The United States: Primus announces a voluntary nationwide recall of all lots within expiry of prescription medical food Limbrel® due to rare but serious and reversible adverse events while seeking FDA's cooperation to restore access for patients with medical necessity (English Only)
 
The US Food and Drug Administration (FDA) announces that Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. All lots within expiry of the following products are included in this recall: 
- Limbrel (flavocoxid) 250mg capsules 
- Limbrel250 (250mg flavocoxid with 50mg citrated zinc bisglycinate) capsules 
- Limbrel (flavocoxid) 500mg capsules 
- Limbrel500 (500mg flavocoxid with 50mg citrated zinc bisglycinate) capsules 

Limbrel has been marketed since 2004 as a medical food available only by prescription for patients under active and ongoing supervision of a physician for the dietary management of osteoarthritis (OA), a degenerative disease of the joints and the most common form of arthritis. 

Between 1 Jan 2007 and 9 Nov 2017, FDA received 30 adverse event reports of elevated liver function tests or acute hypersensitivity pneumonitis associated with the use of Limbrel products. These conditions present in rare cases with varying degrees of severity in patients taking Limbrel for the first time in the initial weeks of exposure, and may go unnoticed by the patient until they consult with their physician or until symptoms develop that require hospitalization. There have been no deaths reported with the use of Limbrel, and in all reported cases adverse effects resolved without residual effects after discontinuing use of the product. 

Primus retained independent medical and former senior FDA safety experts to conduct a further investigation of these cases and the ingredients in Limbrel. It is the opinion of these experts based on a thorough review of the medical literature, adverse event reports to FDA, and FDA's health hazard evaluation that there is no basis on which to conclude that Limbrel potentially causes life-threatening adverse effects, and that none of the reported adverse events show liver failure or respiratory failure. Nonetheless, in an effort to cooperate with FDA, Primus voluntarily ceased its promotion and distribution of Limbrel on 21 Dec 2017, and is now recalling Limbrel as FDA has requested. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm594357.htm 

In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by FDA, and was posted on the Drug Office website on 22 Nov 2017 and 6 Dec 2017. 

Ends/Tuesday, Jan 30, 2018 
Issued at HKT 15:00 

轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/