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The Facts About Supplement Safety

Educate yourself about supplement vs. medication safety armed with facts and not propaganda:

 Dr. Adria Rothfeld-Magenheim, DC, MS, CNS

Recent headlines have once again attempted to discredit the use of supplements, with conclusions based upon very selectively chosen snippets of data, leading to significant misrepresentation. In an effort to illustrate how convoluted the path from the research to the headlines actually is, I will explore the statements with arguments that are well-validated.  

Drug vs. Supplement Safety:

Drugs are known to cause well over 125,000 deaths per year when taken correctly as prescribed yet the FDA allows “fast-track” approvals and countless new additions to the marketplace.

The Food and Drugs Administration (FDA) in the United States says that at least 1 death occurs per day and 1.3 million people are injured each year due to medication errors.

Medication errors occur in nearly 1 out of every 5 doses given to patients in the typical hospital.

Patients who suffered unintended drug events remained in the hospital an average of 8 to 12 days longer. These hospital stays cost an additional $16,000 to $24,000.

A recent review of 48 studies in the United Kingdom revealed that adverse drug reactions to newly marketed drugs are 60% more common in women than in men.

On average, women have a lower body weight, smaller organ size, reduced blood flow and a higher proportion of fat compared with men. Overall differences in hormonal activity between the sexes affect the way drugs are processed.

So why are dietary supplements on the chopping block? Maybe it is somehow connected to this statement: The study is the first to document the extent of severe injuries and hospitalizations tied to dietary supplements, a rapidly growing $32 billion a year industry that has attracted increased scrutiny in the past year….

The following is data that should help to clarify the real issues:

    • As noted by Orthomolecular Medicine News Service, Americans easily take more than 60 billion doses of nutritional supplements every year:”Well over half of the U.S. population takes daily nutritional supplements. Even if each of those people took only one single tablet daily, that makes 165,000,000 individual doses per day, for a total of over 60 billion doses annually. Since many persons take far more than just one single vitamin or mineral tablet, actual consumption is considerably higher, and the safety of nutritional supplements is all the more remarkable.Over 60 billion doses of vitamin and mineral supplements per year in the USA, and these are the stats: . In 2010, not one single person [in the US] died as a result of taking vitamins (Bronstein, et al, (2011) Clinical Toxic).”
    • “In 2004, the deaths of 3 people [in the US] were attributed to the intake of vitamins. Of these, 2 persons were said to have died as a result of megadoses of vitamins D and E, and one person as a result of an overdose of iron and fluoride. Data from: ‘Toxic Exposure Surveillance System 2004, Annual Report, Am. Assoc. of Poison Control Centers.’”
  • Even if these figures are taken as correct, and even if they include intentional and accidental misuse, the number of alleged vitamin fatalities is strikingly low, averaging less than one death per year for over two and a half decades. In 19 of those 27 years, AAPCC reports that there was not one single death due to vitamins.


Still, the Orthomolecular Medicine News Service Editorial Board was curious: Did eleven people really die from vitamins? And if so, how?

(OMNS, June 14, 2011) Over a twenty-seven year period, vitamin supplements have been alleged to have caused the deaths of a total of eleven people in the United States.

The American Association of Poison Control Centers (AAPCC) attributes annual deaths to vitamins as:

2009: zero

2008: zero

2007: zero 2006: one

2005: zero

2004: two 2003: two 2002: one 2001: zero

2000: zero 1999: zero 1998: zero 1997: zero 1996: zero 1995: zero 1994: zero 1993: one 1992: zero 1991: two 1990: one 1989: zero 1988: zero 1987: one 1986: zero 1985: zero 1984: zero 1983: zero

Here we go again: A large new study by the federal government found that injuries caused by dietary supplements lead to more than 20,000 emergency room visits a year.

Let’s look closely at the statistics upon which this study is based:

  • 21% of these were based upon unsupervised children who had accidentally ingested supplements.
  • Among adults 65 and older, choking caused 37.6% of all ER visits for supplement-related adverse events.
  • Weight loss and energy enhancing products caused 71.8% of supplement related adverse events involving palpitations, chest pain or tachycardia and most of these adverse effects were in persons 20-34 years of age.

The following data has been published in JAMA, The Journal of the American Medical Association.

