Cipro and Levaquin: Antibiotics Get "Black Box" Warning

Special Alert: July 2008

Medications Linked to Tendon Ruptures in Patients

In July 2008, the U.S. Food and Drug Administration (FDA) announced that antibiotics Cipro and Levaquin should carry the agency's most urgent safety warning. Called "black box" warnings, the labels warn consumers about serious drug side effects.

Cipro and Levaquin have been found to lead to dangerous tendon ruptures in patients. These tendon ruptures can cause long-term, sometimes permanent disabilities and the need for extensive surgery.

What are Cipro and Levaquin?

Cipro and Levaquin belong to a class of antibiotics called floroquinolones, which are sold under various brand names by different manufacturers. Cipro is made by Bayer and is usually used to treat urinary tract infections. The antibiotic became well-known during the anthrax attacks in 2001 because it was one the drugs stored by the government for use in case of a terror attack. Cipro was approved by the FDA in 2000 to treat anthrax inhalation and in 2003 to treat urinary tract infections.

Levaquin, made by Ortho McNeil, is a potent antibiotic used to treat respiratory infections. Levaquin was approved by the FDA in 2003.

Possible Side Effects of Taking Cipro and Levaquin

Cipro:

• Tendon ruptures
• Seizure
• Confusion, hallucinations, depression, or thoughts of hurting yourself or others
• Sudden pain or swelling near your joints
• Nausea, stomach pain, low fever, lost appetite, dark urine, clay-colored stools, jaundice
• Watery or bloody diarrhea
• Urinating more or less than usual
• Numbness, tingling, or unusual pain anywhere in your body
• Chest pain, pounding or fast heartbeats

Levaquin:

• Tendon ruptures
• Watery or bloody diarrhea
• Seizures
• Confusion, hallucinations, unusual thoughts or behavior
• Dizziness, fainting, fast or pounding heartbeat
• Sudden pain or swelling near your joints
• Easy bruising or bleeding
• Urinating less than usual or not at all
• Numbness, burning, pain, or tingly feeling in your hands or feet
• Pale or yellowed skin, dark colored urine, fever, weakness
• Fever, sore throat, and headache with a severe blistering, peeling, and red skin rash
• Jaundice

Overview of Cipro and Levaquin

The consumer interest group Public Citizen has petitioned the FDA three times – in 1996, 2005, and 2006 – to add black box warnings to the Cipro and Levaquin. After the group sued the FDA for ignoring the petitions, the agency recommended adding the warnings to the drugs' labels. According to Public Citizen, the FDA has received several hundred reports of tendon ruptures and hundreds of additional cases of tendonitis and other tendon disorders linked to the antibiotics.

Often, a pain in the tendon signals the onset of a tendon rupture, but some of the ruptures reported to the FDA occurred without warning. Tendons are cords of tissue that connect muscles and bones and are vital to movement. The most common type of rupture reported to the FDA affected the Achilles tendon in the heel.

You Need Experienced Lawyers Who Understand Dangerous Drug Cases to Fight On Your Side

If you or a loved one have been hurt by taking Cipro or Levaquin, you need to act quickly. When our drug injury attorneys and staff get involved with your case, we immediately get to work investigating the cause of your drug reaction and fighting for your legal rights to fair compensation.