Levaquin Side Effects Make It Unusable For Preventing Kidney Transplant Infections: Study

The antibiotic Levaquin is likely unsuitable for preventing the BK virus following kidney transplant operations, according to the findings of a recent study. 

Canadian researchers reported in the Journal of the American Medical Association (JAMA) that the side effects of Levaquin and potential adverse events, including the development of antibiotic resistant bacteria, indicate that risks associated with use of the popular antibiotic treatment to prevent the BK virus outweigh the potential benefits.

The BK virus is a common problem linked to the use of drugs that suppress the immune system among kidney transplant patients. These drugs prevent the body from rejecting the new kidney as foreign tissue, but they also lower the body’s defenses against other viruses, like BK viruria, which is often linked to transplant failure.

Researchers from the University of Ottowa and a number of other Canadian hospitals and universities looked at whether Levaquin, a popular antibiotic, could be used to shore up patients’ defenses against BK virus infections. However, they determined that a three-month course of Levaquin would be necessary, which could lead to a number of adverse events.

The researchers conducted a double-blind, placebo-controlled clinical trial involving 154 kidney transplant patients. About half were given Levaquin for three months, starting five days after their transplant operation. The other half were given a placebo for that time period.

However, BK virus infections occurred in 29% of the patients given Levaquin, and 33% of the patients given a placebo. The researchers determined that the effects of the therapy were too small to recommend the drug’s use, particularly considering that they detected an increased risk of resistant infections in the Levaquin group concerning bacteria that was usually susceptible to the drug, suggesting that they were becoming Levaquin resistant over time. Levaquin is usually only prescribed for about 10 days to treat most infections.

“Among kidney transplant recipents, a 3-month course of levofloxacin initiated early following transplantation did not prevent BK viruria. Levofloxacin was associated with an increased risk of adverse events such as bacterial resistance,” the researchers concluded. “These findings do not support the use of levofloxacin to prevent posttransplant BK virus infection.”

Levaquin Nerve Damage Risks

The study comes amid increasing concern over the side effects of Levaquin and other fluoroquinolone antibiotic drugs, which have been linked to a risk of severe and permanent nerve damage, known as peripheral neuropathy.

Other members of this popular class of antibiotics include Cipro, Avelox and other medications. However, Levaquin has been the best-selling fluoroquinolone in recent years, generating over $1.3 billion in annual sales before generic versions became available in 2011.

In 2013, the FDA issued a drug safety communication to announce that it is requiring the manufacturers of Levaquin and other fluoroquinolones to change their warning labels about the risk of peripheral neuropathy problems, providing warnings for the first time that symptoms may continue for months or even years after an individual stops taking the drug.

While prior warnings suggested that it was rare of users to suffer a Levaquin neuropathy injury and that the problems often resolve once the medication is no longer used, fluoroquinolone antibioitics have actually been linked to a large number of reports involving permanent and disabling nerve damage that may last the rest of a user’s life.

In 2014, a study published in the medical journal Neurology added further support for these warnings, indicating that side effects of Levaquin and other fluoroquinolones may double the risk of peripheral neuropathy.

Researchers recommendeded that doctors more carefully weigh the risks and benefits of Levaquin and other fluoroquinolones when prescribing them to patients for less severe infections or conditions, suggesting that many former users may have been able to avoid Levaquin neuropathy if stronger warnings had been provided in the past.

Given the widespread use of the medication, many peripheral neuropathy lawsuits are being reviewed by lawyers, with many expecting that several thousand cases will be filed over the coming months and years.