Not So ‘Inactive’ Ingredients In Drugs Are Doing More Harm Than Good
Savers are well versed in the dangers of the active ingredients in pharmaceuticals designed to treat osteoporosis and osteopenia (but fail miserably!). In fact, the dangers of those drugs and the fear-mongering to which Big Pharma stoops to sell them, are one of the reasons why I founded the Save Institute.
But every pill, injection and suppository contains more than just the laboratory- developed compounds intended to treat whatever symptom is targeted. Those are the active ingredients. These drugs also contain inactive ingredients, many of which are toxic.
Those ingredients might be intended to add mass to the pill, to add sweetness or mask an unpalatable flavor, to increase bioavailability, or to act as a vehicle for the drug. As you surely know by now, everything you ingest or even apply on your skin can affect your health, including the health of your liver, which in turn, affects your bone density.
What you should know – but what no doctor is likely to mention, and no pharmaceutical manufacturer will disclose – is that some of these “inactive” ingredients are toxic and harmful to your well-being and to your bones.
Today we’ll have a look at some of these questionable compounds and why you should avoid them.
Not So Inactive Ingredients
You would think that if an ingredient is toxic it wouldn’t be found in a drug that is supposed to improve your health. And yet, drugs are full of them.
Scientists argue that the quantity of these substances is so small that they do not cause any harm. However, we know about the presence of many of these toxins because of research that was conducted following negative reactions that unsuspecting patients experienced when taking the drugs.
Just because for most people the impact of these small doses of toxic ingredients may not be established does not mean they are not toxic, and it doesn’t mean they aren’t having a negative impact.
So let’s get started with the most commonly found toxic inactive ingredients in both prescription and over-the-counter drugs.
These Sweeteners Won’t Sweeten Your Life
Two artificial sweeteners make this list. You might not think about the sweetening of drugs, but many are bolstered with artificial flavors to make them more palatable. Aspartame and Saccharine are the guilty parties we’ll look at today, and both crop up occasionally in drugs.
Aspartame has had a long and chequered history of approval, recension, approval and subsequent controversies, some founded and other questionable. It’s a dipeptide of aspartic acid and a methyl ester of phenylalanine and is used in many pharmaceutical products. Labels for all drugs must list the phenylalanine content, so you can track its presence that way.
This is specifically because those with phenylketonuria must avoid phenylalanine.
Most people who report negative responses to aspartame suffer headaches, and up to 11% of patients with chronic migraines report that their headaches have been triggered by the sweetener. Studies have showed conflicting results in attempts to establish this link.
Anecdotal reports have linked aspartame to neuropsychiatric disorders like panic attacks, manic episodes, visual hallucinations, mood shifts, and dizziness. One study showed that this response was more likely in those with major depression. Their symptoms included nervousness, dizziness, memory impairment, headache and nausea.
There have even been reports to the FDA of seizures caused by aspartame, and some people have been confirmed to have hypersensitivity reactions resulting from ingestion. Though this response it notably rare.
Saccharin Isn’t Much Better
The other artificial sweetener that deserves our scrutiny is saccharin. It’s found in many oral drugs, both solid and liquid in form. Saccharin was one of the very first artificial sweeteners, developed in the 19th century. Predictably it has a long history of testing and many reversals in scientific opinion about its suitableness for human consumption.
For many years foods containing saccharin had to display a label stating that the “use of this product may be hazardous to your health” due to studies conducted in the 70s that found it to cause cancer in laboratory animals. Shockingly, it remained on the market, due largely to industry influence over public opinion.
However, further studies discovered that the mechanism that resulted in the development of cancer in mice does not exist in humans. That danger being disproved, the warning was subsequently removed. Granted, the episode does not inspire confidence.
While saccharin does taste sweet, it has no nutritional value and offers no energy. In fact it passes through the body undigested. As far as your body is concerned, it’s a useless substance. You might recognize the little pink packets of it, marketed as Sweet ‘N’ Low.
