Denosumab Associated with Dermatologic Toxicity – FDA Adverse Events Reporting System

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At the May 2012 Annual Meeting of the Society-for-Investigative-Dermatology, one of the presentations, entitled “Denosumab is associated with dermatologic toxicity in the FDA-Adverse Events Reporting System (AERS) database,” discussed reports of “cutaneous ([skin] adverse events” (CAE) reported to the FDA’s AERS, from June 1, 2011 to June 30, 2012.

Of the 33 reports of denosumab-associated CAE, 29 were women, ranging in age from 54 to 86 years, 21 of whom had been given Prolia®. These women experienced hair changes, stomatitis (inflammation of the mucous lining of any part of the mouth, e.g, cheeks, lips, tongue, gums), dry skin, and skin rash, which included exfoliative dermatitis (skin inflammation so severe the skin peels). “Serious CAE” requiring hospitalization occurred in 81.8% of these people; two women died. The comment made by the researchers, “Denosumab-associated dermatologic toxicity warrants further close monitoring.”

Don’t let the makers of Prolia® experiment on YOU!

Here’s a link to the abstract from this research presentation at the Journal of Investigative Dermatology:
http://www.nature.com/jid/journal/v132/n1s/full/jid201286a.html


More information on Denosumab – Prolia : Click Here



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Posted in AlgaeCal Medical Advisors, Bone Health News, Osteoporosis Treatment News | Tagged , , , , , | 11 Replies
Lara Pizzorno

About Lara Pizzorno

A member of the American Medical Writers Association with 26+ years of experience writing for physicians and the public, am Editor of Longevity Medicine Review as well as Senior Medical Editor for SaluGenecists, Inc. In addition to reviewing the latest in longevity research for clinicians, Lara summarizes health & nutrition research for the Textbook of Natural Medicine e-dition, The World's Healthiest Foods (www.whfoods.org), Dr. Pizzorno's blog as WebMD's Integrative Medicine & Wellness Expert, and also blogs on EcoMii. Recent publications include: - Your Bones (Praktikos, April 2011) - Contributing author to the Textbook of Functional Medicine, (IFM, 2006) - Articles for Integrative Medicine: A Clinician's Journal (Innovisions Communications, Inc., 2005 through present) - Textbook of Natural Medicine (Elsevier, 2005, e-dition through present) - Lead author of Natural Medicine Instructions for Patients (Elsevier, 2002) - Co-author of The Encyclopedia of Healing Foods (Scribner's, 2005) - The World's Healthiest Foods Essential Guide for the healthiest way of eating (George Mateljan Foundation, 2006 through present) Lara graduated Phi Beta Kappa, magna cum laude from Wheaton College (Norton, MA, 1970), received her Master's in Religious Studies with Honors from Yale Divinity School (New Haven, CT, 1973), Master's in Literature from the University of Washington (Seattle, 1986), and has been a licensed massage therapist since 1986. Avocations include Pilates (currently working on Stott Pilates Instructor certification), motorcycling, organic gardening, healthy cooking. PublicationsYour Bones: How You Can Prevent Osteoporosis & Have Strong Bones for Life Naturally Book synopsis: When in her mid-forties, the author, now 63, was diagnosed with osteopenia--a loss of bone density that is the precursor to osteoporosis. Today, by following the recommendations discussed in this book, she has strong, healthy bones and will be the first woman in generations in her family not to die from osteoporosis. The bisphosphonate drugs prescribed for osteoporosis—eg Fosamax, Boniva -- should be your last choice: not only do they have numerous nasty side effects, they cause retention of old, brittle bone instead of creating new, healthy bone and actually promote fractures! Your Bones will teach you how to identify those factors in your life that are putting your bones at risk and will arm you with the cutting edge information you need to have healthy bones for life, naturally—relying on diet, exercise and supplements. Every statement this book is backed up with peer-reviewed medical research. Your Bones is an essential handbook for anyone wanting to prevent osteoporosis in later life. Available on Amazon

11 thoughts on “Denosumab Associated with Dermatologic Toxicity – FDA Adverse Events Reporting System

  1. Pingback: Could Fluoride in Your Tap Water or Toothpaste Be Destroying Your Bones? — AlgaeCal Bone Health Blog

  2. Debbie on said:

    Ms. Pizzorno,
    I am 54 years old….I took Fosamax for 5+ years for osteopenia. I had a bone density in Aug. 2011, and my diagnosis changed from osteopenia to osteoporosis in the spine. My doctor recommended that I make an appointment with an endocrinologist out-of-town. I had my appointment in Feb. 2012, and the recommendation was to take prolia. I did have an injection in April 2012. Several days later I went to the walk-in clinic for an urinary tract infection and 4 days after that….I went in for an upper respiratory infection. In a matter of a week-10 days I had been on 3 antibiotics. I am not usually sick person. During the 6 months my cholesterol went up, so I am now on cholesterol medication (LDL-bad cholesterol). I have chose not to take the 2nd injection of prolia that was due in October. I have ordered algaecal and stronium boost, but it hasn’t arrived yet. My doctor here in my town suggested Evista, but told me that it wouldn’t build bone…it would just help me maintain what I had. Can I take Evista with the algaecal/stronium boost? I really would like to take the algaecal/stronium boost without the Evista if I could. What do you know about Evista? I couldn’t find any articles that you had written on Evista. I had checked out your book from the library and read it…then I bought my own copy and I’m reading it again. I walk between 2-5 miles daily with walking videos/outside walking. I have some walking videos that use weights. I have also have been a lifetime member of Weight Watchers for 28 years…active Lifetime member for 12 years…healthy eating is a life style for me. Weight Watchers recommends 3 servings of milk for anyone over 50, so I try very hard to have it every day. Thank you so much!!!

