** FDA Safety and Adverse Event Warning**

Carbamazepine and Patients of Asian Ancestry
(Carbatrol®, Equetro®, Tegretol® and generics)

On December 12, 2007, the Food and Drug Administration (FDA) issued a Safety Information and Adverse Event Report regarding the use of Carbamazepine and the development of dangerous and even fatal skin reactions (Steven Johnson syndrome and toxic epidermal necrolysis) in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502. The HLA-B*1502 allele occurs almost exclusively in patients with ancestry across Asia, including South Asian Indians.

The FDA is recommending that patients of Asian ancestry be screened for the presence of the HLA-B*1502 allele before starting treatment with Carbamazepine. If the test is positive, then therapy with Carbamazepine should not be used unless the expected benefit clearly outweighs the increased risk of serious skin reactions.

Patients who have been taking Carbamazepine for more then a few months without developing skin reactions are at low risk for these events, even for patients of any ethnicity or genotype, including patients positive for the HLA-B*1502 allele.

For more information, please refer to the information listed on the Food and Drug Administration’s Web site.

http://www.fda.gov/medwatch/safety/2007/safety07.htm#carbamazepine

Scope and Target Population:

This guideline addresses the management of acne vulgaris for all patients. It emphasizes initial diagnosis and treatment options. It provides clinical guidance especially to primary care physicians. Treatment of rare forms of acne and of refractory disease are not included except to indicate when referral is appropriate. This guideline excludes rosacea and folliculitus.

Clinical Highlights and Recommendations:

• Patient perception of improvement is the best measure of successful treatment.
  
• Although acne is not a life threatening disease, the clinician must be aware of potentially debilitating psychosocial effects.
  
• Treatment with both a topical retinoid and a topical antibiotic has been found to be an effective course of treatment.
  
• Customize a treatment plan that the patient will be able to follow according to his/her needs.
  
• The patient needs to understand that acne may get worse before it gets better. It typically takes eight weeks of treatment before a response is noted.
  
• Isotretinoin therapy is highly regulated.

Priority Aims:

1. Improve the selection of appropriate treatment for patients with acne based on severity.
   
2. Increase the number of patients who report satisfaction with the treatment of their acne.
   
3. Increase the number of patients with appropriate follow-up for acne treatment.