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flavocoxid (Limbrel)
Not a prescription medication
Not an over-the-counter medication
Not a dietary supplement
Not a COX-2 inhibitor
FDA recommends stop taking, contact health provider [4]
Indications:
- marketed to treat metabolic processes associated with osteoarthritis
Dosage:
- Limbrel250, Limbrel500
Complications:
- reversible hepatotoxicity [2,4]; 4 cases (0.01%)
- all cases in women [2]
- incidence may be higher than that previously reported [4]
- hypersensitivity pneumonitis [4]
Mechanism of action:
1) extract containing plant flavanoids
- baicalin (from Scutellaria baicalensis) & catechin (from Acacia catechu)
- also contains zinc
2) no proof of effectiveness
Notes: cost $90/month
General
pharmaceutical herb; medicinal herb; herbal supplement; botanical
References
- Prescriber's Letter 12(5): 2005
Medical Food: Limbrel
Detail-Document#: 210515
(subscription needed) http://www.prescribersletter.com
- Chalasani N et al
Acute Liver Injury due to Flavocoxid (Limbrel), a
Medical Food for Osteoarthritis: A Case Series
Ann Intern Med. 19 June 2012;156(12):857-860
PMID: 22711078
http://annals.org/article.aspx?articleid=1183011
- Reichenbach S and Juni P
Medical Food and Food Supplements: Not Always as Safe
as Generally Assumed
Ann Intern Med. 19 June 2012;156(12):894-895
PMID: 22711083
http://annals.org/article.aspx?articleid=1183012
- Prescriber's Letter 19(9): 2012
Liver Toxicity and Limbrel
Detail-Document#: 280907
(subscription needed) http://www.prescribersletter.com
- FDA Safety Watch. Nov 21, 2017
Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory -
Linked to Potentially Life-Threatening Health Problems.
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm586111.htm
- Limbrel Product Information
http://www.limbrel.com/downloads/limbrel_pi.pdf
Components
medroxyprogesterone actetate; acetoxymethylprogesterone (Provera, Cycrin, Amen)