HEALTH

Probiotic strain may aid colicky infants, study finds

BY Michael Johnsen

STOCKHOLM A new study now available online in the journal Pediatrics supported earlier clinical research about the benefits of a specific probiotic strain on colic symptoms in infants, BioGaia recently announced.

In the new study, infants supplemented with Lactobacillus reuteri Protectis showed a significant reduction in crying time. After one week of supplementation, the reduction in crying time was 74% in the L. reuteri Protectis group, compared with 38% in the placebo group.

The primary outcome was a reduction in average crying time to less than three hours per day, which is the limit of colic, within three weeks.

“These results are in line with previous studies on colics and confirm the benefit of L. reuteri in colicky infants,” stated Francesco Savino, department of pediatrics at Regina Margherita Children’s Hospital, University of Turin, Italy.

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Prolatis recalls male-enhancement product

BY Michael Johnsen

SALT LAKE CITY Prolatis earlier this week announced a voluntary nationwide recall of the company’s product sold under the brand name Prolatis’ after being informed by the Food and Drug Administration that lab analysis has found their male-enhancement products to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used as treatment for male erectile dysfunction.

That makes Prolatis’ an unapproved drug, as opposed to a dietary supplement.

The active drug ingredient is not listed on the product label. Product manufactured prior to Aug. 9, 2010 is included in this recall. Prolatis’ is sold nationwide in double blister packs and 40-count bottles at “GNC and other smarter retailers” according to the company’s website. Prolatis’ had also been sold on CVS.com.

The recall is being conducted as a precautionary measure, the company asserted.

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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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