Is Your OTC Pain Reliever Going to Kill You?

Although acetaminophen (Tylenol) is heavily marketed for its safety, FDA recommends health care professionals to discontinue prescribing and dispensing drug products with more than 325 mg of acetaminophen due to the high risk of liver injury.  Severe liver injury may occur in patients who:

  • Took more than the prescribed dose of an acetaminophen containing product in a 24 hour period.
  • Took more than one acetaminophen containing product at the same time.
  • Drank alcohol while taking acetaminophen products.

Acetaminophen is widely used as an over the counter pain reliever and fever medication and is often combined with other ingredients such as cough and cold ingredients.  Patients may be unaware that many products (both prescription and OTC) may contain acetaminophen, making it easy to accidentally take too much [1-5]. In fact,  acetaminophen poisoning accounts for approximately one-half of all cases of acute liver failure in the United States and Great Britain[16].

Ibuprofen (Motrin, Advil) is also widely used for pain and inflammation but not without risk.  Ibuprofen carries a black box warning from the FDA regarding the cardiovascular and gastrointestinal risks associated with its use.  Patients taking ibuprofen have an increased risk of serious cardiovascular thrombotic events including myocardial infarction and stroke. Researchers in Denmark observed a nearly threefold increase in the number of deaths from gastrointestinal bleeding within one year of ibuprofen prescription [14].  The risk of side effects is so high for elderly patients the American Geriatrics Society has recommended that patients over the age of 65 avoid NSAID use if at all possible [6-10].  This real risk was studied by RE Tarone who noted a marked rise in baseline rate of gastrointestinal bleed with advancing age with the large majority of cases occurring among persons age 65 or older.  The average relative increase in risk of gastrointestinal bleeding was found to be fourfold or slightly higher in NSAID users and six fold or higher at heavy prescription levels [15].

NSAID High Risk Groups

Medications such as Tylenol and ibuprofen, which are readily available over-the-counter, are perceived to be safe medications; but research has proven that they are not without risk.  Physicians, payers and patients are requesting a safe more effective alternative to treat pain which becomes increasingly important as the population ages.

Medical foods such as Theramine treat the dietary deficiencies that are associated with pain and inflammation.  Pain reduction is accomplished by moderating responsiveness to noxious stimuli, regulating the transmission of pain signals and controlling inflammation. The use of medical foods has been long standing and there have been no reports of GI bleed in over 10 years on the market.

Two multi-center double-blind clinical trials established the safety and efficacy of Theramine in the treatment of chronic back pain.  In a clinical study comparing the medical food Theramine and a non-steroidal anti-inflammatory medication, Theramine was shown to be more effective than low dose NSAIDs in treating low back pain.  Clinical data indicate significant reduction in back pain with the administration of Theramine alone, while administration of a low dose NSAID had no appreciable effect on pain.

An important observation by researchers EL Fosbol and L Kober note that, “Individual NSAIDs have different cardiovascular safety that needs to be considered when choosing appropriate treatment.  In particular, rofecoxib and diclofenac were associated with increased cardiovascular mortality and morbidity and should be used with caution in most individuals.  This notion is also valid for healthy individuals and underlines the importance of critical use of NSAID therapy in the general population and also that over-the-counter retail of NSAIDs should be reassessed.”[13]

 

REFERENCES

 

1.  Wolf M; King J; Jacobson K; et al “Risk of Unintentional Overdose with Non-prescription Acetaminophen Products”  J Gen Intern Med 2012 Dec; 27(12): 1587-1593

2.  “Acetaminophen Toxicity in Children” Pediatrics vol. 108 No. 4 Oct. 1 2001

3.  Farrell S; Tarabar A; et al “Acetaminophen Toxicity” Medscape June 24, 2011

4.  Plaisance K “Toxicities of Drugs Used in the Management of Fever” Clinical Infectious Diseases 2000 31 Supp 5: S219-S223

5.http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm

6.http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm085282.htm

7.  Pilotto A; Franceschi M; Leandro G; Di Mario F; “NSAID and aspirin use by the elderly in general practice:  effect on gastrointestinal symptoms and therapies:  Drugs Aging 2003; 20(9): 701-10.

