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FDA issues new warning on long term use of osteoporosis drugs

Following a previous article on the benefits of taking a ‘holiday’ from such drugs there are now two new concerns.

AnnA Rushton

In the USA a warning has been issued that a class of widely prescribed osteoporosis drugs may significantly increase the risk of a rare type of thigh fracture.  Indeed  the FDA is so concerned that they have ordered a new warning label for all drugs in the bisphosphonate family, including Merck’s Fosamax (marketed generically as alendronate), Roche’s Boniva, Novartis’ Reclast and Warner Chilcott’s Actonel.

That is certainly taking it seriously, but they are also looking to protect the drugs users by  also requiring that consumer-friendly guides be distributed with every bisphosphonate prescription to make sure that patients understand the risks and how to minimize them.

The new risk of thigh fracture is worrying because it occurs with little or no preceding trauma and may be preceded for months by a dull, aching pain in the thigh or groin. The agency said that patients experiencing such symptoms should visit a doctor at once to try and prevent a fracture.

The second warning looks to have a rather more substantial and wide ranging impact as the FDA is also directing doctors to reassess whether patients should continue taking the drugs after five or more years.   According to the National Osteoporosis Foundation, the drugs appear to offer little or no benefit after this time, while the rate of fractures seems to increase.

This class of drugs has been around for some time and are intended to stop the bone-thinning processes of osteoporosis by interfering with the mechanism by which the body normally breaks down old bone cells and replaces them with new ones. Some doctors now believe that interfering with this process may cause bones to weaken over time, however.

Certainly John Lee was very clear in his condemnation of such drugs, arguing that they merely maintained weakened old bone longer and that in order to deal effectively with osteoporosis natural progesterone was needed.  This is because bone is a dynamic structure that requires not only the removal of old bone but its replacement with new bone in a continual lifelong process.  These drugs merely slow down the process of bone loss but cannot build new bone as only bio-identical natural progesterone can do this.

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Please feel free to discuss this article in the comments section below, but note that the author cannot respond to queries made there.
Comments 10
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AnnA Rushton | 7:53 pm, May 21st, 2016

Athena such medical questions cannot be answered here. Please send this information to who will be able to help you.

Mrs Athina Savvides | 9:00 pm, May 17th, 2016

After being on biphosphinates for 12yrs then suffering from spontaneous fractures first ankle and calf . Taken off biphosphinates and put on strontium ranelate. 2yrs later
Foot fracture taken off strontium and 2 months later suffer from sacrum fracture and pubic ramus fracture. Still recovering 11 months later now had infusion of zalendronate believe to be another form of biphosphinates? When reading comments originally it says serenity cream can be used then another
Article says whilst on biphosphinates cannot use natural progesterone along side? Would the annual infusion be included in this as unable to use along side? Please advise? And should one come off all medication and just use natural progesterone for osteoporosis?

Igor | 7:53 pm, October 24th, 2012

on osteoporosis!, July 16, 2004Bya0 (Wingdale, NY United States) This reeivw is from: I bought and read every title on this subject when I was unexpectedly diaganosed with osteoporosis. I got tired of reading the same things again and again. This book did not just rehash the same old same old but gave me MUCH better insights into the risk factors, a far better explanation of how exercise helps, and clear, concise directions for each of the exercises. I hope that everyone, especially younger people read this book and work with the exercises, because this disaease is devastating to active people. Thank you, Miss Daniels!

balanced alkaline diet plan | 4:52 pm, September 23rd, 2012

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Leni | 11:28 am, August 11th, 2012

Calcium citrate is the best one you have mnntioeed because it is organic and organic calcium is absorbed much better than inorganic calcium such as calcium oxide or calcium carbonate. Calcium gluconate and other organic calcium would also be fine.Calcium and magnesium are friends and interact but you must avoid a gross excess of one because then the one in gross excess is absorbed at the expense of the other one due to preferential absorption and you could end up deficient in the other one.The best magnesium to take is magnesium orotate or other organic magnesium because they are absorbed much better than inorganic magnesium such as magnesium oxide and carbonate and dolomite. Dolomite is calcium carbonate plus magnesium carbonate. Although carbonates contain carbon this carbon is regarded as inorganic carbon because carbonates behave like inorganic anions.