JAMA. 1998 Apr 15;279(15):1200-5. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Lazarou J, Pomeranz BH, Corey PN

OBJECTIVE: To estimate the incidence of serious and fatal adverse drug reactions (ADR) in hospital patients.

The authors, led by Jason Lazarou, culled 39 previous studies on patients in hospitals. These patients, who received drugs in hospitals, or were admitted to hospitals because they were suffering from the drugs doctors had given them, met the following fate:

Every year, in the US, between 76,000 and 137,000 hospitalized patients die as a direct result of the drugs.

Beyond that, every year 2.2 MILLION hospitalized patients experience serious adverse reactions to the drugs.

The authors write: “…Our study on ADRs [Adverse Drug Reactions], which excludes medication errors, had a different objective: to show that there are a large number of ADRs even when the drugs are properly prescribed and administered.”

So this study had nothing to do with doctor errors, nurse errors, or improper combining of drugs. And it only counted people killed who were admitted to hospitals. It didn’t begin to tally all the people taking pharmaceuticals outside hospitals who died as consequence of the drugs.

DATA SYNTHESIS: The overall incidence of serious ADRs was 6.7% and of fatal ADRs was 0.32% of hospitalized patients. We estimated that in 1994 overall 2,216,000 hospitalized patients had serious ADRs and 106,000 had fatal ADRs, making these reactions between the fourth and sixth leading cause of death.

I hear repeatedly that supplements are unsafe since they are not “FDA regulated.” To respond, our supplements meet FDA guidelines and are pharmaceutical grade, but unlike medications which rely on the understaffed overworked FDA to oversee them, our GMP/NSF supplements are 3rd party tested by independent labs, ensuring that they meet label claims.

So how protected are we by the FDA? A lot less than you are led to believe:

Below is a list of approved drugs and how long they were on the market from the time the industry was warned of their serious danger until being withdrawn:


Generic Name (BRAND NAME) Worst Pills, Best Pills News Readers Warned Date Withdrawn in U.S. Years between Withdrawal and Worst Pills Warning
sibutramine (MERIDIA) 4/1/1998 10/8/2010 12.5 years
tegaserod (ZELNORM) 6/1/2004 3/30/2007 2.8 years
gatifloxacin (TEQUIN) 7/1/2002 5/1/2006 3.8 years
valdecoxib (BEXTRA) 12/1/2002 4/7/2005 2.4 years
rofecoxib (VIOXX) 4/1/2001 9/29/2004 3.5 years
cerivastatin (BAYCOL) 3/1/1998 8/8/2001 3.4 years
cisapride (PROPULSID) 8/1/1998 3/24/2000 1.7 years
troglitazone (REZULIN) 1/1/1998 3/21/2000 2.2 years
grepafloxacin (RAXAR) 4/1/1998 8/11/1999 1.4 years
bromfenac (DURACT) 12/1/1997 6/22/1998 0.6 years
dexfenfluramine (REDUX) 7/1/1996 9/15/1997 1.2 years
  • Table 2. Twenty Drugs Approved After 1992 and Later Withdrawn From the Market for Safety Reasons:
No Generic Name (BRAND NAME) Date of U.S. approval Date of U.S. withdrawal Time on the Market
20 sibutramine (MERIDIA) 11/22/1997 10/8/2010 12.9 years
19 efalizumab (RAPTIVA) 10/28/2003 4/8/2009 5.5 years
18 trasylol (APROTININ) 12/29/1993 11/5/2007 3.9 years
17 tegaserod (ZELNORM) 7/24/2002 3/30/2007 4.7 years
16 gatifloxacin (TEQUIN) 12/17/1999 5/1/2006 6.4 years
15 technetium (99m TC) fanolesomab (NEUTROSPEC) 7/2/2004 12/19/2005 1.5 years
14 hydromorphone (PALLADONE) 9/24/2004 7/13/2005 0.8 years
13 valdecoxib (BEXTRA) 11/16/2001 4/7/2005 3.4 years
12 natalizumab (TYSABRI) 11/23/2004 2/28/2005 0.3 years
11 rofecoxib (VIOXX) 5/20/1999 9/29/2004 5.4 years
10 levomethadyl (ORLAAM) 7/9/1993 9/2/2003 10.2 years
9 cerivastatin (BAYCOL) 6/26/1997 8/8/2001 7.3 years
8 rapacuronium (RAPLON) 8/18/1999 3/30/2001 1.6 years
7 alosetron (LOTRONEX) 2/9/2000 11/28/2000 0.8 years
6 cisapride (PROPULSID) 7/29/1993 3/24/2000 9.7 years
5 troglitazone (REZULIN) 1/29/1997 3/21/2000 3.1 years
4 grepafloxacin (RAXAR) 11/6/1997 8/11/1999 1.8 years
3 bromfenac (DURACT) 7/15/1997 6/22/1998 0.9 years
2 mibefradil (POSICOR) 6/20/1997 6/8/1998 1.0 years
1 dexfenfluramine (REDUX) 6/1/1996 9/15/1997 1.3 years


