, patients should also read the Patient Product
Information, Important Information Concerning Your Treatment with Accutane
(isotretinoin). All patients should sign the Informed Consent/Patient Agreement.
• Females of childbearing potential should be instructed that they must not be pregnant when
Accutane therapy is initiated, and that they should use 2 forms of effective contraception 1
month before starting Accutane, while taking Accutane, and for 1 month after Accutane has
been stopped. They should also sign a consent form prior to beginning Accutane therapy.
They should be given an opportunity to enroll in the Accutane Survey and to review the
patient videotape provided by the manufacturer to the prescriber. It includes information
about contraception, the most common reasons that contraception fails, and the importance of
using 2 forms of effective contraception when taking teratogenic drugs. Female patients
should be seen by their prescribers monthly and have a urine or serum pregnancy test
performed each month during treatment to confirm negative pregnancy status before another
Accutane prescription is written (see boxed CONTRAINDICATIONS AND WARNINGS).
• Accutane is found in the semen of male patients taking Accutane, but the amount delivered to
a female partner would be about 1 million times lower than an oral dose of 40 mg. While the
no-effect limit for isotretinoin-induced embryopathy is unknown, 20 years of postmarketing
reports include 4 with isolated defects compatible with features of retinoid exposed fetuses.
None of these cases had the combination of malformations characteristic of retinoid
exposure, and all had other possible explanations for the defects observed.
• Patients may report mental health problems or family history of psychiatric disorders. These reports should be
discussed with the patient and/or the patient’s family. A referral to a mental health professional may be
necessary. The physician should consider whether or not Accutane therapy is appropriate in this setting (see
WARNINGS: Psychiatric).
• Patients should be informed that they must not share Accutane with anyone else because of the risk of birth
defects and other serious adverse events.
• Patients should not donate blood during therapy and for 1 month following discontinuance of
the drug because the blood might be given to a pregnant woman whose fetus must not be
exposed to Accutane.
• Patients should be reminded to take Accutane with a meal (see DOSAGE AND
ADMINISTRATION). To decrease the risk of esophageal irritation, patients should swallow
the capsules with a full glass of liquid.
• Patients should be informed that transient exacerbation (flare) of acne has been seen,
generally during the initial period of therapy.
• Wax epilation and skin resurfacing procedures (such as dermabrasion, laser) should be
avoided during Accutane therapy and for at least 6 months thereafter due to the possibility of
scarring (see ADVERSE REACTIONS: Skin and Appendages).
• Patients should be advised to avoid prolonged exposure to UV rays or sunlight.
• Patients should be informed that they may experience decreased tolerance to contact lenses
during and after therapy.
• Patients should be informed that approximately 16% of patients treated with Accutane in a
clinical trial developed musculoskeletal symptoms (including arthralgia) during treatment. In
general, these symptoms were mild to moderate, but occasionally required discontinuation of
the drug. Transient pain in the chest has been reported less frequently. In the clinical trial,
these symptoms generally cleared rapidly after discontinuation of Accutane, but in some
cases persisted (see ADVERSE REACTIONS: Musculoskeletal). There have been rare
postmarketing reports of rhabdomyolysis, some associated with strenuous physical activity
(see Laboratory Tests: CPK).
• Pediatric patients and their caregivers should be informed that approximately 29% (104/358)
of pediatric patients treated with Accutane developed back pain. Back pain was severe in
13.5% (14/104) of the cases and occurred at a higher frequency in female than male patients.
Arthralgias were experienced in 22% (79/358) of pediatric patients. Arthralgias were severe
in 7.6% (6/79) of patients. Appropriate evaluation of the musculoskeletal system should be
done in patients who present with these symptoms during or after a course of Accutane.
Consideration should be given to discontinuation of Accutane if any significant abnormality
is found.
• Neutropenia and rare cases of agranulocytosis have been reported. Accutane should be
discontinued if clinically significant decreases in white cell counts occur.
Hypersensitivity: Anaphylactic reactions and other allergic reactions have been reported.
Cutaneous allergic reactions and serious cases of allergic vasculitis, often with purpura (bruises
and red patches) of the extremities and extracutaneous involvement (including renal) have been
reported. Severe allergic reaction necessitates discontinuation of therapy and appropriate medical
management.
Drug Interactions:
• Vitamin A: Because of the relationship of Accutane to vitamin A, patients should be advised
