Prescribing Advice for GPs

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Fosavance

Fosavance has been launched by MSD. This product contains Alendronate 70mg and colecalciferol 70micrograms in a once a week tablet. It will be priced at the same level as Fosamax, that is an NHS List price of £22.80 for 4 tablets.

It is licensed for the treatment of postmenopausal osteoporosis in patients at risk of vitamin D insufficiency. Further information is available in the Summary of Product Characteristics.

At present, Bisphosphonates (like Alendronate) are recommended for use in addition to a suitable Calcium and Vitamin D supplement. This product is being promoted based upon the fact that population data in the UK shows that the vast majority of people obtain sufficient calcium from their diet. The exception to this appears to be female patients who are aged over 65 and who live alone.

This product is an attempt at patent extension by the manufacturers of Fosamax as the patent is due to expire very soon. The place for this product remains unclear at present as supplementation with Calcium and Vitamin D supplements is the current empirical treatment.

Additionally, it may be difficult to assess the risk of Vitamin D insufficiency in order to comply with the product license. The skin produces Vitamin D naturally during exposure to sunlight.

Action: This product should not be used in preference to standard treatment (Calcium and Vitamin D supplement with or without a Bisphosphonate) until further data can demonstrate that Calcium supplementation is not required in patients who have already suffered an osteoporotic bone fracture, especially as patients with "postmenopausal osteoporosis" are likely to be female patients who are over 65 and living alone.

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48 Comments to “Fosavance”

  1. I have been prescribed Fosavance. I have severe osteoporosis in the spine and osteopenia in the hip. I am pre menaoausal and age 45. The doctor did not ask whether I was pre or post menapausal during my visit. I afterwards did some research and saw that it is prescribed to post menaoausal woman only. I'm very confused. He also asked me to take a thyroid, liver, kidney and urine test. Please help.

    Comment by Sarah Grech — April 3, 2017 #
    Reply

    1. @Sarah Grech

      Fosavance (and alendronic acid) are licensed for the treatment of post-menopausal osteoporosis because that is where these drugs have been studied. There hasn't been much research done in your age group but it seems your doctor felt that treatment was necessary. If you are still concerned you'll needs to discuss this with your doctor. The additional tests that have been requested are being done, I suspect, to try to find a cause for your osteoporosis.

      Comment by Matthew Robinson — April 4, 2017 #
      Reply

  2. I have been on Fosavance for a few years, and have heard that it is recommended to take a break as the old bone that does not get replaced tends to get dry and brittle causing fractures. Can you comment on this - thanks.

    Comment by Janet Scherer — November 11, 2014 #
    Reply

    1. @Janet,

      The FLEX Study was done a few years ago now and found no increased risk of fracture in a 2 year period of stopping treatment after 5 years on treatment as compared to continuing. These drugs are also linked with an increased risk of mid-bone fractures after prolonged use so treatment breaks are now becoming more recognised. It would be worth discussing your duration of treatment and reviewing your risk with your doctor.

      Comment by Matthew Robinson — November 11, 2014 #
      Reply

  3. I've been on Fosavance for the past 10 months. Is there any weight loss associated with Fosavance as I have lost 5 kg and dropped to clothing sizes since starting the medicine.

    Comment by Nishani — August 18, 2014 #
    Reply

    1. @Nishani,

      Weight loss is not a listed side effect but it has been reported twenty times through UK Post Marketing Surveillance or Yellow Card system with weight gain reported eleven times in the same period. I guess any weight loss could be due to the gastrointestinal side effects of nausea, vomiting and dyspepsia.

      Comment by Matthew Robinson — August 18, 2014 #
      Reply

  4. I was prescribed fosavance and after having used it for four months I discontinued the medication in my own as I had acid reflux. I've had hives and one attack of angioedema and am on antihistamines but I'm afraid to take them now as I had heart palpitations for trying it for five continuous days. The chest infectious diseases doctor says I may have an autoimmune problem. Three months ago I had painkiller for my tooth infection, antibiotics, antihistamines and corticosteroid injection for angioedema. Are these side effects of taking fosavance. It's been over 7 months since I stopped fosavance. I'm 45 and not pos-menopausal. Appreciate your advice. Thank you.

    Comment by Ameera — July 17, 2014 #
    Reply

    1. @Ameera,

      Acid reflux or other upper gastrointestinal symptoms like heartburn, indigestion or dyspepsia are known common side effects affecting between 1 in 10 and 1 in 100 people who take this medication. Skin reactions such as rash and itching are less common (1 in 100, to 1 in 1,000). Angioedema is also a know issue (1 in 1,000 to 1 in 10,000).

