 |
answer text |
<p>The Yellow Card Scheme is the system used in the United Kingdom for reporting adverse
drug reactions (ADRs). This acts as an early warning system for the identification
of previously unrecognised adverse reactions and also provides valuable information
on recognised ADRs, allowing the Commission on Human Medicines and Medicines and Healthcare
products Regulatory Agency (MHRA) to identify and refine the understanding of risk
factors that may affect the clinical management of patients.</p><p> </p><p>The following
table shows spontaneous suspected ADR reports for fluoroquinolones in association
with tendon injury, mitochondrial dysfunction and oxidative stress to 25 May 2021
in the UK.</p><p> </p><table><tbody><tr><td><p>Reaction</p></td><td><p>Number of reports</p></td></tr><tr><td><p>Tendon
disorders*</p></td><td><p>1,381</p></td></tr><tr><td><p>mitochondrial cytopathy, mitochondrial
toxicity, mitochondrial myopathy acquired</p></td><td><p>1</p></td></tr><tr><td><p>Oxidative
stress</p></td><td><p>2**</p></td></tr></tbody></table><p> </p><p>Source: MHRA Sentinel
database for Adverse Drug Reactions.</p><p> </p><p>Notes:</p><p> </p><p>*Tendon disorders
includes 21 different relevant reaction terms.</p><p>**These reports are duplicates
and have been subsequently merged on the database.</p><p> </p><p>The frequency of
tendonitis range from 1 in 100 to less than 1 in 10,000, depending on the specific
fluoroquinolone medicine. For the products that provide an estimate of the frequency
of tendon rupture, this is listed as less than 1 in 10,000. Mitochondrial dysfunction
and oxidative stress are among the possible mechanisms that might lead to tendon injury
or other ADRs caused by fluoroquinolones, but this association is not fully understood
and mitochondrial dysfunction and oxidative stress are not listed as ADRs in the product
information for fluoroquinolones.</p><p> </p><p>The MHRA continues to review information
about the safety of all medicines, including fluoroquinolones, and will take appropriate
regulatory action as appropriate on the basis of new safety information. Serious side
effects of fluoroquinolone antibiotics can be varied, potentially affecting several
different parts of the body. An assessment of the potential merits of fluoroquinolone
toxicity as a clinical diagnosis in response to tendon injury, mitochondrial dysfunction
or oxidative stress has not been made.</p>
|
|
