Drug Side Effects Responsible for
4,335,990 Clinic/ER Visits Annually
Drug side effects causing adverse reactions from pharmaceutical drugs are responsible for 4,335,990 annual visits to outpatient clinics and emergency departments throughout the United States, according to an eleven-year study published September, 2010 in a leading medical journal. Visits for adverse drug events (ADEs) increased over the study period from 9.0 to 17.0 per 1000 persons. Overall, outpatient ADEs resulted in 107,468 hospital admissions annually.[1]
ADEs are a common complication of medical care resulting in high morbidity and medical expenditure yet historical population level estimates are limited. The study objective was to provide national estimates and characterizations of outpatient ADEs and determine risk factors associated with these events.
Researchers examined data between 1995 and 2005 from the National Center for Health Statistics which collects information on U.S. patient visits to outpatient clinics and emergency departments and measured the national annual estimates and risk factors for outpatient ADEs requiring medical treatment. Authors concluded that both patient age and multi pharmaceutical use are risk factors for ADE-related healthcare visits, which have substantially increased during the study period.
The incidence of ADEs has particularly increased among patients 65 years and older with as many as 1 in 20 persons seeking medical care for an ADE from drug side effects.
The study was published in final edited form as Adverse Drug Events in the Outpatient Setting: An 11-Year National Analysis in the journal Pharacoepidemiology and Drug Safety in September, 2010.
Study: ADE's from prescription drug side effects cause 700,000 ER visits annually
An earlier federal study targeting drugs obtained by prescription, National surveillance of emergency department visits for outpatient adverse drug events estimated that drug side effects causing adverse reactions are responsible for 700,000 visits to U.S. emergency rooms every year. It was published the Journal of the American Medical Association October 18, 2006.[2]
The report was put together by the Centers for Disease Control and Prevention, the FDA and the Consumer Product Safety Commission, and included data collected in 2004 and 2005 from 63 hospitals in the United States. Similar studies have been conducted previously, but this is the first to include national figures in order to identify which specific drugs were the most problematic.
Three drugs—the blood thinner warfarin, the diabetes drug insulin, and heart medication digoxin--were responsible for one-third of the drug side effects emergency visits in people older than 65. Patients older than 65 were more than twice as likely to need emergency care for a drug reaction than younger patients, and almost seven times as likely to require hospitalization for the drug side effect.
Other drugs at the top of the list of drugs causing adverse reactions were aspirin, followed by the antibiotics amoxicillin and trimethoprim-sulfamethoxazole. "I think it is a big problem," said Dr. David Bates of Brigham and Women's Hospital in Boston, who previously conducted research into the subject. "The absolute number of patients identified in the study is high."
According to Bates, many of the drug reactions were preventable though more careful prescribing, and lower amounts being prescribed to elderly patients, who are at a higher risk of kidney problems and other healthcomplications, might reduce overdose numbers.[3]
"These toxic reactions to prescription drugs make perfect sense once you realize what these drugs are actually made of," said Mike Adams, a consumer health advocate and critic of dangerous prescription drugs. "Common blood thinner drugs, for example, are made of warfarin, a rat poison chemical. These chemicals kill rats by causing massive internal bleeding, and yet patients happily swallow this poison on the advice of a doctor, and then wonder why they end up in the emergency room."[3]
Prescription and non-prescription drug side effects are inevitable
It's a public fact that drug side effects are connected to all prescription medications. A side effect is usually regarded as an undesirable secondary effect which occurs in addition to the desired therapeutic effect of a drug or medication. The public does not seem to be aware that non-prescription medications have dangerous side effects, especially when used chronically or in overdose amounts.
Over-the-counter drugs also have caused adverse drug events (ADEs) requiring emergency intervention. Consumers are often unaware of the side effect dangers in over-the-counter medication, such as non-steroidal anti-inflammatory drugs (NSAIDs).