The Save Institute is firmly against the ingestion of saccharin, aspartame and also the sweetener sucralose (found in Splenda.) This stance is protective against potential undiscovered dangers, preserves kidney and liver function, and acts as a guideline that encourages the consumption of whole, natural foods.
Nutrition is a weapon against bone loss, and we must use it to its fullest capacity!
This compound is found in many injectable drugs and solutions as a preservative. Several cases of neonatal deaths and respiratory and metabolic complications in low-birth-weight premature infants have been associated with use of benzyl alcohol in bacteriostatic saline intravascular flush and endotracheal tube lavage solutions.2 The danger of the substance to infants raises immediate concerns of course.
This “inactive” ingredient has also been associated with bronchitis and hemoptysis when used to dilute albuterol for nebulization in an adult. It may also rarely lead to hypersensitivity reactions like contact dermatitis as well as other allergic symptoms like nausea, fatigue, fever, or angioedema.
For a long time, sulfiting agents were added to foods as antioxidants. In particular six sulfite compounds (sulfur dioxide, potassium metabisulfite, sodium sulfite, sodium metabisulfite, sodium bisulfite, and potassium bisulfite) were categorized “Generally Recognized as Safe” for use in foods and drugs.
The FDA eventually revoked this status for these sulfites being used in raw fruits and vegetables, but they only did this is 1986 after receiving reports of more than 250 cases of adverse reactions, including six deaths.3
If you’re familiar with the way the FDA operates, the you won’t be surprised that they would have initially approved something that later killed unsuspecting consumers.
While those sulfites are not added to raw fruits and vegetables anymore, although they are still used in many processed foods and pharmaceutical drugs. It’s relevant to mention here that synthetic sulfites deplete your body of a nutrient that is essential to bone health: thiamin.
Most reactions to sulfites are respiratory in nature, and the drugs that most commonly contain them are asthma treatments. However there are cases of nonimmunologic anaphylactoid reactions, which are serious allergic reactions.
Coloring Outside The Lines
Dyes and coloring agents are used in many pharmaceuticals. This is either intended to make the drugs more visually appealing, or to achieve a marketing goal by creating a recognizable product. This is branding at the expense of safety.
You have probably been warned about Yellow No. 5, also known as the azo dye tartrazine, which is known to be potentially dangerous in aspirin-intolerant individuals. In particular, 2% to 20% of asthmatics are sensitive to aspirin.
Reactions to tartrazine are similar to those produced by aspirin, and don’t only occur in people who have a history of aspirin intolerance. They include bronchospasm, eosinophilia, angioedema, and nonimmunologic urticaria. Rarely, an anaphylactoid reaction will occur.
Other azo dyes like tartrazine, sunset yellow, and new coccine may cause exacerbations of recurrent allergic vascular purpura. These reactions are why you will see Yellow 5 specifically included in labels. In fact the FDA requires prescription drugs that contain the dye to include the following text in their precautions labelling:
“This product contains FD+C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD+C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.”
If you experience the usual set of aspirin reactions (asthma, rhinitis, and urticaria), or anaphylactoid reactions, you may also develop reactions from other dyes, including amaranth, indigo carmine (Blue No. 2), erythrosine, ponceau, new coccine, Brilliant Blue (Blue No. 1), sunset yellow, methyl, blue, Red No. 40 and quinoline yellow. That’s quite a long a list, and some artificial colorants, such as FD&C Yellow #6, FD&C Green #3, and Citrus Red #2 have been scientifically shown to harm the liver.
Other Colors To Watch
Sunset yellow, despite its pleasing name, has been reported to have some less than pleasing effects, including abdominal pain, vomiting and indigestion. A dye called erythrosine, which contains iodine, has been linked to dermatologic reactions including desquamation, erythroderma and photosensitivity.
While the FDA permits its use in foods and drugs, it is no longer used in topical products due to concerns about carcinogenicity. Strange that you shouldn’t rub something on your skin because it may cause cancer, but the FDA allows it in food.
