All Posts Tagged With: "Heparin"
Contaminated Heparin Seized by the FDA
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant [...]
Popularity: 17% [?]
7Nov2008 | PharmaWatchDog | 0 comments | Continued
Tainted Heparin Kills 62
The FDA said today there have been 62 fatal allergic reactions following the use of contaminated heparin.
In the 15 months from Jan. 1, 2007 through March 31, 2008, the FDA received reports of 103 deaths following heparin use, but only 62 of the deaths were linked to one or more allergic reactions, including severe hypotension, [...]
Popularity: 61% [?]
9Apr2008 | PharmaWatchDog | 0 comments | Continued
FDA Missed Heparin Plant Inspection in China
A mix-up with similar names meant the FDA did not inspect a Chinese plant that makes the active ingredient in the heparin products linked to a recent spike in adverse events.
The mix-up wasn’t discovered until recently and an FDA inspection team is now headed to China to remedy the lapse, FDA officials said today [...]
Popularity: 47% [?]
19Feb2008 | PharmaWatchDog | 1 comment | Continued
Heparin Sodium Injection Serious Adverse Events
FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for [...]
Popularity: 48% [?]
18Feb2008 | PharmaWatchDog | 1 comment | Continued
