Antibiotic Label Updates Made After Decades

The antibiotic class fluoroquinolones were developed for serious infections; however, they’re frequently prescribed for less severe conditions as well. Now, after more than 30 years on the market, recent research suggests they can lead to dangerous health complications. As a result, drug labels are receiving updates to reflect the new safety information.

Antibiotics Get Label UpdatesOftentimes when people get sick or have an infection, an antibiotic is prescribed to ease pain and treat the health condition. But what happens if an antibiotic causes more harm than good?

The antibiotic class fluoroquinolones was developed for serious infections, such as hospital-acquired pneumonia and other dangerous bacterial infections. However, they’re frequently prescribed for less serious viruses such as sinusitis, bronchitis and other conditions that can be remedied with less potent drugs.

Topping billions of dollars in sales each year, the most commonly prescribed fluoroquinolones on the market are:

  • Ciprofloxacin (Cipro)
  • Gemifloxacin (Factive)
  • Levofloxacin (Levaquin)
  • Moxifloxacin (Avelox)
  • Ofloxacin (Floxin)

While these antibiotics have been around for more than 30 years, new studies suggest they can lead to severe or even life-threatening health complications.

Are Fluoroquinolones Overprescribed?

Overprescribing of FluoroquinolonesAccording to the Centers for Disease Control (CDC), an estimated 50 percent of fluoroquinolone prescriptions are ineffective. That accounts for more than 20 million people every year. This is because a large number of prescriptions are written for patients seeking care for a common cold, flu or other infections caused by viruses that do not respond to antibiotics.

Other medical organizations, including the Infectious Diseases Society of America, advise against using fluoroquinolones for minor illnesses. Nevertheless, many doctors continue to prescribe them since they’re known to fight a wide variety of bacteria. Unfortunately, this practice may ultimately lead to overprescribing – putting lives in danger of serious side effects and life-threatening conditions.

What Makes Fluoroquinolones Dangerous?

A central part of fluoroquinolones, fluoride allows the drug to penetrate into sensitive tissues around the body – including the brain. It can also cause significant damage to a person’s immune system by draining energy and preventing antibodies from forming.

Other side effects associated with the use of fluoroquinolones include:

  • Retinal detachment
  • Hallucinations
  • Blood disorders
  • Kidney or liver damage
  • Irregular heart rhythms
  • Digestive problems
  • Depression
  • Tendon issues

Numerous reports rank levofloxacin and ciprofloxacin – both fluoroquinolones – in the top five drugs causing serious, adverse events as submitted to the FDA. Additionally, another study found more than 100,000 complaints from Levaquin consumers relating to the drug’s harmful side effects, including ruptured tendons, nerve damage, confusion and violent vomiting.

FDA Safety Message On Fluoroquinolones

In May 2016, the FDA issued a warning advising the public about the adverse effects associated with fluoroquinolone antibacterial drugs. The warning advises patients with sinusitis, bronchitis and uncomplicated urinary tract infections to look into alternative treatment methods. For these conditions, the harmful side effects linked to fluoroquinolones generally outweigh any benefits.

The agency released the new information after a safety review found that fluoroquinolones can cause disabling and potentially permanent side effects that affect the tendons, muscles, joints, nerves and central nervous system.

As a result of the recent findings, the FDA is requiring all fluoroquinolone antibacterial drug labels to be updated to reflect the new safety information.

Legal Action Against Fluoroquinolones

Manufacturers of fluoroquinolone drugs are now facing thousands of lawsuits that allege there was a lack of adequate warnings about their serious effects. Many consumers also claim that dangerous drugs stayed on the market because of corrupt practices between doctors and pharmaceutical companies.