8.  Smith SG “Dangers of Non-steroidal Anti-inflammatory drugs in the elderly” Can Fam Physician vol. 35 March 1989

9.  American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults

10.  Gurwitz JH; Everitt DE; Monane M; Glynn RJ, Choodnovskiy I; Beaudet MP; Avorn J; “The impact of ibuprofen on the efficacy of antihypertensive treatment with  hydrochlorothiazide in elderly persons” J Gerontol A Biol Sci Med Sci 1996 Mar; 51 (2): M74-9

11.  Shell WE; Charuvastra E; DeWood M; May L; Bullias D; Silver D “ A Double-blind controlled trial of a single dose naproxen and an amino acid medical food Theramine for the treatment of low back pain”  Am J of Ther 2010

12.  Shell WE; Pavlik S; Roth B; Silver M; Breitstein M; May L; Silver D “ Reduction in pain and inflammation associated with chronic low back pain with the use of the medical food Theramine”  Amer J of Ther 2014

13.  Fosbol EL; Kober L; Torp-Pedersen C; Gialason GH “ Cardiovascular safety of non-steroidal anti-inflammatory drugs among healthy individuals”  Expert Opin Drug Saf 2010 Nov; 9(6): 893-903

14.  Lipworth L; Friis S; Blot Wj; McLaughlin JK; Mellemkjaer L; Johnsen SP; Norgaard B Olsen JH “ A population based cohort study of mortality among users of ibuprofen in Denmark”  Am J Ther 2004 May-Jun; 11(3): 156-63

15.  Tarone RE; Blot WJ; McLaughlin JK “Nonselective non-aspirin non-steroidal anti-inflammatory drugs and gastrointestinal bleeding:  relative and absolute risk estimates from recent epidemiologic studies”  Am J Ther 2004 Jan-Feb; 11(1): 17-25

The Problem with Prescription Pain Killers

Pain is a big deal. On one level, it’s very useful. It tells us when there’s something wrong, and is pretty efficient at giving us a handy indication when what we’re doing may not be particularly good for us. Those who cannot feel pain [1] suffer from horrendous associated problems, and frequently damage themselves quite badly without being alerted to the fact that they’re doing so by pain. However, unlike a man-made alarm, the body does not come with an ‘off’ switch which one can hit once one’s been made aware of the problem. Chronic pain is a major issue, and one of the most troubling symptoms of a great many medical conditions. It’s a factor which seriously affects people’s lives, and good pain management is recognized as being vital to the all-important quality of life [2] experienced by those needing medical treatment. Having said this, however, it is also being increasingly recognized that the people of North America are becoming dangerously dependent upon prescription painkillers. All too often, we pop a pill when we do not really need to, and plenty of us are relying on prescribed narcotic painkillers when we would undoubtedly be a lot better off with some other method of pain-relief. While there is certainly a place for narcotic painkillers in the management of seriously painful conditions, it needs to be recognized that these drugs do come with a major health warning – and alternatives or avoidance should be the preferred options if at all possible.

Narcotic Painkillers

Opioid painkillers were originally designed for cancer pain and somehow over time have become a first line therapy for many physicians despite the potential for addiction. What may be lesser known, however, are the dangers inherent within these drugs, and the startling scope of America’s dependence upon them. Put simply, opioids such as Vicodin and codeine bind to opioid receptors within the brain, which dulls the brain’s pain response. These receptors are designed to work with the body’s natural opioids – endorphins [3]. Endorphins are released during exercise, and numb pain as well as promoting a feeling of wellbeing, enabling and motivating us to stay on the move and thus potentially to survive for longer. Narcotics fulfil the same role – but in hyper-exaggerated form. Narcotic analgesics swamp our opioid receptors, saturate them to the point where we’re utterly numbed and frequently rather high. They’re very effective as a method of pain relief, but also quite dangerous and are associated with a host of dangerous side effects.

Painkiller Addiction

It’s very easy to develop a taste for opioid painkillers. Why wouldn’t you? They keep pain at bay, and they make you feel good. They’re also, unfortunately, highly addictive. Their very nature means that you’re inclined to seek out more and more – and America’s healthcare system doesn’t exactly discourage you from overdoing it. Big pharmaceutical companies do, after all, stand to make a lot of money from plenty of pill-popping patients. North America has the world’s worst rate of prescription painkiller addiction by a long, long way [4]. Places with nationalized healthcare (in which pharmaceutical companies would have nothing to gain from touting their product to the public) are not in any more pain than the people of America, but they’re far less addicted to painkillers. The solution for someone from the USA to the slightest malady invariably involves popping a pill, while those from other countries are put on courses of pills only when necessary, and given alternative pain-relief methods more often. Each system obviously has its pros and cons – but in this particular case the figures concerning painkiller addiction speak for themselves. More overdose deaths in the USA have been caused by prescription narcotics since 2003 than cocaine and heroin put together – partly (if not wholly) because narcotic prescription rates have increased enormously in this time [5].

