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Chapter 25 : Adverse Effects

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Abstract:

The fluoroquinolone class of agents has been plagued by a number of compounds that have undergone an extensive clinical evaluation and have achieved distinctive clinical results but were not introduced into the market because of unacceptable safety and tolerability. Sparfloxacin use was severely curtailed because of associated phototoxic effects and cardiotoxicity. Grepafloxacin was also removed from the market shortly after its introduction because of cardiotoxicity. Fluoroquinolones presently marketed, or those that are in the final stage of clinical trials, seem to be well tolerated, with average adverse event rates of 20 to 30% for most compounds that are not significantly different from those of cephalosporins. Bone marrow cells are the most rapidly dividing eukaryotic cells, and therefore, considered most susceptible to agents affecting DNA synthesis. Ciprofloxacin, enoxacin, levofloxacin, nalidixic acid, ofloxacin, pipemidic acid, and N1-cyclopropyl quinolones were capable of inducing micronuclei in in vitro assays of mouse bone marrow cells. Allergic interstitial nephritis (AIN) is thought to be the most common form of fluoroquinolone nephrotoxicity and is attributed to a type III hypersensitivity reaction. Fluoroquinolones are usually well tolerated with a minimum of serious adverse effects, and renal toxicity is uncommon. Desensitization to ciprofloxacin in a patient with a prior history of maculopapular rash was attempted successfully. In summary, antibiotic treatment, in general, can lead to vaginitis induced by Candida in a frequency varying between 0.5 and 8%.

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Quinolone structure-side effect relationships. Modified from reference with permission.

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Tables

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Table 1

Serious fluoroquinolone-associated adverse events leading to drug withdrawals, severe restrictions, or suspensions from the market

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Table 2

Overall incidence of fluoroquinolone-associated adverse events

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Table 3

Overall incidence of adverse events associated with fluoroquinolones (U.S./European data)

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Table 4

Drug discontinuation rate of new fluoroquinolones due to adverse events

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Table 5

Post-launch adverse reaction spontaneous reporting to the FDA (levofloxacin/trovafloxacin)

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25
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Table 6

Skin rashes (%) associated with fluoroquinolones

Citation: Lode H, Rubinstein E. 2003. Adverse Effects, p 407-419. In Hooper D, Rubinstein E (ed), Quinolone Antimicrobial Agents, Third Edition. ASM Press, Washington, DC. doi: 10.1128/9781555817817.ch25

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