Drug update: systemic acne treatments for women

OB/GYN News, August 1, 2002 by Mitchel L. Zoler, Heidi Splete

Drug                      Daily Dosage         Cost/Day *

norgestimate and ethinyl  180-250 [micro]g     $1.11
 estradiol                norgestimate and 35
 (Ortho Tri-Cyclen)       [micro]g ethinyl
                          estradiol

norethindrone acetate     1 mg norethindrone   $1.18
 and ethinyl estradiol    acetate and 20-35
 (Estrostep)              [micro]g ethinyl
                          estradiol








levonorgestrel and        100 [micro]g         $1.13
 ethinyl estradiol        levonorgestrel and
 (Alesse)                 20 [micro]g ethinyl
                          estradiol






Drug                      Comment **

norgestimate and ethinyl  First birth control pill with FDA
 estradiol                approval for acne. Contains 35 [micro]g
 (Ortho Tri-Cyclen)       of estrogen. Generally well tolerated.


norethindrone acetate     Approved by the FDA for treating
 and ethinyl estradiol    moderate acne. Formulated so that
 (Estrostep)              ethinyl estradiol dose rise as pills
                          are used during a cycle, starting at 20
                          [micro]g/day early in cylce and
                          increasing to 30 [micro]g/day and then
                          to 35 [micro]g/day. May be better
                          tolerated in some women than
                          alternative formulations. Currently
                          the lowest estrogen does with FDA
                          approval for acne.

levonorgestrel and        Application for acne indication
 ethinyl estradiol        submitted to FDA in January 2001;
 (Alesse)                 approval expected this year. Delivers
                          20 [micro]g of ehtinyl estradiol daily
                          throughout cycle, making it the
                          lowest-estrogen formulation. May be
                          better tolerated in women with
                          bloating or nausea on higher-dose
                          formulations.

OTHER SYSTEMIC AGENTS

Drug                      Daily Dosage         Cost/Day *

tetracycline              1 g                  $0.22























doxycycline               150 mg               $0.87
                                               (doxycycline
                                               hyclate);
                                               $3.72
                                               (doxycycline
                                               monohydrate)














minocycline               75-100 mg            $4.66
                                               (100 mg b.i.d.)









isotretinoin              1-2 mg/kg            419.50
(Accutane)                                     (40 mg b.i.d.)



























Drug                      Comment **

tetracycline              Effective for moderate inflammatory
                          acne, but an oral contraceptive may be
                          a better choice if acne seems to have
                          a hormonal influence. Tetracycline
                          resolves moderate acne, precluding need
                          for isotretinoin, which has more side
                          effects. Some patients have success
                          using tetracycline plus birth control
                          pills. May disrupt effectiveness of
                          birth control pills, so additional
                          conctraception should be used.
                          Tetracycline dosage varies widely.
                          Patients whose acne is mostly under
                          control can get by on 250 mg/day. Avoid
                          in women who are pregnant or breast-
                          feeding and in women taking
                          isotretinoin; not recommended for women
                          over 40 with vascular problems. Can't
                          be taken immediately before or after
                          eating, which makes compliance
                          challenging. May cause
                          photosensitivity, so patients on
                          tetracycline must use sun protection.

doxycycline               Tetracycline-related antibiotic that's
                          more convenient for some patients since
                          it can be taken with food and milk.
                          Taking at breakfast and dinner
                          increases compliance, although taking
                          at bedtime can cause indigestion.
                          Downside is more pronounced
                          phototoxicity than tetracycline and
                          higher cost. Can't be prescribed to
                          patients taking isotretinoin. May
                          disrupt effectiveness of birth control
                          pills, so additional contraception
                          should be used. Two forms of
                          doxycycline exist: the hyclate salt
                          and the monohydrate salt. Safety and
                          efficacy are similar, but there is a
                          substantial price difference and the
                          monohydrate causes fewer
                          gastrointestinal side effects.

minocycline               Most recent drug available in
                          tetracycline class. More effective
                          than other drugs in class, but also
                          more expensive. Reports of liver
                          toxicity and photosentivity with use.
                          Usually reserved for acne that does
                          not respond to other antibiotics.
                          May disrupt effectiveness of birth
                          control pills, so additional
                          contraception should be used.

isotretinoin              Very effective for treating nodular
(Accutane)                cystic acne but has most severe side
                          effects of any systemic acne
                          treatment. Discuss potential adverse
                          effects thoroughly with patients
                          before prescribing. Because of
                          teratogenic risk, women of child-
                          bearing age taking isotretinoin should
                          use two forms of contraception to
                          prevent pregnancy. If patient isn't
                          already using an oral contracetive,
                          physician may want to suggest a
                          formulation approved for acne
                          treatment. To curb the number of women
                          who become pregnant while on
                          isotretinoin, the manufacturer launched
                          an intensive education and control
                          program early this year aimed at
                          physicians and pharmacists. Dosage is
                          divided and taken twice a day; course
                          of treatment is about 5 months. If side
                          effects appear, lower the daily dosage
                          and extend the treatment period to
                          deliver the full regimen. Patients
                          on isotretinoin must avoid
                          tetracycline, doxycycline, and
                          minocycline, which raise the risk of
                          pseudotumor cerebri.

* Cost/day is based on the average wholesale price in the 2001 Red Book
for a 100-unit container or closest available size of the generic
formulation, unless otherwise specified.

** Comments reflect the opinions and expertise of the following sources:
Dr. Diane Berson, director of dermatology, Iris Cantor Women's Health
Center, and assistant professor of dermatology, Cornell University, New
York.

Dr. Julia R. Nunley, associate professor of dermatology, Virginia
commonwealth University, Richmond.

Dr. Alan R. Shalita, chairman and distinguished teaching professor,
department of dermatology, State University of New York Downstate
Medical Center, Brooklyn.

Dr. James C. Shaw, associate professor, division of dermatology,
University of Toronto.