The U.S. Food and Drug Administration (FDA) believes the fluoroquinolone antibiotic gemifloxacin mesylate—sold as Factive—might cause nerve damage and tendon injuries.
What Is Factive and What Is It Prescribed For?
Factive is a member of the fluoroquinolone class of antibiotics, which the FDA approves for the treatment of chronic bronchitis and pneumonia. Made and sold by Cornerstone Therapy, the FDA approved Factive in 2003, and it comes in the form of oral tablets, injectable solutions, and topical formulations applied to the ears and eyes.
According to its label, Factive works by inhibiting DNA synthesis in bacteria and is bacteriacidal.
Factive Might Cause Dangerous Side Effects
According to its drug label, Factive might cause the following adverse side effects:
- Tendon rupture
- Myasthenia gravis (muscle weakness)
- QT prolongation (unusual heart rate fluctuations)
- Central nervous system disorders (tremors, restlessness, lightheadedness, and confusion)
- Hypersensitivity reactions (loss of consciousness and cardiovascular collapse)
- Life-threatening skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome)
- Clostridium difficile associated diarrhea (diarrhea caused by overgrowth of the bacterium C. difficile)
- Peripheral neuropathy (pain, burning, tingling, numbness, and nerve damage)
FDA warnings associated with Factive and other fluoroquinolone antibiotics have become more common over time. In 2008, the agency added a black box warning, the most serious type of alert, to Factive’s label to advise the public that Factive use is associated with tendon rupture. Patients over 60, those taking corticosteroids, and patients who have undergone a transplant are the most likely to suffer from a tendon rupture. Sometimes tendon problems can occur long after patients have ceased taking Factive.
In August 2013, the FDA issued a drug safety communication advising the public that it was requiring a label-change to Factive and other fluoroquinolone antibiotics to “better describe the serious side effect of peripheral neuropathy,” which can occur soon after Factive treatment begins. It is associated with oral and injectable fluoroquinolones but not topical formulations of the drugs that are applied to the eyes and ears.
RLG’s Factive Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Factive lawsuit on your behalf if necessary. RLG will also keep you up to date on any Factive class action lawsuits, additional FDA Factive warnings, and Factive FDA recall announcements. If you have taken Factive and believe it harmed you, contact RLG today.