against taking vitamin supplements containing vitamin A to avoid additive toxic effects.
• Tetracyclines: Concomitant treatment with Accutane and tetracyclines should be avoided
because Accutane use has been associated with a number of cases of pseudotumor cerebri
(benign intracranial hypertension), some of which involved concomitant use of tetracyclines.
• Micro-dosed Progesterone Preparations: Micro-dosed progesterone preparations
(“minipills” that do not contain an estrogen) may be an inadequate method of contraception
during Accutane therapy. Although other hormonal contraceptives are highly effective, there
have been reports of pregnancy from women who have used combined oral contraceptives, as
well as injectable/implantable contraceptive products. These reports are more frequent for
women who use only a single method of contraception. It is not known if hormonal
contraceptives differ in their effectiveness when used with Accutane. Therefore, it is
critically important for women of childbearing potential to select and commit to use 2 forms
of effective contraception simultaneously, at least 1 of which must be a primary form, unless
absolute abstinence is the chosen method, or the patient has undergone a hysterectomy (see
boxed CONTRAINDICATIONS AND WARNINGS).
• Phenytoin: Accutane has not been shown to alter the pharmacokinetics of phenytoin in a
study in seven healthy volunteers. These results are consistent with the in vitro finding that
neither isotretinoin nor its metabolites induce or inhibit the activity of the CYP 2C9 human
hepatic P450 enzyme. Phenytoin is known to cause osteomalacia. No formal clinical studies
have been conducted to assess if there is an interactive effect on bone loss between phenytoin
and Accutane. Therefore, caution should be exercised when using these drugs together.
• Systemic Corticosteroids: Systemic corticosteroids are known to cause osteoporosis. No
formal clinical studies have been conducted to assess if there is an interactive effect on bone
loss between systemic corticosteroids and Accutane. Therefore, caution should be exercised
when using these drugs together.
Prescribers are advised to consult the package insert of medication administered concomitantly
with hormonal contraceptives, since some medications may decrease the effectiveness of these
birth control products. Accutane use is associated with depression in some patients (see
WARNINGS: Psychiatric and ADVERSE REACTIONS: Psychiatric). Patients should be
prospectively cautioned not to self-medicate with the herbal supplement St. John’s Wort because
a possible interaction has been suggested with hormonal contraceptives based on reports of
breakthrough bleeding on oral contraceptives shortly after starting St. John's Wort. Pregnancies
have been reported by users of combined hormonal contraceptives who also used some form of
St. John's Wort.
Laboratory Tests:
Pregnancy Test: Female patients of childbearing potential must have negative results from 2
urine or serum pregnancy tests with a sensitivity of at least 25 mIU/mL before receiving the
initial Accutane prescription. The first test is obtained by the prescriber when the decision is
made to pursue qualification of the patient for Accutane (a screening test). The second
pregnancy test (a confirmation test) should be done during the first 5 days of the menstrual
period immediately preceding the beginning of Accutane therapy. For patients with amenorrhea,
the second test should be done at least 11 days after the last act of unprotected sexual intercourse
(without using 2 effective forms of contraception).
Each month of therapy, the patient must have a negative result from a urine or serum pregnancy test. A pregnancy
test must be repeated each month prior to the female patient receiving each prescription.
• Lipids: Pretreatment and follow-up blood lipids should be obtained under fasting conditions.
After consumption of alcohol, at least 36 hours should elapse before these determinations are
made. It is recommended that these tests be performed at weekly or biweekly intervals until
the lipid response to Accutane is established. The incidence of hypertriglyceridemia is 1
patient in 4 on Accutane therapy (see WARNINGS: Lipids).
• Liver Function Tests: Since elevations of liver enzymes have been observed during clinical
trials, and hepatitis has been reported, pretreatment and follow-up liver function tests should
be performed at weekly or biweekly intervals until the response to Accutane has been
established (see WARNINGS: Hepatotoxicity).
• Glucose: Some patients receiving Accutane have experienced problems in the control of their
blood sugar. In addition, new cases of diabetes have been diagnosed during Accutane
therapy, although no causal relationship has been established.
• CPK: Some patients undergoing vigorous physical activity while on Accutane therapy have
experienced elevated CPK levels; however, the clinical significance is unknown. There have
been rare postmarketing reports of rhabdomyolysis, some associated with strenuous physical
activity. In a clinical trial of 217 pediatric patients (12 to 17 years) with severe recalcitrant
