Drugs Today – Sept/Oct 2009

FDA warns against certain OTC nasal sprays

Over-the-counter Zicam intranasal cold medications may cause long-term or permanent loss of the sense of smell and should not be used, warns the Food and Drug Administration (FDA). More than 130 cases of anosmia linked to use of zinc-containing nasal sprays have been reported to the FDA since 1999. The cite products are Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs (kid size). The FDA sent a warning letter to the drugs’ marketer, Matrixx Initiatives, stating that it is “aware that [the marketer] appears to have more than 800 reports related to loss of sense of smell” associated with the products.

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Monitor patients receiving Gardasil vaccine for syncope

The FDA again cautions healthcare professionals to monitor patients who receive the human papillomavirus vaccine Gardasil for 15 minutes after vaccination “to prevent falls and injuries” related to fainting. A revised label for Gardasil now contains the syncope warning. Patients should remain seated or lying for 15 minutes after receiving the vaccine.

Read more about the label revision.

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Maxipime safety cleared by FDA

The FDA’s investigation of the antibiotic Maxipime (cefepime), approved for treating pneumonia and other infections, concluded that the drug is not associated with a higher death rate than similar drugs. Maxipime “remains an appropriate therapy for its approved” uses, the FDA stated.

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Onglyza approved for once-daily treatment of type 2 diabetes

Onglyza (saxagliptin) has been approved for once-daily treatment of type 2 diabetes in patients at risk of heart disease. Onglyza is a DPP-4 inhibitor, blocking an enzyme that degrades GLP-1 (a hormone that stimulates insulin release from the pancreas). This blockade leads to increased GLP-1 levels and lower blood glucose levels. Bristol-Myers Squibb, the manufacturer, will conduct postmarketing studies to further determine Onglyza’s heart safety in higher-risk patients. Last month, the FDA rejected alogliptin, another DPP-4 inhibitor and is requiring it manufacturer to perform additional studies on heart risks.

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Hepatitis C biomarker discovery may predict response to treatment

Treatment for hepatitis C can be difficult, so discovery of a biomarker that may predict response to treatment offers patients and their physicians a way to guide treatment. Duke University researchers discovered the marker in a segment of DNA near the IL28B gene. The biomarker predicts who is most likely to respond to treatment and who isn’t. More important, it may offer insight into why responses to hepatitis C treatment vary so widely among racial and ethnic groups.

Read more at about the biomarker.

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NSAID use may affect accuracy of prostate cancer screening

Researchers have found that chronic use of aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) may mask the true level of prostate-specific antigen (PSA) levels in men being screened for prostate cancer. Lead investigator Jay Fowke of Vanderbilt University Medical Center stated, “aspirin and other NSAIDs may lower PSA levels below the level of clinical suspicion without having any effect on prostate cancer development, and if that is true, use of these agents could be hampering our ability to detect early-stage prostate cancer through PSA screening.”

Read more about this study.

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