US Pharm. 2006;10:80.

E. coli Outbreak Traced to Natural Selection Foods
All spinach implicated in the recent Escherichia coli O157:H7 outbreak has been traced to Natural Selection Foods LLC of San Juan Bautista, California, FDA reported in late September. Furthermore, an investigation coordinated by the CDC and involving epidemiological and laboratory evidence obtained by multiple states showed that spinach processed by other manufacturers does not pose a danger of E. coli infection.

Natural Selection Foods issued a recall of all implicated products on September 15, while four other companies (i.e., Pacific Coast Fruit of Portland, Oregon; Triple B Corporation, doing business as S.T. Produce, of Seattle; RLB Food Distributors, L.P., of West Caldwell, New Jersey; and River Ranch of Salinas, California) initiated voluntary secondary recalls of products that contained recalled spinach from Natural Selection Foods.

According to FDA, central California has had a long history of E. coli outbreaks involving leafy greens. The agency and the state of California expect the greens industry to develop a comprehensive plan to minimize the risk of another E. coli outbreak.

To learn more about the E. coli outbreak, visit the FDA's Web site at www.fda.gov/oc/opacom/hottopics/spinach.html.

Ortho Evra Associated with Blood Clot Risk
Ortho's birth control patch, Ortho Evra (norelgestromin/ethinyl estradiol), has been linked to nonfatal venous thromboembolism (VTE), according to its manufacturer and the FDA. The agency reported that two separate studies found that Ortho Evra increased the risk of VTE, despite having differing results. One study found that the risk of VTE associated with Ortho Evra use was similar to that associated with use of oral contraceptive pills containing 35 mcg of ethinyl estradiol and norgestimate. However, the second study found an approximate twofold increase in the risk of VTE events in those using the patch compared to those taking norgestimate-containing oral contraceptives with 35 mcg of estrogen.

Women with health concerns or risk factors for thromboemboli disease should talk to their health care professionals about using Ortho Evra versus other forms of birth control, the FDA advised, reiterating a statement contained in the product's prescribing information.

Lead Screening Test's Availability Broadened
A decision to increase the availability of a portable lead test system to more than 115,000 certified point-of-care locations should allow children and adults to be tested and treated for lead poisoning easier and faster, FDA recently announced.

The LeadCare II Blood Lead Test System, manufactured by ESA Biosciences, is used to screen for harmful levels of lead using a finger stick or venous whole blood sample. It produces results within three minutes of testing.

Because FDA broadened access to the test by granting an application to categorize the test as waived under the Clinical Laboratory Improvement Amendment, the test can now be administered in health care clinics, mobile health units, and schools.

Avastin Linked to Rare Neurologic Disorder
Cases of reversible posterior leukoencephalopathy syndrome (RPLS) have been reported in patients taking Genentech's Avastin (bevacizumab), according to FDA. Symptoms of the brain-capillary leak syndrome have been reported from 16 hours to one year following initiation of the metastatic colorectal cancer drug.

RPLS is a rare neurologic disorder associated with hypertension, fluid retention, and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. Symptoms include headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances.

According to FDA, there have also been reports of nasal septum perforation in patients taking Avastin. Seven patients have experienced this adverse effect, stated Genentech in a letter to health care professionals.

Both adverse effects have been added to Avastin's prescribing information.

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