Bisphosphonates & Avandia - Drugs Meant to Heal May Actually Cause Harm!

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Currently use of 2 main drugs is being questioned. Avandia, used for treating Diabetes, is already in the dock for causing heart attacks or heart failure, the other, whose benefit is now being questioned, is a drug meant to reduce or prevent fractures due to fragility of bones- Bisphosphonates.

Bisphosphonates are normally prescribed to people who have osteoporosis and are susceptible to fractures especially of vulnerable areas such as the spine or hips. These drugs go by the brand names Actonel, Boniva or Fosamax to name a few. Shockingly in some cases have shown that they can cause fracture of the thighbone or an unusual degenerative disease of the jaw bone. A few orthopaedic experts however still feel that that the benefits of using bisphosphonates for osteoporosis is greater than the risks, and advocate cautious use of the same.

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25 April, 2011 | Vijayalakshmi Iyengar | Reply

Highly exciting news that scientists have developed a new injectable serum which will help ward off or beat osteoporosis by building new bones. This new shot (developed by a biotech company AMGEN along with their Belgian partner), is it will reduce the frequency of treatments for people who suffer from brittle bones and the associated pain. Till date the drugs used simply prevented the old bone from breaking down and they had to be taken on a daily basis, which was inconvenient. The new medicine given once a month or even once in 3 months, helps by binding sclerostin -a protein that slows down or blocks the building of new bone, and prevents it from acting.
A trial on 400 women who were given the `sclerostin antibody jab’, compared favorably with the existing drugs in the market. However a bigger study is on the cards to establish its safety and efficacy before its on sale.
However, recently The FDA has approved Forteo (teriparatide), a new daily injectable drug for osteoporosis that stimulates new bone formation. Forteo is a portion of human parathyroid hormone (PTH), which regulates calcium metabolism in bones.
Read more on osteoporosis on http://tinyurl.com/3dawlyq
Vijayalakshmi Iyengar
Sr.Dietitian
Nutritionvista.com

05 November, 2010 | Jan | Reply

I personally think people should have their hips, spine, jaw and any other painful or suspected bones evaluated before beginning a prescription of Fosamax to make sure they don't have a misalignment that could result in a fracture as the bones become stronger.
Some people may require starting with a pair of Orthotics in their shoes to realign their bones before trying to harden these bones. Hardening a bone quickly that is becoming thin and brittle inside due to pressure from misalignment could lead to fractures to people at an earlier time in their life than expected. That's my opinion. I've been walking around with minimal orthotic support. My one leg is shorter than the other, and this causes pain and pressure on my hip in the area indicated as causing fractures from using Fosamax. I just think if I took this pill before starting a strict use of orthotics, including a lift in the one shoe, and other means to keep my bones sraight, my right hip bone could easily become broken due to the damage that is already there.

26 October, 2010 | Virender Mehta | Reply

I completely agree with Naresh.its not possible to say whether drug is completely safe for use in just a limited trial period. To assess long term safety, post marketing surveillance by the drug manufacturing companies should be made compulsory by regulatory authorities.

26 October, 2010 | Naresh Verma | Reply

Drugs do undergo rigorous processes and trials before they are labelled as safe for use. However, all the adverse effects or toxicities cannot be elicited in the limited number of volunteers used in the phased trial. Drug regulatory bodies should be aware of these facts and take prompt initiatives to withdraw their sale if they are found unfit for long term use later.

25 October, 2010 | Mohit Verma | Reply

For many, drugs have become a necessity now a days and not a choice. I am sure that there must be many other drugs that are meant for treating serious disorders which might be future Avandias or biphosphonates. Its high time that medicine market should be regulated more stringently.

25 October, 2010 | Radhika Singh | Reply

We know it well that drugs can be put into clinical trial only for a particular period of time. However that should not mean that it is cent percent safe for use. There can be safety issues in long term use of particular drugs. So in my opinion, drugs, even when they are approved for use should be kept under study so as to know their long term efficacy and any harmful effect, if any.

26 October, 2010 | Aparna K T | Reply

After a certain period of time during the clinical trial for drugs when the team has sufficient data to conclude that it is going to alleviate the condition for which it has been produced and has been approved, the funds to continue the trial is limited. Therefore long term clinical trials are not conducted.

