The antibiotic Noroxin has been associated with many rare but serious side effects, including aortic aneurysms, tendon ruptures, and a debilitating type of nerve damage known as peripheral neuropathy.
FDA Warning: Noroxin Risks Outweigh Benefits for Common Infections
May 12, 2016 — The FDA is warning that the risk of disabling side effects from Noroxin outweighs its benefit for some of the most common infections. Click here to read more.
The agency is also asking patients to seek immediate medical attention if they develop side effects:
“Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations.”
What is Noroxin?
Noroxin (norfloxacin) is a broad-spectrum antibiotic medication in the fluoroquinolone class. It is manufactured by Merck & Co. and it has been approved by the U.S. Food and Drug Administration (FDA) since 1986.
What Does Noroxin Treat?
- Uncomplicated urinary tract infections (including cystitis)
- Sexually transmitted diseases (cervical or uterine gonorrhea)
- Prostatitis (prostate infection) due to E. coli)
- Traveler’s diarrhea
What is the problem?
Fluoroquinolones are powerful antibiotics that can damage collagen in connective tissue, which is why they have been linked to side effects like tendonitis and retinal detachments. Collagen is also found in the aorta, and recent studies have raised concern about aortic aneurysms.
Noroxin and Aortic Aneurysms
Aortic aneurysms occur when a weak spot develops in the aorta. Over time, blood flowing through the aorta causes it to “balloon” outward, often as a complication of high blood pressure. In rare cases, the aorta suddenly bursts open and causes massive internal bleeding.
A study published in October 2015 by researchers in Taiwan found that current users of fluoroquinolone antibiotics were 2.4-times more likely to develop aortic aneurysms. Another study published in November found a 3-fold increased risk of aortic aneurysms associated with fluoroquinolones.
Black Box Warning: Tendonitis and Tendon Ruptures
The label on Noroxin carries a boxed warning about the risk of tendon injuries, including tendonitis (tendon inflammation) and tendon rupture. These injuries primarily affect the Achilles tendon at the back of the heel, but can also affect tendons in other areas of the body. Tendons are fibrous tissues that connect bones and muscles.
Noroxin Black Box Warning:
“Fluoroquinolones, including NOROXIN, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.”
Noroxin and Nerve Damage
In rare cases, Noroxin may cause nerve damage that does not go away even after you stop taking Noroxin. This side effect is called peripheral neuropathy. Although peripheral neuropathy is rare, it is twice as common in people on fluoroquinolone antibiotics than other antibiotics, according to a study published in 2014 by the journal Neurology.
Symptoms of Neuropathy
Symptoms may appear within hours or days after your first dose of Noroxin. Call your doctor immediately if you experience numbness, tingling, pain, burning in the arms or legs, or a change in your ability to sense textures or temperatures. These complications may be permanent.
FDA Strengthens Nerve Damage Warnings
Peripheral neuropathy was originally added to the label on Noroxin in 2004. Unfortunately, this risk information may not have been adequate. In 2013, the FDA decided to update warnings with emphasis on the rapid onset of symptoms and potentially permanent complications. Drug-makers are now facing hundreds of lawsuits from people who say warnings about nerve damage were inadequate.
Common Side Effects
Common side effects of Noroxin include diarrhea, nausea, heartburn, weakness, dizziness, vaginal inflammation (vaginitis), intestinal irritation, anxiety, stomach cramps, and headache.
Severe Side Effects
- Aortic aneurysms
- Peripheral neuropathy
- Tendon ruptures
- Central Nervous System (CNS) effects
- Seizures
- Hearing voices, hallucinations, paranoia
- Confusion
- Allergic reaction
- Swelling of the lips, tongue, face, throat
- Skin rash
- Heart rhythm changes
- Intestine infection
- Nerve damage
- Low blood-sugar
- Sensitivity to sunlight
- And more
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