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DSB Reports & Updates – July 2015

FDA Scours the Internet for Safety Signals. A Bloomberg News report shows how the FDA is using Google or Yahoo keyword searches to identify new safety signals or drug interactions, often more than a year before they were brought to light by the FDA based on prior methodologies dependant on cumulative literature reports, pharmacovigilance and voluntary Medwatch reporting.

FDA Uses Patient Groups to Detect Signals. FDA is partnering with a networking forumcalled - a site that allows people with the same disease or condition to connect with others and share their experiences. The group has more than 350,000 members reporting on about 2,500 conditions. Thus far, the for-profit company has collected more than 110,000 adverse event reports on roughly 1,000 different medications since 2009.

FDA Issues New Guidance on Paternal Drug Exposures and Developmental Risks. Little is known about effects of paternal drug exposures and the outcomes of pregnancy. The FDA has issued a new guidance document to help industry address this unmet need. The issue of how drugs affect men, and in turn their offspring (and partners), is the focus of FDA's latest guidance on male-mediated development risks, “Assessment of Male-Mediated Developmental Risk for Pharmaceuticals” (Citation source The guidance is an overview of regulators' approach to assessing how drugs affect sperm and seminal fluid, which can both affect fetal development and offspring.

Prolonged risk of specific malignancies following cyclophosphamide therapy among patients with granulomatosis with polyangiitis. Faurschou M, et al. Rheumatology (2015) 54 (8): 1345-1350. The incidence of cancer among granulomatosis with polyangiitis patients was studied. For those not exposed to cyclophosphamide there was no increase in cancer risk. Any dose of CYC was associated with skin cancers and those receiving > 35grams had a late increased risk of bladder cancer only. Cancer risk appeared to increase over time.


FDA Updates – June-July 2015

FDA Strengthens MI and CVA Risks Associated with NSAIDs. FDA issued a drug safety announcement that it would strengthen warnings that NSAIDs increase the chance of a heart attack or stroke and that these warnings would appear in the product labels for both prescription and OTC NSAIDs. The language will reflect that these events may occur as early as the first weeks of NSAID use and that the risk may increase with chronic use of the NSAID. The risk appears greater at higher doses. These events may occur regardless if the patients has heart disease or risk factors for heart disease. Patients treated with NSAIDs following a first heart attack were more likely to die in the first year after the heart attack compared to patients who were not treated with NSAIDs after their first heart attack. There is an increased risk of heart failure with NSAID use.

Safety of biologic and nonbiologic disease-modifying antirheumatic drug therapy in veterans with rheumatoid arthritis and hepatitis B virus infection: a retrospective cohort study. Burton MJ, et al. Arthritis Res Ther 2015 May 22;17:136. Using data from the US Veterans Administration Healthcare system these investigators found that HBV testing associated with DMARD initiation or hepatotoxicity was infrequent. Yet for those with RA and HBV, the risk of hepatotoxicity is low (2.7%), and comparable between biologic and nonbiologic DMARDS (2.8% vs. 2.6%, P = 0.87).

FDA released new labeling changes for the following medications:

Tofacitinib (Xeljanz) - "The risk of herpes zoster is increased in patients treated with Xeljanz and appears to be higher in patients treated with Xeljanz in Japan." Also, in diabetics, it should be noted that "asthere is a higher incidence of infection in diabetic population in general, caution should be used when treating patients with diabetes."

Codeine - FDA warned against using codeine in children who recently had surgery to remove their tonsils and/or adenoids.

The author has no conflicts of interest to disclose related to this subject

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