Comparing deaths from medical drugs, vitamins, all US wars

Jon Rappoport cited the review, “Is US Health Really the Best in the World?”, by Dr. Barbara Starfied (Journal of the American Medical Association, July 26, 2000).

Here are two key quotes he cites from her article:

“The FDA and its “quack-buster” allies go after vitamins, demean “unproven remedies,” and generally take every possible opportunity to warn people about “alternatives,” on the basis that they aren’t scientifically supported.

Meanwhile, the very drugs these mobsters are promoting—and in the case of the FDA, CERTIFYING AS SAFE AND EFFECTIVE—are killing and maiming people at a staggering rate.”

The masses are treated to non-stop PR on the glories of the US medical system.

In the Wikipedia entry, “US military casualties of war,” the grand total of all military deaths in the history of this country, starting with the Revolutionary War, is 1,312,612.

In any given 10 years of modern medical treatment? 2,250,000 deaths.

Consider how much suppression is necessary to keep the latter number under wraps.

Here are some that may sound familiar, perhaps you’ve even taken them yourself?

Accutane (Isotretinoin) on the market for 27 YEARS
Use: Acne Manufacturer: Hoffman-La Roche 1982 to June 2009
Cause for recall: increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.
Darvon & Darvocet (Propoxyphene) on the market for 55 YEARS  
Use: Opioid pain reliever Manufacturer: Xanodyne 1955 to Nov. 19, 2010  
Cause for recall: serious toxicity to the heart; between 1981 and 1999 there were over 2,110 deaths reported The UK banned Darvon and Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen.  
DES (Diethylstibestrol) on the market for 31 YEARS  
Use: synthetic estrogen to prevent miscarriage, premature labor, and other pregnancy complications Manufacturer: Grant Chemical Co. 1940 to 1971  
Cause for recall: clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug) but they are unclear as studies are just beginning Studies in the 1950s showed the drug was not effective at preventing miscarriages, premature labor, or other pregnancy complications.  

Propulsid (Cisapride) on the market for 7 YEARS
Use: Severe nighttime heartburn associated with gastroesophageal reflux disease (GERD) Manufacturer: Janssen Pharmaceutica 1993 to July 14, 2000
Cause for recall: more than 270 cases of serious cardiac arrythmias (including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation) reported between July 1993 and May 1999, with 70 being deaths. Propulsid is also banned in India (2011) and available for limited use in Europe. It is still available for use in animals in the US and Canada.
Vioxx (Rofecoxib) on the market for 5.3 YEARS
Use: NSAID (pain relief) Manufacturer: Merck May 20, 1999 to Sep. 30, 2004
Cause for recall: increased risk of heart attack and stroke; linked to about 27,785 heart attacks or sudden cardiac deaths between May 20, 1999 and 2003 Ads for Vioxx features Olympic gold medalists Dorothy Hamill and Bruce Jenner. Vioxx was prescribed to more than 20 million people.
Zelnorm (Tegaserod maleate) on the market for 4.6 YEARS
Use: irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in women younger than 55 Manufacturer: Novartis July 24, 2002 to Mar. 30, 2007
Cause for recall: higher chance of heart attack, stroke, and unstable angina (heart/chest pain) The FDA permitted restricted use of Zelnorm on an emergency basis (with prior case-by-case authorization from the FDA) on July 27, 2007.
 So next time you are warned about the dangers of supplements, think about what you are not being told and consider whose interests are really behind this deep-rooted deception.  




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