Tue, Jul-19-16, 14:37
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Plan: P:E/DDF
Stats: 225/150/169
BF:45%/28%/25%
Progress: 134%
Location: NC
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Yes, a few weeks ago FDA strengthened its warnings on them for Kidney injury. That study was mentioned on the People's Pharmacy news round-up but then hearing Dr. Westman say this about drug and diet possible interaction...thought should post it here.
https://www.drugwatch.com/2016/06/2...injury-warning/
Quote:
This latest label change from the FDA is another in a long string of safety concerns linked to Invokana and other SGLT2 inhibitors. Earlier this month, the agency began investigating data from the CANVAS trial that showed an increase in leg, foot and toe amputations in people who used the drug. While the link is not definitive, the agency said 5 to 7 out of every 1,000 patients had a risk of amputation.
In May 2015, the agency warned that Invokana increased the risk of ketoacidosis — a potentially fatal condition caused by excess blood acid. In December 2015, the FDA released another safety communication and warned the drug can also lead to blood infections and kidney injuries.
In addition to these concerns, researchers in the ongoing CANVAS trial are investigating drug’s heart safety. Data from the trial showed people who took the drug had an elevated risk of stroke in the first month of treatment.
The litany of side effects led some patients to file lawsuits against J&J and its Janssen Pharmaceuticals unit. Plaintiffs say the drug companies failed to properly warn the public about serious side effect risks.
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Jeez, is that all? Amputations, ketoacidosis, elevated risk of stroke in ONE month? Yikes! |