Hypersensitive individuals should be particularly careful to avoid dyes, but of course I recommend never eating prepared foods with artificial coloring. Enjoy the natural beauty of whole foods! If it doesn’t look good enough to eat without chemical alteration… then it’s just not good enough to eat.
For the same reasons, I always advise seeking natural and lifestyle solutions to keep you healthy and avoid these dyes and other toxins in pharmaceuticals.
This compound is a very common bactericidal preservative used in asthma drugs, namely albuterol and metaproterenol nebulizer solutions in the US, and in beclomethasone and ipratropium bromide nebulizer solutions elsewhere in the world.
Breathing in pure benzalkonium chloride results in a bronchoconstriction that comes on faster and lasts longer than what sulfites induce. This response is easily reproducible, consistent, and occurs in relation to the size of the dose.4 It is often paired with a cough and a burning sensation, and sometimes by facial flushing and pruritus (a severe itching of the skin.)
These sorts of reactions to drugs containing benzalkonium are not often clearly attributed to the compound because the reactions are dose-related and cumulative and might be unclear because of the active ingredient in the drugs. It most often occurs in patients using multiple agents containing benzalkonium or who receive frequenting dosing.
Like sulfites, this excipient is used primarily in anti-asthmatic drugs. In several studies, the lowest doses of pure benzalkonium chloride that produced a constriction of breathe ranged from 124 to 159 ug. Albuterol contains 50 ug per .5 mL, so a single doses is unlikely to cause a reaction.5
As usual, I recommend finding natural alternatives, but if you need to take these drugs, ask your doctor to prescribe benzalkonium-free drugs that may be more effective anyway.6
Lactose is the disaccharide sugar (composed of galactose and glucose) that is naturally found in milk. It gets used in tablets and capsules as a filler or diluent and in powders to add bulk. For those who are lactose intolerant, consuming lactose in any form may lead to the familiar results: diarrhea, abdominal cramping, bloating and flatulence.
These symptoms are produced either by the formation of lactic acid in the intestine by bacteria from undigested lactose, or else from a high intestinal osmotic load resulting from unabsorbed carbohydrate with production of carbon dioxide and hydrogen gas by bacterial fermentation. Either way, it’s not a good outcome from a drug that was meant to make you feel better, not worse.
And also be aware that lactose intolerance can develop at any age. A sudden onset is more likely the older you get, and if you have stopped drinking milk (which I recommend, for numerous reasons you can read about here) then you may not have noticed this change until you consume lactose in an unexpected source.
This “inactive” ingredient is used as a drug solubilizer in topical, oral, and injectable medications. It’s a synthetic organic compound with the chemical formula C3H8O2, manifesting as a viscous colorless liquid that is nearly odorless and tasteless. The FDA classifies it as generally safe, but, not surprisingly, for some, it causes adverse reactions.
Lactic acidosis may occur in some individuals because propylene glycol is metabolized to lactic acid. After intravenous administration, hemolysis, lactic acidosis, central nervous system depression and hyperosmolality have been reported. Hyperlactemia in particular is associated with high propylene glycol levels, typically in patients with renal insufficiency, but it is generally of minor clinical significance.7
Rapid infusion of drugs containing high concentrations of propylene glycol have been associated with hypotension, respiratory depression, arrhythmias and seizures. There have been several reports of localized contact dermatitis from the application of the compound as a vehicle to skin or mucus membranes, and in a series of 487 patients with eczematous contact dermatitis, 4.5% were found to be sensitive to propylene glycol.
In a sensitized patient, oral or parenteral administration can make dermatitis worse. Some drugs with a high concentration of propylene glycol, like phenytoin, diazepam, digoxin and etomidate may induce thrombophlebitis when administered intravenously. In one study, 22% of patients experienced venous reactions to the short-term anesthetic etomidate in propylene glycol, but no reactions to etomidate lipid emulsion.8
Osteoporosis Drugs Are Unsurprisingly Guilty
As if the potentially disastrous results of the active ingredients of osteoporosis drugs weren’t bad enough, even the “inactive” ingredients pose problems.
