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Coadministration of boceprevir with ritonavir-boosted HIV protease inhibitors could reduce drugs' effectiveness

FDA has notified healthcare professionals and patients that drug interactions between the hepatitis C virus (HCV) protease inhibitor boceprevir (Victrelis, Merck) and certain ritonavir-boosted human immunodeficiency virus (HIV) protease inhibitors (atazanavir, lopinavir, darunavir) can potentially reduce the effectiveness of these drugs when they are used together.

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FDA Pipeline Preview, March 2012 (ViroPharma, Novartis, Amgen, Del Mar Pharmaceuticals, CSL Behring, Genentech, Salix, Gilead, Pfizer, Repligen)

Recent FDA action (through February 2012) related to C1 esterase inhibitor [human], progesterone vaginal gel 8%, meningococcal [Groups A, C, Y, and W-135] oligosaccharide diphtheria CRM197 conjugate vaccine, denosumab, VAL-083, recombinant fusion protein linking coagulation factor VIIa with albumin, pertuzumab in combination with trastuzumab, crofelemer 125-mg tablets, emtricitabine/tenofovir disoproxil fumarate, tafamidis meglumine, synthetic version of the natural human hormone secretin, doxycycline hyclate

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New diet drug overwhelmingly endorsed by FDA committee

A new weight-loss medication got an overwhelming endorsement on Wednesday from FDA?s Endocrinologic and Metabolic Drugs Advisory Committee. The committee voted 20-2 in favor of approving phentermine/topiramate (Qnexa, Vivus).

Antibiotic amoxicillin no help in treating acute rhinosinusitis

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No significant difference was found in treating patients experiencing clinically diagnosed uncomplicated acute rhinosinusitis with antibiotic amoxicillin compared with patients who received placebo, according to a study in the February 15 issue of JAMA.

No benefit of B vitamins or omega-3 on cancer outcomes, study finds

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There are no beneficial effects of supplementation with relatively low doses of B vitamins and/or omega-3 fatty acids on cancer outcomes in individuals with prior cardiovascular disease, according to a study published online February 13 in the Archives of Internal Medicine.

ACIP expands recommendations for whooping cough vaccine to 65 and older

The Advisory Committee on Immunization Practices (ACIP) wants all US adults to get vaccinated against whooping cough, according to the Associated Press. The panel voted to expand its recommendation to include all those aged 65 years and older who haven?t gotten a whooping cough shot as an adult.

FDA acts to bolster supply of critically needed cancer drugs

FDA announced a series of steps to increase the supply of critically needed cancer drugs, including temporarily importing an unapproved drug from India. The moves are building on President Barack Obama's executive order to help prevent future drug shortages, FDA said

ACP recommends metformin as first-line therapy for type 2 diabetes

Physicians should prescribe oral metformin as a first-line therapy for most patients with type 2 diabetes, as well as for those whose blood sugar cannot be controlled with diet, exercise, and weight loss, according to new guidelines from the American College of Physicians.

FDA issues 3 draft guidances on biosimilars

FDA has issued 3 draft guidances for the development of biosimilar versions of approved biologic products, which will help flesh out the abbreviated approval pathway created by the Patient Protection and Affordable Care Act signed into law in 2010

SSRIs increase risk of falls, injuries for elderly patients with dementia

Nursing home residents with dementia who use average doses of selective serotonin reuptake inhibitors (SSRIs) are three times more likely to have a fall resulting in injury compared with those who don’t use SSRIs, according a study published online January 18 in the British Journal of Clinical Pharmacology