5-Hour Energy Shots Linked to 13 Deaths

5-Hour Energy shots are linked to 13 deaths and 33 hospitalizations, the FDA confirms.So far, 5-Hour Energy maker Living Essentials LLC has received 92 reports from people who fell ill after using the product. Since the product is sold as a nutritional supplement, the company is required to relay such reports to the FDA.The reports themselves do not prove that 5-Hour Energy had anything to do with any of the deaths or illnesses.

via 5-Hour Energy Shots Linked to 13 Deaths.

Change in Kidney Markers Not Just Function of Age

In a large cohort study, relative mortality risk for reduced eGFR was higher in every age category, but fell with increasing age (P<0.05), with similar albeit less evident findings for increased albuminuria, Josef Coresh, MD, PhD, of the Chronic Kidney Disease Prognosis Consortium Data Coordinating Center in Baltimore, and colleagues reported online in the Journal of the American Medical Association.

Overall, Coresh and colleagues found that death and ESRD risks were higher at lower eGFR and higher albuminuria in every age category.

via Change in Kidney Markers Not Just Function of Age.

AHA: No Excess Bleeding Risk with Dabigatran (Pradaxa)

Although the FDA review discounted an excess bleeding risk with dabigatran, it did not address another potential concern — the ability to reverse the anticoagulant effect acutely in cases of emergency.

Antman acknowledged that there is no specific, approved antidote for dabigatran or any of the novel anticoagulants, although it is an area of active investigation and the topic of several studies that will be presented at the AHA meeting in the coming days.

He said it’s not true, however, that clinicians don’t have any options. Intravenous administration of blood coagulation factors — prothrombin complex concentrates that are available in every hospital — can help to reverse the effect, though not completely.

In comparison, the effects of warfarin can be reversed with the administration of vitamin K. Antman noted. But that that doesn’t always work either, and patients can die because of it, he added.

via AHA: No Excess Bleeding Risk with Dabigatran.

Linzess – Think IBS with Constipation

Linzess is felt to act as a guanylate cyclase-C agonist. An agonist increases the activity of a process, the opposite of an antagonist. Linzess seems to act locally on the surface of the inside of the intestinal lining cells and by activation of guanylate cyclase-C increases levels of intracellular cGMP (cyclic guanosine monophosphate) which results in increased levels of chloride and bicarbonate in the intestinal lumen and speeds up gastrointestinal transit.

via Does Linzess have a role in IBS with constipation?.

Mirapex (pramipexole) Possible Risk of Heart Failure

ISSUE: FDA notified healthcare profesionals about a possible increased risk of heart failure with Mirapex (pramipexole). Results of recent studies suggest a potential risk of heart failure that needs further review of available data. Because of the study limitations, FDA is not able to determine whether Mirapex increases the risk of heart failure. FDA is continuing to work with the manufacturer to clarify further the risk of heart failure with Mirapex and will update the public when more information is available.

via Safety Alerts for Human Medical Products > Mirapex (pramipexole): Drug Safety Communication – Ongoing Safety Review, Possible Risk of Heart Failure.