    • Hi Debbie,
      Please accept my apologies for taking so long to respond — have been traveling & giving a series of Wellness Lectures on bone health up in Vancouver, BC. Just catching up now with emails. You were not imagining that denosumab (Prolia) was causing your infections. Denosumab increases risk of infections since its mechanism of action is to block off the RANK ligand, which pre-osteoclasts must bind to in order to develop into mature osteoclasts. Unfortunately, our T and B cells (key cells of our immune system) also need to bind to RANKL to mature, so denosumab interferes with immune function. In addition, denosumab also has ALL the same adverse effects as the bisphosphonates because denosumab, like the bisphosphonates, prevents normal bone remodeling. In the 2nd edition of Your Bones, which my publisher tells me will be out in March 2013, I have written quite a bit about denosumab (also more on the bisphosphonates and teriparitide, the other drugs prescribed for osteoporosis). ANY of these drugs should be your absolute last resort.
      Yes, you can safely take AlgaeCal Plus and Strontium Boost along with Evista. However, if you can work with a doctor who will support your efforts to restore the health of your bones naturally, your best option would be to not use this drug either. Evista is a SERM (selective estrogen receptor modifier); its adverse effect profile is less horriffic than the other bone drugs; but it is far from innocuous. Potential side effects include the formation of serious blood clots in the legs, lungs, and eyes; leg swelling/pain, trouble breathing, chest pain, and vision changes. In a study published in New England Journal of Medicine in 2006, raloxifene was shown to produce significantly more strokes and blood clots than placebo. Here is a link to this NEJM paper: http://www.nejm.org/doi/full/10.1056/NEJMoa062462
      Since you are 54, I am pretty sure you are neither pregnant nor hoping to become pregnant, but for younger women, raloxifene is contraindicated since it is a teratogenic drug, i.e., can cause developmental abnormalities/birth defects.
      My suggestion to you is that you use Your Bones to help you identify any factors in your current lifestyle that may be promoting bone loss and eliminate these as much as possible, and that you check to see that your diet and supplement program is supplying you with optimal amounts of all the nutrients your bones require to rebuild. If you have the book, you already know that I explain in depth how to figure out what’s causing your bone loss and what you need that you are not getting in sufficient amounts to rebuild bone. I think the three most crucial nutrients for bone health are vitamin D3, K2 and calcium — please check out the blog I wrote about the relationship among these three key nutrients for bone; it’s on AlgaeCal and is the most recent of my blogs posted. Walking is great weight bearing exercise — you might also check into Pilates (VERY safe since you can work on the Reformer and be totally supported and also target the specific areas of bone that you need most to build) and perhaps a Zumba class or weight lifting class. At my gym, 24 Hour Fitness, they offer a great weight lifting class called BodyPump – it’s really fun, and you can start out with very light weights. You want to give your bones a strong signal to rebuild, which all forms of weight bearing exercises will do for you. Please feel free to write if you have further questions and let me know how you are doing. Your overall lifestyle sounds good — you’re just needing more of some nutrient or have missed something that’s causing you to lose bone more quickly than you are rebuilding it. Is your digestion good? If not, I will have some further suggestions for you as this could be a major factor. Bottom line — if I was able to rebuild my bones with all my genetic susceptibilities for osteoporosis — I am truly the poster woman for this disease as I have every possible genetically inherited issue that causes it — ANYONE can do it! I wish you GLORIOUS health and know you can achieve it.

  3. Debbie on said:

    Thank you so much for responding to my questions! I responded early to your e-mail, but I wanted to check on my multivitamin too. My multivitamin (Sam’s Club complete multi) has 25 mcg of Vitamin K and also 400 IU of Vitamin D. I’ve read your book and some articles, but I wanted to be sure…can I take this multivitamin with algaecal plus or do I need to get a multivitamin without Vitamin K? I have looked at the health food store for a different vitamin (without Vitamin K) but the amountsor percentages of most of the vitamins in Health food store vitamins are more than what my mulitvitamin has. Thanks so much!

