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FDA Actions in Brief July 2012

Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)

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Caffeine consumption may reduce BCC risk

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A recent study in Cancer Research suggests that modest caffeine consumption may be associated with a significantly lower relative risk of basal cell carcinoma.

CDC updates recommendations for HBV management

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The Centers for Disease Control and Prevention recently updated its 1991 recommendations for the management of hepatitis B virus (HBV)-infected healthcare providers and students to prevent HBV transmission to patients.

Fertility drug use and breast cancer risk

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The Two Sister Study, funded in part by Susan Komen for the Cure, was conducted to examine the possible risks associated with fertility drugs and breast cancer. The results were published July 6 in the Journal of The National Cancer Institute.

CER studies will shape coverage decisions

ByJill Wechsler

To reduce the money spent on treatments that don't work, health plans and payers are examining closely how Comparative Effectiveness Research (CER) can steer patients and providers to more appropriate care. This approach is gaining momentum from the Patient Centered Outcomes Research Institute (PCORI), which is poised to distribute some $120 million in coming months—and nearly $400 million in 2013—to launch a range of CER projects.

FDA approves aclidinium bromide inhalation powder to treat COPD

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FDA has approved aclidinium bromide inhalation powder (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

FDA approves first at-home HIV test

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FDA recently approved the first over-the-counter test for HIV, providing a confidential in-home testing option for the virus that causes AIDS, with results in as little as 20 minutes.

FDA: Label change for single IV dose of ondansetron

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FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.

FDA approves generic Arthrotec

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FDA has approved Watson's generic diclofenac sodium and misoprostol delayed-release tablets (Arthrotec, G.D. Searle, a subsidiary of Pfizer), indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

Fixed-dose ARB combo superior treatment for hypertension

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A fixed-dose combination of azilsartan medoxomil and chlorthalidone 40/25 mg (Edarbyclor, Takeda Pharmaceuticals) was statistically superior to a fixed-dose combination of olmesartan medoxomil-hydrochlorothiazide 40/25 mg for the treatment of stage 2 systolic hypertension, according to a study published online in the American Heart Association journal Hypertension.

Comorbidities increase likelihood of ADRs in elderly

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Comorbidity from chronic diseases and severity of illness increased the likelihood of adverse drug reactions in senior patients, according to a new study published online June 26 in the Annals of Pharmacotherapy.

Global drug spend projected to reach more than $1 trillion by 2016

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Annual global spending on medicines will reach nearly $1.2 trillion by 2016, while U.S. spending growth is projected to soar to between $350 and $380 billion by 2016, according to a report issued recently by the IMS Institute for Healthcare Informatics.

Study: Older patients often ignore prescription warning labels

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Brightly colored prescription warning labels applied by pharmacies fail to adequately capture the attention of older patients, suggesting that current labeling standards should be reconsidered to make them more effective, according to a study published online June 14 in PLoS ONE.

Study: Vitamin D plus calcium reduced mortality among elderly

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Vitamin D plus calcium supplementation consistently reduced mortality among elderly patients compared with vitamin D supplementation alone, according to a study published online May 17 in the Journal of Clinical Endocrinology and Metabolism.