nodular acne, transient elevations in CPK were observed in 12% of patients, including those
undergoing strenuous physical activity in association with reported musculoskeletal adverse
events such as back pain, arthralgia, limb injury, or muscle sprain. In these patients,
approximately half of the CPK elevations returned to normal within 2 weeks and half
returned to normal within 4 weeks. No cases of rhabdomyolysis were reported in this trial.
Carcinogenesis, Mutagenesis and Impairment of Fertility: In male and female Fischer 344 rats
given oral isotretinoin at dosages of 8 or 32 mg/kg/day (1.3 to 5.3 times the recommended
clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body surface area) for
greater than 18 months, there was a dose-related increased incidence of pheochromocytoma
relative to controls. The incidence of adrenal medullary hyperplasia was also increased at the
higher dosage in both sexes. The relatively high level of spontaneous pheochromocytomas
occurring in the male Fischer 344 rat makes it an equivocal model for study of this tumor;
therefore, the relevance of this tumor to the human population is uncertain.
The Ames test was conducted with isotretinoin in two laboratories. The results of the tests in one
laboratory were negative while in the second laboratory a weakly positive response (less than 1.6
x background) was noted in S. typhimurium TA100 when the assay was conducted with
metabolic activation. No dose-response effect was seen and all other strains were negative.
Additionally, other tests designed to assess genotoxicity (Chinese hamster cell assay, mouse
micronucleus test, S. cerevisiae D7 assay, in vitro clastogenesis assay with human-derived
lymphocytes, and unscheduled DNA synthesis assay) were all negative.
In rats, no adverse effects on gonadal function, fertility, conception rate, gestation or parturition
were observed at oral dosages of isotretinoin of 2, 8, or 32 mg/kg/day (0.3, 1.3, or 5.3 times the
recommended clinical dose of 1.0 mg/kg/day, respectively, after normalization for total body
surface area).
In dogs, testicular atrophy was noted after treatment with oral isotretinoin for approximately 30 weeks at dosages of
20 or 60 mg/kg/day (10 or 30 times the recommended clinical dose of 1.0 mg/kg/day, respectively, after
normalization for total body surface area). In general, there was microscopic evidence for appreciable depression of
spermatogenesis but some sperm were observed in all testes examined and in no instance were completely atrophic
tubules seen. In studies of 66 men, 30 of whom were patients with nodular acne under treatment with oral
isotretinoin, no significant changes were noted in the count or motility of spermatozoa in the ejaculate. In a study of
50 men (ages 17 to 32 years) receiving Accutane (isotretinoin) therapy for nodular acne, no significant effects were
seen on ejaculate volume, sperm count, total sperm motility, morphology or seminal plasma fructose.
Pregnancy: Category X. See boxed CONTRAINDICATIONS AND WARNINGS.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because of the
potential for adverse effects, nursing mothers should not receive Accutane.
Pediatric Use: The use of Accutane in pediatric patients less than 12 years of age has not been
studied. The use of Accutane for the treatment of severe recalcitrant nodular acne in pediatric
patients ages 12 to 17 years should be given careful consideration, especially for those patients
where a known metabolic or structural bone disease exists (see PRECAUTIONS: General). Use
of Accutane in this age group for severe recalcitrant nodular acne is supported by evidence from
a clinical study comparing 103 pediatric patients (13 to 17 years) to 197 adult patients (≥18
years). Results from this study demonstrated that Accutane, at a dose of 1 mg/kg/day given in
two divided doses, was equally effective in treating severe recalcitrant nodular acne in both
pediatric and adult patients.
In studies with Accutane, adverse reactions reported in pediatric patients were similar to those
described in adults except for the increased incidence of back pain and arthralgia (both of which
were sometimes severe) and myalgia in pediatric patients (see ADVERSE REACTIONS).
In an open-label clinical trial (N=217) of a single course of therapy with Accutane for severe
recalcitrant nodular acne, bone density measurements at several skeletal sites were not
significantly decreased (lumbar spine change >-4% and total hip change >-5%) or were increased
in the majority of patients. One patient had a decrease in lumbar spine bone mineral density
>4% based on unadjusted data. Sixteen (7.9%) patients had decreases in lumbar spine bone
mineral density >4%, and all the other patients (92%) did not have significant decreases or had
increases (adjusted for body mass index). Nine patients (4.5%) had a decrease in total hip bone
mineral density >5% based on unadjusted data. Twenty-one (10.6%) patients had decreases in
total hip bone mineral density >5%, and all the other patients (89%) did not have significant
decreases or had increases (adjusted for body mass index). Follow-up studies performed in 8 of
