Human Skeleton

Human Skeleton

WELCOME TO STRONTIUM FOR BONES BLOG

Have you experienced negative, and even dangerous, side effects from Fosamax (alendronate), Boniva (ibandronate), Actonel (risedronate), Reclast (zoledronic acid), Prolia (denosumab), Forteo (teriparatide), Tymlos (abaloparatide), or other drugs prescribed for osteoporosis? If you have, then rest assured there is a safe, effective treatment for this condition. Strontium, primarily in the form of strontium citrate, is taken orally once a day.

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Blog Archive

Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, February 12, 2013

Vitamin D Supplements and USP Verification


Vitamin D supplement potency varies widely, and the amount of vitamin D in over-the-counter and compounded supplements does not necessarily match the amount listed on the label, according to a research letter published February 11, 2013, in the journal JAMA Internal Medicine.

The analysis showed that the amount of vitamin D in these supplements ranged from 9 percent to 146 percent of the amount listed on the label. Not only was there variation among different brands and manufacturers, but also among different pills from the same bottle. The researchers were surprised by the variation in potency among these vitamin D pills. The greatest concern is that individuals with low levels of vitamin D in their blood and consistently taking a supplement with little vitamin D in it, could face health consequences.

The U.S. Food and Drug Administration (FDA) is considering new safety guidelines for some supplements, but, for the most part, the industry remains unregulated. Some manufacturers participate in a voluntary quality verification program operated by the U.S. Pharmacopeial Convention (USP) — an independent, nonprofit organization that sets public standards for the quality of dietary supplements. In order to receive the USP verification mark, manufacturers' facilities undergo annual good manufacturing-practice audits, and their products are tested for quality, potency and purity. Dr. LeBlanc and her colleagues included one supplement from a USP Verified manufacturer in their sample. They found the amount of vitamin D in pills from that bottle was generally more accurate than the other bottles tested.

"The USP verification mark may give consumers some reassurance that the amount of vitamin D in those pills is close to the amount listed on the label," said Erin S. LeBlanc, MD, MPH, lead author and investigator with the Kaiser Permanente Center for Health Research in Portland, Oregon. "There are not many manufacturers that have the USP mark, but it may be worth the extra effort to look for it."

The researchers tested 55 bottles of over-the-counter vitamin D from 12 different manufacturers. The over-the-counter vitamin D pills used in the analysis were purchased at five different stores in Portland, Oregon. The compounded vitamin D was made by a compounding pharmacy in Portland. The analysis was conducted by Eagle Analytical Services, an independent lab in Houston.


USP Verified Dietary Supplements


Click on the brand names below to see a list of USP Verified products and a list of the retail stores where you can buy the products.



Note: I use Nature Made Multi For Her 50+, a multivitamin that contains 1000 IU vitamin D3. There are also several Nature Made vitamin D supplements: Vitamin D—400 IU, Vitamin D3 1000 IU Softgels, Vitamin D3 2000 IU Softgels, and Vitamin D3 5000 IU Softgels. This brand is carried at several brick-and-mortar stores. I buy mine online at www.iherb.com. If you use my code, KAP600, at checkout, you and I both get a discount.

Thursday, September 23, 2010

Strontium Ranelate Available In Mexico As Protos

I had been asked if strontium ranelate is available in Mexico. I knew the drug was available in different countries (not the U.S.) under various brand names. A spokesperson from Servier International just replied to my question: "Is Protelos available in Mexico? If it is available, what brand name is it sold under?" Here is the reply:

"Thank you for your interest for strontium ranelate/Protelos. In response to your question below, please be advised that strontium ranelate is available in Mexico under the brand name of Protos, however, please note that strontium ranelate has not been submitted to the FDA and, thus, is not approved for use in the USA."
Sincerely, M. Rebuffe-Scrive
Servier International

Friday, May 28, 2010

Proton Pump Inhibitors May Increase Fracture Risk

On May 25, 2010, the U.S. Food and Drug Administration (FDA) announced that it would add safety information about the possible increased risk for hip, wrist, and spine fractures to the prescription and over-the-counter (OTC) labels for Proton Pump Inhibitors (PPIs), which include esomeprazole (Nexium), omeprazole (Prilosec, Zegerid), and lansoprazole (Prevacid).

PPIs treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus. Ironically, PPIs are commonly prescribed to treat side effects, such as dyspepsia or heartburn, commonly associated with bisphosphonates.

Dr. Amar R. Deshpande, an assistant professor of gastroenterology at the University of Miami Miller School of Medicine, said PPIs may disrupt the body's ability to absorb calcium, which, in turn, can increase the risk for fractures. He also believes this class of drugs is overused and often taken for too long.

The FDA is advising consumers to not stop taking PPIs until they have consulted with their doctors. However, patients should be aware of the increased risk for fractures. The highest risk was seen in people taking higher doses of PPIs, or among those who took them for a year or more. For people taking OTC proton pump inhibitors, the FDA said they should only be taken for 14 days to help ease frequent heartburn. If heartburn continues, people should see their doctor. Under no circumstances should over-the-counter PPIs be taken for more than three 14-day periods in a year, the agency said.

Wednesday, May 21, 2008

Availability Of Protelos In U.S.

Is your company seeking approval of Protelos (strontium ranelate)for osteoporosis in the United States of America? If so, at what stage in the process is it?

BoneLady

Thank you for your interest for Protelos. Protelos is registered in 84 countries worldwide but has not yet been filed to the FDA and thus, for the time being, it is not possible to give you any indication on availability date in the USA.

Sincerely,

M. Rebuffé-Scrive
Scientific Director Servier International Canada, USA, Northern, Central & Eastern Europe

Wandering Skeleton

Wandering Skeleton
Artist: Joel Hoekstra

Osteoporotic Bone

Osteoporotic Bone
Source: www.mayoclinic.com

How Strontium Builds Bones

Strontium is a mineral that tends to accumulate in bone. Studies have shown that oral doses of strontium are a safe and effective way to prevent and reverse osteoporosis. Doses of 680 mg per day appear to be optimal. See my "For More Information About Strontium" links section.

Osteoporosis is caused by changes in bone production. In healthy young bones there is a constant cycle of new bone growth and bone removal. With age, more bone is removed and less new bone is produced. The bones become less dense and thus more fragile.

Scientists believe that strontium works in two ways. It may stimulate the replication of pre-osteoblasts, leading to an increase in osteoblasts (cells that build bone). Strontium also directly inhibits the activity of osteoclasts (cells that break down bone). The result is stronger bones.

When taking strontium, be sure to take 1200 mg calcium, 1000 IU vitamin D3, and 500 mg magnesium daily. It is best to take strontium late at night on an empty stomach. Calcium and strontium may compete with each other for absorption if taken together.