Data driven decision gives predictability and enhance certainty

1. Safety Alert
Fluroquinolones
Roohi B. Obaid
Karachi, July 2018
When Data Speaks Out Loud

2. When Data Speaks Out Loud Roohi B. Obaid July 2018 Page 1 of 3
Safety Alert - Fluoroquinolones
When Data Speaks Out Loud
Unreasonable Side Effects have a Cost and Burden on Health too
A drug comes out as a candidate of registration
after a series of research. These research results
pass through rigorous process of screening,
assessment, review and evaluation by the
regulatory agency before coming into market.
The commercial interest indulges in its way and
thus, responsibility of the government increases
manifold in every dimension. Credibility of the
data, review of the claim, evaluation of potential
hidden data, critical assessment of growing
concerns etc. are not a simple math, but an
extremely complex challenge for regulators.
Upon expiry of patent of a new drug, series of its
copies in terms of generics knock the door and
enter into the market.
The knowledge is always expanding with the
evolution of science and data. Engagements of
consumers, healthcare professionals and family
members in providing real time information
related to drugs not only open new horizons but
gain attention to review the original and old data
with new reports. It is now about four decades
when Fluoroquinolones (antibiotics) class of
drugs got approved and entered the market one
after the other to treat certain serious bacterial
infections. They stop or kill the growth of
bacteria responsible for infections. Common
side effects like nausea, diarrhea, headache,
dizziness, light headedness, trouble sleeping
were established, whereas, unusual joint pain,
muscle weakness, numbness, confusion,
hallucinations, decreasing level of blood sugar
were also reported.
Unmatched extensive consumption of
Fluoroquinolones from rest of the world here in
Pakistan is a matter of deep concern. This is due
to irrational use of drugs by the professionals,
misuse and abuse by the society due to weakness
in prescription control and pharmacy services in
the community. If someone compares the
utilization of this class of drugs with the
reference countries from where drugs have been
originated, it will reveal up to ten-fold or even
more difference can be safely concluded.
Leading corporate companies here in Pakistan
are celebrating sales volume instead of
concentrating on its unnatural utilization and
associated potential burden on healthcare system
by and large. The same way, when reporting of
unwanted harmful signals is compared, we again
find about hundred time difference in the
statistics of reporting. Pakistan has
countervailin
g trends in
terms of
utilization
and reporting
of associated
harmful
events, while
the same leading corporate companies are
working here and outside Pakistan
simultaneously under one management. This is
not only strange as far as moral corporate
More than a billion
rupees is being paid
by the consumer on
Fluoroquinolones
Family members or the
patient him or herself are
consulting Psychiatric
Physicians and
Diabetologists for
behavioral changes and
disturbance in sugar levels
of their loved ones.
Physicians are adding drugs
without considering it is a
side effect of
Fluoroquinolones.

3. When Data Speaks Out Loud Roohi B. Obaid July 2018 Page 1 of 3
responsibility is concerned but also a clear
indicator of regulatory performance and its
weakness that favors economic benefit of
company over patient safety.
Recently in July 2018, the United States-Food
and Drug Administration (US-FDA) reinforced
safety information associated with the drugs and
asked to add on label about serious low blood
sugar levels and mental health side effects. A
patient should be evaluated while prescribing
this class of drugs, if he is taking diabetic
medicines, as he may experience serious
hypoglycemic conditions that may lead to death.
If prescription of the said class of drugs is
necessary, patient must know about the sign and
symptoms of low blood sugar levels that
includes confusion, dizziness, feeling shaky,
unusual hunger, headache, irritability, very fast
pulse, pale skin, sweating, trembling, weakness,
and unusual anxiety. Change in mood, behavior
and thinking must be taken as a great concern
and not go unnoticed by the physician or family.
If patient reports side effects involving the
tendons, muscles, joints or nerves, US-FDA
recommends immediate stopping of
administering or taking the drug and switching
to other non-fluoroquinolone drug. The new
change in label asks manufacturer to add words
“hypoglycemic coma” and new sub-heading i.e.
“Psychiatric Adverse Reactions”.
Let’s see the back mirror, how the regulatory
agencies detects the signals and conducts meta-
analysis
of
informati
on, data
and
reporting
experien
ces to
conclude
particula
rly in the
interest
of
patient
safety. In
July 2008, after 3 decades of drug approval and
utilization “Tendinitis and Tendon Rupture”
were added in box warning of the prescribing
information because use of the said drug
increases its risk. The agencies described the
realities evolved, provided candid information in
detail and recommended consideration of
potential benefit and risk to each individual
before prescribing the Fluoroquinolones. In
August 2013, peripheral neuropathy potential
was communicated and was asked to put on the
label as a warning. In May 2016, US-FDA asked
for restrictions of its use in certain
uncomplicated infections and warned about
disabling side effects that can occur together.
These side effects include tendons, muscles,
joints, nerves and central nervous system that
may be permanent and irreversible. Its use is
restricted and discouraged in patients with acute
sinusitis, acute bronchitis, and uncomplicated
urine tract infections where other treatment
options are available. In July 2016, US-FDA
came up with its clear concern that its benefits in
some serious bacterial infections outweigh the
risks, that’s why the agency was of opinion that
availability of Fluoroquinolones as a therapeutic
option is appropriate for such cases.
We have situations of self-medication,
availability of drug without prescription,
questionable authenticity of prescription, zero
Hundreds of brands are
freely available in Pakistan
and extensively used
without appropriate
supervision.
Fluoroquinolones include
Levofloxacin, Ofloxacin,
Ciprofloxacin, Gemifloxacin,
Moxifloxacin, Norfloxacin,
etc.
Pakistan has counter
veiling trends in terms of
utilization and reporting,
while the same corporate
companies are working
here and outside Pakistan.
This is a clear indicator of
regulatory performance
and its weakness that
favors economic benefit of
company over patient
safety

4. When Data Speaks Out Loud Roohi B. Obaid July 2018 Page 2 of 3
supervision of pharmacy services on antibiotic
therapies, absence of culture sensitivity test
practice, unethical marketing practices,
physician bribing, increased ego and knowledge
deficit among professionals in health care
system. Consumers are compelled to be a victim
by their choice on their pocket for events that
can easily be avoided. Family members or the
patient him or herself are consulting Psychiatric
Physicians and Diabetologists for behavioral
changes and disturbance in sugar levels of their
loved ones. Physicians are adding drugs without
considering it as a side effect of
Fluoroquinolones. More than a billion rupees is
being paid by the consumer on
Fluoroquinolones. Hundreds of brands are freely
available in Pakistan and extensively used
without appropriate supervision.
Fluoroquinolones include Levofloxacin,
Ofloxacin, Ciprofloxacin, Gemifloxacin,
Moxifloxacin, Norfloxacin, etc. Public
awareness through sincere and scientific
information in a simple and clear language can
reduce significant unreasonable burden of
serious side effects of drugs. These are
indeemodern indicators to judge nation’s
strength and moral. We have to work ourselves
and no one will come to rescue us.
Author may be reached at rooahama@gmail.com.