Parker Waichman LLP

Black-Box Warning On Cipro and Levaquin

  Cipro And Levaquin Black Box Warning. The U.S. Food and Drug Administration (FDA) has announced that it will seek to add black box warnings about the risk of tendon rupture associated with Cipro and Levaquin. The drugs are in a class of antibiotics used to treat bacterial infections and black box warnings are the […]

Cipro

 

Cipro And Levaquin Black Box Warning. The U.S. Food and Drug Administration (FDA) has announced that it will seek to add black box warnings about the risk of tendon rupture associated with Cipro and Levaquin. The drugs are in a class of antibiotics used to treat bacterial infections and black box warnings are the strongest warning the FDA issues. Cipro is made by Bayer AG and Johnson & Johnson makes Levaquin. Six months ago, the consumer group Public Citizen sued the FDA to require it to add black-box warnings to the drugs.

Cipro and Levaquin belong to the antibiotic group known as fluoroquinolones, which are sold by several drug makers under a variety of brand and generic names. Although the drug labels warn of the risk of tendon ruptures, none include black-box warnings. A black-box warning is in bold type, surrounded by a black box to make it stand out. Such warnings usually appear at the top of drug labels. Any advertising of products that carry black box labels must also include the black box warning information as part of the advertisement. The FDA also announced it will ask the drug companies to create a Medication Guide to be provided to patients to alert them about possible side effects.

Serious reports of tendonitis and tendon rupture are on the rise with the use of these drugs

Serious reports of tendonitis and tendon rupture are on the rise with the use of these drugs, which finally prompted the FDA to ask drug companies to add the stronger labeling. The ruptures generally related to the use of fluoroquinolones involve the Achilles tendon as well as ruptures of the shoulder, hand, biceps, and thumbs. Tendons are the areas that connect your muscles to your joints. The Achilles tendon is at the back of the ankle. The risk of tendonitis and tendon rupture linked to drugs such as Cipro and Levaquin is “especially increased” in patients older than 60, as well as those who have received kidney, heart, or lung transplants and people on “concomitant” steroid therapy.

Fluoroquinolone Antimicrobial Drugs include:  Cciprofloxacin, marketed as Cipro and generic ciprofloxacin; ciprofloxacin extended release, marketed as Cipro XR and Proquin XR; gemifloxacin, marketed as Factive; levofloxacin, marketed as Levaquin; moxifloxacin, marketed as Avelox; norfloxacin, marketed as Noroxin; and ofloxacin, marketed as Floxin and generic ofloxacin.

The FDA believes that the addition of a black box warning and a Medication Guide would strengthen the existing warning information already included in the prescribing information for fluoroquinolone drugs.

The FDA warns that physicians “should advise patients, at the first sign of tendon pain

The FDA warns that physicians “should advise patients, at the first sign of tendon pain, swelling, or inflammation—symptoms that typically precede tendon rupture and tendonitis—to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug.”  Fluoroquinolone is only suggested for the treatment or prevention of an infection proven to be caused by, or strongly suspected to be caused by, bacteria.

According to the FDA release, other side effects experienced in those taking Fluoroquinolones include “seizures, hallucinations, depression, heart rhythm changes (QTc prolongation and torsade de points), and intestine infection with diarrhea. Rarely, damage to the liver, kidneys or bone marrow, and changes to blood sugar may occur.”

Need Legal Help Regarding Cipro?

The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Huge thank you to Christina Morace!! She handled my case with care and professionalism answering any questions i had. With her by my side i knew I would get justice!! Thank you!!
Rhonda Wynn
2 years ago
5 Star Reviews 150
I was in a car accident about a month ago, and had no idea what to do or where to go for help. As I was struggling to walk one morning, when the commercial for Park Waichman came on and the jingle stuck in my head "1800 Just Call, just call that's all!" Well, I called, and like the jingle says, that's all I had to do. Everyone at the office has been a very present help, and always answer my calls and emails timely. Julie and Maryann have been so patient and wonderful with my constant questions, and have taken care of everything! Joanne has been a constant reassurance in reaching out to check on me and make sure that my medical needs are being addressed by my health care providers and that my care is progressing as best as possible. She has a very warm and kindhearted demeanor, which makes everything seem like it will be ok. Thank you for that Joanne, it means the world to me! I would highly recommend the team at Parker Waichman.
ELEONOR PAZMINO
5 years ago
5 Star Reviews 150
On the Christmas Eve of 2015 I had a car accident I felt lost and confused. I had no idea what I was going to do or how I was going to get my car fixed. My supervisor referred me Jorge Peniche who works for Parker Waichman. He came to meet me at my house the same day I spoke to him and helped me till the end of my case. I was very pleased with the lawyers and Jillian was very helpful in the process, her and Jorge were ready to answer any of my questions. Thank you Parker and Waichman!!
Fanta Jondot
5 years ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038