    • Hi Debbie, the Sam’s vitamin has such small amounts of these nutrients, it should not be an issue. Re vit D (what form? D3 is way more active than D2; D2 is cheaper so is used in lesser quality supps) and vit K (again what form? 25 mcg of MK-4 is meaningless — if taking MK-4 you require 15 milligrams taken 3 times daily for a total of 45 milligrams per day, thus 25 micrograms is meaningless), 25 mcg of MK-7 is better but still far less than the 90-100 mcg shown in the research to be helpful)

  4. Again, thank you so much for responding!!! The vitamin D is D3 400 IU and the vitamin K (as Phytonadione) 25 mcg. I had been advised at Algaecal to find another multivitamin without Vitamin K, so I had been looking in my city. Most of the vitamins I would find without Vitamin K really had an increased percentage in the other vitamins included. I was trying to stay with what my body was used to. I have been taking 4 capsules of the Algaecal plus so with my regular multivitamin the amount of Vitamin K would be 125mcg. The vitamin D3 would be 1200IU with my multivitamin and algaecal. I just didn’t want to take too much…I really appreciate your help!!!

    • The form of vit K in your multiple is K1 NOT either form of K2. K1 does have some beneficial effects on bone as it is anti-inflammatory, but K1 will not activate the proteins that put calcium into bone (osteocalcin) and keep it out of arteries, kidneys, breasts and your brain (matrix Gla protein). For this you need at least 100 mcg of K2 as MK-7 or 15 mg of K2 taken three times daily (every 6 hours) if as MK-4. Who at AlgaeCal advised you to not take more K2 than is supplied in AlgaeCal Plus — this is incorrect information unless you are taking Coumadin (warfarin) in which case, you can still use K2 as MK-7 but should be doing so with doctor supervision to ensure your INR remains stable. If on Coumadin, the dose recommended of MK-7 is 90 mcg/day. For everyone else, K2 (MK-7) is very safe. In studies using more than 800 mcg daily no side effects have been seen. In Japan, people regularly eat natto — a one cup serving of natto delivers more than 400 mcg of MK-7.
      Re vitamin D3, the only way to tell if you are getting sufficient amounts of vit D is to have your blood drawn to check your levels of 25(OH)D — this is the form of vit D in the circulation. Optimal levels are 60-80 ng/mL. This blood test should be covered by your insurance. Most people need at least 2,000 IU of D3 daily to get into this range. Many need 5,000 IU or even 10,000 IU per day to get into optimal range. I have explained all this at length in Your Bones — the book will be available at your library if you do not wish to purchase a copy; it is published by Praktikos, a non-profit, and costs less than $10.00.

  5. Debbie on said:

    Again, thanks so much for the information! I have a copy of your book…this is all new to me…a little confusing. I will read it again…I usually have my vitamin D checked every 3 months with my cholesterol and thyroid bloodwork. Again, thank you!

    • You’re so welcome! Hope Your Bones will help you make more sense of what your bones need to rebuild healthfully and safely. Don’t hesitate to ask if you have further questions. Be well! Lara

  6. Pierre on said:

    Lara, I have read many of your articles over the past two years as I struggled with taking the strontium citrate. Previously I have asked Algaecal the following question(s) without an answer. So permit me to pose it to you. Is there any reports of adverse reactions with the use of strontium citrate at the recommended dosage of 680 MG.??? Any issues with DRESS??? DVT??? Cardiovascular problems due to the strontium citrate sold by Algaecal??? I have purchased the Algaecal Plus and the Strontium Boost….but been reticent to take the strontium based on the reports of the EMA etc. Although I am aware of the molecular difference in the ranelate and the citrate. The question would be is it the strontium or the ranelate that causes the vascular issues??? And I have read your explanation previously. Merely wish to reassure myself before I begin the protocol with the strontium citrate. My BMD has dropped using merely the Algaecal Plus. Thanks, Pierre

    • Hello Pierre,
      Instances of DRESS or DVT have been reported in the medical literature only for strontium ranelate.
      No reports of these ADRs or cardiovascular problems have been made for strontium citrate.

      However, each of us is unique, and even a compound that is safe and effective for 100,000,000 people may cause some kind of reaction in the 100,000,001 person who uses it. I have only had one such report. A woman contacted me about 6 months ago – hundreds of people have written me since Your Bones was published – to let me know that she had developed swollen lymph glands after taking strontium citrate. When she discontinued it, the swelling quickly resolved.

      Since your BMD has not yet improved with only AlgaeCal Plus, my suggestion to you is to try strontium citrate as it may be very helpful for you and is highly unlikely to cause any adverse effects. To be on the extra cautious side, start out with half or even one-quarter of the recommended dosage for one month. Then gradually increase over several weeks to the full dosage.

      Most importantly, if you do not yet know why you are losing excessive amounts of bone, please read Part III (where I discuss the numerous factors that increase your risk for osteoporosis) in the 2nd edition of Your Bones, and also look at the Labs Appendix, in which I explain the key labs that can help you (and your doctor) determine why YOU are losing bone. My dear friend, Dr. Sidney Baker, MD, would have you think about it this way – if you are sitting on 2 tacks (one being insufficient nutrients your bones need – and AlgaeCal Plus / Strontium Boost should help address this – and a second tack being – we don’t know), then removing just one tack is not going to make the pain (bone loss) go away. You must remove both tacks to heal.

      So, please read Your Bones and feel free to write me with any questions you have as to what you think might be the remaining “tack” or “tacks”; I am happy to do my best to help you determine the underlying causes of your excessive bone loss,

      Lara

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