FDA Issues Safety Advisory Regarding Fluoroquinolones (Levaquin)

162017_132140396847214_292624_nOn May 12, 2016, the FDA issued a Safety Announcement in which it warned that “the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with acute sinusitis, acute bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.”

The FDA’s action was based on its safety review that showed that fluoroquinolones antibacterial drugs when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together, which can involve the tendons, muscles, joints, nerves, and central nervous system. 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.

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Also on May 12, 2016, the FDA began requiring labeling changes for fluoroquinolones, including an updated boxed warning, reflecting the above (i.e., that the serious side effects associated with fluoroquinolones generally outweigh the benefits for patients with sinusitis, bronchitis and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options).

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However, also on May 12, 2016, the FDA rejected a petition filed with the FDA on July 23, 2014 by the Southern Network on Adverse Reactions (SONAR) that requested that the labeling for Levaquin contain additional language warning of “Possible Mitochondrial Toxicity,” to “reflect new safety information.”

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Fluoroquinolones antibacterial drugs include such popular brand name medications such as Cipro, Avelox, and Levaquin. Levaquin was the best-selling antibiotic in the United States in 2010 (in 2010, Johnson & Johnson, which manufactures Levaquin, settled more than 800 of the 3,400 lawsuits filed by Levaquin users who alleged that they were unaware of the dangers of taking Levaquin before they suffered serious side effects – one reported Levaquin settlement involved Johnson & Johnson paying $1.8 million for tendon rupture).

Many people who took Levaquin have complained that they have suffered serious side effects, such as tendon ruptures, severe joint pain, difficulty breathing, dizziness, depression, anxiety, neurological damage, and even paralysis. Over 33 million people in the United States take one or more fluoroquinolones antibacterial drugs each year.

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What should you do if you or a loved one suffered a serious side effect(s) from using Levaquin, Cipro, or Avelox, and you were not warned about the dangers? You should promptly seek to consult with a drug claim lawyer in your U.S. state who may investigate your drug claim for you and represent you in a claim against a drug manufacturer and/or other(s), if appropriate, to seek compensation for the harms you suffered.

If you or a loved one were injured (or worse) due to a prescription drug error, a dispensing error, a dosing error, a counterfeit drug, or the prescription medications Levaquin, Cipro, or Avelox, or a bad drug, visit our website to be connected with drug claim lawyers in your state who may assist you, or call us toll-free in the United States at 800-295-3959.

Turn to us when you don’t know where to turn.

This entry was posted on Thursday, July 7th, 2016 at 5:17 am. Both comments and pings are currently closed.

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