the patients with decreased bone mineral density for up to 11 months thereafter demonstrated
increasing bone density in 5 patients at the lumbar spine, while the other 3 patients had lumbar
spine bone density measurements below baseline values. Total hip bone mineral densities
remained below baseline (range –1.6% to -7.6%) in 5 of 8 patients (62.5%).
Geriatric Use: Clinical studies of isotretinoin did not include sufficient numbers of subjects aged
65 years and over to determine whether they respond differently from younger subjects.
Although reported clinical experience has not identified differences in responses between elderly
and younger patients, effects of aging might be expected to increase some risks associated with
isotretinoin therapy (see WARNINGS and PRECAUTIONS).
ADVERSE REACTIONS: Clinical Trials and Postmarketing Surveillance: The adverse
reactions listed below reflect the experience from investigational studies of Accutane, and the
postmarketing experience. The relationship of some of these events to Accutane therapy is
unknown. Many of the side effects and adverse reactions seen in patients receiving Accutane are
similar to those described in patients taking very high doses of vitamin A (dryness of the skin
and mucous membranes, eg, of the lips, nasal passage, and eyes).
Dose Relationship: Cheilitis and hypertriglyceridemia are usually dose related. Most adverse
reactions reported in clinical trials were reversible when therapy was discontinued; however,
some persisted after cessation of therapy (see WARNINGS and ADVERSE REACTIONS).
Body as a Whole: allergic reactions, including vasculitis, systemic hypersensitivity (see
PRECAUTIONS: Hypersensitivity), edema, fatigue, lymphadenopathy, weight loss
Cardiovascular: palpitation, tachycardia, vascular thrombotic disease, stroke
Endocrine/Metabolic: hypertriglyceridemia (see WARNINGS: Lipids), alterations in blood sugar
levels (see PRECAUTIONS: Laboratory Tests)
Gastrointestinal: inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease),
hepatitis (see WARNINGS: Hepatotoxicity), pancreatitis (see WARNINGS: Lipids), bleeding
and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other
nonspecific gastrointestinal symptoms
Hematologic: allergic reactions (see PRECAUTIONS: Hypersensitivity), anemia,
thrombocytopenia, neutropenia, rare reports of agranulocytosis (see PRECAUTIONS:
Information for Patients and Prescribers). See PRECAUTIONS: Laboratory Tests for other
hematological parameters.
Musculoskeletal: skeletal hyperostosis, calcification of tendons and ligaments, premature
epiphyseal closure, decreases in bone mineral density (see WARNINGS: Skeletal),
musculoskeletal symptoms (sometimes severe) including back pain and arthralgia (see
PRECAUTIONS: Information for Patients and Prescribers), transient pain in the chest (see
PRECAUTIONS: Information for Patients and Prescribers), arthritis, tendonitis, other types of
bone abnormalities, elevations of CPK/rare reports of rhabdomyolysis (see PRECAUTIONS:
Laboratory Tests)
Neurological: pseudotumor cerebri (see WARNINGS: Pseudotumor Cerebri), dizziness,
drowsiness, headache, insomnia, lethargy, malaise, nervousness, paresthesias, seizures, stroke,
syncope, weakness
Psychiatric: suicidal ideation, suicide attempts, suicide, depression, psychosis, aggression,
violent behaviors (see WARNINGS: Psychiatric Disorders), emotional instability
Of the patients reporting depression, some reported that the depression subsided with
discontinuation of therapy and recurred with reinstitution of therapy.
Reproductive System: abnormal menses
Respiratory: bronchospasms (with or without a history of asthma), respiratory infection, voice
alteration
Skin and Appendages: acne fulminans, alopecia (which in some cases persists), bruising, cheilitis
(dry lips), dry mouth, dry nose, dry skin, epistaxis, eruptive xanthomas,7 flushing, fragility of
skin, hair abnormalities, hirsutism, hyperpigmentation and hypopigmentation, infections
(including disseminated herpes simplex), nail dystrophy, paronychia, peeling of palms and soles,
photoallergic/photosensitizing reactions, pruritus, pyogenic granuloma, rash (including facial
erythema, seborrhea, and eczema), sunburn susceptibility increased, sweating, urticaria,
vasculitis (including Wegener’s granulomatosis; see PRECAUTIONS: Hypersensitivity),
abnormal wound healing (delayed healing or exuberant granulation tissue with crusting; see
PRECAUTIONS: Information for Patients and Prescribers)
Special Senses: Hearing: hearing impairment (see WARNINGS: Hearing Impairment), tinnitus.
Vision: corneal opacities (see WARNINGS: Corneal Opacities), decreased night vision which
may persist (see WARNINGS: Decreased Night Vision), cataracts, color vision disorder,
conjunctivitis, dry eyes, eyelid inflammation, keratitis, optic neuritis, photophobia, visual
disturbances
Urinary System: glomerulonephritis (see PRECAUTIONS: Hypersensitivity), nonspecific
urogenital findings (see PRECAUTIONS: Laboratory Tests for other urological parameters)
Laboratory: Elevation of plasma triglycerides (see WARNINGS: Lipids), decrease in serum
high-density lipoprotein (HDL) levels, elevations of serum cholesterol during treatment
