Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

Data Speaks; What We Missed

Underline Threat of Aorta Rupture

  • Be the first to comment

Data Speaks; What We Missed

  1. 1. Safety Alert Fluoroquinolones Roohi B. Obaid Karachi, Jan 2019 Data Speaks; What We Missed
  2. 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. 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. 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.

    Be the first to comment

    Login to see the comments

  • drasra1

    Feb. 23, 2019

Underline Threat of Aorta Rupture

Views

Total views

219

On Slideshare

0

From embeds

0

Number of embeds

1

Actions

Downloads

3

Shares

0

Comments

0

Likes

1

×