Why Are There Cipro Lawsuits?
Cipro’s manufacturer, Bayer Pharmaceuticals has faced multiple lawsuits filed by people who have experienced side effects such as tendon rupture or neurologic damage and by the families of those who experienced serious aortic injuries. Cipro and other fluoroquinolones may cause aortic dissection and aortic aneurysm, both of which are commonly fatal.
Bayer is also facing a number of lawsuits against another fluoroquinolone medication that it manufactures, Avelox. Because of side effects and toxicity, some manufacturers of other fluoroquinolones like Levaquin, have opted to discontinue manufacturing their medications.
Why Have Plaintiffs Filed Cipro Lawsuits?
Plaintiffs claim that Bayer and other pharmaceutical companies that produce and sell fluoroquinolones did not adequately warn users of the serious side effects. These serious side effects can lead to permanent nerve damage, tendonitis, and the rupturing of tendons.
Which Companies Are Facing Cipro Lawsuits?
Even though Bayer is the main focus of the Cipro lawsuits, many producers such as Johnson & Johnson and Merck & Co. have faced lawsuits as well for similar complaints.
What Cipro Lawsuit Settlements Have There Been?
Cipro’s manufacturer Bayer previously faced class action Cipro lawsuits due to claims that the company was conspiring to keep generic medications off of the market. The class action pricing lawsuit was settled in 2014 with a payment of $74 million but Bayer is facing a number of Cipro injury lawsuits.
Fluoroquinolone manufacturers like Johnson & Johnson have already settled a number of lawsuits for drugs similar to Cipro (the amount is undisclosed). They were possibly facing up to 3,000 lawsuits but have since opted to discontinue manufacturing Levaquin.
No Cipro lawsuit settlements have been announced but past medical injury lawsuits have provided compensation for medical costs, lost wages, pain and suffering, and in some cases, punitive damages.
What Cipro Lawsuits Are There?
Many lawsuits have already been filed against Bayer and Johnson & Johnson concerning their dangerous drugs. There were previously over 2,000 pending cases against Levaquin® and Johnson & Johnson in multidistrict litigation (MDL) in a Minnesota Federal District Court.
There are currently more than 200 cases currently pending in MDL, and many more lawsuits are expected.
What Is Cipro?
Ciprofloxacin is part of a class of drugs called quinolone antibiotics. Cipro works by stopping the growth of bacteria to keep the bacterial infection from spreading. Since it’s an antibiotic, it only works for bacterial infections and will not work on viral infections such as the cold or flu. Additionally, using Cipro when it is not prescribed could run you the risk of developing disabling and potentially permanent side effects.
What Is a Fluoroquinolone?
Fluoroquinolone is a class of antibiotics used to treat bacterial infections. There are many forms of fluoroquinolone, with the most popular being Cipro, Levaquin, and Avelox.
This class of antibiotics has been used to alleviate the effects of respiratory and urinary tract infections. However, with the warnings from the FDA, their use has been limited to individuals who are allergic to other strands of antibiotics.
How Does Cipro Work?
Fluoroquinolones or “floxins” like Cipro work by limiting bacterial cell division and repair through the inhibition of enzymes needed for DNA production. Essentially, it prevents the bacteria from growing and making the infection worse.
Cipro is a broad-spectrum antibiotic which means that it can treat a number of different bacterial infections like UTIs and STIs.
Which Company Created Cipro?
In 1987, Bayer received US Food and Drug Administration approval for orally administered ciprofloxacin; the intravenous form was approved in 1991. Bayer’s Cipro patent expired in 2004, leading Cipro to become a widely distributed, inexpensive antibacterial.
Since then, the FDA has released warnings and restrictions related to the adverse effects that Cipro causes.
When Was Cipro Approved by the FDA?
Ciprofloxacin was approved by the FDA on July 21, 1994. The FDA black box warning for Cipro and other fluoroquinolone antibiotics was added in July 2008.
What Is Cipro Prescribed To Treat?
Since Cipro is a broad-spectrum antibiotic, it can be used to treat a multitude of different bacterial infections such as:
- Urinary tract infections
- Chest infections
- Skin and bone infections
- Sexually transmitted infections
- Eye infections
- Ear infections
- Any other infections that other antibiotics have been unable to treat
What Are the Side Effects of Cipro?
Like all medications, Cipro causes side effects. While common side effects are tolerable and will go away with time, some Cipro side effects may be more serious or even life-threatening.
What Are the Common Cipro Side Effects?
Common Cipro side effects include:
- Nausea and vomiting
- Diarrhea or constipation
What Are the Adverse Cipro Side Effects?
Adverse side effects of Cipro include:
- Peripheral nerve damage
- Central nervous system effects
- Anaphylaxis or severe allergic reaction
- Tendon rupture or damage
- Aortic aneurysm or dissection
- Sudden pain in tendons, arms, or legs
- Chest pain
- Abdominal pain
- Difficulty breathing
- Changes in consciousness
- Changes or loss of sensation in arms, legs, or skin
Any of the above-listed symptoms and side effects should be reported to a healthcare practitioner immediately.
What Are the FDA’s Warnings About Cipro?
The U.S. Food and Drug Administration (FDA) began requiring that all fluoroquinolones, including Cipro, list “black box” or boxed statement warnings on all prescribing information in 2008. Since its issuance in 2008, the Cipro boxed warning has been updated several times. In 2016, the FDA announced required stronger black box warnings for common antibiotics such as Cipro.
What Is a Black Box Warning?
A boxed warning -previously called a “black box” warning- is the highest safety-related warning the Food and Drug Administration assigns. These warnings can be added, updated, and removed depending on what the FDA deems necessary. Boxed warnings are specifically used to warn consumers of the major risks of a certain drug.
Why Does Cipro Have a Black Box Warning?
Cipro’s black box warning also includes a recommendation that it should only be used for infections that are determined to be sensitive to Cipro and that the medication should be limited to use in patients who cannot be treated with other medications.
Cipro’s black box warnings state that there is a risk of:
- Tendon rupture
- Central nervous system damage
- Peripheral nerve damage
- Exacerbation of myasthenia gravis
Is Cipro Still on the Market?
Cipro is an FDA-approved fluoroquinolone and is still available on the market in 2023. The boxed statement warning recommends that Cipro use should be reserved for patients who have no other alternative treatment options for bacterial bronchitis or acute bacterial sinusitis. Cipro is not approved for use in children and should be limited to patients who are at greater risk for cartilage disruption, such as the elderly.
Despite still being FDA-approved, some of the producers of Cipro have voluntarily stopped producing/selling the drug.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.