- March 20, 2018
- Joint Pain
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Have You Been Experiencing Prolia Side Effects? You’ll Want to Read This!
How often does a pharmaceutical come along that is hailed as a wonder drug? Today, it seems we hear roof-top halleluiahs about this or that new drug practically on a weekly basis. How often does this claim end up being true? The answer: rarely. It would seem that one of the latest to come out of the laboratories –Prolia- is yet another that’s not living up to the hype. In fact, for many women, it could be making the very condition it was designed to help even worse.
The National Stem Cell Institute (NSI), a leading regenerative medicine clinic in the United States, has seen drugs that claim to prevent osteoporosis come and go over the years. Like osteoarthritis, osteoporosis is a degenerative bone disease. Osteoporosis is seen more often in women, though men aren’t entirely immune. In most cases, it’s an age-related disease that weakens bones and puts the sufferer at greater risk of bone fracture. The makers of Prolia claim it’s a game-changer in the fight against osteoporosis. But is it changing the game for the better or for worse?
Prolia is the manufacturer’s name for the drug denosumab. It’s an antibody that was developed with the intent to slow down the weakening of bones, most especially in women who are at high risk for bone fracture after menopause. However, it is also administered to men with osteoporosis and is used as an auxiliary treatment for bone cancer.
Prolia was developed to be superior to other well-known osteoporosis prevention medications such as Fosamax and Boniva. Fosamax and Boniva are taken in pill form: Fosamax, weekly, and Boniva, once a month. Prolia is given as an injection every six months. But does the convenience of a six-month injection outweigh the laundry list of Prolia side effects and risks?
Reported Prolia Side Effects
The list of Prolia side effects below have been reported on the website RxList. It’s a long one and, according to the website, it’s doesn’t include all of them.
- Low calcium levels
- Back pain,
- Muscle pain,
- Pain in arms and legs
- Skin problems, including eczema, blisters, dry skin, peeling, redness, itching, and small bumps
- Serious infection of the skin, ear, stomach or gut
- Bladder infection
- Fever, chills, or night sweats
- Red, swollen, tender or warm skin (may or may not be accompanied by pus
- Severe stomach or abdominal pain
- Ear pain, drainage, difficulty hearing
- Frequent painful or burning urination
- Pink or bloody urine
- Severe itching, burning, rash, blistering, peeling, or dryness of the skin
- Persistent cough
- Shortness of breath
- Pinpoint purple or red spots beneath the skin
- Flu-like symptoms
- Weight loss.
- Swelling, pain, tenderness, warmth, or redness anywhere on the body
- Severe stomach pain
- Numbness or tingly around the mouth, fingers or toes
- Faster or slower than normal heart rate
- Muscle cramps or contractions
- Overactive reflexes
- Severe pain in the upper stomach that spreads to your back
- Nausea or vomiting
- Overall weakness
What They Don’t Tell You Happened in Clinical Trials
According to an article published on the University of Southern California’s Center for Health Journalism’s blog, monkeys used in Prolia clinical trials developed tooth and jaw abscesses. Two of the monkeys died of protozoal infections. Meanwhile, human test subjects developed cervical, ovarian, pancreatic, gastric, thyroid, and breast cancers. Indeed, the development of these cancers was reported as the “most common adverse event that led to discontinuation” during the trials.
During Prolia trials, 10 people had to be hospitalized due to the skin infection cellulitis . One of these persons died. Yet, in 2010, the Food and Drug Administration (FDA) approved Prolia for use in fracture prevention in women with osteoporosis. In fact, the approval came two months earlier than expected.
Doing all it could to ensure Prolia would be prescribed by doctors, its manufacturer Amgen sent out a thousand-person strong army of representatives to target medical specialists and primary care physicians and sell them on the perceived benefits of prescribing Prolia to their patients. This, in spite of FDA clinical reviewer Adrienne Rothstein, MD warning that Prolia side effects included risks to multiple layers of the immune system. Dr. Rothstein also pointed out that “three subjects required hospitalization for pneumonia after a single dose.”
How Did This Happen?
About twelve years ago, the push was on to find hormone replacement drugs that didn’t put menopausal women at risk of developing cancer and heart disease. Prolia was touted by Amgen as a safe alternative to bisophosphonates like Fosamax and Boniva. But even though the denosumab that is makes up Prolia belongs to a different class of pharmaceuticals, it began appearing early on that Prolia was no safer than what was already on the market.
