Teva Pharma Recalls Anti-Anxiety Drug Propofol

" ... Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible ... "

Press Trust of India
New York
July 17, 2009

US drug maker Teva Pharmaceuticals has voluntarily recalled Propofol Injectable -- a drug used in the treatment of anxiety -- following incidents of side effects on patients.

According to the US health regulator Food and Drug Administration (FDA), Teva Pharmaceuticals USA "is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials..."

The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers, the FDA said in a statement on Thursday.

"Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms," the statement noted.

The FDA said adverse health effects, such as fever, chills, or rigors, are possible with exposure to product (Propofol) with elevated levels of endotoxins.

"Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels," it added.

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