21 October, 2010 | Kanika Jain | Reply

Though stringent regulations or ban or label advisories have been issued for these drugs but as a consumer, recent episodes makes us think about few questions.
•Is it high time to tighten the clinical trials of drugs before they actually hit the market?
•Should there be new safety standards which pharmaceutical companies need to meet before getting approval from concerned agencies?
•What is the role of approval agencies? Should that be revised too?
•Should there be long term clinical trials even after a drug is approved to assess long term safety?
•What about those who have already been on these controversial drugs for years?
•What about many other drugs available in market being prescribed by doctors for other ailments whose long term safety has not yet been supported\contradicted by the research studies.
•Is it that greed of major pharmaceutical houses for huge profit is over- powering the benefit and welfare of patients concerned? If yes, should there be a watchdog panel to monitor practices of pharmaceutical companies too like fair clinical trials, responsible advertisement and selling of drugs?

21 October, 2010 | Sonika, R | Reply

Good!
The more we raise awareness on bisphosphonates the better.
Thanks

21 October, 2010 | Sunder Rajan | Reply

In India, I am sure both will be available on black market, even though they are banned. Govt has no say when compared to determined pharmacy's and companies.

21 October, 2010 | Dr. Sudershan Gupta | Reply

On World Osteoporosis day there were many activities and seminars all over N.Delhi, to awaken people about taking precautions to prevent Osteoporosis . Bisphosphonates is given to people to help them deal with the malady.
I have a couple of points to make
1.Not everybody who is on bisphosphonates have these strong side effects (thigh fracture or jaw disease)-Are we not overreacting ?
2. DO you have any alternatives right now for a person suffering from this malady?
Research articles are sometimes far removed from practical applications, we need not jump every time they have a new theory.

22 October, 2010 | Vijayalakshmi Iyengar | Reply

Dear Dr Gupta, Yes, I agree that we should not overreact when a research finding contraindicates use of a drug which is doing much good but some rare side effects are threatening its use.
However as you well know there is no way to be a 100 percent certain what the outcome with long term use will be. Meanwhile medical care dictates we must err on the side of caution.

Avandia is a classic example of a drug which seemed so effective in the treatment of diabetes, but on prolonged use began to cause serious problems.
Research findings help caution the doctor of possible side effects which he may or may not have encountered with till date and puts him and the patient on guard, watchful for any untoward reactions.
To answer your question on bisphophonates, as stated in the article an expert in osteoporosis, Dr Siris herself expressed fear that the drug which was an excellent remedy for preventing fractures in osteoporotic people, might unfortunately get vetoed against its use in the light of the extremely rare conditions of thigh fractures and jaw disease. So only time will tell if bisphophonates will stay or go the Avandia way.

Meanwhile, we dietitians will continue to advocate a nutrient rich diet and daily moderate exercise that will play a significant role in improving bone health.

Thank you for your insight - I am sure it is toughest for the physicians who have to take a call on whether to prescribe a drug or not.
Please do let me know if I could be of further help with regards to any diet and nutrition information.
Sincerely,
Mrs Vijayalakshmi Iyengar

21 October, 2010 | Maria Jose Rivera | Reply

These companies need to stop selling to all these people who do not know problems of these medications.

What to believe is the big question. How to trust a company who want to make profit form people suffering.

It is better eat healthy - less fat in food and less calories and beer and more fruits and vegetables. cooking at home is good.
Thanks

Also be informed of problems so you can avoid harmful medications.
Thank yo u.

22 October, 2010 | Mrinal | Reply

Dear Ms. Rivera,
From a patients point of view it could be upsetting that companies try and push a drug to market and later find out if it has any harmful side effects.

However, think of all the sick and infirm that benefit as well from this kind of research.

Yes, diet and exercise are great, but when the body already has an illness like osteoporosis or cancer or elevated blood pressure - drugs MUST come into play to correct the problem at the earliest or else the patient faces an escalation in his condition.

If you ever worry about a medication - please do talk to your doctor about your fears and concerns and follow his / her advise. Doctors are aware of these potential side effects and knowing your health history puts them in the best position to prescribe a drug or not for you.
Best wishes.

22 October, 2010 | Goel | Reply

Drug companies may make profits but drugs are a necessity, so dont always confuse the trees for the woods.
Good diet is most important but can you cure people after they get a disease with just a good diet & exercise and without drugs?

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