In the September 2013 edition of Drug Safety, an article was published outlining the increased risk for tendon injury in patients taking a fluoroquinolone antibiotic in combination with a corticosteroid. Researchers sought to, “…determine the strength of the association between fluoroquinolone use and tendinopathy, and to identify risk factors for this complication.”
Fluoroquinolones (Avelox, Cipro, Factive, Floxin, Levaquin, Noroxin, Ocuflox, Quixin, Vigamox) are a class of antibacterial drugs indicated for the treatment of a variety of infections. Corticosteroids are administered alone or in combination with other medications to treat inflammation and other conditions where the adrenal glands produce insufficient amounts of steroids hormones.
Results from 16 studies examining tendonitis and tendon rupture with use of fluoroquinolones were analyzed. Five studies observed specifically Achilles tendon effects, and found that patients taking fluoroquinolones were at increased risk for Achilles tendon rupture in the first month after exposure to such medications. Another 5 studies found that patients taking oral corticosteroids concomitantly with fluoroquinolones were at increased risk for developing tendon injury compared to patients undergoing fluoroquinolone monotherapy. This interaction varied with administration of different fluoroquinolones.
Findings published earlier this year by the Mayo Clinic stated that almost 70% of Americans are taking prescription drugs, and that more than 50% of Americans take more than one medication. The report also listed antibiotics as the most commonly prescribed drug class. This information combined with the evidence of joint medication use described above highlights the importance of drug interactions, and the need to further study such relationships.
RxScore is a proprietary algorithmic scoring model based predominantly on post-marketed safety data from over five million FAERS reports. RxScore is presented on a 100-point scale meant to reflect both the breadth and seriousness of side effect(s) by incorporating nine differentially weighted categories including FAERS fields such as “Outcome,” “Event Seriousness,” “Report Type,” and “Event Reporter,” a disproportionality measure, and existing FDA warnings and DEA risk classifications. The score is also negatively adjusted by factoring in both “Condition Seriousness” and a patient’s existing comorbidities. A score of 100 indicates the highest potential adverse event risks.
Of the nine drugs evaluated by AdverseEvents that belong to the fluoroquinolone class of drugs, Levaquin (levofloxacin) has the highest RxScore. This signifies an above average level of risk compared to the other drugs in the same class.
To see the RxScores for all of the drugs in the fluoroquinolone drug class or to learn more about how RxScore supports comparative drug safety analysis, please login to AdverseEvents Explorer or contact firstname.lastname@example.org.
Fluoroquinolone antibiotics (Avelox, Cipro, Factive, Floxin, Levaquin, Noroxin, Ocuflox, Quixin, Vigamox) are indicated for the treatment of infections caused by susceptible strains of bacteria. Fluoroquinolones are broad-spectrum antibacterial drugs that prevent duplication of bacterial cells.
Using FAERS data (from 11/01/1997 to 12/31/2012), aggregated and standardized by the AdverseEvent RxFilter process, we identified 83,190 serious adverse events which listed fluoroquinolones as a suspect drug. Of these reports, 41,901 listed as the primary suspect.
The most commonly reported side effects were tendon rupture, tendonitis, and arthralgia (joint pain). We identified 11,518 hospitalizations and 2,499 patient deaths where fluoroquinolones were indicated as the primary suspect.
Note: This analysis does not take into account the number of patients taking each medication.