News Scan for Aug 19, 2013

Two MERS cases in Saudi Arabia
Cyclospora total reaches 600
FDA renews sterile product warning

Report: Saudi Arabia has two more MERS cases

Saudi Arabia has identified two more cases of MERS-CoV (Middle East respiratory syndrome coronavirus) infection, according to a brief, machine-translated report today from the Saudi Ministry of Health (MOH). They are the first cases reported since Aug 1.

The two cases are in the Riyadh region, according to the report, which was posted on FluTrackers, an infectious disease message board. The patients are 50 and 59 years old, have multiple chronic diseases, and are being treated in hospital intensive care units.

The translated statement gave no information on the patients' gender, illness onset dates, occupations, or possible exposures.

The illnesses raise Saudi Arabia's MERS total to 76 cases, with 39 deaths, according to translated MOH information. The global count of MERS cases has now reached 96, of which 47 have been fatal, according to the US Centers for Disease Control and Prevention. The new cases have not yet been noted by the World Health Organization.

Of the three latest cases reported before today, two were in the Riyadh region.
Aug 19 translated report via FluTrackers


US Cyclospora infections surpass 600

The US Centers for Disease Control and Prevention (CDC) today said it has received reports of 10 more Cyclospora infections, including the first case reported from Tennessee. The additional cases raise the CDC's national total to 586 and the number of affected states to 20.

Health officials in Texas, the state with the most infections, in an update said 267 infections have been reported there, which is 23 more than the CDC's count for that state. Including those cases boosts the nation's total to 609.

Of 440 patients with available information, 36 (8%) were hospitalized, the CDC said. Patient ages range from 1 to 92 years, with a median of 51 Fifty-five percent of patients are female. The latest illness onset was Jul 31, though most patients got sick from the middle of June through early July.

It's still not clear if cases in all of the states are related to outbreaks in Iowa and Nebraska, where restaurant-related clusters of infections were linked to a bagged lettuce mixture supplied by a Taylor Farms facility in Mexico.
Aug 19 CDC update
Aug 19 Texas update

FDA repeats warning about NuVision's sterile products

The US Food and Drug Administration (FDA) recently reminded health providers that they should not administer any sterile products made and distributed by NuVision Pharmacy, a compounder based in Dallas. In an Aug 16 statement, the FDA said its latest advisory is related to a May 18 recommendation that healthcare staff check their supplies for the company's sterile products and refrain from using them.

The FDA sent a letter to the company in July outlining poor sterile production practices observed by its inspectors in April and asking the company to recall all of its sterile products that haven't passed their expiration dates.

In April the company recalled methylcobalamin injection and lyophilized injection products because of inspection problems and FDA reports of fever, flu-like illness, and injection-site soreness related to one of the recalled products. However, the FDA said the company has refused to recall its other sterile products and that the agency can't require the company to take the step.

A statement on NuVision's Web site says the FDA is inspecting compounding pharmacies using standards for manufacturers and that it is not a manufacturer. The firm said it is in compliance with standards for compounding pharmacies and that state laws don't require compounding pharmacies to follow manufacturing standards. The company also says its injectables are tested by a third-party lab before dispensing and that it is not recalling all of its sterile injectables.
Aug 16 FDA announcement
NuVision statement


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