Levaquin Alert
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In light of the issues the Food and Drug Administration in July, 2008 ordered the makers of the drug Levaquin to place a black box warning on the drug Levaquin.
A recently filed Levaquin lawsuit alleges that Ortho-McNeil Pharmaceutical did not provide adequate warnings to doctors and patients about the possibility of the drug causing such severe Levaquin side effects: the FDA has reported more than 60 percent of fluoroquinolone-related tendon injuries are linked to Levaquin.
Levaquin or levofloxacin is a member of a class of drugs known as quinolones, which are prescribed to fight bacterial infections.
Numerous complaints by users have led the FDA to put a "black box" warning on the drug to increase awareness of its link to tendon ruptures and tendonitis.
In 2006, Public Citizen filed a petition with the FDA, requesting that stronger warnings be issued regarding Levaquin tendon rupture side effects.
The consumer group also filed a federal lawsuit asking the court to require the FDA to act on their petition-- requesting that new warnings be added about side effects of antibiotics--in accordance with the Administrative Procedure Act.
It is important to note that the FDA Warning states: "Ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin.
Post-marketing surveillance reports indicate that this risk may be increased in patients receiving concomitant corticosteroids, especially the elderly.
Levofloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been confidently excluded.
Tendon rupture can occur during or after therapy with quinolones, including levofloxacin.
Signs & Symptoms of Tendon Rupture
The tendon most frequent ruptures are Achilles Tendons, Tendon Ruptures in the Rotator Cuff (shoulder), the Biceps, the Hand, and the Thumb.
Symptoms often associated with an Achilles tendon rupture are:
- Sudden and severe pain
- Swelling and bruising
- Difficulty walking
- Signs & Symptoms of Tendonitis
- Symptoms of Tendonitis that are produced near a joint aggravated by movement include the following:
- Pain
- Tenderness
- Mild swelling, in some cases.
- Tendonitis in various locations in your body produces these specific types of pain:
- Tennis elbow causes pain on the outer side of your forearm near your elbow when you rotate your forearm or grip an object.
- Golfer's elbow causes pain on the inner part of your elbow.
- Achilles tendonitis causes pain just above your heel.
- Adductor tendonitis causes pain in your groin.
- Patellar tendonitis causes pain just below your kneecap.
- Rotator cuff tendonitis causes shoulder pain.
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