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Levaquin and Avelox Lawsuits Over Aortic Aneurism and Aortic Dissection

Levaquin is a prescription medication that is used to treat bacterial infections in the body. Part of an antibiotic class known as fluoroquinolones, Levaquin is used to treat bacterial infections, anthrax exposure and the plague. Levaquin is most commonly prescribed for the treatment of urinary tract infections (UTI’s) and respiratory infections including bronchitis and pneumonia.

Levaquin (generic name Levofloxacin) is manufactured by Janssen Pharmaceuticals, a division of the Johnson & Johnson Company. Levaquin first gained Food and Drug Administration (FDA) approval in 1999. This medication is considered a second-generation fluoroquinolone drug. The first generation of this type of medication is Cipro, the most commonly prescribed bacterial infection fighting medication. Levaquin is available in tablet form or is used in an intravenous solution.

Avelox is a prescription medication manufactured by Bayer Pharmaceuticals in conjunction with Merrick Pharmaceuticals. It is a fourth-generation fluoroquinolone drug that was approved by the FDA in 1999 for the treatment of drug resistant bacterial infections. Prescribing information targeted this drug for drug resistant pneumonia, ear infections and meningitis. It was also authorized for the treatment of bacterial infections on the skin.

Avelox is available in 400 milligram tablet form or as an intravenous treatment. This pharmaceutical product is the third most often prescribed medication in the fluoroquinolone category of medications.

Parties Involved In The Lawsuits

There are several lawsuits against the makers of Lavaquin at this time. The most recent lawsuit was filed in March 2016 against Janssen Pharmaceuticals and its parent company Johnson & Johnson in the amount of $800 million alleging that the company willfully withheld important information about the dangers related to their drug. Studies have now confirmed that use of this dangerous medication leads to a significant increase in Aortic Aneurism or Aortic Dissection.

At the same time, Johnson and Johnson was named in a criminal charge against the former FDA Commissioner, Margret Hamburg, regarding this medication. The former commissioner is being charged with violating the RICO (Racketeer Influenced and Corrupt Organizations) Act for the agencies handling of this dangerous medication.

Bayer Pharmaceuticals along with its partner Merrick Pharmaceuticals has been named in the allegations against their similar medication Avelox. Neither Bayer or Merrick was named in the RICO Act case.

Timeline Of Important Facts

1999  

Levaquin is approved for use by the Food and Drug Administration for the treatment of bacterial infections, including pneumonia, urinary tract infections, anthrax exposure and plague.

2002  

The FDA amends the label to include potential risks associated with this drug to include tendonitis. This was done without much notice to the bpublic or to the medical industry.

2006  

The FDA upgrades the warning label on Levaquin to include tendonitis and potential for tendons rupturing. Tendon ruptures were seen more often in people over the age of 60 and those who were also taking corticosteroids.

2008  

The FDA issues a Black Box warning on the medication stating that it had potentially dangerous side effects. This Black Box warning included the information that Levaquin caused problems with natural collagen levels and that tendon ruptures have been seen in the Achilles tendon, the rotator cuff, and in other areas.

2008  

Over 2,000 lawsuits were filed against Janssen Pharmaceuticals and Johnson & Johnson due to tendon problems from using Levaquin. A Multi District Litigation was formed in the District of Minnesota surrounding these cases.

2011  

The Food and Drug Administration approves a generic version of Levaquin named Levofloxacin. The same side effects have been associated with these medications since its release.

2013  

The Food and Drug Administration issues a special communication and warning stating that there is a direct connection between the use of fluoroquinolone antibiotics and the increase of neuropathy in non-diabetic patients.

2014  

Lawsuits begin to emerge for damages caused by Levaquin relating to neuropathy. Lawsuits begin to emerge connecting the use of Levaquin and similar antibiotics with idamage to the heart causing irregular heart rythms.

2015   November

A new study is released by the Journal of the American Medical Association (JAMA) that shows that there is a significant increase in risks associated with fluoroquinolone use and aortic aneurisms and dissections.

2016   May

The FDA requires new Black Box warnings for these medications to include the high risk associated with their risk concerning tendon damage and ruptures, damage to muscles, joints, nerves and the central nervous system.

Side Effects Associated With Use Of These Drugs

There are several side effects associated with the use of Levaquin and Avelox. According to the prescribing labels attached to the medication, the following are considered common side effects:

  • Vomiting or upset stomach
  • Dizziness or lightheadedness
  • Diarrhea
  • Headache
  • Insomnia
  • Oral or Vaginal Yeast infections

Side Effects sometimes associated with the use of these drugs, taken from their drug label:

  • Bruising is occurring
  • Signs of new infection, such as a sore throat
  • Change in the amount of urine (decrease)

Seek immediate care of the following occur:

  • Consistent or worsening headache
  • Vision changes
  • Seizures, shaking or convulsions
  • Dizziness leading to fainting and irregular heart beat
  • Confusion, depression, or thoughts of suicide
  • Yellowing of the skin
  • Intense stomach pain

Rare Side Effects include:

  • Peripheral neuropathy
  • Weakening of the tendons, tendonitis, tendon ruptures
  • Clostridium difficile ( A violent form of diarrhea )

The warning labels currently do not have warnings related to the potential side effect of aortic aneurism or dissection.

Warning Signs of An Aortic Aneurism or Aortic Dissection

An aneurism is a bulge in a vein that can eventually rupture. Sadly, there are no warning signs of these aneurisms and they are not discovered until it is an emergency situation. Many times the aortic aneurisms can be found when a CT Scan or MRI is being conducted for other reasons.

Once an aneurism occurs, the symptoms include severe chest and/or back pain, difficulty breathing, and loss of consciousness.

When aortic dissection occurs, blood leaks from the artery into the body. This causes less blood to reach the organs. Many symptoms, including organ failure, stroke, or extreme fatigue can indicate that aortic dissection is occurring. A physician can diagnose this problem with the right imaging equipment.

In most cases, surgery is required to fix the problem and a portion of the aorta is removed and reconnected to eliminate the tear. Dissection is as bad as an aneurism and can lead to death if not treated.

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