"Each day, more than 30 million Americans take an NSAID for quick, easy pain relief from common ailments like headaches and arthritis. Because these drugs are easily accessible and can be very effective, there is a misperception out there that they have no risks," said Byron Cryer, M.D., an associate professor of medicine at the University of Texas Southwestern Medical School in Dallas, Texas.
"In reality, there are serious side effects associated with inappropriate use that patients need to recognize. There is no medical test to determine who will develop side effects, and there usually are no warning signs. Education is imperative to help patients recognize the risk factors and have discussions with their physicians,” said Cryer,[4]
FDA official: “Nation’s drug safety system has “pretty much broken down”
On June 8, 2005 a federal drug official, Dr. Janet Woodcock, told a medical committee at the Institute of Medicine that the FDA’s drug safety system had “pretty much broken down,” according to an article in the N.Y. Times.[5]
Woodcock, a deputy commissioner of operations at the Food and Drug Administration, had been asked by the advisory board for safety improvements following the FDA’s adverse publicity from drug side effects and the withdrawal of two top-selling painkillers, Vioxx and Bextra. She said that there was room for “a lot of improvement” in the FDA’s uncovering dangers in drugs already on the market.
“The keystone of the current system is the prescriber and that person is the one who decides if the benefits of a drug outweigh the risks for that patient,” Dr. Woodcock said. “This system has obviously broken down to some extent, as far as the fully informed provider and the fully informed patient.”
Dr. Woodcock also said the agency hoped to change the way drugs were developed by the industry so that rare side effects might be identified before a drug is marketed widely.
She emphasized, though, that the agency could do only so much to curb drug side effects problems with drugs already on the market. "The bottom line is that a lot of drug safety problems are actually preventable," she said, because "most adverse events are from known side effects."
Study: TV commercials minimize drug side effects
Because of stringent federal restrictions, there were practically no pharmaceutical television commercials for most of the 1990's.
TV commercials by drug companies began to mushroom when the FDA relaxed its guidelines in 1997 and now dominate the airwaves. But many commercials appear to stretch or exceed the boundaries when it comes to “fair and balanced” presentation of the health risks of drug side effects.
A study conducted at the Grady College of Journalism and Mass Communication, released January 4, 2008, determined the average one-minute commercial spent less than 13 percent of its time discussing the side effects of drugs advertised, and 30 second commercials spent less than 15 percent.[6]
In addition, the study, published in the journal Health Communication discovered almost all ads disclosed drug side effects by voice-over presented in a way that people aren’t likely to comprehend or even pay attention to. Just 2.2 percent of ads had the disclosure in voice-over as well as in text form.
The 1997 FDA guidelines allowed drug companies to greatly expand the scope of their advertising but required the companies to “present a fair balance between information about effectiveness and information about risk.”
Apparently, the White House is listening. According to the article, Ten Misleading Drug Ads in Forbes.com, February 2, 2010, President Obama spurred a renewed effort by the FDA to confront questionable marketing claims by drugmakers, which resulted in 41 enforcement letters sent during 2009, twice the number sent in 2008.[7]
Majority of pharmaceutical medical journal ads miniminze drug side effects
Is your doctor getting misinformation by drug manufacturers in the medical journals he reads? Researchers show “that the current system is not in the best interest of the health of the public.”
According to a study led by Mount Sinai School of Medicine researchers of 192 pharmaceutical advertisements in biomedical journals found that only 18 percent were compliant with FDA guidelines, and over half failed to quantify the serious risk of drug side effects including death.
The study, Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing, was published online August 18, 2011 in the journal Public Library of Science (PLoS) One.[8]
“Marketing research has consistently shown that journal advertising is the most profitable form of drug marketing, with an estimated return on investment of five dollars for every dollar spent," said Dr. Deborah Korenstein, lead author of the study and Associate Professor of Medicine at Mount Sinai School of Medicine. Her remarks appeared in an online article, Majority of Pharmaceutical Ads Do Not Adhere to FDA Guidelines, New Study Finds on August 18, 2011 in ScienceDaily.[9]
"Our study, the first in nearly 20 years to provide a systematic assessment of the adherence of US advertisements to FDA guidance, shows that the current system is not in the best interest of the health of the public," she said.
