Research shows the antibiotic moxifloxacin—sold under the brand name Avelox or Avalox (or Avelon [oral solution] and Vigamox [eye drops])—causes liver disorders, Stevens-Johnson Syndrome and tendon injuries.
What Is Avelox? When Is It Prescribed?
Avelox is a brand name for the drug moxifloxacin hydrochloride. Developed by German pharmaceutical giant Bayer AG, it is also marketed by Bayer’s partner Schering-Plough Corporation. This prescription medication is used to treat bacterial infections, but only in limited circumstances after other antibiotics have failed. Avelox is a drug of last resort because it interacts with other drugs and even herbal supplements.
Bayer first patented moxifloxacin in 1991, but it took the FDA another eight years to approve the drug. Bayer intended it to replace ciprofloxacin. Avelox can be administered in three ways, most commonly by oral tablets containing 400mg of moxifloxacin. Another way is intravenous injection of 400mg moxifloxacin in 0.8% saline solution. Finally, Avelox can be administered in eye drops containing 5mg/mL of moxifloxacin. Due to its limited uses, Avelox can only be prescribed for chronic bronchitis, sinusitis, pneumonia, and certain skin conditions.
Avelox is a broad-spectrum fluoroquinolone antibiotic, meaning that it can be used against many different bacteria strains. Broad-spectrum antibiotics effectively combat undetermined life-threatening bacterial infections (such as meningitis) and symptoms caused by multiple concurrent bacterial infections. Avelox functions by disrupting DNA replication and cell division within bacteria. The drug is expensive and there are many cheaper and more effective antibiotics available.
Bayer’s Avelox sales revenue in 2007 was $697.3 million worldwide, and the drug still brings Bayer roughly $500 million per year. Since it entered the market, though, controversies have eroded consumer confidence in Avelox. In July 2008, the FDA placed a “black box” warning, the agency’s most serious alert, on Avelox, but there are no known efforts to effect an Avelox recall or to ban the drug.
Avelox Might Cause Life-Threatening Side Effects
In October 2008, the U.S. Food and Drug Administration (FDA) required Bayer to include a warning on Avelox packaging to inform the public of side effects the drug causes. Avelox is known to cause liver disorders, and like many other fluoroquinolones, Avelox use correlates to muscle injuries, especially in tendons, the tissues that binds muscles together. It can also cause a horrible life-threatening skin condition known as Stevens-Johnson Syndrome.
Bayer informed European doctors in “Dear Doctor” letters that Avelox could cause severe liver damage with symptoms including yellowing of the skin and eyes, severe itching, dark urine, and pale-colored stool. The European Medicines Agency restricted Avelox’s uses. In March 2010, Canada followed suit.
The tendon problems caused by Avelox were not only recently discovered. To the contrary, medical studies determined that existing fluoroquinolones caused muscle disorders back in the early 1970s. The FDA did not act quickly to issue an Avelox warning. In 2005 and 2006, a consumer advocacy group, Public Citizen, and the Attorney General of Illinois petitioned the FDA to require a black box warning on Avelox. In 2008, both petitioners finally sued the FDA to require the Avelox warning, and in October of that year it finally did so.
In August 2013, the FDA issued a drug safety communication advising the public that it was requiring a label change to Avelox and other fluoroquinolone antibiotics to “better describe the serious side effect of peripheral neuropathy,” which is the medical term for potentially permanent nerve damage. Peripheral neuropathy can occur soon after Avelox 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.
Some fear that Avelox is over-prescribed and is now no longer effective because bacteria have developed resistances to it. Indeed, fluoroquinolones are among the most prescribed antibiotics in the United States, even though the FDA requires that they be used only as a therapy of last resort. Frequently, they are even used for conditions for which they aren’t approved.
RLG’s 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 an Avelox lawsuit on your behalf if necessary.
If you have taken Avelox and believe it harmed you, contact RLG today.