Boniva for example has a long list of inactive ingredients: colloidal silicon dioxide, crospovidone, microcrystalline cellulose, povidone and sodium stearyl fumarate. The tablet film-coating contains hypromellose, talc, titanium dioxide and triacetin.
Titanium dioxide has been singled out by many in the scientific community as a potential neurotoxin. It impacts the functioning of the astrocyte cells that regulate the exchange of signal-carrying neurotransmitters in the brain. They also supply energy to the neurons in charge of processing the signals that astrocytes regulate, and many other functions.9
I have written more about the significance of mood and mental health to the successful production of bone, and they are essential.
And Then There’s Forteo
The osteoporosis drug Forteo contains a yet longer list of inactive ingredients: glacial acetic acid, sodium acetate (anhydrous), mannitol, meta-cresol, and water for injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.
Meta-cresol is a precursor to pesticides and many other compounds, as it is used in the development of chemicals.
You Get To Decide How You Keep Yourself Healthy
While life-saving medicines are worth the risk that inactive (or, all too often, active) ingredients may pose, it’s very important to avoid drugs as much as possible. Too often patients are lulled into a state of passive acceptance by Big Pharma and the Medical Establishment, when in reality most physical conditions are treatable without the use of drugs.
And even if your doctor does not believe that you can improve your health without the assistance of quick-fix drugs, I’m here to tell you that you can achieve this goal.
If you’re concerned about the acidifying, liver damaging and toxifying substances you ingest or use as personal care products, and would like to embark on a natural path, I recommend learning more about OsteoCleanse™, the 7 Day Bone Building Accelerator. By cleansing your liver and kidneys in seven steps, you’ll improve your overall health and the health of your bones.
With OsteoCleanse™ by your side, you’ll kick-off a healthy shift in your lifestyle, detoxify your liver, improve kidney function, and accelerate your bone-building endeavors.
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Till next time,
1 Lipton RB, Newman LC, Cohen JS, Soloman S. “Aspartame as a dietary trigger of headache.” Headache. 29:90–92. 1989.
2 Sulfiting agents: revocation of GRAS status for use on fruits and vegetables intended to be served or sold raw to consumers: final rule. Fed Reg 51:25021–25026. 1986.
3 Walton RG, Hudak R, Green-Waite RJ. “Adverse reactions to aspartame: double-blind challenge in patients from a vulnerable population.” Biol Psychiatry. (1993). 34:13–17.
4 Brown WJ, Buist NR, Gipson HT, Huston RK, Kennaway NG. “Fatal benzyl alcohol poisoning in a neonatal intensive care unit.” (1982) Lancet. 1:1250.
5 Menendez R, Lowe RS, Kersey J. “Benzalkonium chloride and bronchoconstriction.” J Allergy Clin Immunol. (1989) 84:272–274.
6 Zhang YG, et al. “Effect of inhaled preservatives on asthmatic subjects. II. Benzalkonium chloride.” Am Rev Respir Dis (1990) . 141:1405–1408.
7 O’Driscoll BR, Taylor RJ, Horsley MG, Chambers DK, Bernstein A. “Nebulised salbutamol with and without ipratropium bromide in acute airflow obstruction. Lancet.” (1989) 1:1418–1420.
8 Demey HE, Daelemans RA, Verpooten GA, et al. “Propylene glycol-induced side effects during intravenous nitroglycerin therapy.” Intensive Care Med. (1988) 14:221–226.
9 Doenicke A, Kugler A, Vollmann N. “Venous tolerance to etomidate in lipid emulsion or propylene glycol (hypnomidate).” Can J Anaesth. (1990) 37:823–824.
10 Christina L. Wilson et al. “Mitochondrial dysfunction and loss of glutamate uptake in primary astrocytes exposed to titanium dioxide nanoparticles.” Nanoscale (2015). Web: http://pubs.rsc.org/en/Content/ArticleLanding/2015/NR/C5NR03646A