US Pharm. 2008;33(2):11.
FDA Modifies Prescribing Information for Contraceptive Skin Patch
The FDA issued a notice that it modified the prescribing information for the Ortho Evra Contraceptive Transdermal Patch to include the results of a new epidemiological study that found women who used the birth control patch were at a higher risk of developing venous thromboembolism (VTE) than those who used birth control pills. VTE can lead to pulmonary embolism.
The FDA believes that Ortho Evra is a safe and effective method of contraception when used according to the labeling, which recommends that women with concerns or risk factors for serious blood clots talk with their health care provider before using the product.
Shingles Vaccination Reduces Postherpetic Neuralgia in Seniors
Research published in The Journal of Painrevealed that older patients who are admistered a shingles (herpes zoster) vaccination might also be minimizing their chances of developing a chronic pain condition known as postherpetic neuralgia.
Shingles affects approximately one million Americans every year. While antiviral therapies have improved the medical management of the condition, many patients still develop pain complications, most commonly postherpetic neuralgia. According to the study, vaccinated patients had a 51% reduction in the incidence of herpes zoster and a 61% reduction in the onset of shingles versus the placebo group. In addition, the rate of post!=herpetic neuralgia was 66% lower in the vaccinated group. The herpes zoster vaccine was approved by the FDA in 2006 and is indicat!=ed for the prevention of shingles in individuals age 60 and older.
Thimerosal Probably Not a Primary Cause of Autism
An increase in the diagnosis of autism and related conditions in recent years has led many people to believe that thimerosal, a mercury-containing preservative in vaccines administered to children, was the main cause of the upsurge in cases. A report in Archives of General Psychiatry indicates that this may not be the case at all, echoing a 2004 report by the Institute of Medicine that said there was a lack of data supporting the theory that thimerosal causes autism.
According to the report, Robert Schechter, MD, MSc, and Judith K. Grether, PhD, of the California Department of Public Health studied the prevalence of autism in children in California from 1995 through March 2007. "The estimated prevalence of autism for children at each year of age from 3 to 12 years increased throughout the study period," they reported. During that period, exposure to thimerosal during infancy and early childhood declined as the preservative was eliminated from most childhood vaccines. Despite this, although the number of developmental disabilities increased, it did so at a slower rate.
The researchers cautioned, "Although our analysis of [the data] shows an increase in autism in California despite the removal of thimerosal from most vaccines, we support the continued quest for the timely discovery of modifiable risk factors for autism and related conditions. Continuing evaluation of the trends in the prevalence of autism for children born in recent years is warranted to confirm our findings."
FDA Approves Blood Test for MRSA
The FDA approved for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus). The new blood test, BD GeneOhm StaphSR Assay, is manufactured by BD Diagnostics and uses molecular methods to identify whether a blood sample contains genetic material from the MRSA bacterium or from the more common and less dangerous staph bacter!=ium, which can still be treated with methicillin. In effect, this test reduces time spent waiting for results from more than two days to two hours, which leads to a quicker diagnosis and more effective treatment.
The FDA cautions that the test should be used only in patients suspected of having a staph infection and should not be used as the sole basis for diagnosis, as it may reflect the bacterium's presence in patients who have been successfully treated for staph infections. It also will not rule out other complicating conditions or infections.
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