** 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:The guideline will address the management of chronic pain for physiologically mature adolescents (between 16-18 years) and adults. It can be applied to pediatric populations where noted. It is not intended for the treatment of migraine headaches, cancer pain, advanced cancer pain, or in the context of palliative care or end of life management.
Definitions
Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage (International Association for the Study of Pain).
Acute pain states can be brief, lasting moments or hours, or they can be persistent, lasting weeks or several months until the disease or injury heals. The condition has a predictable beginning, middle and end.
Chronic pain is defined as persistent pain, which can be either continuous or recurrent and of sufficient duration and intensity to adversely affect a patient's well-being, level of function, and quality of life. This is not time dependent; however, at six weeks (or longer than the anticipated healing time) patients should be thoroughly evaluated for the presence of chronic pain. At the end of the spectrum of chronic pain, is
Chronic Pain Syndrome – the work group defines this as a constellation of behaviors related to persistent pain that represents significant life role disruption.
Clinical Highlights and Recommendations:- Chronic pain is separate from acute pain and is a difficult clinical problem to treat.
- Chronic pain is a persistent, life-altering condition. The target is management, not elimination.
- A patient-centered, multifactorial, comprehensive care plan is necessary, one that includes addressing biopsychosocial factors. Addressing spiritual and cultural issues is also important. It is important to have a multidisciplinary team approach coordinated by the primary care physician to lead a team including specialty areas of psychology and physical rehabilitation.
- The goal of treatment is an emphasis on improving function through the development of long-term, self-management skills including fitness and a healthy lifestyle.
- Medications are not the primary focus of treatment in managing pain.
Priority Aims:- Improve the treatment of patients with chronic pain by completing an appropriate biopsychosocial assessment.
- Improve the function of patients with chronic pain by developing and using a comprehensive treatment plan that includes a multispecialty team approach.
- Improve the effective use of medications in the treatment of patients with chronic pain.
- Ensure the appropriate use of interventional techniques as per guideline and technology assessment reports in the treatment of chronic pain.
