FDA Reverses Stance on Fracture Warnings for OTC Heartburn Meds

Does anyone really pay any attention to the warnings that follow a magazine ad or tv ad? 

Do the people who are thinking about taking some new (or old) drug ever listen to or read the warnings?  

Have to wonder why would anyone would ever want to take something with so many side effects?  

There is an old adage that goes something like this, 

sometimes the cure is worse than the disease!

We must become educated consumers.  Do you own homework and research before taking anything, OTC or prescription.

Maybe we should try a natural alternative before undertaking a new drug therapy.  

Would't you agree?

All the best

Lou & Debbie

FDAnews Drug Daily Bulletin

March 28, 2011  | Vol. 8 No. 61

 

FDA Reverses Stance on Fracture Warnings for OTC Heartburn Meds

The FDA is doing an about face on its stance regarding the fracture risks for OTC proton pump inhibitors (PPIs), ruling labels need not carry such warnings. After reviewing available data, the agency found patients at highest risk for fractures and osteoporosis received high doses of prescription PPIs — higher than that of OTC drugs — and used the medications for a year or longer.  “In contrast to prescription PPIs, OTC PPIs are marketed at low doses and are only intended for a 14-day course of treatment up to three times per year,” the FDA said Wednesday. 

Drug Industry Daily