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Accutane (isotretinoin)

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Accutane may cause bone spurs (osteophytes) (several case(s)).

This drug may also cause the following symptoms that are related to bone spurs:

Bone spurs of the nose (single case)

Medical Source Information
Yellow highlights indicate symptoms related to bone spurs.

Musculoskeletal side effects have included skeletal hyperostosis; calcification of tendons and ligaments; premature epiphyseal closure; decreased bone mineral density; musculoskeletal symptoms (sometimes severe) including back pain, myalgia, and arthralgia; transient chest pain; arthritis; tendonitis; other types of bone abnormalities; elevated creatine phosphokinase; and rare postmarketing reports of rhabdomyolysis. Muscular and joint pain, mild to moderate in severity, generally resolved following discontinuation of therapy. Spontaneous reports of osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have been reported. At least one case of myositis and several cases of osteophytes have been reported.

Osteophytes generally form in the axial skeleton, especially the cervical spine, of patients receiving long-term therapy. Osteophytes also occur more frequently in patients receiving dosages greater than 2 mg/kg/day. One patient with a previous rhinoplasty experienced bilateral nasal bone osteophytes after five weeks of isotretinoin therapy. Myalgias and arthralgias that are mild and transient generally do not require discontinuation of therapy. Many patients with myalgias also have small hyperostotic lesions of the spine. One patient, treated with isotretinoin for promyelocytic leukemia, developed myositis, fever, and pleural effusion that slowly resolved after isotretinoin was discontinued. Causality for osteoporosis, osteopenia, bone fractures, and delayed healing of bone fractures have not been established, although an effect cannot be ruled out. Longer term effects have not been studied.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:

aggressive/violent behavior, psychosis/schizophrenia, depression or mood disturbances
Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)

Lab and Diagnostic Tests
If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them):

Monitor sugar, liver function tests and liver function tests
Hearing test (including tests for high frequency hearing loss) if hearing loss is suspected or if ringing of the ears occurs
Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash

References

Musculoskeletal syndromes associated with acne. Knitzer RH, Needleman BW Semin Arthritis Rheum 1991;20:247-55.
Strenuous exercise with isotretinoin. Del Campo DV J Am Acad Dermatol 1984;11:301.
Analysis of common side effects of isotretinoin. McLane J J Am Acad Dermatol 2001;45:S188-94.
Isotretinoin has yet to be shown to affect bone density. Whitmore SE Arch Dermatol 2000;136:424.
Severe acute myopathy induced by isotretinoin. Fiallo P, Tagliapietra AG Arch Dermatol 1996;132:1521-2.
Isotretinoin effects on bone. DiGiovanna JJ J Am Acad Dermatol 2001;45:S176-82.
Skeletal toxicity with isotretinoin therapy: a clinico-radiological evaluation. Carey BM, Parkin GJ, Cunliffe WJ, Pritlove J Br J Dermatol 1988;119:609-14.
Isotretinoin. A review of its pharmacological properties and therapeutic efficacy in acne and other skin disorders. Ward A, Brogden RN, Heel RC, Speight TM, Avery GS Drugs 1984;28:6-37.
Adverse reactions to isotretinoin. A report from the Adverse Drug Reaction Reporting System. Bigby M, Stern RS J Am Acad Dermatol 1988;18:543-52.
Isotretinoin: a reappraisal. Conner CS Drug Intell Clin Pharm 1984;18:308-9.
Long-term safety of isotretinoin as a treatment for acne vulgaris. Goulden V, Layton AM, Cunliffe WJ Br J Dermatol 1994;131:360-3.
Elevated creatine phosphokinase with isotretinoin. McBurney EI, Rosen DA J Am Acad Dermatol 1984;10:528-9.
Myositis with tretinoin. Miranda N, Oliveira P, Frade MJ, Melo J, Marques MS, Parreira A Lancet 1994;344:1096.
Isotretinoin: new therapy for severe acne. Perry MD, McEvoy GK Clin Pharm 1983;2:12-9.
Product Information. Accutane (isotretinoin). Anonymous Roche Laboratories, Nutley, NJ. PROD;
Achilles and suprapatellar tendinitis due to isotretinoin. Rodriguez IH, Allegue F J Rheumatol 1995;22:2009-10.
Bilateral nasal bone osteophytosis associated with short-term oral isotretinoin therapy for cystic acne vulgaris. Novick NL, Lawson W, Schwartz IS Am J Med 1984;77:736-9.
How safe is oral isotretinoin? Meigel WN Dermatology 1997;195:22-8.
Evolution of skeletal hyperostoses caused by 13-cis-retinoic acid therapy. Pennes DR, Martel W, Ellis CN, Voorhees JJ AJR Am J Roentgenol 1988;151:967-73.
Enthesopathy of the patellar tendon insertion associated with isotretinoin therapy. Scuderi AJ, Datz FL, Valdivia S, Morton KA J Nucl Med 1993;34:455-7.
Acne fulminans with severe myalgia precipitated by isotretinoin therapy. Huston NR, Mules R N Z Med J 1985;98:821.

Multum version: 154.0 (Jun 16, 2010)

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