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July 2009
Acetaminophen, also known as N -acetyl-p-aminophenol (APAP), is one of the most commonly used drugs to relieve pain, colds and sore throats, and reduce fever. Familiar over-the-counter (OTC), products containing acetaminophen include Tylenol®, Excedrin®, Sudafed®, NyQuil® and Theraflu®.
The FDA’s advisory committee has recently voted to lower the maximum dose of non-prescription acetaminophen in efforts to protect the consumer from potential liver damage from unintentional over use of the drug.
The committee also voted to eliminate prescription acetaminophen-combination drugs, or at least strip the amount of acetaminophen contained in the drugs of which should carry a black-box warning; the severest safety label for prescription medications. Such combination prescription products include the painkillers Vicodin and Percocet which use hydrocodone and oxycodone in combination with acetaminophen.
More information on the advisory committee’s meeting may be obtained from the committee’s web page at:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm
Acetaminophen-induced liver toxicity occurs when the conjugative pathways of metabolism become saturated resulting in an inadequate supply of conjugating glutathione. The toxic metabolite, N -acetyl-p-benzoquinone-imine (NAPQI), causes oxidative and inflammatory damage with hepatocellular death, necrosis, and frank liver failure.
Adverse drug reactions are a major cause of morbidity and mortality worldwide. These reactions may be classified as either nonimmunologic, such as drug toxicity, or immune-mediated reactions. Of the later, the Gell and Coombs classification system offers a widely accepted conceptual framework for understanding the predominant immune mechanisms involved. “Drug allergy” is primarily reserved for Type I hypersensitivity reactions involving IgE. Type II and Type III hypersensitivity reactions involve antibodies, IgG or IgM for example, directed at drug-hapten coated cells, or tissue deposition of drug-antibody complexes, respectively. Clinical onset of Type II reactions are variable. Of Type III, timing of symptoms may range from 1-3 weeks after drug exposure. All immunologic drug reactions may present with involvement of any organ system.
Bear in mind, there are multiple mechanisms postulated for adverse drug reactions, many of which remain to be fully elucidated. Clinical evaluation should include a detailed history of all medications taken within the last month including dosage and temporal relationship to signs and symptoms. Laboratory testing of specific antibodies may aid in the assessment of drug sensitization.
Available Now! - Painkiller Antibody Assessment Panel
through Serum & Finger stick
■ Acetaminophen ■ Acetylsalicylic acid ■ Ibuprofen
To view complete test panel information please click here.
Park, Alice. (Jul. 3, 2009). The FDA and painkillers: what’s safe now?
TIME from http://www.time.com/time/health/article/0,8599,1908408,00.html
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