Physician-directed pharmacerutical advertising is regulated in the United States by the FDA, but adherence to current guidelines prior to the study was unknown. The study's objective was to determine adherence rates to FDA guidelines and describe content important for safe prescribing.
The study concluded that few such print advertisements adhere to all FDA guidelines, and over half fail to quantify serious risks. The authors conclude FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.
Consumers should report drug side effects adverse reactions to the FDA
Question: Why do patients take a medication in spite of its side effects?
Answer: Because the doctor and patient believe the benefits outweigh the drug side effects.
Caution: It’s important to be informed about side effects of specific drugs so you can make an informed decision about whether to take the medication, and so that you can recognize possible side effects when they occur.
The FDA's Center for Drug Evaluation and Research (CDER) conducts vigilant premarket review of all drugs, but it doesn't guarantee a drug's safety. All possible side effects of a drug can't be anticipated based on preapproval studies involving only several hundred to several thousand patients.
After marketing, if enough people report the same side effect, then it can be investigated to see if it's really the drug causing the side effect and whether the package insert needs to be modified, or in some cases (like Vioxx), the drug has to be taken off the market.
The FDA maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug approval process. [10]
The Adverse Event Reporting System (AERS) was created by FDA for storing and analyzing data. Reporting of adverse events caused by drug side effects is voluntary in the United States. The FDA receives some adverse event and medication error reports directly from health care professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, lawyers and others) and from drug manufacturers.
If you have experienced adverse drug reactions, the FDA has a program called MedWatch for reporting serious reactions and problems with medical products, such as drugs and medical devices.
Consumers are invited to report an adverse drug event to the FDA at fda.gov/medwatch
Two of top 3 prescriptions dispensed for year of 2010 are painkiller drugs
Overall, the number of prescriptions dispensed in 2010 was 3.99 billion, a historically low increase from 2009 of 1.2% as reported in the May 2011 issue of Pharmacy Times.
The top medication on the list in 2010 was once again the painkiller Hydrocodone with 131.2 million prescriptions, up three million from 2009. In fact, two of the top three drug prescriptions dispensed for 2010 included the painkiller drugs hydrocodone acetaminophen (HYCD/APAP) made as generics by two separate manufacturers. Here are the top 10 drugs in the U.S. Market by dispensed prescriptions, 2010 (listed drug, manufacturer, purpose of drug, and # of prescrptions):[11]
- Hydrocodone/APAP Watson (Painkiller) 58,205,644
- Amoxicillin Teva (Antibiotic) 58,107,874
- Hydrocodone/APAP Mallinckrodt (Painkiller) 48,571,746
- Lipitor Pfizer (Cholesterol) 45,817,079
- Levothyroxine Sodium Mylan (Thyroid) 41,698,380
- Lisinopril Lupin (ACE Inhibitor) 38,348,332
- Simvastatin Lupin (Cholesterol) 29,711,605
- Plavix Bristol-Myers Squibb/sanofi-aventis (Blood Thinner) 29,634,338
- Nexium AstraZeneca (Heartburn) 28,695,328
- Singulair Merck (Asthma/Allergy) 28,479,750
Not all painkiller drugs are prescription. Some painkiller drugs fall under the category of non-steroidal anti-inflammatory drugs (NSAID), including aspirin, ibuprofen, naproxen and celecoxib (Celebrex) COX-2. See NSAID Side Effects.
Study: Painkillers lead in causing emergency room treatment
Both prescription and non-prescription painkillers dominate a 2007 ISMP report of the top 10 drugs most commonly implicated in adverse events from drug side effects requiring treatment in a hospital emergency department, including four commonly used drugs: aspirin, ibuprofen, acetaminophen, and hydrocodone/acetaminophen.