      You don't say why you were given this medication in the first place but I would suggest you return to your doctor and ask why this medication is recommended and also raise your concerns about the apparent side effects you have experienced.

      Comment by Matthew Robinson — July 17, 2014 #
      Reply

  5. I have been taking Fosavance for about 5 years , with no apparent ill effects. I am 64 ,female, and was put on it for osteopenia and family history of osteoporosis. However a blood test recently shows a very low alkaline phosphatase( 24 IU/L). Could this be due to the Fosavance , and should I consider coming off it?

    Comment by Clare Greene — April 17, 2014 #
    Reply

    1. @Clare,

      An isolated ALP is difficult to assess. It may be due to bone or liver disorders but these are usually associated with other changes too, for example with liver disorders you might see changes in bilirubin and AST also and with bone disorders you might expect to see calcium changes.

      Also, in the UK Fosavance is not licensed for the treatment of osteopenia, only osteoporosis. I would suggest you discuss your blood results and continued treatment with your doctor at the next routine appointment.

      Comment by Matthew Robinson — April 17, 2014 #
      Reply

  6. I am 52 years old and have been on fosovance for over 18 years and has recently told by my dr to stop taking the medication. I went through menopouse at a young age it started when I was 32. I still have my ovaries and is on hrt and estrogel my question to you should I be concerned that I have been on fosovance for too long and have I done more damaged then good. Regards Bev
    Canada

    Comment by Bev Keegan — January 27, 2014 #
    Reply

    1. @Bev,

      There is current debate about the optimal duration of treatment with medicines like Fosavance. I suspect your doctor has stopped it as he feels you have taken the therapy for a sufficient amount of time.

      Comment by Matthew Robinson — January 28, 2014 #
      Reply

  7. I have been taking calcium supplements and a monthly colecalciferol for my osteopenia for 8 years now. My last pelvic bone scan in April 2010 showed an improvement in the readings. I have been active in doing load bearing exercise.
    I recently moved to the Netherlands, and when my usual medication finished I consulted a doctor who didn't understand very much English. I am now post menopausal, so he prescribed Fosavance, and I decided before I got the prescription I would check it out - and here I am. I'm afraid to take this medication after reading about its side effects, and, of course, I wonder if it's necessary. Thank you for your advice.

    Comment by Alison Buchanan-Vaassen — December 2, 2012 #
    Reply

  8. I am 38 yrs old and have recently been prescribed fosavance for ostopenia (moderate ostopenia of the lower back). I have consumed three tablets so far. My concern is that every where I read I get to know that it is meant for post-menopausal women. Should I still take it? Or is consumption of calcium and vitamin D enough?

    Comment by Bani — July 29, 2012 #
    Reply

    1. @Bani,

      You need to speak to your doctor about this. In the UK, Fosavance is not recommended by the manufacturer for treating osteopenia, only post-menopausal osteoporosis. Alendronate, the main ingredient is recommended for men but again osteoporosis rather than osteopenia.

      Clearly, you have some concerns about the treatment and from the details you have given it seems that the manufacturers recommendations for use don't appear to apply to you, but your doctor will have more information and will be able to explain and hopefully reassure you.

      Comment by Matthew Robinson — July 29, 2012 #
      Reply

  9. I have been taking Fosavance for 8 months for osteopenia and had a DEXA scan yesterday only to find that there has been a slight deterioration of bone loss in my lumbar spine. My femur and wrist meaurements were normal.
    I am 61 years old and my mother had osteoporosis.
    I have side effects from this drug (aching bones and muscles) and would like to discontiue it completely. Is it really necassary to treat osteopenia with these types of drugs? I go to the gym twice a week and do weight bearing exercises and am in general good health and fit. Thanks for your advice.

    Comment by Arlene Khaireldin — May 16, 2012 #
    Reply

    1. @Arlene,

      Good question, and one to which we don't really know the answer. You might find this article in the New England Journal of Medicine makes good reading. Continued treatment with these drugs should certainly be reassessed periodically and consideration given to the pros and cons of carrying on with therapy.

      That discussion is best held with your doctor and should take into account your individual situation, family history, how long you've already been on the treatment and what level of impact the side effects are having.