An Easy Death

A major issue with opioid painkillers is that they’re not only all too easy to get hold of, and highly addictive – they’re also unpredictable killers. While medical science is pretty good at estimating doses according to body weight and so on, the problem of tolerance is always going to rear its ugly head. The body develops a resistance to opioids over time which means that one must take a higher and higher dose in order to achieve the desired effect. And, at any moment, that dose might prove just too high for the body to cope with. Opioids kill in a number of ways. The most common of these is respiratory depression. This can be reversed – but only if the overdose is low and medical aid arrives quickly [6]. If this is not the case, then the overdoser finds themselves unable to adequately fill their lungs and essentially starves of oxygen. It is far better not to risk this, not to get addicted, and to seek alternatives to narcotic analgesics whenever possible!

[1] Gillian Mahoney, “Meet the Child Who Feels No Pain”, ABC, Oct 2013

[2] Nathanial Katz, “The Impact of Pain Management on Quality Of Life”, Journal of Pain and Symptom Management, Jul 2002

[3] PBS, “Role of endorphins discovered, 1975”

[4] Arnold M. Washington, “America’s Painful Love Affair With Painkillers”, Rehabs

[5] National Safety Council, “Opioid painkillers: How they work and why they can be risky”

[6] Ben Wolford, “Respiratory Depression Reversed In Trials With Drug That Fights Opioid Side Effect”, Medical Daily, Aug 2014

 

A Safe Way to Manage Obesity

Over two thirds of Americans are overweight and over one third are defined as obese and the number of people with obesity in the world now exceeds those with malnutrition (1).  Being overweight or obese significantly increases your risk of heart disease, diabetes, high blood pressure and arthritis.  Yet despite the public’s awareness of these issues, obesity remains an epidemic.

People often describe the frustrations of trying to lose weight, whether it is through failed diets or exercise programs.  They either don’t lose weight at all or lose only to gain it back a month or two later. Effective weight loss programs that allow for long term success are desired but many patients struggle despite the available resources. The time constraints of work and family are difficult to overcome and patients often need help or a jump start to get their weight loss regimen going.

The cornerstones of an appropriate diet to lose weight include lowering caloric intake, decreasing complex carbohydrate ingestion, avoiding “empty calories” such as processed sugars and regular aerobic exercise. Fad or gimmick diets that help you to lose weight fast often lead to rebound weight gain and psychological distress.  Healthy weight loss should be targeted for 1-2 pounds per week over the course of many weeks.  The first five pounds usually come off fast and then the weight loss slows down.  People get discouraged and give up during this phase as it can be the most difficult part of the process.  Additionally, many patients suffer from uncontrollable appetite while dieting and this limits the effectiveness of the diet.

5 tips for weight loss

Recent data points to unique nutritional deficiencies as a contributing factor to Obesity. The medical foods  Apptrim and Apptrim-D  are specifically designed to treat these specific nutrient and  micro-nutrient deficiencies by supplying obese patients with a bioavailable source of amino acids and nutrients.  AppTrim and AppTrim-D contain the amino acids that specifically produce the neurotransmitters that are involved in controlling appetite, hunger and satiety.  Neurotransmitters are the brain’s messengers that tell the nerves what to do and help your stomach and brain communicate with each other. Obese patients often lack the neurotransmitters required to suppress appetite and food cravings. AppTrim helps to decrease appetite, carbohydrate cravings and improves early satiety thus helping an individual maintain a diet and weight loss goals.

Several double blind placebo controlled trials using AppTrim have been performed.  These studies have demonstrated that patients taking AppTrim along with diet and exercise lost more weight and felt less hungry than patients using diet and exercise alone.  Also, since AppTrim is a medical food, it contains only ingredients that are Generally Recognized as Safe (GRAS) by the FDA. Obesity is a very complex disease and effective management requires a comprehensive approach that includes addressing the distinct nutrient and micro-nutrient deficiencies in addition to diet and exercise. 

1. Ogden C. L., Carroll, M. D., Kit, B.K., & Flegal K. M. (2014). Prevalence of childhood and adult obesity in the United States, 2011-2012. Journal of the American Medical Association, 311(8), 806-814