What’s the Problem?
Studies have found that side effects of the antibiotic medication Noroxin may include a severe form of nerve damage called peripheral neuropathy, as well as tendon ruptures, tendonitis, and aortic aneurysm / aortic dissection.
What is Noroxin?
Noroxin (generic: norfloxacin) is used to treat a variety of bacterial infections. It belongs to a class of antibiotic drugs called quinolones that work by stopping the growth of bacteria. The Japanese pharmaceutical company Kyorin Seiyaku K.K. (Kyorin) patented norfloxacin in 1979 and licensed it to Merck & Co. The U.S. Food & Drug Administration (FDA) approved Noroxin in 1986, and it comes in the form of oral tablets, injectable solutions, and topical formulations applied to the ears and eyes.
FDA Warnings on Noroxin
- In September 2008, FDA required that Noroxin labels carry a “black box” warning regarding an increased risk of tendon rupture associated with use of the drug. Patients over 60, those taking corticosteroids, and patients who have undergone a transplant are the most likely to suffer from a tendon rupture. In some cases, tendon problems can occur long after patients have stopped taking Noroxin, according to the FDA.
- FDA issued a Drug Safety Communication in August 2013 advising the public that it was requiring a label change to Noroxin and other fluoroquinolone antibiotics to “better describe the serious side effect of peripheral neuropathy,” which can occur soon after treatment with the drugs begin. Peripheral neuropathy is associated with oral and injectable fluoroquinolones but not topical formulations that are applied to the eyes and ears, according to the FDA.
- On May 12, 2016, FDA warned that the risk of disabling side effects from Noroxin and other fluoroquinolone antibiotics may outweigh their benefit for some of the most common infections. The agency is concerned that the drugs are being inappropriately prescribed for minor infections when an antibiotic with fewer potential side effects would suffice. FDA said that not only does this practice unnecessarily expose patients to a risk of severe side effects, but it contributes to the growing epidemic of antibiotic-resistant infections.
Peripheral Neuropathy Symptoms
- Change in sensation to light touch, pain, or temperature
- Change in sense of body position
- Loss of reflexes
- Muscle wasting
Aortic Aneurysm / Aortic Dissection
In November 2015, a study published in JAMA Internal Medicine found that Noroxin and other fluoroquinolone antibiotics may increase the risk of aortic aneurysm or aortic dissection by degrading collagen in patients’ bodies. Aortic aneurysm occurs when an abnormal bulge develops in the aorta, the largest artery in the human body. Dissection is characterized by a tear in the wall of the aorta.
Noroxin Side Effects
Serious side effects of Noroxin may include:
- Peripheral neuropathy
- Tendon damage / tendon ruptures
- Abdominal Aortic Aneurysm
- Aortic Dissection
- Stevens-Johnson syndrome (SJS)
- Toxic Epidermal Necrosis (TEN)
- Central nervous system disorders
- Hypersensitivity reactions
- Loss of consciousness
- Cardiovascular collapse
- Life-threatening skin reactions
- And more
1979 – Drug patented
1979 – Norfloxacin patented by Kyorin Seiyaku K.K.
Oct 1986 – Approved by the FDA
October 31, 1986 – Noroxin first approved by the FDA.
Sep 2008 – FDA warning required
September 2008 – FDA requires “black box” warning on Noroxin regarding an increased risk of tendon ruptures.
Aug 2013 – Drug Safety Communication issued
August 15, 2013 – Drug Safety Communication issued regarding an increased risk of peripheral neuropathy with Noroxin and other fluoroquinolone antibiotics.
Nov 2015 – JAMA Internal Medicine study published
November 2015 – Study published in JAMA Internal Medicine finds that fluoroquinolone antibiotics may increase the risk of aortic aneurysm and/or aortic dissection.
May 12, 2016 – FDA warns of side effect risk
May 12, 2016 – FDA warns that the risk of side effects from Noroxin and other similar antibiotics may outweigh their benefits.
Jul 2016 – Fluoroquinolone labels updated
July 26, 2016 – Fluoroquinolone labels updated to include information about “disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient.”
- Noroxin (norfloxacin) Tablets Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER). U.S. Food & Drug Administration (FDA). September 2008.
- “Fluoroquinolone Antibacterial Drugs: Drug Safety Communication- Risk for possibly permanent nerve damage”. U.S. Food & Drug Administration (FDA). August 15, 2013.
- “Risk of Aortic Dissection and Aortic Aneurysm in Patients Taking Oral Fluoroquinolone”. JAMA Internal Medicine. November 2015.
- “FDA Drug Safety Communication: FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together” U.S. Food & Drug Administration (FDA). May 12, 2016.
- “FDA Drug Safety Communication: FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects”. U.S. Food & Drug Administration (FDA). July 26, 2016.