Antibiotics rank high among the drugs that can cause liver damage. Of these, it’s been noted that “fluoroquinolones are among the most widely prescribed antibiotic agents in North America.” As prescriptions for these drugs continue to climb, adverse effects have surfaced, such as liver injuries like hepatotoxicity and renal failure, and Stevens Johnson Syndrome (SJS).

The most well known and widely prescribed antibiotics in the quinolone family are Cipro (ciprofloxin), Levaquin (levofloxacin) and Avelox (moxifloxacin), but they are not the only ones out there. One of the lesser known is Trovan.

Created by Pfizer in the late 90s, Trovan hit the market in February 1998 with a full marketing campaign. All companies have a goal for growth, and this product for Pfizer was no different. Hundreds of millions were spent developing and marketing the drug, and doctors were prescribing it to close to 300,000 patients a month. Not soon out of the gate, Wall Street analysts were betting that Pfizer could generate up to $1 billion in sales in a year off Trovan. But one year later tragedy struck.

In the drive to put out a blockbuster drug and appease stockholders, Pfizer’s clinical trials for Trovan suffered. According to an article in The New York Times, “To maximize Trovan’s potential, Pfizer had conducted clinical studies — enough so that regulators had approved Trovan for 14 different uses, the largest number ever for a drug’s initial approval.” A million prescriptions were written for a number of uses, but “serious possible side effects that were never apparent in clinical trials surfaced quickly when the drug was prescribed widely.”

Quinolone side effects are allegedly underwarned, and many weren’t even known when Trovan came to market. But just months after Trovan was released, patients began reporting that they were suffering liver toxicity. By June 9, 1999, over 100 reports of liver problems had been submitted. The U.S. Food and Drug Administration (FDA), which had already asked Pfizer to update the label with warnings of liver toxicity in July 1998, now warned doctors that Trovan should only be used in hospitals and only in rare cases. Regulators pulled the drug off pharmacy shelves, and Pfizer followed up with letters to doctors and pharmacies explaining the restrictions, but not everyone received the news in time. By the time it came off the shelf, at least 14 people taking Trovan had suffered acute liver failure, six of whom died.

Quinolone Risks

Fluoroquinolones are a family of antibiotics used to treat a variety of bacterial infections, including pneumonia, bronchitis, conjunctivitis and urinary tract infections. However, these drugs are also prescribed in cases where antibiotics don’t help.

Various studies have looked at the impact of quinolones. Generally well-tolerated, serious adverse reactions have also been noted. The host of possible side effects from these medications include liver damage, peripheral neuropathy, Stevens Johnson Syndrome (SJS) and it’s more severe cousin toxic epidermal necrolysis (TEN), intestinal cramping and infections, and psychotic reactions. Quinolones have also been linked to tendonitis and tendon rupture.

Quinolone lawsuits and quinolone class action lawsuits allege that the warning labels on these antibiotics minimized the risks associated with the drug. Moreover, many plaintiffs allege that the fluoroquinolone manufacturers knew of the risks and failed to provide consumers and medical professionals with sufficient warning.

One of Pfizer’s top scientists at the time of Trovan, Dr. John F. Niblack, said there are risks associated with all drugs. He asked, “What if a medicine helped 9,999 people, but hurt one? … What risks are we willing to accept?” That is a question that will be addressed in courtrooms around the country.