The combination drug hydrocodone and acetaminophen, now available as the generic HYCD/APAP, also ranked first and third on the most prescribed list (above paragraph) in 2010. The drug is more recognizable by the brand names Vicodin, Lortab, Lorcet and Norco.
Here are the top 10 drugs most commonly implicated in causing ER treatments during 2007, according to the Institute for Safe Medication Practices (ISMP)--the nation's oldest voluntary drug safety reporting program.[12]
- Insulin
- Anticoagulants
- Amoxicillin
- Aspirin
- Trimethoprim-sulfamethoxazole
- Hydrocodone/acetaminophen
- Ibuprofen
- Acetaminophen
- Cephalexin
- Penicillin
Drug side effects of hydrocodone/acetaminophen
Hydrocodone and acetaminophen are combined to achieve relief from moderate to moderate-severe pain.
Hydrocodone is a narcotic pain-reliever and a cough suppressant, similar to codeine, that works by binding to opioid receptors in the brain and spinal cord.
Acetaminophen is a non-narcotic analgesic (pain reliever) and antipyretics (fever reducer) that decreases the formation of prostaglandins, therefore relieving pain.
This combination drug has replaced Vioxx, Bextra (both no longer on the market) and Celebrex (side effects linked to causing heart problems) as most commonly prescribed by physicians treating moderate to severe pain related primarily to arthritis. It is a schedule 3 controlled substance that is a very addictive painkiller.
Here is a partial list of the drug side effects of hydrocodone-acetaminophen:
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, flushing, vision changes, or mental/mood changes may occur. Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/irregular breathing, slow/irregular heartbeat, change in the amount of urine. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: impairment or loss of hearing (especially with high doses for long periods).
If you do not have liver problems, the adult maximum dose of acetaminophen is 4 grams per day (4000 milligrams). If you take more than the maximum daily amount, it may cause serious (possibly fatal) liver disease. Tell your doctor immediately if you have any of the following symptoms of liver damage: severe nausea, yellowing eyes or skin, dark urine, stomach pain, extreme fatigue. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.
"There are a lot of people taking drugs to treat the side effects of drugs”
The following quote is taken from the article, Prescription Drug Side Effects: Medications can cuase other conditions unrelated to the health problems they're prescribed to treat, by Patricia Barry in AARP Bulletin on September 1, 2011:
"There are a lot of people taking drugs to treat the side effects of drugs," says Gordon Schiff, M.D., an internist on the faculty of Harvard Medical School and associate director of the Brigham Center for Patient Safety Research and Practice in Boston. "And sometimes that makes sense, and maybe the initial drug is essential. But when you're taking a drug to treat the side effect of a drug which is treating the side effect of another drug, it gets to be rather a house of cards."[4][13]
Quoting author Barry from the article: “....medications can cause other conditions unrelated to the health problems they're prescribed to treat. Unaware of this, patients very often consult their doctors about this 'new' condition — only to be prescribed yet another drug that could produce still more side effects.”
“This syndrome is known as a drug 'cascade.' It's not as well studied as more dramatic problems with prescription drugs — such as when apparently safe drugs turn out to be deadly — but it is of growing concern. Experts estimate that tens of millions of people are suffering every day — often without knowing why.”
July 2010 study shows abuse of pain pills is a growing menace
Drug side effects of painkillers include addiction. A recent study shows that peopling seeking treatment for prescription pain-killer abuse rose 400 percent in the ten-year period between 1998 and 2008. It was released in July, 2010 by the Office of National Drug Control Policy (ONDCP).[14]
Experts say the nation is in the grip of a prescription drug-abuse epidemic--especially when it comes to opioids such as OxyContin, Vicodin, Percodan and methadone.
