Blockage of flow of blood in vessels can be life-threatening.
(PRWEB) June 03, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on safety alerts for Soliris (eculizumab).
The FDA announced on June 2, that certain lots of Soliris (eculizumab) Concentrated Solution for IV Infusion, by Alexion, are recalled due to visible particulates. Soliris (eculizumab) is used to treat two ultra-rare and life-threatening disorders: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
FDA’s reason for the recall is based on visible particulates that, if administered, can pose a potential safety risk in immune reaction and blood clots. Blockage of flow of blood in vessels can be life-threatening.
The recalled lots are: 10007A, 10002-1, 00006-1, 10003A, 10004A, 10005A, 10005AR, 10006A and 10008A.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds “we are determined to keep an eye on FDA announcements concerning Soliris (eculizumab) and inform the public. For that reason", he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
The US FDA advises “Any person in possession of vials of Soliris from these lots should stop use and arrange for return of the product to Alexion immediately.” And the Agency adds “Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Unaffected lot numbers can continue to be used according to the instructions for use.”
AttorneyOne.com has further information on Soliris (eculizumab) at the website including latest major drug and medical products law news.
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