Changes in Levaquin package insert. No warning on irreversible condition anymore.

A couple of days ago I went to the official Johnson and Johnson website for Levaquin. I printed off a copy of the package insert for Levaquin about a year ago. That package insert states that Levofloxacin should be discontinued if the patient experiences symptoms of neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation in order to prevent the development of an irreversible condition. 

A few days ago when I went to the safety information section for Levaquin on the company website there is no longer the statement at the end of the warning that says irreversible condition. I cut and pasted below the new updated warning for Levaquin that is on the Johnson & Johnson ( JNJ ) company website. This warning no longer contains the wording: in order to prevent the development of an irreversible condition. I highlighted the section that this phrase was in previously in the old package insert. I guess the company felt it was important to remove any language that contains the phrase irreversible condition

It always seems to be a matter of profits over public safety warnings.  

http://www.levaquin.com/levaquin/IMPORTANT SAFETY INFORMATION FOR LEVAQUIN®

 

Fluoroquinolones, including LEVAQUIN, 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. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking LEVAQUIN® until tendinitis or tendon rupture have been ruled out, and avoid exercise and using the affected area.

LEVAQUIN® is contraindicated in persons with known hypersensitivity to LEVAQUIN®or other quinolone antibiotics. Serious and occasionally fatal allergic reactions, as well as some of unknown origin, have been reported in patients receiving therapy with quinolones, including LEVAQUIN®. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash, hives, or other symptoms of an allergic reaction. Skin rash may be a sign of a more serious reaction to LEVAQUIN®.

Hepatotoxicity (liver damage) has been reported in patients receiving LEVAQUIN®. Call your doctor right away if you have unexplained symptoms such as: nausea or vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, itching, unusual or unexplained tiredness, loss of appetite, light colored bowel movements, dark colored urine or yellowing of your skin or the whites of your eyes.

Convulsions have been reported in patients receiving quinolone antibiotics including LEVAQUIN®. Tell your physician if you have a history of convulsions. Central nervous system disorders including convulsions, confusion, insomnia, depression, and anxiety may occur after the first dose. You should talk to your physician right away if you experience these or other changes in mood or behavior.

Changes in sensation and possible nerve damage (peripheral neuropathy) including pain, burning, tingling, numbness, and/or weakness have been reported.

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3 Responses to “Changes in Levaquin package insert. No warning on irreversible condition anymore.”

  1. http://www.fda.gov/medwatch/SAFETY/2004/nov_PI/Levaquin_PI.pdf

    page 20
    Peripheral Neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting
    small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness
    have been reported in patients receiving quinolones, including levofloxacin. Levofloxacin should
    be discontinued if the patient experiences symptoms of neuropathy including pain, burning,
    tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain,
    temperature, position sense, and vibratory sensation in order to prevent the development of an
    irreversible condition.

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