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Last Updated
July 22, 2016
NEWSROOM > Latest News > Current
Current | 2015 News | 2014 News | Prior to 2014

April 18, 2016
Study: PPIs May Lead to Kidney Damage
A new study offers further evidence that using proton-pump inhibitors (PPIs) to alleviate conditions such as 
heartburn and acid reflux may seriously damage the kidneys. Tapping into Department of Veterans Affairs national 
databases, researchers identified 170,000 new users of PPIs and tracked them for 5 years. By the end of the study 
period, 15% of the PPI users had been diagnosed with chronic kidney disease. By comparison, the condition was 
confirmed in only 11% of 20,000 first-time users of histamine H2 receptor blockers—another class of drugs used to 
suppress gastric acid. After controlling for age, comorbidities, and other factors, the PPI users had a 28% greater 
risk for kidney disease.
While only a tiny fraction of study participants developed end-stage kidney failure, the risk was 96% higher for the 
PPI cohort. Despite the low overall risk, study author Ziyad Al-Aly, MD, of VA Saint Louis Health Care System says 
the finding suggests that PPI use should be limited. "[Patients should] use PPIs only when it is medically necessary, 
and should limit duration of exposure to the minimum necessary to treat the underlying medical condition," said Al-
Aly, who reported the results in the Journal of the American Society of Nephrology. (Source: APhA Pharmacy Today, 
April 13, 2016
U.S. Task Force Issues New Recommendations for Daily Aspirin
The U.S. Preventive Service Task Force finalized its guidelines on the use of aspirin for the primary prevention of 
cardiovascular disease (CVD) and colorectal cancer. The task force now recommends that people between the ages 
of 50-59 who are at increased risk for cardiovascular disease and do not have an elevated risk of bleeding should 
consider low- dose aspirin for the primary prevention of both CVD and colorectal cancer. For adults 60-69 the 
decision to start on a low-dose aspirin regimen should be made on a case-by-case basis. (Source: USPSTF publishes 
recommendation on taking aspirin to prevent heart attack, stroke, and colorectal cancer. Annals of Internal 
Medicine. 2016.)
April 11, 2016
Resource Guide: Preventing Unintentional Medication Poisoning in Children
In 2012, nearly 6,000 children aged 0 through 4 were hospitalized and another 55,000 were treated and released 
from U.S. emergency rooms for medication poisoning (Health Care Utilization Project, National Inpatient Sample 
and National Emergency Department Sample, 2012). These poisonings resulted in $154 million in medical spending 
and $14 million in parent work losses (CSN EDARC analysis). Nearly all emergency department visits to young 
children (95 percent) are a result of unsupervised children getting into medication; only five percent of these visits 
were due to errors on the part of the caregiver (Pediatrics, 2011).  Additionally, America's poison centers managed 
over 508,000 cases of pharmaceutical exposures in children 12 and under in 2014 alone. That's about one call per 

This resource guide provides links to organizations, programs, publications, and resources focused on medication 
safety. It is divided into four sections: (1) Organizations, (2) Policy and Legislation, (3) Current Prevention 
Programs and Resources, and (4) Publications. Each item in this resource guide includes a short description and a 
link to the resource itself. 
April 7, 2016
Biosimilars – Information for Consumers
Many of today’s important medications are biological products. Biological products are made from
living organisms. The material they are made from can come from many sources, including humans,
animals and microorganisms such as bacteria or yeast. Biological products are manufactured through
biotechnology, derived from natural sources or, in some cases, produced synthetically.  Biological
products are among the medications used to treat conditions such as rheumatoid arthritis, anemia,
low white blood cell counts, inflammatory bowel disease, skin conditions such as psoriasis and
various forms of cancer. 

Most biological products are more complex in structure and have larger molecules or mixtures of
molecules than conventional drugs (also called small molecule drugs). Conventional drugs are made
of pure chemical substances and their structures can be identified.  Most biologics, however, are
complex mixtures that are more difficult to identify or characterize.

The FDA has approved a second biosimilar product—Inflectra (Infliximab-dyyb), a biosimilar to
Remicade (infliximab)—and expects to approve other biosimilars in the future. The FDA approved
Zarxio (filgrastim-sndz), a biosimilar to Neupogen (filgrastim), in March 2015.
April 1, 2016
FDA Unveils Draft Guidance on Biosimilar Labeling
FDA released on Thursday draft guidance on biosimilar labels. According to the guidance, biosimilar labeling—as 
with generics—should include a description of the clinical data that supported safety and efficacy of the reference 
product. FDA notes, however, that in situations where a biosimilar is not approved for the same indications as its 
reference product—unlike with generics—"it may be necessary to include information in the biosimilar product 
labeling relating to an indication(s) for which the biosimilar product applicant is not seeking licensure, in order to 
help ensure safe use (e.g., when safety information in the reference product labeling is related to use of the product 
and is not specific to a particular approved indication(s) or when information specific to only the biosimilar product's 
indication(s) cannot be easily extracted)." The draft guidance also states that the label should be written in a way 
that does not imply that the biosimilar product is approved for a reference product indication or use that has not 
been approved for the biosimilar product. "The overall risk-benefit profile of the reference product is relevant to the 
biosimilar product, even if a particular serious adverse reaction or other risk included in the reference product 
labeling may not have been reported with the biosimilar product at the time of licensure," FDA said.  Read More (NCPIE source: APhA Pharmacy Today 4/1/16)