Problems from Levaquin, Cipro Linked To Persistent Adverse Events: ISMP

A recent report issued by the Institute for Safe Medication Practices (ISMP) highlights the risk of persistent and long-term health problems from Levaquin and Cipro, indicating that many adverse event reports submitted to the FDA last year involved individuals disabled by side effects of the popular antibiotics.

In the group’s QuarterWatch report (PDF) issued last week, which analyzed FDA adverse event reports submitted in 2015 for all prescription medications, ISMP indicates that the antibiotics Levaquin and Cipro were linked to more reports of persistent side effects than any other drug.

In about 65% of the reports, the patient was disabled by the side effects of Levaquin or Cipro, highlighting the need for recent FDA warnings that indicate the risks associate with the drug outweigh the benefits provided in treating many of the uncomplicated infections they have been used to treat in recent years.

Levaquin and Cipro are part of a widely used class of antibiotics, known as fluoroquinolones, which also includes Avelox and others. Millions of prescriptions for the antibiotics are filled each year, despite side effects that may cause permanent nerve damage, tendon ruptures, heart problems, skin problems, vision problems and aortic injuries.

The ISMP reports that there were 489 cases of persistent adverse side effects linked to the use of Levaquin that were reported to the FDA last year, and 366 cases of persistent adverse effects linked to Cipro. In this case, persistent effects is defined as those effects that continue even after the patient has stopped taking the drug.

“The primary persistent injuries reported were joint, muscle, and tendon disorders and pain and discomfort associated with those conditions,” the ISMP report indicates. “These two fluoroquinolone antibiotics are widely used, with ciprofloxacin accounting for 5.9 million dispensed outpatient prescriptions in Q4 2015, and levofloxacin 3.5 million. Because antibiotics are typically used in short-term treatment, it means literally millions are exposed each year.”

The ISMP notes that the lack of reports involving generic versions of the drugs could indicate that the number of patients suffering permanent Levaquin and Cipro injuries is much higher than what has been reported. In addition, many experts say that only about 10% of drug adverse events are ever reported to the FDA, which could mean that thousands of patients nationwide who took these drugs have suffered permanent and persistent injury.

Antibiotic Side Effect Concerns

Last year, an FDA advisory hearing was held to evaluate the problems with fluoroquinolone antibiotics, including the risk of heart complications, tendon ruptures, retinal detachments and a form of debilitating nerve damage, known as peripheral neuropathy.

After evaluating the recommendations made by the advisory panel, the FDA issued a drug safety communication last month, warning that the side effects of Levaquin, Avelox and other fluoroquinolones make them too dangerous to treat uncomplicated infections, indicating that the antibiotics should only be used for those that do not have alternative treatment options.

The importance of this warning is highlighted by the fact that the FDA statement and advisory panel did not include an evaluation of recent data that suggests users face also an increased risk of suffering an aortic aneurysm or aortic dissection while using Avelox, Levaquin or another fluoroquinolone.

In recent years, thousands of Levaquin lawsuits, Cipro lawsuits and Avelox lawsuits and have been filed by individuals throughout the United States who have suffered debilitating injuries while using the medications, including peripheral neuropathy and tendon ruptures. The complaints allege that the drug makers failed to adequately warn about the risks associated with the medications, withholding information from consumers and the medical community.

With the emergence of recent new risk information, potential aortic aneurysm lawsuits and aortic dissection lawsuits are also being pursued by lawyers for individuals and families of those who may have died after using a fluoroquinolone antibiotic.

The lawsuits allege that individuals throughout the U.S. were unnecessarily exposed to the serious health risks due to fluoroquinolone antibiotics, indicating that the drug makers placed their desire for profits before consumer safety by promoting the drugs for a variety of common infections, while failing to warn about the risk of aortic aneurysm, aortic dissection, peripheral neuropathy and other problems.