FDA Warns of Serious Injuries – Antibiotic Lawsuits Move Forward

Published By:
Jessie Paluch
Jessie Paluch

Attorney Jessie Paluch, founder of TruLaw, has over 25 years of experience as a personal injury and mass tort attorney, and previously worked as an international tax attorney at Deloitte. Jessie collaborates with attorneys nationwide — enabling her to share reliable, up-to-date legal information with our readers.

This article has been written and reviewed for legal accuracy and clarity by the team of writers and legal experts at TruLaw and is as accurate as possible. This content should not be taken as legal advice from an attorney. If you would like to learn more about our owner and experienced injury lawyer, Jessie Paluch, you can do so here.

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FDA Warns of Serious Injuries – Antibiotic Lawsuits Move Forward

Last week, the FDA finally took action on the dangers of fluoroquinolones antibiotic use opening the door for antibiotic lawsuits.

According to the FDA Safety Communication,

Systematic use of fluoroquinolones (such as Cipro, Levaquin, Avelox, Floxin and Factive) is associated with disabling and potentially permanent serious side effects that can occur together.  These side effects can involve the tendons, muscles, joints, nerves and central nervous system.

The FDA Advisory Panel that heard from 30 members of the public in November 2015, recommended the use of the term “fluoroquinolones associated disability” (or FQAD) to describe these potentially permanent serious side effects that can occur together.

But in May 2016, the FDA stopped short of naming this disability.

Aortic Dissection

Despite the lack of a name, these serious side effects will now be the subject of a strengthened warning on the fluoroquinolone family of antibiotics, which includes such drugs as Levaquin, Cipro, Avelox, Factive, and Floxin.

These labels will now include a “limitation of use” so that it is no longer appropriate for medical professionals to prescribe one of these antibiotics to treat sinusitis, bronchitis or an uncomplicated urinary tract infection.

According to the FDA,

serious side effects associated with these popular antibacterial drugs outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options.

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Fluoroquinolone Side Effects

In November 2015, thirty otherwise healthy individuals described some of the serious side effects that became a serious disruption to their lives.

While these injuries vary from person to person, some reported injuries include aortic dissection, aortic aneurysms, peripheral neuropathy and the constellation of disorders affecting the tendons, muscles, joints, nerves and central nervous system.

Antibiotic Lawsuits Moving Forward

Lawsuits on behalf of individuals living with these serious injuries are being filed against the manufacturers of Levaquin, Cipro, Avelox, Factive and Floxin alleging that these drugs put individuals at risk of injury without warning.

Fluoroquinolones (FQs) have been used for over 20 years and critics note that they are overprescribed.

According to the CDC, FQs are the fourth-most prescribed antibiotic nationwide – prescribed to 33 million Americans in 2013 alone.

In the past few years, advocates have worked hard to get the word out about the serious side effects from FQ toxicity.

These individuals, many of whom are currently suffering from these life-altering side effects,  refer to these collective injuries as “floxing” and “antibiotic toxicity.”

They have set up Facebook pages and website in an effort to get the word out through social media.

The FDA warning and label change will be helpful in these efforts to get the word out to the public, but also to get word to health care professionals who often come up with no specific diagnosis for the constellation of symptoms from these antibiotics.

Published By:
Jessie Paluch
Jessie Paluch

Experienced Attorney & Legal SaaS CEO

With over 25 years of legal experience, Jessie is an Illinois lawyer, a CPA, and a mother of three.  She spent the first decade of her career working as an international tax attorney at Deloitte.

In 2009, Jessie co-founded her own law firm with her husband – which has scaled to over 30 employees since its conception.

In 2016, Jessie founded TruLaw, which allows her to collaborate with attorneys and legal experts across the United States on a daily basis. This hypervaluable network of experts is what enables her to share reliable legal information with her readers!

AFFF Lawsuit

AFFF Lawsuit claims are being filed against manufacturers of aqueous film-forming foam (AFFF), commonly used in firefighting.

Claims allege that companies such as 3M, DuPont, and Tyco Fire Products failed to adequately warn users about the potential dangers of AFFF exposure — including increased risks of various cancers and diseases.

Suboxone Lawsuit

Suboxone Tooth Decay Lawsuit claims are being filed against Indivior, the manufacturer of Suboxone, a medication used to treat opioid addiction.

Claims allege that Indivior failed to adequately warn users about the potential dangers of severe tooth decay and dental injuries associated with Suboxone’s sublingual film version.

Social Media Lawsuits

Social Media Harm Lawsuits are being filed against social media companies for allegedly causing mental health issues in children and teens.

Claims allege that companies like Meta, Google, ByteDance, and Snap designed addictive platforms that led to anxiety, depression, and other mental health issues without adequately warning users or parents.

Vaginal Mesh Lawsuits

Transvaginal Mesh Lawsuits are being filed against manufacturers of transvaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Claims allege that companies like Ethicon, C.R. Bard, and Boston Scientific failed to adequately warn about potential dangers — including erosion, pain, and infection.

Bair Hugger Lawsuit

Bair Hugger Warming Blanket Lawsuits involve claims against 3M — alleging their surgical warming blankets caused severe infections and complications (particularly in hip and knee replacement surgeries).

Plaintiffs claim 3M failed to warn about potential risks — despite knowing about increased risk of deep joint infections since 2011.

Baby Formula NEC Lawsuit

Baby Formula NEC Lawsuit claims are being filed against manufacturers of cow’s milk-based baby formula products.

Claims allege that companies like Abbott Laboratories (Similac) and Mead Johnson & Company (Enfamil) failed to warn about the increased risk of necrotizing enterocolitis (NEC) in premature infants.

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