Trovan is the trade name for trovafloxacin, an antibiotic that was once used to treat a wide variety of bacterial infections. It was sold under the name “Trovan” by Pfizer and as “Turvel” by Laboratorios Almirall. It is a broad-spectrum antibiotic, which means it was designed to treat various bacterial infections.
Currently, the drug is not approved for use in the U.S. or the European Union due to its association with cases of acute liver failure, which led to liver transplants and death in some patients. It was withdrawn from the market due to the risk of hepatotoxicity, which is chemical-driven liver damage.
Did Trovan Have the Same Side-Effects as Other Fluoroquinolones?
Trovan was in the class of antibiotics known as fluoroquinolones. Fluoroquinolones are a controversial category of antibiotics. In May 2016, a drug safety communication from the federal Food and Drug Administration (FDA) advised that fluoroquinolones should only be prescribed for certain infections and only if no other treatment options were available.
This warning was necessary due to potentially permanent, disabling side effects. The drug safety communication also notified the public that labeling updates were required to reflect this new safety information.
The FDA approved changes to the safety labeling for fluoroquinolones to improve warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections.
While fluoroquinolones are an effective treatment for serious bacterial infections, an FDA safety review found they are associated with side effects involving tendons, muscles, joints, nerves, and the central nervous system. These side effects might cause a person to become disabled. These side effects can manifest within hours of taking the medication or may not appear for weeks after taking fluoroquinolones. Moreover, they are potentially permanent.
Trovan was not associated with the damaging side effects of other fluoroquinolones, e.g., ruptured tendons, muscles, joints, nerves, and the central nervous system. Rather, Trovan’s problem was toxicity to the liver.
Generally, the risk of these serious, negative side effects from fluoroquinolones outweigh the benefits for patients with bacterial sinusitis, an acute episode of chronic bronchitis, and ordinary urinary tract infections, and the FDA has determined that fluoroquinolones should be used to treat these conditions only in patients with these conditions who have no alternative treatment options.
The fluoroquinolones that are still on the market are ciprofloxacin, sold under the trade name “Cipro,” gemifloxacin, sold under the trade name “Factive,” levofloxacin, sold under the trade name “Levaquin,” moxifloxacin sold under the trade name “Avelox,” and ofloxacin sold under the trade name “Floxin.”
What Is the History of Trovan?
The FDA approved trovafloxacin for the treatment of patients in December 1997. It was approved only for people aged 18 years and older. Patients suffered liver toxicity within months after the drug first became available. In 1998, the FDA asked Pfizer to add information about possible liver toxicity in the information provided in each Trovan package.
In June 1999, the FDA advised doctors to limit the prescription of trovafloxacin due to adverse side effects associated with the drug. There were over 100 cases of acute liver injury reported to the FDA. In May 2000, the FDA withdrew the authorization to market trovafloxacin altogether.
Trovafloxacin received marketing authorization from the European Union (EU) in October 1998. In June 1999, in light of the reports of adverse events, the Committee for Proprietary Medicinal Products recommended the suspension of the marketing authorization for a year. The suspension took effect in August 1999. It was renewed in September 2000. Subsequently, Pfizer voluntarily withdrew the Trovan from the market in the EU.
Trovan sales during its first full year on the market contributed $160 million to Pfizer’s total revenue. Investors expected it to eventually bring in $1 billion per year from Trovan sales. Of course, this expectation led to disappointment when Trovan had to be withdrawn from the market.
What If I Have Been Injured by Trovan
Whether Trovan can injure a person is questionable, as the drug was withdrawn from the market in 2000. It is not available in European Union member nations either. So, a person should not be able to take Trovan now.
If a person believes they were injured by taking Trovan, they would want to consult a personal injury attorney immediately. There would be several issues that an attorney would have to sort out before they would be able to file a lawsuit seeking damages.
If a person took Trovan before it was taken off the market, the main issue would be the statute of limitations. A statute of limitations is a time limit that the law places on filing lawsuits. Each state has its own statutes of limitations for different types of lawsuits.
For example, if a person were to file a lawsuit for medical malpractice against a physician who prescribed Trovan or a pharmacist who supplied a person with Trovan, they would have to work with the statute of limitations for the state in which they file their lawsuit.
In California, the statute of limitations for a medical malpractice suit is whichever is first, three years after the injury, or one year after discovery. This means that even if a person only discovered that Trovan was the cause of their liver damage within the past year, their lawsuit would probably be blocked by the three years after-injury rule. Presumably, their injury would have occurred at a time that was more than three years ago. Basically, a person cannot bring a lawsuit for medical malpractice more than three years after the injury occurred.
Another option would be a strict product liability lawsuit against the manufacturer of Trovan for failure to warn of the dangerous side effects. California’s statute of limitations for a lawsuit for failure to warn is generally two years from when a person suffered the injury.
If a person does not discover their injury until a later time, they can file for up to one year after the discovery of their injury if the following applies:
- The victim did not have knowledge that would have alerted a reasonable person to suspect that they had suffered an injury due to an inadequate warning related to their medication; or
- A reasonable and conscientious investigation would not have led the person to understand that a warning defect related to their medication had contributed to their injury.
Proving that it was reasonable for a person not to have understood that inadequate warning about the negative effects of Trovan had led to their injury for so many years would be challenging.
In addition, if the person somehow obtained Trovan even though it should no longer be available by prescription from pharmacies, explaining how the person came to possess Trovan might present yet another problem. The situation would raise the possibility that the person came into possession of Trovan through some illegal transaction. Again, dealing with this issue would be challenging at best.
Do I Need the Help of a Lawyer for My Trovan Issue?
If you think that you have been injured by taking Trovan or any other antibiotic that is classified as fluoroquinolone, you want to consult with a class action attorney at your earliest possible convenience.
As noted above, in the case of Trovan, it is no longer on the market, so dealing with this issue would be a significant legal challenge. As for other fluoroquinolones, the issues are different and more straightforward. An experienced lawyer should be able to determine your options and guide you to the one that best protects your rights.