Arga | 7:18 am, August 11th, 2012

Coral calcium has been hyped a lot, but my nuittrion prof was not impressed with it. As a supplement in pill form, we’d look for calcium citrate, chelated calcium or (last choice) calcium lactate.A good idea is to buy high-quality products and rotate among brands each time you buy. We are never 100% sure that these natural products have in them exactly the ingredients they say, hence the high-quality names and the rotation.At the risk of sounding like a nag, may I add a few remarks:1) there’s something wrong with your 2mg dosage. A minimum dose for an osteoporosis patient would be one gram per day, which is 1000 milligrams. Please pay strict attention to the label on the bottle. You are looking for the elemental calcium content, not the milligrams or grams of calcium compound. For example, a 600 mg Ca tablet can actually contain only 150 mg of elemental calcium. Most high-quality manufacturers will specify on the label the milligram content of the compound and also the milligram content of elemental calcium. If the label does not present this information, it would be best to avoid this product.2) calcium (Ca) must always be combined with magnesium (Mg). The reason is that a high-calcium or calcium-only intake will result in a net calcium depletion of the bone tissue. The body must always maintain Ca/Mg in a specific balance in the bloodstream. If the human being overdoses on calcium only, the ingenious body will dissolve bone tissue to obtain the magnesium necessary to keep the blood balance. This important fact is sometimes neglected by medical doctors. A common practice is to prescribe 1 or 2 grams of calcium only, while neglecting magnesium. A recipe for disaster.The proportion of Ca to Mg is about 2 to 1. Most high-quality calcium preparations will also present magnesium in the right proportion. Or you can buy them separately. If buying separately, the same caution re elemental magnesium will apply. Ideally, you will be looking for something like 1 gram of elemental calcium plus 500 mg elemental magnesium per day.This should be taken in staggered doses during the day, with meals because Ca Mg absorb better with food. For example, one 500 mg Ca with 200-250 mg Mg with lunch, another with dinner, a third with breakfast if you like.3) all osteoporosis patients should modify and re-work their entire nuittrion program. The goal here is to prevent calcium loss from the bones, rather than simply increasing the oral intake. Can you find someone to work with you, possibly in a low-cost clinic associated with a good school of naturopathy or a nuittrion faculty in your area.Your goal here is to change gradually from a diet that burns to an acid ash this is the typical North American diet to one that leaves a more alkaline ash. Foods to reduce are meat, excessive protein, junk foods, processed commercial foods, soda pop, excessive sugar, white flour products and coffee. Foods to increase are simple. More vegetables. More fruit. More vegetables. Whole grains. More vegetables. Beans and lentils. More vegetables.4) more on nuittrion. Authorities are divided as to whether calcium from dairy products such as milk, yoghurt and cheese or calcium from dark-green-leafy vegetables is better assimilated by the human body. I mean really good authorities with plenty of academic studies to back up each point of view. What to do when the authorities can’t agree? The answer seems simple keep lots of both in your diet.The dark-green-leafies include broccoli, rapini, chard, kale, beet and turnip greens, and to a much lesser extent the deeply colored lettuces such as oak leaf and romaine.If your nuittrion is not very healthy right now, it will take some time to accustom yourself to a better regime, perhaps an entire year. That’s why a knowledgeable nuittrionist or naturopath could help with support suggestions. I’d start by visiting my local farmers’ market, most cities have them now, and please especially check out the organic produce. 5) a walk on the wild side something to think about. Wild greens are chock-full of valuable minerals including calcium, magnesium and potassium, and they’re brimming with vitamins. Dandelion leaves, for example, contain more minerals and vitamins than spinach. Another high-mineral wild green leaf is nettles, traditionally made into nettle soup or an infusion to drink (combine with fruit juice or your favorite tea if you like.) You can find these wild greens at a local farmers’ market, or perhaps at your health food store. You could even learn to find and gather them in the countryside yourself.One interesting herb called horsetail helps to deposit calcium into bone tissue. It grows wild across north America and is sold in health food stores. You’d make it into an infusion (steep for 4 hours or more to extract the minerals.) In the morning, combine with tea heat as a breakfast beverage. Use this no more than 1 or at the most 2 weeks out of 4, as it contains silica. This is good for your joints in small quantities, but should not be taken daily for long period of time.6) certain foods are a big caution because they contain oxalic acid. This combines with calcium in the bloodstream and gets excreted as calcium oxalate, so the result of eating these foods is a net calcium loss. These foods are: rhubarb, spinach, sorrel and to a much lesser extent, chocolate. It’s OK to have rhubarb 1 or 2 or 3 times a year, when it’s fresh, but it’s not OK to scarf down spinach 3 times a week while believing it’s good for you. Pop-eye was wrong.7) I’m sure your doctor has gone on and on about how you must do weight-bearing exercises. These build up bone tissue. Walking is just great. It’s perfect for you. Please leave that car at home. Could you join a hiking or walking group. They’re interesting fun a painless way to save your bones. Swimming, by the way, is not considered a weight-bearing exercise, because the water supports the body. Bicycling is not as helpful as walking, because the bike bears the weight, not the human skeleton. re: Fosamax. The questionable news about this is that the bone tissue that results is lacey and brittle. Studies have shown that patients taking this and other similar medications have just as many fractures as control groups, even if their bone readings improve in tests.9) if you smoke, your doctor has already lectured you about this. It’s a real no-no for osteoporosis patients.Wishing you the very best. It’s a long year of work, but I personally believe osteoporosis can be avoided. If the disorder is present it can be stopped. I even believe it can be reversed,

concerned | 3:35 pm, February 2nd, 2012
concerned | 3:34 pm, February 2nd, 2012

Given the issues with ongoing Fosamax lawsuits (see, e.g., this is of even more concern. Why aren’t prescribing physicians as informed as the orthopedic surgeons who have to treat the femur fracture?

AnnA Rushton | 8:28 am, January 25th, 2011

John Lee was the physician who coined the term estrogen dominance and promoted the benefits of natural hormones for a range of hormonal imbalances.

He was known internationally for his books and lectures and his role in clarifying the essential role that natural progesterone has in bone building and therefore for treatment of osteoporosis.

If you want to know more about his work then his books include:

Essential Hormone Balance with Virginia Hopkins
What Your Doctor May Not Tell You About Menopause
What Your Doctor May Not Tell You About Breast Cancer
What Your Doctor May Not Tell You About Premenopause

You will find his books at

Denzel | 8:06 am, January 25th, 2011

Who is John Lee? Unknown specialist in osteoporosis.

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