Billions of people use medications each day. Drugs are meant to treat, provide relief
from or cure an ailment. But, taking drugs comes with a price - adverse drug reactions
- and we are not even talking about the cost of medications, which can be exorbitant.
Adverse drug reactions may be due to all types of drugs, prescription as well as
nonprescription, with the latter known as over-the-counter (OTC) drugs. Researchers
at Children's Hospital Boston reported that more than half a million children in the US
suffer from medication side effects every year. Of those affected, the majority are
under the age of 5 and 5% of cases led to hospitalization. In the general population,
US surveillance data show that more 700,000 adverse drug reactions are reported
every year. And we are not even talking about the cases that go unreported!
Whereas, allergic reactions, medication mix ups, drug-drug interactions, and
accidental overdose all play a role in adverse drug reactions, the most common
adverse drug reactions are the effects from the drug itself - a virtual double-edged
A classic example is the wonder drug aspirin which has been in existence for more
than 100 years. Aside from being an analgesic and antipyretic agent, it is also used in
the treatment and prevention of cardiovascular disorders. Yet, it has one major side
effect that is potentially dangerous - gastrointestinal bleeding.
And who would have thought that plain old cough syrup could be dangerous.
Evidence has been piling up that OTC Cough and Cold Medications (CCMs) are not
harmless. Next to painkillers and vitamin supplements, perhaps the most commonly
bought OTC drugs are CCMs for children. Between February 1999 and June 2005,
the Philadelphia Medical Examiner's Office reported 15 cases of deaths among
children 16 months and younger which could be related to the use of OTC CCMs.
As a result, the US FDA Nonprescription Drugs Advisory Committee convened to
discuss the safety of OTC CCM drugs especially for children under the age of 2. New
FDA OTC products recommendations came out in January 2008 and were updated in
October 2008. And in 2008, researchers investigated the link between sudden infant
death (SIDS) and the use of cough and cold medications. The study results support
"the recommendation that such medications should not be given to infants and that
these medications may play a role in unexpected infant deaths..."
Sadly, adverse drug reactions do not have to be acute. Long term effects can also be
worse than the disease itself! Unfortunately, despite exhaustive research and approval,
drugs can cause irreparable harm before being pulled from the marketplace. Although
Vioxx and Avandia are highlighted, there have been many prescription drugs that have
removed and without a doubt, more will follow.
The drug rofecoxib (Vioxx) was a popular prescription drug to treat chronic pain due
to arthritis. However, after just over 5 years in the market, it was withdrawn due to
increased risk of heart attack and stroke.
The anti-diabetic drug rosaglitazone (Avandia) has a controversial reputation
regarding cardiac safety. In 2007, the US FDA issued a safety alert on Avandia and
required its manufacturer GlaxoSmithKline to include a black box warning. And
despite the continued controversy surrounding its use, a FDA advisory panel in July
2010 voted 20-10 to keep the drug in the marketplace but subject to certain
Perhaps there is no drug safety controversy bigger than that one surrounding vaccines,
especially childhood vaccines. It remains to be seen whether the controversy over the
adjuvants in the seasonal flu and the H1N1 vaccine will surpass the notoriety of the
childhood vaccination controversy which continues to rage!
In 1999, the Centers for Disease Control and Prevention (CDC) and the American
Academy of Pediatrics (AAP) asked that thimerosal be removed from vaccines.
During the last 10 years, thimerosal has been excluded from childhood vaccines but it
remains in most other vaccines including most of the flu vaccines including the recent
adjuvant added H1N1 flu vaccine.
And recent evidence also suggests that the Gulf War Syndrome with its severe
neurologic complications is most likely related to an adjuvant or a combination of
adjuvants used in the mass vaccinations of the GI's.
Besides the inherent risk of untoward side effects prescription drug abuse is on the
rise. Michael Jackson and Heath Ledger are two of the many celebrities who became
victims of prescription drug abuse and misuse. It could be sleeping pills, pain killers,
or antidepressants or simply for recreation to get high.
