Hundreds of people across Canada have sustained tendon injury as a result of taking a popular prescription medication called Levaquin.
Levaquin is a prescription antibotic generally prescribed for the treatment of numerous bacterial infections. Many people use Levaquin to help combat ear infections, bronchitis, pneumonia and chlamydia. Levaquin is a fluoroquinolone antibiotic. It is concentration-dependent, so bacteria are killed most efficiently when the right amount of medicine is absorbed into the body.
Levaquin is the most prescribed fluoroquinolone antibiotic in the world. The drug is a product of Johnson and Johnson. It was approved by Health Canada in 1997 for the treatment of bacterial infections in adults.
Since that time, a growing number of injuries have been reported. In fact, over 450 reports of injury have been submitted to Health Canada in association with Levaquin. Many of these complaints relate to tendon ruptures and related injuries. The FDA has received notice of even more complaints. According to the FDA database: at least 262 reported case of tendon ruptures have been reported, 274 cases of other tendon disorders, 259 cases of tendonitis, and 61% of these tendon ruptures were caused by Levaquin.
Although prior epidemiological studies indicated that Levaquin was associated with an increased risk of tendonitis and tendon rupture, the drug manufacturers chose not to adequately warn the public and the consumers of this risk. Ultimately, they were forced to.On July 8, 2008, the FDA ordered the manufacturers to add a Black Box warning to Levaquin. A Black Box warning is the strongest warning available for prescription drugs. These blackbox warnings apply to pills, tables, capsules and injectable formulas. The FDA also required that a guidebook be provided to patients warning about the possible side effects.
A black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is named for the black border that usually surrounds the text of the warning. A black box warning will typically indicate that medical studies reveal that the drug carries a significant risk of serious or even life-threatening adverse effects.
A black box warning is the most severe and urgent warning possible. Through its mandatory black box warning, the FDA declared that the evidence suggested that use of Levaquin could lead to tendon rupture and other similar injuries. The FDA also claimed that these types of injuries could lead to extensive surgery to repair.
This type of warning was necessary because the manufacturers and distributors of Levaquin had previously decided to «hide» any caution within the small print of an exceedingly long Levaquin label. Compared to the severity and probability of the injuries, this was felt to be an inadequate warning to both doctors and patients.
Patients and their doctors must be able to rely on drug manufacturers to provide fair and adequate warnings on any safety issues associated with the use of the drug. It is only when all risks are sufficiently disclosed that a patient can make a proper determination of whether to take the drug.
In the pharmaceutical business, sometimes full disclosure will take a back seat to the pursuit of higher profits. When this happens, the patients and consumers suffer. Wagners Law Firm has commenced a class action lawsuit against the manufacturers and distributors of Levaquin. The class action seeks to include all Canadians who have been harmed by the drug and the defendants’ choice to provide inadequate warnings in the face of known risks.
The purpose of the class action is two-fold: provide an efficient means of providing justice for those wronged by the wrong-doings of the pharmaceutical companies and promote behaviour modification by holding these companies accountable.