Increased alkaline phosphatase, SGOT (AST), SGPT (ALT), GGTP or LDH (see WARNINGS:
Hepatotoxicity)
Elevation of fasting blood sugar, elevations of CPK (see PRECAUTIONS: Laboratory Tests),
hyperuricemia
Decreases in red blood cell parameters, decreases in white blood cell counts (including severe
neutropenia and rare reports of agranulocytosis; see PRECAUTIONS: Information for Patients
and Prescribers), elevated sedimentation rates, elevated platelet counts, thrombocytopenia
White cells in the urine, proteinuria, microscopic or gross hematuria
OVERDOSAGE: The oral LD50 of isotretinoin is greater than 4000 mg/kg in rats and mice
(>600 times the recommended clinical dose of 1.0 mg/kg/day after normalization of the rat dose
for total body surface area and >300 times the recommended clinical dose of 1.0 mg/kg/day after
normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in
rabbits (653 times the recommended clinical dose of 1.0 mg/kg/day after normalization for total
body surface area). In humans, overdosage has been associated with vomiting, facial flushing,
cheilosis, abdominal pain, headache, dizziness, and ataxia. All symptoms quickly resolved
without apparent residual effects.
Accutane causes serious birth defects at any dosage (see boxed CONTRAINDICATIONS AND
WARNINGS). Females of childbearing potential who present with isotretinoin overdose must be
evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to
the fetus, as described in the boxed CONTRAINDICATIONS AND WARNINGS. Non-pregnant
patients must be warned to avoid pregnancy for at least one month and receive contraceptive
counseling as described in the boxed CONTRAINDICATIONS AND WARNINGS. Educational
materials for such patients can be obtained by calling the manufacturer. Because an overdose
would be expected to result in higher levels of isotretinoin in semen than found during a normal
treatment course, male patients should use a condom, or avoid reproductive sexual activity with a
female who is or might become pregnant, for 30 days after the overdose. All patients with
isotretinoin overdose should not donate blood for at least 30 days.
DOSAGE AND ADMINISTRATION: Accutane should be administered with a meal (see
PRECAUTIONS: Information for Patients and Prescribers).
The recommended dosage range for Accutane is 0.5 to 1.0 mg/kg/day given in two divided doses
with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1.0 mg/kg/day,8 it was found
that all dosages provided initial clearing of disease, but there was a greater need for retreatment
with the lower dosages. During treatment, the dose may be adjusted according to response of the
disease and/or the appearance of clinical side effects — some of which may be dose related.
Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk
may require dose adjustments up to 2.0 mg/kg/day, as tolerated. Failure to take Accutane with
food will significantly decrease absorption. Before upward dose adjustments are made, the
patients should be questioned about their compliance with food instructions.
The safety of once daily dosing with Accutane has not been established. Once daily dosing is not
recommended.
If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks
of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and
if warranted by persistent or recurring severe nodular acne, a second course of therapy may be
initiated. The optimal interval before retreatment has not been defined for patients who have not
completed skeletal growth. Long-term use of Accutane, even in low doses, has not been studied,
and is not recommended. It is important that Accutane be given at the recommended doses for
no longer than the recommended duration. The effect of long-term use of Accutane on bone loss
is unknown (see WARNINGS: Skeletal: Bone Mineral Density, Hyperostosis, and Premature
Epiphyseal Closure).
Contraceptive measures must be followed for any subsequent course of therapy (see boxed
CONTRAINDICATIONS AND WARNINGS).



Re: from the accutane info sheet (Archive in acne.)

Posted by Walt Stoll on February 16, 2003 at 06:53:12:

In Reply to: from the accutane info sheet posted by researcher on February 15, 2003 at 13:06:08:

Thanks, Researcher.

And that does not even include the section about Contraindications & Warnings?

Namaste`

Walt

Follow Ups:


Re: Starting Accutane

Posted by
Karen on February 16, 2003 at 19:45:42:

In Reply to: Re: Starting Accutane posted by Mary on February 15, 2003 at 00:04:24:

Calvin,
I was absolutely CRAZY about a boy in high
school who had bad acne. He was so shy and insecure
that he never noticed the girls that thought he was "to
die for." I can really feel for you as I developed acne
myself in my late 20's and it occupied my every waking
thought. It eventually cleared up, but I understand how
you feel. Physical health is important so if you can hold
off for a couple of more years it will improve. Mental
health is important too so don't commit suicide over
your skin. If you are desperate then try the accutane. If
you can hold off a little longer then try what Dr Stoll has
to offer.
I wish I could help you more.

Karen

Follow Ups:


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