Underline Threat of Aorta Rupture

1. Safety Alert
Fluoroquinolones
Roohi B. Obaid
Karachi, Jan 2019
Data Speaks; What We Missed

2. Safety Alert - Fluoroquinolones
Data speaks what we missed
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 also gain
attention to review the original and old data with
emerging dawn. It is now about four decades
when Fluoroquinolone (FQ) an antibiotic 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 FQ 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 as well as abuse by
the society due to weakness in prescription
control and pharmacy services in the
community. Billions of rupees per year are being
paid by the Pakistanis on FQ, it’s time to assess
balance what we experienced and at what cost. If
someone compares the utilization of this class of
drugs with the reference countries from
where drugs have been originated,
it will safely reveal up to ten-
fold or even greater
difference. 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 countervailing trends in terms of
utilization and reporting of associated harmful
events, while the same leading corporate
Billions of rupees per
year are being paid
by the Pakistanis on
FQ, it’s time to assess
balance what we
experienced and at
what cost.

3. companies are working here and outside
Pakistan simultaneously under one management.
This is not only strange as far as moral corporate
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 Dec 2018, the United States-Food
and Drug Administration (US-FDA) updated
about a rare but increased risk of rupture in the
aorta with Fluoroquinolone (FQ) antibiotics. The
aorta is the largest artery in the body. If it swells
more than 1.5 times the normal size, it is Aortic
Aneurysm. This condition may lead to
dangerous bleeding and even death. In one lac
people FDA estimated about 9 aortic aneurysms
in the general population and about 300 aortic
aneurysms in the high risk individuals such as
patients of hypertension or peripheral
atherosclerosis vascular diseases etc.
Experience of sudden and severe constant pain
in the stomach, chest or back upon taking the FQ
requires immediate medical attention because
aortic aneurysm does not show up until swelling
becomes large or bursts. FQ are being used for
the last several decades as a drug of choice and
antibiotic of interest among general physicians.
The blind use in Pakistan may be judged by
comparing the utilization record of Pakistan with
other countries of origin. If someone goes deep
to calculate impact based on established data, it
will undoubtedly conclude that thousands of
patients per year died because of aortic ruptures.
There is no sound of death and the same can be
avoided by influencing through safety alerts,
regulations and effective enforcement.
In July 2018 FDA had 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
or she 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 include 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 should
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 information, data and reporting
experiences to conclude particularly 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
FQ. 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
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

4. 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 FQ 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
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 FQ. More than a
billion rupees is being paid by the consumer on
FQ. Hundreds of brands are freely available in
Pakistan and extensively used without
appropriate supervision. FQ 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 indeed
modern indicators to judge nation’s strength and
moral. We have to work ourselves and no one
will come to rescue us.
Reference: United States Food and Drug Administration (US-FDA).
Author may be reached at rooahama@gmail.com.
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
Hundreds of brands are freely
available in Pakistan and extensively
used without appropriate supervision.
FQ include Levofloxacin, Ofloxacin,
Ciprofloxacin, Gemifloxacin,
Moxifloxacin, Norfloxacin, etc.