Are Levaquin Warnings Getting to the Patient?

December 13, 2011, 10:30AM. By Gordon Gibb

Trenton, NJIn October, a jury in State Court of New Jersey ruled in favor of the defendant in a levaquin lawsuit, finding that Levaquin manufacturer Johnson & Johnson (J&J) had provided adequate warnings about the risks associated with the flouroquinolone antibiotic.

However in an investigative report aired in June on the PBS NewsHour, Dr. Ray Woosley noted that a black box warning of the kind that has been recently assigned to Levaquin by the US Food and Drug Administration (FDA) is in actual fact intended to inform the prescribing physician, not the patient.

While the patient guides that are required for some medications are worded at the layperson level, says the pharmacologist and internist who heads up the nonprofit Critical Path Institute in Tucson, "…it's two, totally different types of information. And, many times, the serious warnings that the doctor is informed of may not be in the patient information."

J & J may have won the levaquin side effects lawsuit in New Jersey alleging levaquin tendon ruptures. However, the manufacturer of the powerful and potent antibiotic faces about 2,000 more lawsuits brought by disgruntled and injured patients across the country.

One of those alleged victims of Levaquin is Jenne Wilcox, a young mother and former first-grade teacher who had to give up her job and was suddenly bedridden after taking Levaquin prescribed to her following routine sinus surgery. According to an interview on The NewsHour in June, Wilcox initially developed severe pain in her joints and muscles??"issues that grew worse even after she stopped taking Levaquin.



It wasn't long before she could no longer walk. Effectively bedridden for two years, she has improved in recent years to the point where she can handle physical therapy three times a week with the help of her husband. She still endures levaquin muscle pain.

However, her doctor cannot say if Jenne Wilcox will ever improve to the point where she can go back to work and lead a relatively normal life. The young mother and teacher had to quit her job, and the loss of her income cost the Wilcox family their home.

John Fratti, a another levaquin medication victim who now works part-time as a consumer advocate for the FDA, noted in the PBS NewsHour interview that he has lost hundreds of thousands of dollars in lost wages due to his Levaquin issues??"not to mention thousands of dollars in out-of-pocket medical bills stemming from his disability following a round of the Levaquin antibiotic.

Doctors interviewed in the NewsHour segment noted that levaquin medication is an extremely powerful and effective drug that was designed to treat the most serious infections??"and thus, any risks associated with the drug, in such context, would be the lesser evil when compared with those associated with a serious infection going unchecked. However, there are those who feel Levaquin is being over-prescribed, likening the use of levaquin medication to using cannon fire to kill a mosquito.

What's more, drugs are initially tested on a small group of patients with a certain set of criteria. A drug testing well against such tightly controlled criteria is then released to the public at large, without really knowing the true impact a drug would have on the wider population.

Further, the adverse reaction database maintained by the FDA is considered antiquated and outdated, with a potential 10 percent of actual adverse reactions making their way to the FDA. That suggests that 90 percent of adverse reactions go unreported.

The jury in New Jersey felt that warnings on levaquin medication were sufficient to inform the two plaintiffs who claimed levaquin tendon problems. It is not known if the plaintiffs will appeal.

As for Jenne Wilcox, she is still waiting to get her life back after experiencing levaquin side effects. Meanwhile a viewer posting in the "Comments" section of the NewsHour website urged, "Don't wait like I did! File a levaquin lawsuit NOW!"