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Who's Minding the DRUG Store?

posted 12 Sept 2010, 04:18 by Mpelembe   [ updated 12 Sept 2010, 04:19 ]

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

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 sword!

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 restrictions.

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

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 medicines.

Wrong Diagnosis - - good
resource for adverse drug reactions.

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. - 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'

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