Alerts and Advisories

Health Alerts > 7/14/09 Drug Recall and West Nile virus

 

Propofol Voluntary Recall

 

The Centers for Disease Control and Prevention (CDC) and the Food and Drug

Administration (FDA) have been investigating recent cases of febrile reactions among patients undergoing endoscopy in the United States. This investigation has revealed that all of the case-patients received the anesthetic Propofol from 100 ml vials manufactured by Teva Pharmaceuticals.  Testing done by the FDA has found that two lots of this product that were in use in facilities reporting febrile reactions were positive for elevated levels of endotoxin.  To date, all case-patients have recovered.

The lots are 31305429B and 31305430B.

Teva Pharmaceuticals is initiating a voluntary recall for these lots, and clinicians are advised to immediately stop using these lots of Teva Pharmaceuticals Propofol. CDC, FDA and Teva Pharmaceuticals are continuing to investigate this issue.

 

West Nile Virus

We have identified our first positive sample of mosquitoes infected with West Nile virus.  We will be spraying for adult mosquitoes Tuesday evening in the Rothman road area.  Please visit our website for additional information.

Quick review of West Nile Virus:

The incubation period of West Nile encephalitis (WNE) is 1-6 days, perhaps as long as 14 days in immunosuppressed patients.

Symptoms

       Most people who are infected (at least most children) are asymptomatic or have a flu like illness. A minority of people develop neurologic disease.

       Many patients describe prominent GI symptoms, especially vomiting and diarrhea.

       Nonspecific symptoms may include sore throat, backache, myalgias, and arthralgias.

       Most patients with WNE present with features of encephalitis, aseptic meningitis (meningoencephalitis), or both.

       Symptoms include a mild febrile illness accompanied by headache, mental confusion, tremors, or flaccid paralysis.

       Symptoms are most prominent in very young and very old people.

Diagnosis (this is true for West Nile, Lacrosse or Powassan):

Confirmed case:

Four-fold or greater change in virus-specific serum antibody titer                 OR

Isolation of virus from or demonstration of specific viral antigen or genomic sequences in tissue, blood, CSF, or other body fluid                                                                                    OR

Virus-specific immunoglobulin M (IgM) antibodies demonstrated in CSF by antibody-capture enzyme immunoassay (EIA)                                                                                                      OR

Virus-specific IgM antibodies demonstrated in serum by antibody-capture EIA and confirmed by demonstration of virus-specific serum immunoglobulin G (IgG) antibodies in the same or a later specimen by another serologic assay (e.g., neutralization or hemagglutination inhibition). (This is the preferred method because it does not require the patient return for repeat titers and yet results in a confirmed case if both methods utilized result in positive tests)

 

Please call with any questions
Deb McMahan, MD  


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