Medsafe warns consumers not to take Miracle Mineral Solution and how to report an adverse reaction

Have a good read and take care when playing around with any "miracle cures".  Accurate reporting of any adverse reactions to any procedure is essential if we are to know its real safety.  Less than 10% of adverse events ever get recorded.  We must do better than that to ensure we know what is both safe and effective.

Press release follows:

Medsafe warns consumers not to take Miracle Mineral Solution

Medsafe has been alerted to the Miracle Mineral Solution products (also known as "Miracle Mineral Supplement" - MMSI and MMSII) in the past and has communicated with the company to require them to cease making claims that their products are an effective treatment for several serious diseases. Copies of our correspondence with the company are available on the MMS website. Medsafe will be contacting the distributor of these products to advise them to stop selling these products as medicines.

The Food Standards Authority in the UK warned the British public against the use of Miracle Mineral Solution on 29 September 2010. This follows similar warnings from the Food and Drug Administration in the United States and Health Canada in Canada about the use of these products.

These products, when used as directed, produce an industrial bleach that can cause serious harm to health. The products instruct consumers to mix the 28% sodium chlorite solution with an acid such as citric acid. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labelling, can cause nausea, vomiting, diarrhoea and symptoms of severe dehydration.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Internet claims for these products include the treatment of multiple unrelated diseases, including HIV, hepatitis, acne, cancer and other conditions.

In New Zealand, MMS is sold as a mineral supplement and has not been assessed for quality, safety and effectiveness and granted approval for sale as a medicine.

Medsafe is currently investigating other options available to them with respect to MMS and supports the recommendations made by authorities in the UK, US and Canada that consumers who have MMS should stop using it immediately and throw it away.

Consumers who have experienced any negative effects from MMS should consult with a healthcare professional as soon as possible. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the New Zealand Pharmacovigilance Centre for Adverse Reaction Monitoring (CARM) at the University of Otago - carmnz@otago.ac.nz

 About this website 

The advice in these articles is given freely without promise or obligation. Its all about giving you and your family the tools and information to take control of your health and fitness.

"Bone strengthening" drugs associated with numerous side effects

When reading this notice for medical practitioners from Medsafe, please bear in mind that what is being advised applies to all "bone-sparing" drugs of the bisphosphonate class, including the Fosamax which, among other brands, is the subject of thousands of court actions in the USA.
http://blog.garymoller.com/search/label/fosamax-lawsuits

I use the phrase "bone-sparing" with extreme cynicism because just two of this class of drug are blamed for causing 31,500 femur and hip fractures in the USA alone!

Bear in mind that less than 10% of adverse reactions ever get reported.

Read on and read the links I have provided.  As I said in an earlier article, "You would have to be nuts to be taking these".

Key Messages

• Patients who are treated with zoledronic acid can experience acute phase reactions.
• Symptoms include fever, diffuse musculoskeletal pain, gastrointestinal effects, and eye inflammation.
• The risk of renal reactions can be prevented by keeping patients adequately hydrated prior to and following infusions.

Acute Phase Reactions

Zoledronic acid (marketed as Aclasta and Zometa in New Zealand) is a bisphosphonate administered to patients by intravenous infusion. Prescribers are reminded that patients may experience an acute phase response or adverse effects on renal function following administration.

Acute phase reactions may present with the following symptoms: chills, fever, influenza-like symptoms, night sweats, rigors and shivering, diffuse musculoskeletal pain, gastrointestinal effects, and eye inflammation¹.

Acute phase responses can occur at any time up to approximately two weeks following an infusion¹. The majority of patients will experience symptoms within the first three days after an infusion¹. These reactions are usually self-limiting and resolve completely within 24 to 48 hours². However, in some patients symptoms may persist for longer periods.

Supportive and symptomatic management with paracetamol and non-steroidal anti-inflammatory drugs is recommended, once other serious causes of fever such as infection have been excluded². Pre-treatment with paracetamol or ibuprofen may also be helpful for some patients².

Renal Reactions

Renal reactions can also occur shortly after infusion. Adequate hydration can help to reduce the risk of renal deterioration after a zoledronic acid infusion^4–6. Renal deterioration, progression to renal failure and dialysis has been reported in patients following the initial dose of zoledronic acid⁵.

If patients show signs of renal function decline after infusion, the benefits and risks of harm of continued treatment should be evaluated.

Factors which may increase the risk of renal deterioration following zoledronic acid infusions are:

• dehydration
• pre-existing renal impairment
• multiple cycles of zoledronic acid or other bisphosphonates
• concomitant use of nephrotoxic drugs
• a shorter infusion time than recommended.

Bisphosphonates are also associated with ocular inflammatory effects such as uveitis and scleritis³. Ocular complications are uncommon. However, patients should be advised to seek immediate medical attention if they experience any ocular symptoms while being treated with a bisphosphonate.

The Centre for Adverse Reaction Monitoring (CARM) has received 153 reports of musculoskeletal adverse reactions starting within one month after a zoledronic acid infusion. CARM also received 26 reports of ocular adverse reactions and 33 reports of urinary adverse reactions within one month following an infusion.