      Comment by Matthew Robinson — May 16, 2012 #
      Reply

  10. Thank you SO much for a thorough and prompt reply. You confirmed what my online research suggests re: both the photosensitivity rash and, more importantly, whether I need to be taking this drug at all. I have booked an appt with my Dr for follow up. Thanks again, from Canada.

    Comment by Maureen MacDonald — August 25, 2011 #
    Reply

  11. @Maureen,

    The manufacturer (and UK regulatory authorities) are aware of some skin problems associated with this drug. 'Rash' and 'Rash with photosensitivity' are both listed in the known side effects and are Uncommon and Rare respectively.

    I guess it's possible that you may have missed that part of your ankle with the SPF50 and gotten the sun sensitive rash.

    That said, based on the information you have given above, your bone mineral density as you have reported indicates osteopenia, not osteoporosis. Also, your fracture was not a low trauma one if you broke it crashing a bicycle. So, I'd question whether you should be on treatment in the first place - certainly the current guidelines in use in the UK would not recommend that you were treated.

    I would suggest you return to your doctor and raise your concerns about treatment with them and perhaps ask what recommendations they are following that are suggesting you are treated.

    Comment by Matthew Robinson — August 25, 2011 #
    Reply

  12. Apologies, I should also mention I take liquid calcium/magnesium supplement and minimum 3,000 IU Vitamin D each day. I am a triathlete, so do regular weight bearing exercise.

    Comment by Maureen MacDonald — August 25, 2011 #
    Reply

  13. I have taken two doses of Fosovance. After the second one, I developed a 2 inch diameter red inflammation on my ankle. It's not itchy and after four days the redness is decreasing a bit but it's still there. I can think of nothing else that would cause this. I was out in the sun for several hours that day, but wearing 50 SPF sunscreen with frequent reapplication. Is this a possible Fosovance side effect? Has anyone experienced anything similar.

    For context, I am a very athletic, post-menopausal 54 year old. I broke my wrist after a bicycle crash in April 2011 and my bone density was -1.7 in Oct 2010 (decreased from the previous year) so my Dr. prescribed Fosovance. (I tried her initial prescription of didricol and was so sick I quit after three days). I have also had chest tightness for about three days after each tablet of Fosovance. I'm beginning to think the end doesn't nearly justify the means with this drug.

    Any comments on the rash would be welcome.

    Comment by Maureen MacDonald — August 25, 2011 #
    Reply

  14. Sorry, forgot to mention that recently I had a bone density index test & the result was -6.4

    Comment by Rajesh Misra — May 26, 2011 #
    Reply

  15. I am currently using Fosavance. How effective is it for me as I am a patient of Osteogenesis Imperfecta.

    Comment by Rajesh Misra — May 26, 2011 #
    Reply

    1. There have been studies that have examined use of oral alendronate in Osteogenesis Imperfecta (OI) although mainly in children. I assuming you are an adult.

      They have been shown to increase bone mineral density in children and adults and also reduce the rate of fragility fractures in children. You may find this article of interest.

      Comment by Matthew Robinson — May 26, 2011 #
      Reply

  16. Your answers are much appreciated, thank you. As for the osteoporosis / osteopenia, some sites (hip / lower back) which tested osteoporotic at first scan, showed improvement and were pronounced osteopenic at second scan after a year. Some sites which tested osteopenic at first scan showed improvement and tested normal at second scan. But then there was also a reversal in one or two sites which showed slight deterioration. Jogging etc is impossible and painful due to all the steel keeping my knee and ankle together, although the bones in both have healed well. Walking I do as much as time allows. Thanks for the advice.

    Four more Q's if I may. 1) Is the testosterone (HRT) a definite advantage to the bones and commonly prescribed? 2)Could the dexa scanner be suspect and should I try another machine for the next yearly test to check if there are any major differences. In other words how reliable and accurate are these scanners? 3) How common is my condition among males of my age? 4) Is there any particular osteo specialist or research group you could recommend in South Africa, as the GP's, the orthopaedic surgeons who fixed my fractures, and the urologist who prescribed the HRT are still confounded regarding my condition after five years.

    Please do not hesitate to indicate if I am imposing on your time with my questions. Many thanks.

    Comment by Grant Swart — October 20, 2010 #
    Reply

    1. @Grant,

      I understand a little more about your diagnosis now, but if some sites were indicating osteoporosis then that is your condition even if other sites indicate osteopenia. You take the worst site and base the diagnosis on that. If you can't jog due to pain then fair enough, walk as best you can.