The 3 classes of prescription drugs most commonly abused are: opioids such as
codeine, oxycodone, and morphine; central nervous system (CNS) depressants such as
barbiturates and benzodiazepines and stimulants such as dextroamphetamine and
methylphenidate. Teenagers and young adults are among the most common
prescription drug abusers. Statistics showed that 2.1 million American teenagers (12
to 17 years of age) abused prescription drugs in 2006.
So who's minding the 'Drug' Store?
In developed countries, there is nothing more strictly regulated than drug safety. The
basic principle of drug development is "First do no harm". Drugs are rigorously tested
before they can be approved for marketing. The FDA oversees the approval of drugs
for marketing in the US. It also regulates the so-called product labeling which gives
information on dosage and mode of administrations as well as side effects of the drugs,
the so-called almost irreadable package inserts! Similar drug regulatory bodies exist
in most countries.
In addition, unexpected adverse events due to drug use must be reported to health
authorities. However, most adverse reactions remain unreported and in fact a great
percentage of ER visits continue to be related to drug side effects and drug-drug
interactions, and in some cases, too many prescription drugs.
However, every now and then, serious drug reactions occur in relation to drugs
already in the market. How can this happen despite the strict drug regulations?
(1) Children are different than adults! Dosages for pediatric patients are usually
calculated by simply considering them as "mini-adults". Recent studies revealed that
children may actually react differently to certain drugs compared to adults and these
can cause reactions that are sometimes unexpected. A recent study, for example, show
that commonly used cough drugs that contain codeine and corticosteroids have
different effects and reactions in adult and pediatric patients. In 2008, some countries
are now requiring drug companies to actually test drugs on children before they can
be approved for pediatric use.
(2) Long-term side effects remain a sore spot. Some side effects may take years to
emerge. In the case of the arthritis drug Vioxx, drug problems only arose after years of
long-term use, long after the drug has been approved for marketing. Similarily, for the
mass vaccinations during the Persian Gulf War.
(3) Genetic variances. In some cases, drugs may react differently in certain people
with rare genetic variants, and can lead to side effects that might not be observable
during controlled clinical trials. For example, the statin drugs simvastatin and
pravastatin may produce side effects in people who carry reduced-function single
nucleotide polymorphism (SNP) of the SLCO1B1 gene.
(4) Cover ups. Despite strict regulation and watchdog groups, pharmaceutical
companies sometimes commit mistakes from inadvertent errors to downright
negligence. Citing the case of Vioxx, there have been questions as to whether its
manufacturer Merck correctly reported its side effects. More recently, Pfizer
subsidiary Pharmacia & Upjohn Co was fined $1.3 billion for fraudulent marketing of
the arthritis drug valdecoxib Bextra despite safety issues. Bextra was withdrawn from
the US market in 2005 due to increased risks for heart attacks.
To help keep you and your family safe, check out the following resources.
Consumer Reports 'Best Buy Drugs' - free guidance for consumers on prescription
Wrong Diagnosis - http://www.wrongdiagnosis.com - good resource for adverse drug
The Consumer Healthcare Products Association (CHPA)-the 128-year-old-trade
association representing U.S. manufacturers and distributors is a good resource for
OTCs and nutritional supplements.
OTCsafety.org - educates parents with its public service campaign "﻿Treat
with Care" on how to use OTC CCMs for children safely.
FDA Drug Safety and Availability - information for consumers and health
professionals on new drug warnings and other safety information, drug label changes,
and shortages of medically necessary drug products.
MedWatch - the FDA safety information and adverse event reporting program.
YellowCard UK - the Yellow Card scheme is run by the MHRA and the Commission
on Human Medicines (CHM), and is used to collect information from both health
professionals and the general public on suspected side effects.
MedEffect Canada - MedEffect e-Notice is a free service to stay on top of advisories,
warnings and recalls for health products that Canadians use every day.
The take home message is - you cannot rely solely on the regulatory drug approval
agencies, the adverse drug reactions reporting bodies, watchdog groups or even the
above resources. Always pay attention to the drug inserts, if you can read them, and
not just the TV commercials.
Now, more than ever, it's up to you to mind the 'Drug' store!