HEALTH

FDA’s new video addresses fracture risk when using PPIs

BY Michael Johnsen

SILVER SPRING, Md. The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription and over-the-counter labels for proton-pump inhibitors that include new safety information about a possible increased risk of fractures of the hip, wrist and spine with the use of these medications.

 

The video is a part of the FDA’s Drug Info Rounds, “a program by pharmacists for pharmacists,” and presented by the Division of Drug Information pharmacists division of FDA.

 

 

SILVER SPRING, Md. The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription and over-the-counter labels for proton-pump inhibitors that include new safety information about a possible increased risk of fractures of the hip, wrist and spine with the use of these medications.

 

The video is a part of the FDA’s Drug Info Rounds, “a program by pharmacists for pharmacists,” and presented by the Division of Drug Information pharmacists division of FDA.

 

 

The new safety information is based on FDA’s review of several epidemiological studies. Some studies found that those at greatest risk for these fractures received high doses of proton-pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals ages 50 years or older and the increased risk of fracture primarily was observed in this age group.

 

 

Even though the increased risks were primarily observed with higher doses of PPIs, or with use over a long periods of one year or more, the FDA incorporated these changes into low-dose OTC PPIs as a precaution. OTC PPIs are indicated for a two-week use.

 

 

Healthcare professionals should be aware of the possible increased risk of fractures of the hip, wrist, and spine with the use of proton-pump inhibitors, and when prescribing, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition, the FDA stated.

 

 

To see the full video, click here.

 

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CRN taps FDA’s Sharfstein as annual symposium’s keynote speaker

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition on Thursday announced the Food and Drug Administration’s principal deputy commissioner Joshua Sharfstein is slated to return as a keynote speaker at The Conference, CRN’s annual symposium for the dietary supplement industry.

Sharfstein will make the opening address to attendees, providing an update on the FDA’s dietary supplement-related regulatory activities on Sept. 30.

Sharfstein will discuss the impact of the current regulatory landscape of the recently fully implemented dietary supplement good manufacturing practices, as well as the adverse event reporting law. Sharfstein also will provide attendees with advice on what a responsible industry can do to aid the FDA in its mission to protect the public health.

Additionally, Sharfstein will update conference attendees on critical supplement industry issues, such as the new dietary ingredient notification guidance.

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WHO: H1N1 in post-pandemic period, but it’s not over

BY Allison Cerra

NEW YORK The World Health Organization’s director-general Margaret Chan issued a statement on Tuesday that the H1N1 influenza has entered the post-pandemic period, but warned that the virus has not yet gone away.

While WHO has reported marginal levels of H1N1 transmission worldwide as of late, Chan said it expects the H1N1 virus to take on the behavior of a seasonal influenza virus and continue to circulate for some years to come.

 

NEW YORK The World Health Organization’s director-general Margaret Chan issued a statement on Tuesday that the H1N1 influenza has entered the post-pandemic period, but warned that the virus has not yet gone away.

While WHO has reported marginal levels of H1N1 transmission worldwide as of late, Chan said it expects the H1N1 virus to take on the behavior of a seasonal influenza virus and continue to circulate for some years to come.

 

"Pandemics, like the viruses that cause them, are unpredictable," she said. "So is the immediate post-pandemic period. There will be many questions, and we will have clear answers for only some. Continued vigilance is extremely important, and WHO has issued advice on recommended surveillance, vaccination, and clinical management during the post-pandemic period.

 

"As I said, pandemics are unpredictable and prone to deliver surprises. No two pandemics are ever alike. This pandemic has turned out to be much more fortunate than what we feared a little over a year ago," Chan added.

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