It was announced August 9th., 2010 that patients that take PPI’s chronically have a higher risk of osteoporosis, and especially if you are over 50 years of age. Here is the announcement in its entirety.
From the FDA (a branch of the National Institute of Health):
FDA is cautioning healthcare professionals and patients that proton pump inhibitors (PPIs) may increase the risk of fractures of the hip, wrist, and spine. The drugs’ labeling will be revised to reflect these concerns. PPIs are used to reduce gastric acidity and include Nexium (esomeprazole), Dexilant (dexlansoprazole), Prilosec (omeprazole), Zegerid (omeprazole and sodium bicarbonate), Protonix (pantoprazole), Aciphex (rabeprazole) and Prevacid (lansoprazole).
The new safety information is based on FDA’s review of several epidemiological studies. These studies found that patients who received high doses of the drugs or took them for a year or more had the greatest fracture risk. Since most of these patients were older than 50, the increased risk was observed mainly in this age group.
Healthcare professionals prescribing proton pump inhibitors should consider the possibility of an increased fracture risk, and whether a lower dose or shorter duration of therapy might be possible. Patients at risk for osteoporosis should have their bone status managed and should supplement their diets with adequate amounts of vitamin D and calcium.
Patients taking prescription PPIs should understand the possibility of an increased fracture risk, but they should be told not to stop their medication without consulting their healthcare professional. People using over-the-counter PPIs to treat heartburn should be cautioned not to take these drugs for more than 14 consecutive days, and not to take more than three 14-day treatment courses in one year.
Essentially they are saying that sufficient Vitamin D and Calcium should be taken. What was not said is that anyone who is prescribed a PPI by their physician should insist on having their Vitamin D level measured. Knowing your Vitamin D level will help prevent you from having osteoporosis since 3 out of 4 Americans are below normal on Vitamin D and low Vitamin D contributes to the possibility.
The “Institute of Medicine” which is a division of the National Institute of Health in Washington DC which is funded by our tax dollars has held a series of meetings being in 2009 and ending on March 26, 2010, on the “Dietary References for Vitamin D and Calcium.” The last 6 meetings were closed and not open to the public. So much for transparency in government. The conclusion and recommendations for increasing the amount of Vitamin D that all Americans should have, have not been published as of this date.
In the meantime, it is suggested that anyone who is on PPI’s chronically should go to www.grassrootshealth.net and learn more about how important Vitamin D is to your health. When you have armed your self with the facts about Vitamin D, then it is time to see your physician and have an intelligent talk about preventing osteoporosis as well as helping prevent other illnesses.
It appears that the Wheels of Medicine in DC turn slowly since the Public Interest is not always put in front of Private Interests. Why else would they need to have closed meetings on a mundane subject as staying healthy with sufficient intake of Vitamin D from the sun, supplements or fortified foods?
The FDA recently approved the OTC sale of Prevacid without a prescription. Isn’t it sad that they did not have all the facts before they allowed the product to be sold from gas station to drug store to discount store?
Wouldn’t it be wonderful if the FDA and the Institute of Health which are both divisions of our National Institute of Health would talk to each other and work in concert to improve our Vitamin D levels as quickly as possible? I guess I’m dreaming again.
T. Braun, Pharmacist, Buyer, Marketing Executive for a Major Drug Chain. Active for over 45 years in Pharmacy.
Legal Stuff: Disclaimer – This document is informational in nature. Medical advice should be secured through your physician.
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