Healthcare professionals are encouraged to report all suspicions of medicine adverse reactions to CARM.

References

1. Reid IR, Gamble GD, Mesenbrink P, et al. 2010. Characterization of and risk factors for the acute-phase response after zoledronic acid. The Journal of Clinical Endocrinology and Metabolism 95: 4380–4387.
2. Tanvetyanon T, Stiff PJ. 2006. Management of the adverse effects associated with intravenous bisphosphonates. Annals of oncology 17: 897–907.
3. Medsafe. 2011. Reminder: Keeping an eye on bisphosphonates. Prescriber Update 32(3): 24. URL: www.medsafe.govt.nz/profs/PUArticles/BisphosphonatesSept2011.htm (accessed 19 May 2015).
4. Attivi D, Kosmalski G, Zeghmouli C, et al. 2014. Effect of intravenous hydration in patients receiving bisphosphonate therapy. International Journal of Clinical Pharmacy 36: 1277–1281.
5. Novartis New Zealand Limited. 2014. Zometa Data Sheet. 21 October 2014. URL: www.medsafe.govt.nz/profs/datasheet/z/Zometaconcinf.pdf (accessed 19 May 2015).
6. Novartis New Zealand Limited. 2014. Aclasta Data Sheet. 8 October 2014. URL: www.medsafe.govt.nz/profs/datasheet/a/Aclastainf.pdf (accessed 19 May 2015).

Source of release:
http://medsafe.govt.nz/profs/PUArticles/June2015/June2015ZoledronicAcid.htm


Further reading:
http://blog.garymoller.com/search/label/fosamax

 About this website 

The advice in these articles is given freely without promise or obligation. Its all about giving you and your family the tools and information to take control of your health and fitness.

Bleeding is the major risk associated with all antithrombotics

What the following notice to medical practitioners does not mention is the over-prescribing of these drugs for many conditions that may be extremely well managed by nutritional interventions, stress management and  other measures such as stopping smoking.  It just seems that it is so much easier to write the patient a script and shove them out the door!

Less than 10% of all adverse reactions get reported and this may be as low as 1%, so the figures below for New Zealand are alarming.  So, what's the true level of harm?

It is interesting to note the disastrous effects of combination therapies, particularly with anti-inflammatories and depression pills, both of which are prescribed with gay abandon in this country.

What statistics do not tell us is the misery that many of the affected individuals and their families suffer as a consequence.  The consequences include disabling brain damage and some deaths.

While the prescribing of anti-clotting drugs may be necessary during acute occasions and following certain surgical procedures, there are few cases, in my opinion, that require this medication for life.

If you, or a loved one, are on these drugs, keep going back to your doctor and ask "when am I going to be able to stop?"  Has your doctor got a proper treatment plan for your ill-health, or not?  If there is no light at the tunnel, then seek a second opinion.  If you are still feeling uneasy, keep looking for healthy long-term solutions.  They are out there.

Notice below.

Gary
______________________________________________

Anticoagulants and antiplatelet agents (antithrombotics) are widely used to treat a number of conditions, with recent guidance on their use being issued by the Best Practice Advocacy Centre (BPAC)¹.

Bleeding is the major risk associated with all antithrombotics. The Centre for Adverse Reaction Monitoring (CARM) continues to receive reports of serious bleeds experienced by patients taking these medicines.

An overview of 12 months of reporting to CARM is shown in Table 1. The main sites of serious bleeding were most often gastrointestinal or intracranial in origin.

Only a small fraction of suspected adverse reactions are reported to CARM, nevertheless these reports show that serious bleeds do occur with antithrombotics and that some bleeds may have been preventable. For example, although combination therapy is recommended for some conditions, adverse reaction data continues to indicate a major risk factor for bleeding is the concomitant use of more than one antithrombotic medicine.

Early treatment of bleeds is desirable and patients and/or carers should be advised to monitor for early signs of bleeding.

Table 1: Antithrombotic CARM reports associated with bleeding from 1 Oct 2010 to 30 Sept 2011.

Medicine	Total number of reports	Number of reports of bleeding (%)	Number of cases reported to be exposed to another anticoagulant or antiplatelet agent (%)	Number of bleeding cases reported to also be exposed to a NSAID or SSRI (%)
Aspirin	28	68	53	42
Clopidogrel	9	67	100	16
Dabigatran*	212	42	59	3
Dipyridamole	3	67	100	50
Enoxaparin	14	50	57	0
Rivaroxaban	3	0	N/A	N/A
Warfarin	32	56	50	11

* Dabigatran has been recently introduced with rapid uptake

Key Messages

• A major risk factor for bleeds is the use of more than one antithrombotic medicine.
• Patients and/or carers should be advised to monitor for the early signs of bleeding.

References

1. A New Zealand Consensus Forum. 2011. The use of antithrombotic medicines in general practice: a consensus statement. Best Practice Journal, 39: 10-21

_______________________________________

About this website

The advice in these articles is given freely without promise or obligation.  Its all about giving you and your family the tools and information to take control of your health and fitness.

