Denosumab Associated with Dermatologic Toxicity – FDA Adverse Events Reporting System

Updated: February 1, 2019

Pills on open hand

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

    July 10, 2012 , 3:31 pm

    […] our bones with the nutrients they require to do this job by themselves is much safer – and as the COMB study has demonstrated–more […]

  2. Debbie

    November 6, 2012 , 7:54 pm

    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!

  3. Lara Pizzorno

    November 7, 2012 , 8:56 am

    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. Debbie

    November 7, 2012 , 11:46 am

    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!!!

  5. Lara Pizzorno

    November 7, 2012 , 3:44 pm

    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 this anticoagulant 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.

  6. Debbie

    November 7, 2012 , 6:36 pm

    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!

  7. Lara Pizzorno

    November 9, 2012 , 9:13 pm

    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

  8. Pierre

    May 24, 2014 , 8:02 am

    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

  9. Lara Pizzorno

    August 12, 2014 , 9:27 am

    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

This article features advice based on cutting-edge research from our industry experts to give you the best possible information to support your bone-building journey.

Lara Pizzorno
MDiv, MA, LMT - Best-selling author of Healthy Bones Healthy You! and Your Bones; Editor of Longevity Medicine Review, and Senior Medical Editor for Integrative Medicine Advisors.,
Dr. Liz Lipski
PhD, CNS, FACN, IFMP, BCHN, LDN - Professor and Director of Academic Development, Nutrition programs in Clinical Nutrition at Maryland University of Integrative Health.,
Dr. Emma Gasinski
PT, DPT, RYT - Physical therapist and certified yoga teacher with a Doctorate in Physical Therapy from Rocky Mountain University of Health Professionals,
Dr. Lawrence (Larry) A. May
MD, FACP, Harvard Medical School Graduate, Physician, Author, Public Speaker - Doctor of Internal Medicine at Providence Cedars-Sinai Tarzana Medical Center and author of several articles and books, including the widely utilized and best selling medical textbook Primary Care Medicine,