"The US Food and Drug Administration (FDA) today approved asfotase alfa (Strensiq, Alexion Pharmaceuticals) as the first-ever therapy for patients who develop hypophosphatasia, a rare metabolic bone disorder, in childhood.
Very rare: Vesiculation, ulceration or necrosis may appear at the test site in highly sensitive persons. Cold packs or topical steroid preparations may be employed for symptomatic relief of the associated pain, pruritus and discomfort.
Strongly positive reactions may result in scarring at the test site.
Uncommon: Immediate erythematous or other reactions may occur at the injection site. The reason(s) for these occurences are presently unknown.
Rare: There have been rare systemic allergic reactions reported that were manifested by immediate skin rash or generalized rash within 24 hours. Two of the reported cases had concurrent symptoms of upper respiratory stridor. These reactions were treated with epinephrine and steroids and resolved. No cause and effect was able to be established with a specific component of skin test.27
Reporting of Adverse Events
Reporting by patients, parents or guardians of all adverse events occuring after a tuberculin skin test should be encouraged. Adverse events following the test should be reported by the health-care provider to the Food and Drug Administration (FDA) MEDWATCH Program at 1-800-332-1088.28
The health-care provider also may report these events to the Director of Medical Affairs, Aventis Pasteur Inc., Discovery Drive, Swiftwater, PA 18370-0187 or call 1-800-822-2463.
Read the Tubersol (tuberculin purified protein) Side Effects Center for a complete guide to possible side effects
Reactivity to the test may be depressed or suppressed for up to 6 weeks in individuals who are receiving corticosteroids or immunosuppressive agents.12
Reactivity to PPD may be temporarily depressed by certain live virus vaccines (measles, mumps, rubella, oral polio, yellow fever, and varicella). Therefore, if a tuberculin test is to be performed, it should be administered either before or simultaneously, at separate sites, with these vaccines in combined form or as separate antigens, or testing should be postponed for 4-6 weeks.8,25
8. American Academy of Pediatrics. Peter G,ed. 2000 Red Book: Report of the Committee on Infectious Diseases. 25th ed. Elk Grove Village, IL: American Academy of Pediatrics.2000.
12. Brickman HF, et al. The timing of tuberculin tests in relation to immunization with live viral vaccines. Pediatrics:1975;55:392-396.
25. National Advisory Committee on Immunization: Canadian Immunization Guide, Fifth Edition. Minister of Public Works and Government Services Canada.1998.
27. Data on file; Aventis Pasteur Inc.
28. Centers for Disease Control and Prevention (CDC). Manual for Surveillance of Vaccine-Preventable Diseases. Chapter 18: Surveillance for adverse events following vaccination September 1997.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2009
Additional Tubersol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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