      In answering your questions, testosterone is involved in bone metabolism so it seems like a good idea. ALL tests involve the acceptance of a degree of error, so if you had been put through the same DEXA scanner twice in a short period (so literally scanned twice in succession) you would likely get different results. Essentially, don't worry to much about the individual results, try to look at the overall picture - which sounds like an overall improvement.

      I'd say the condition would be rare in a male of your age and I expect this is why your doctors are so puzzled. That said, if you read about how osteoporosis is diagnosed, it is based on standard deviations compared to a 'population normal', so there will always be people with low bone mineral densities and people with high bone mineral densities. The difference with you is that this has been identified after your fractures and is now being treated. I'm afraid I don't know of any specialists or clinics in South Africa, that is something you need to ask your doctors about.

      Comment by Matthew Robinson — October 21, 2010 #
      Reply

  17. @Grant,

    I suspect you have osteoporosis but not osteopenia. The conditions are both about bone loss but osteoporosis means you've lost more bone than osteopenia.

    But, you are on the right treatment. It is normal to get fluctuations in your bone mineral density so don't worry about that too much.

    Ask your doctor about your toes, I'm not aware that this is related to treatment but it is possible. As for the long bone fracture risk, the disadvantages of treatment in this respect are still lower than the benefits in terms of prevention of other fractures.

    You should make sure you are taking weight bearing exercise if possible to ensure that you are 'exercising' your bones. By weight bearing, I mean walking, jogging and running rather than swimming or cycling.

    Comment by Matthew Robinson — October 14, 2010 #
    Reply

  18. 4 questions please. I am a 46 year old male and was diagnosed with osteoporosis and osteopenia at approx age 42. That was after two very serious but very unusual fractures of the knee and later the ankle. In addition to Fosavance I have a monthly injection of testosterone and I use a calcium supplement. In other respects I lead a pretty normal working life. 1) After 1 year on Fosavance, dexa scan showed I had a 10,7% overall increase. After 2 years I showed a 4,6% overall loss again. Is this normal? 2) I have seen developing excess bone growths on the side of each big toe, is this known? Could it be Fosavance related? 3) Today there were warnings posted all over the international news concerning the increased risk of femur fracture among users of Fosamax and other alendronates. Is this a problem I should be concerned about? 4) What other treatment should I be getting?

    Comment by Grant Swart — October 14, 2010 #
    Reply

  19. @June,

    The joint pain is a known side effect of one of the active ingredients. It may pass with a little more time but probably not. The cracking you are feeling is probably the same problem, I suggest you return to or doctor for a check.

    Comment by Matthew Robinson — June 28, 2010 #
    Reply

  20. I have been on Fosavance going onto my 3rd week and have very sore joints and they seem to be cracking which they didnt do before. Will the sore joints eventually disipate once my body gets used to it?

    Comment by JUNE TASKER — June 27, 2010 #
    Reply

  21. I have been diagnosed with osteoporosis at 50, at point 3, spinal and hip. I have been on Fosamax before and had acid reflux and uncomfortabel osophogus burns. The drug was dicontinued. I have now been prescribed by the same doctor Fosavance with Vit D, as my conditon is 30% bone loss and its serious? the other possibility suggested was the intravenous injection of Zolindronic Acid. This however seems to be a very severe drug. I am not sure what route to take. I am prepared to try the Fosavance again, but if it causes the same reactions will have to look at other options?

    Comment by Heike Laufer — March 17, 2010 #
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  22. I was on Fosamax for nine months and suffered severe head & ear discomfort.It was only after a Cat scan to help peace of mind brain cancer etc that my thoughts turned to my medication.I stopped taking it & days later I started feeling ok.Obviously I need to take something for my condition.Maybe Fosavance? I must say my bone density test after nine months on Fosamax were exellent.

    Comment by Jean Ford — March 15, 2010 #
    Reply

    1. @Jean,

      Fosavance contains the same active ingredient as Fosamax with the addition of Vitamin D. If we attribute your symptoms to the Fosamax then I suspect that you would most likely have the same issues with Fosavance. I think you should talk to your doctor about possible alternatives.

      Comment by Matthew Robinson — March 15, 2010 #
      Reply

  23. After taking Fosavance for 5 weeks I noticed scalp hair loss and hence I stopped it. I am waiting to see if this has caused my scalp hair loss. I am going to see my doctor regarding this. What advice can you give me to control hair loss that is due to Fosavance and what is my alternative to treat osteoporosis??