Pradaxa Bleeding Events: Four Major Factors Which Contributed To These Serious Side Effects

Warfarin: A
popular rat
poison

New Zealand is in the international spotlight.... For the wrong reasons.

If you live in New Zealand and your doctor has switched your anti-coagulation medication recently from Warfarin, the chances are you have been given a drug called "Pradaxa".  Please go here to learn more about this drug here in New Zealand.

Pradaxa has been associated with a rash of "bleeding" incidents in New Zealand and, I understand, a number of deaths.  This does not mean to say that Warfarin, which it replaces is any safer - it is far from "safe".  By the way, there are safe, natural alternatives that most people on blood thinners may wish to consider; but the switching from the likes of Warfarin to these needs to be carefully exercised with the assistance of a suitably trained health practitioner.

Please go here for some articles about Warfarin.

While the number of incidents seem to be relatively low, please bear in mind that less than 10% of adverse reactions ever get onto official databases.  Some cynics believe the real figure is less than 1%.  I go with the latter.

I have reproduced below a letter from Tom Lamb of Drug Injury Watch.  If you feel you have been harmed by this drug, or similar ones, please drop him a line.  While his main interests are within the USA, I am sure he will be happy to hear from you.

One point of note is the lack of an effective reversal agent.  Which means if you suffer an adverse event, things could go from bad to worse because there is no antidote to effectively neutralise the action of the drug.

Gary
_______________________________

Pradaxa Bleeding Events: Four Major Factors Which Contributed To These Serious Side Effects

More Recent Articles

Search Drug Injury Watch

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Pradaxa Bleeding Events: Four Major Factors Which Contributed To These Serious Side Effects

Prescriber Error, Impaired Renal Function, Patient Age, And Lack Of An Effective Reversal Agent Are Cited
(Posted by Tom Lamb at DrugInjuryWatch.com)

Is your asthma corticosteriod medication destroying your joints?

Corticosteroids and avascular necrosis
Web site: May 2009
Prescriber Update 2009;30(2):14

CARM has received a number of reports of avascular necrosis (AVN) in association with corticosteroid use. The reports describe the involvement of major joints such as hips, knees and ankles, often with bilateral involvement.

International reports have also included other joints, including the shoulder and wrists. AVN usually causes significant chronic pain and reduced mobility, with some patients requiring joint replacements.

The pathogenesis of AVN is not yet fully understood, but may involve steroid induced osteoblast apoptosis.

The CARM reports involve patients who were prescribed corticosteroids for asthma, immunosuppression in transplant recipients, polymyalgia rheumatica, rheumatoid arthritis, eczema, and cerebral oedema. International reports of AVN have included an association with the use of pulse steroid therapy in multiple sclerosis.

AVN usually occurs with high doses of corticosteroids over a period of a few weeks to several years. Other known risk factors for AVN\ include: alcoholism, infections, hyperbaric events, storage disorders, marrow infiltrating diseases, coagulation defects, sickle cell anaemia and some autoimmune diseases.

As some patients who develop AVN remain asymptomatic, the severity of symptoms cannot be taken as a guide to the severity or stage of AVN.

As the clinical outcome is dependent on the stage at which diagnosis of AVN is made, prescribers should be alert to symptoms of joint pain in patients using corticosteroids and are advised to investigate these symptoms early. In the presence of a confirmed diagnosis of AVN, stopping or interrupting corticosteroid treatment should be considered. Prescribers should also consider investigating for further conditions associated with AVN such as, myeloproliferative diseases, coagulation disorders, and autoimmune conditions.

Reference

1. Assouline-Dayan Y. Chang C. Greenspan A. Schoenfeld Y. Gershwin ME. (2002), Pathogenesis and natural history of osteonecrosis. Seminars in Arthritis and Rheumatism, 32(2): 94 – 124.
_____________________________________
Gary comments:
Avascular joint necrosis is nasty stuff and it is happening in sufficient numbers to prompt Medsafe to issue a warning to medical practitioners.

Having had a child on asthma medication, which included longterm use of low dose corticosteroids, this report hits close to home. I have known for about 20 years that longterm use of these asthma medications causes a number of unwanted side effects, including adrenal burnout and soft bones and joints. It was therefore my mission, as her father, to have her safely off these drugs as early as possible in her life and this was achieved through modifying her breathing.

I am aware of men and women on asthma medication requiring joint replacement surgery before age 50. When one looks at the proliferation of knee and hip replacement surgery in New Zewaland and the parallel increase in the use of corticosteroids for the control of asthma, one must wonder about the possibility of there being a link. I think there is. There sure is a link between the use of powerful corticosteroids, like Predinisone, and the early onset of osteoporosis and joint degeneration as reported here.

Don't worry too much about the medical jargon used in the Medsafe report above: What this Medafe report to medical practitioners is saying: There is an association between corticosteroid use and joint disintegration.

Now that Medsafe has warned your doctor of yet another health risk associated with corticosteroid drug use, will you ever be told and offered safer alternatives?

The Medsafe advice to consider stopping administration of these drugs if joint degeneration is noted is not in the patient's best interests. By the time any joint pain is reported, the damage is well and truly on its way and probably irreversible by then!

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