The problem has so escalated that on Sept. 1, 2010 Texas Legislation was enacted that requires pain management clinics to be certified by the Texas Medical Board and run only by physicians with unrestricted licenses.[15]
Dr. Leonard Paulozzi, a medical epidemiologist with the U. S. Centers for Disease Control and Prevention, traces the advent of the pain pill problem to the 1990's, when doctors began more aggressively prescribing such medication to patients complaining of pain.
"Previously, physicians were afraid to use (prescription opioids) for chronic pain for fear their patients would get addicted," Dr. Paulozzi said. "Doctors began to change their mind, and you can trace the increase in opioid abuse through the 90's and up to the present day."
Dr. Paulozzi said that patients begin using prescription opioids for legitimate reasons, such as illness or injury. "Over time, they grow addicted," he said. "Around 25 percent of the adult population struggles with chronic pain such as back injuries and headaches," he commented.
Is America's drug industry out of control?
Does the American pharmaceutical industry need to be saved, mainly from itself?
Increasing uneasiness within the medical community is spawning numerous books and articles calling for industry reform, including restoring impartiality to clinical research and severing the ties between drug companies and medical education.
In her 2005 book, The Truth About the Drug Companies: How They Deceive Us and What to Do About It, author Marcia Angell, M.D. weaves a searing indictment of an industry that has spun out of control.
From twenty years of experience at The New England Journal of Medicine , Dr. Angell watched drug companies stray from their original mission of discovering and manufacturing useful drugs and instead become vast marketing machines with unprecedented control over their own fortunes. “The fact is,” writes Dr. Angell, “that this industry is taking us for a ride, and there will be no real reform without an aroused and determined public to make it happen.”[4][16]
In another book, Overdosed America: The Broken Promise of American Medicine, 2004, author John Abramson, M.D. investigates the commercialization of medicine at every stage, from deceptive clinical trials to aggressive pharmaceutical advertising. He believes that Americans are over diagnosed and overmedicated.
Abramson, an award-winning family doctor on the clinical faculty at Harvard Medical School, describes an untold crisis in American medicine, with drug side effects that may be hazardous to your health.[4][17]
On television, Dr. Oz, a nationally syndicated show starring Mehmet Oz, M.D., on May 12,2011 featured a topic called Four Things Drug Companies Don't Want You To Know About. They were:
- Companies under estimate dangerous drug side effects
- Companies control much of the information your doctor gets about a drug
- You're often prescribed drugs you don't need
- Drugs target the symptom not the cause
A review of the show appeared online in Healthy Body Daily, stating “Dr. Oz and his experts uncover the disturbing secrets drug companies are hiding.”[4][18]
Is America’s dependency on prescription drugs out of control?
Is it time to take control of our own health?
Americans love to take a pill for what ails them. The pharmaceutical industry loves to advertise and supply them. Doctors love to prescribe them. When one pill causes unwanted drug side effects, a second one can additionally be prescribed. And so the cycle continues.
There’s a faction within the health community that believes future advances in health will likely come more from changes in lifestyle, exercise and diet than from medications.
Many of the conditions for which prescription and over-the-counter drugs are prescribed are preventable by losing weight, exercising, stopping smoking, practicing cleanliness and hygiene, eating organic, and consuming more fresh vegetables and fruits.
The most common health disorders, like diabetes and heart disease, are better prevented and treated through changes in diet, exercise, and lifestyle than from medication.
Education is the key to achieving these changes across the landscape of America. There’s increasing evidence that the trend has already begun as millions of Americans are switching to natural dietary supplements as an alternative to the side effects of pharmaceuticals.