    Comment by Prabha — May 19, 2009 #
    Reply

    1. Prabha,

      Alendronate (the main active ingredient in Fasavance®) has been reported to cause alopecia but this is very rare. There are alternatives to alendronate but you'd have to speak to your doctor to see if these are suitable for you.

      Comment by Matthew Robinson — May 22, 2009 #
      Reply

  24. I have been taking FOSAVANCE for one month but, I could not find any more and the druggist changed it by FOSOMAX.Please tell me the difference and should I take it?

    Comment by Masoum — April 3, 2009 #
    Reply

    1. Masoum,

      The difference is that Fosavance additionally contains Vitamin D. If you have concerns that you may not be getting enough Vitamin D from other sources (diet and exposure to sunlight) then talk to your doctor.

      Comment by Matthew Robinson — April 3, 2009 #
      Reply

  25. Christine,
    If you have stopped taking the Fosavance for two weeks and there has been no change in your symptoms it is unlikely to be a local irritation caused by the medication. You should see your doctor for a check up.

    Comment by Matthew Robinson — January 16, 2009 #
    Reply

  26. I have been taking FOSAVANCE for several months and have recently had gastric problems -- discomfort, flatulance, loose stools. Is this likely to be a result of the medication? I have stopped taking FOSAVANCE for two weeks now to see if there is any improvement. How long should I wait to see if things improve? I am 63 years old and FOSAVANCE was recommended because of a family history of osteoporosis.

    Comment by CHRISTINE ELLIS — January 15, 2009 #
    Reply

  27. Sally,

    I have not heard any suggestion that Fosavance is to be withdrawn however alendronate would do the same job one tenth the price on the UK market.

    It may be that your doctor is being encourage to prescribe with 'value for money' in mind, I would suggest you discuss your concerns with your doctor and would strongly advise against buying over the internet.

    Comment by Matthew Robinson — November 18, 2008 #
    Reply

  28. I have heard that Fosavance is to be withdrawn and a cheaper Alendonic acid is to replace it---Is this true? If so will I be able to buy it over the internet? I would appreciate your advice.

    Comment by Sally Phillips — November 17, 2008 #
    Reply

  29. Thank you so much. I am grateful for your help. E Gladwin

    Comment by Mrs Gladwin — November 17, 2008 #
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  30. Mrs Gladwin,

    From the informaiton you have provided Fosavance does seem an unusual choice at this stage and the treatment you have been given would not be a recommendation based on recently published guidelines here in the UK.

    I would suggest that you speak to your doctor about your concerns and also ask for a justification of the treatment compared to the alternatives.

    Comment by Matthew Robinson — November 11, 2008 #
    Reply

  31. I have been prescribed Fosavance, together with a calcium supplement as a result of a DEXA scan that shows I have borderline Osteopenia (T-score of lumbar spine -1.1). I am 43 years old and not yet reached menopause. I have never taken drugs for anything before - is Fosavance really necessary at this stage? (I am living abroad and don't know the doctor).

    Comment by Mrs Gladwin — November 11, 2008 #
    Reply

  32. Marjorie,
    You have been prescribed this drug to strengthen your bones to reduce your risk of having further fractures should you fall.

    There is a distinct possibility that the prednisone has made your bones weaker but the biggest causative factor was your fall. If you can do anything to reduce your chance of falling again including looking at your home, other medicines you take and your footwear and so on then you should. You may also find this article a good read.

    Comment by Matthew Robinson — January 19, 2008 #
    Reply

  33. I have just been prescribed this drug after bone scan revealed that I had 5 fractures one wrist and four in the back -ribs, spine , etc. after a fall. I did not get a bone density after until I had been taking prednisone for an auto-immune disease for over a year. I am 80 years old but the bone density was ok, until the prednisone - I am assumming the fosanavance will help to cure the bone loss. Is this correct?

    Comment by Marjorie Spooner — January 19, 2008 #
    Reply

  34. Eileen,

    The difference is simply the addition of colecalciferol into the Fosavance. Other than that the products are the same.

    I'd have to say that "toxic" is a bit of a strong word to choose to describe Fosamax. If it were genuinely toxic it would not be on the market. Of course, like all medicines it will have side effects that affect some individuals.

    Comment by Matthew Robinson — August 18, 2007 #
    Reply

  35. Sounds like this is the same as Fosamax which I stopped taking months ago as it is toxic...please explain what the difference is between Fosamax and Fosavance??? Thanks Eileen Storzuk - Canada

    Comment by Eileen Storzuk — August 18, 2007 #
    Reply

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