It was only after it had been its approval by the FDA that Amgen issued warnings. Those warning included:
- Serious risk of deficiency of calcium in the bloodstream (hypcalcemia)
- Risk of serious infections
- Suppression of bone turnover (basically, the bone’s ability to form and absorb cells and tissues)
- Serious risk of atypical femoral fracture
- Serious risk of skin problems
Ironically, these are the same risks attributed to the drugs that Prolia was meant to replace. These Prolia side effects were known by the makers of the drug, yet Amgen did not issue warnings until two years after FDA approval. In 2014, the International Journal of Clinical and Experimental Medicine reported that osteonecrosis of the jaw (wherein the jaw is starved for lack of blood) was associated with Prolia.
How did this happen? There is a term used in the pharmaceutical world: “approval creep.”
It describes a technique used by drug manufacturers. When applying to the FDA for one drug, multiple drugs will be tacked onto the coattails of that application. It’s a common practice, whether the primary drug on the application is intended for an entirely different use or not.
Just as ominous is the continuing practice of “warning creep.” Time and time again, drugs like Prolia are approved with only minimal cautions. Only after the drug is approved and used widely in the public sector will many drug manufacturers release “new” and alarming warnings.
Follow the Money
So what’s the motivation behind such aggressive marketing and unethical behavior by the drug manufacturers? No doubt you already know the answer. Once a drug is approved by the FDA, billions of dollars pour into the coffers of the pharmaceutical industry. The story is no different with Prolia. Using Prolia can cost the patient as much as $1650 annually. In the U.S. alone, sales between 2011 and 2013 totaled $884 million, according to Medical Marketing & Media
What’s the Solution?
Making sure you’re as educated as possible on the risk factors of the medications you’re taking is the first line of defense. In as much as you can, also make sure your primary care doctor and/or specialist does not benefit in any way from preferring one drug over another.
Pursue non-drug alternatives whenever you can.
Often, more natural solutions can make a difference in how high a dosage of any given drug you need. These solutions include things as simple yet effective as dietary changes and moderate exercise. Also, today there are advanced non-drug, medical techniques such as stem cell and platelet rich plasma therapies that have established, successful track records in a wide array of illnesses, disorders, and injuries. Below, the National Stem Cell Institute (NSI) offers recommendations on what to look for in a fully licensed stem cell clinic.
What to Look for in a Stem Cell Medical Clinic
When searching for a qualified stem cell therapy center it’s important to remember that not all of them are created equal. Stem cells, when used properly, are your body’s most powerful means for healing that can repair everything from ligaments, tendons and cartilage to organs including your liver, pancreas and lungs and even neurological tissue like your brain, nerves and spinal cord.
Unfortunately, the majority of so called “regenerative medicine clinics” in the world aren’t trained in the latest, most technologically advanced procedures and will therefore provide poor results if any.
The good news is the National Stem Cell Institute (NSI) has established the most advanced stem cell and platelet rich plasma procedures on the planet which has drawn patients from all over the world as well as professional athletes and celebrities because they are recognized as the best in the world at stem cell therapy.
What makes NSI Stem Cell the top stem cell clinic in the world is demonstrated in 5 key areas:
- Highly trained and experienced, board certified doctors and team members who have performed stem cell procedures on thousands of patients with incredible results.
- Cutting edge procedures utilizing all that regenerative medicine has to offer for many chronic degenerative conditions.
- Leading scientific researchers who follow the advanced FDA guidelines to maximize the healing potential of your stem cells and to maintain compliance and ethics.
- Use of only the most potent and viable resource of living, viable stem cells (adipose or fat) and harvested on the same day. No vial that you can purchase will contain living stem cells. If there is no harvest then there are no stem cells.
- Post-operative guidance for supporting stem-cell growth including rehabilitation, diet and supplement protocols. NSI is a full service health care center focused on patient outcomes. Stem cell therapy is only one tool used to help improve patients’ lives.
Patients have raved about their experience at NSI Stem Cell Clinics testifying that it was their unique cutting edge treatments that helped them experience a breakthrough when nothing else worked and helped them avoid surgery and side effects of other treatments.
If you want to learn more about NSI Stem Cell Clinics and see for yourself why people travel from all of the globe for treatment you can setup a complimentary consultation today to see if you are a candidate for their world renown stem cell therapy. You can contact the National Stem Cell Institute at (877) 278-3623.