To avoid painkiller drug side effects, choose natural supplements instead
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References/sources
[1] Bourgeois, FT et al: Adverse Drug Events in the Outpatient Setting: An 11-Year National Analysis. Journal Pharmacoepidemiology and Drug Safety, September, 2010, Vol. 19, Issue 9, pg 901-910. PMC free full text archive September 1, 2011, U.S. NIH/NLM http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2932855/
[2] Budnitz, DS, et. al. National surveillance of emergency department visits for outpatient adverse drug events. Study published JAMA 2006 Oct 18;296(15):1858-66 http://www.ncbi.nlm.nih.gov/pubmed/17047216
[3] Kage, B. Article Medication reactions send 700,000 Americans a year to emergency rooms, October 18, 2006, Natural News.com. http://www.naturalnews.com/020811_bad_medicine_drug_side_effects.html
[4] Article: About.com Many Take More Pain Relievers Than Recommended: Side Effects of Over Use Can Be Serious, updated May 2, 2010 from American Gastroenterological Association http://alcoholism.about.com/od/prescription/a/blaga040522.htm
[5] Harris, G. Article Drug Safety System Is Broken, a Top F.D.A. Official Says, NY Times, June 9, 2005
[6] Macias, W (writer: Fahmy, S). Study finds most TV prescription drug ads minimize risk information, November/December 2007 journal Health Communication, article January 3, 2008. http://news.uga.edu/releases/article/study-finds-most-tv-prescription-drug-ads-minimise-risk-information/
[7] Ruiz, R. Article Ten misleading drug ads, Forbes.com. February 2, 2010 http://www.forbes.com/2010/02/02/drug-advertising-lipitor-lifestyle-health-pharmaceuticals-safety.html
[8] Korenstein D, Keyhani S, Mendelson A, Ross JS Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing. August 17, 2011, PLoS ONE 6(8): e23336. doi:10.1371/journal.pone.0023336 http://www.plosone.org/article/info:doi%2F10.1371%2Fjournal.pone.0023336
[9] Article. ScienceDaily, August 18, 2011 Majority of Pharmaceutical Ads Do Not Adhere to FDA Guidelines, New Study Finds. http://www.sciencedaily.com/releases/2011/08/110818093052.htm
[10] Currnet online publication, FDA, Postmarketing and Surveillance Programs for Drug Side Effects http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/ucm090385.htm
[11] Bartholow, M. article Top 200 Drugs of 2010, May 16, 2011 Pharmacy Times IMS Institute for Healthcare Informatics. The use of medicines in the United States: review of 2010. IMS Institute for Healthcare Informatics Web Site. http://www.imshealth.com/deployedfiles/imshealth/Global/Content/IMS%20Institute/Static%20File/IHII_UseOfMed_report.pdf, Published April 2011. Accessed April 23, 2011 http://www.pharmacytimes.com/publications/issue/2011/May2011/Top-200-Drugs-of-2010
[12] Hahn, K. Article Online, Medscape Education from Medscape Pharmacists, the Top 10" Drug Errors and How to Prevent Them, April, 2007 http://www.medscape.org/viewarticle/556487
[13] Barry, P Article, Prescription Drug Side Effects: Medications can cause other conditions unrelated to the health problems they're prescribed to treat, AARP Bulletin, September 1, 2011. http://www.aarp.org/health/drugs-supplements/info-09-2011/prescription-drug-side-effects.html
[14] Monthly column, Texas Medical Board Adops New Rules, November 30, 2009 (law effective September 1, 2010) Houston Medical Journal, accessed online March 22, 2012 http://www.mjhnews.com/texas-medical-board-adopts-new-rules.html
[15] Angell, M. personal article review, The Truth About the Drug Companies, July 15, 2004, The New York Review of Books. http://www.nybooks.com/articles/archives/2004/jul/15/the-truth-about-the-drug-companies/?pagination=false
[16] Abramson, J. MD. Book Overdosed America: The Broken Promise of American Medicine, review April 8, 2010. Reveals the greed and corruption that drive health care costs skyward and now threatens the public health. www.overdosedamerica.com/
[17] Online article, Dr. Oz: 4 things drug companies don't want you to know, Healthy Body Daily, May 12, 2011. http://healthybodydaily.com/dr-oz-in-case-you-missed-it/dr-oz-4-things-drug-companies-dont-want-you-to-know-secrets-drug-companies-are-hiding
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