Fluoroquinolone antibiotics; deadly drug pulled from market after 20 years

Levaquin Pulled From the Market

READ BEFORE ENTERING; This website is for information purposes only; we are not diagnosing, treating, curing, mitigating, or preventing any disease or medical condition by providing the information contained herein. Before beginning any natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional.

Levaquin has been on the market for over twenty years, causing severe adverse reactions, including many deaths for several years. We like to tell it like it is, but we get put down for being so blunt. We will do it anyway. Levaquin has been killing people for over twenty years.

A report discloses that Johnson & JohnJohnson’sssen Pharmaceuticals subsidiary ceased LevaLevaquin’sduction very quietly last year. This came ahead of new label warnings required by federal regulators to add to the numerous warnings. The latest information references the potential mental health side effects of the already potentially deadly antibiotic.

J & J faced an 800 million dollar lawsuit – The lawsuit is Aston et al. v. Johnson & Johnson et al., case number 1:16-cv-00086, in US District Court for the District of Columbia.

As far back as December  1997, there were known issues with severe adverse side effects with fluoroquinolones – Levaquin was among the best-selling in this class of antibiotics. A group called Public Citizens, a non-profit consumer rights advocacy group, showed that Levaquin was causing tendon disorders.

An FDA warning came almost a year after an investigation by NewsNet5. Its 5 On Your Side program reported that an FDA database comprised “at “least 3,000 patients whose death had been linked to the drug and another 200,000 complaints of side effects including kidney infections and nerve damage.” Thirty-six million prescriptions for fluoroquinolones were written in 2014 alone.

The FDA approved Levaquin in December 1998. They concluded that adequate information was presented to demonstrate that “the drug products are safe and effective” for use as recommended in the agreed-upon label text.

Types of fluoroquinolones

  • ciprofloxacin (Cipro)
  • levofloxacin (Levaquin/Quixin)
  • gatifloxacin (Tequin)
  • moxifloxacin (Avelox)
  • ofloxacin (Ocuflox/Floxin/Floxacin)
  • norfloxacin (Noroxin)

They are pulling the drug off the market just as they are required to add another warning to the current warnings list.

The FDA recommends that healthcare professionals be aware of the new warnings and the potential risk of hypoglycemia that can result in coma, which could occur more frequently in elderly patients or diabetics taking insulin or oral hypoglycemic medication.


Levaquin removed from market

Safe and effective with the possibility of death.

Fatal Side Effects:

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported.

•fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);

•vasculitis; arthralgia; myalgia; serum sickness;

•allergic pneumonitis;

•interstitial nephritis; acute renal insufficiency or failure;

•hepatitis; jaundice; acute hepatic necrosis or failure

•anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities.

Severe and Fatal – Side Possible Effects:

  • Fluoroquinolones, including LEVAQUIN®, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis.
  • Fluoroquinolones, including LEVAQUIN®, are associated with an increased risk of tendinitis and tendon rupture in all ages
  • Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported.
  • 5.4 Other Serious and Sometimes Fatal Reactions Other serious and sometimes fatal events, some due to hypersensitivity and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including LEVAQUIN®. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
    • fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome);
    • vasculitis; arthralgia; myalgia; serum sickness;
    • allergic pneumonitis; •interstitial nephritis; acute renal insufficiency or failure;
    • hepatitis; jaundice; acute hepatic necrosis or failure; Reference ID: 3382318 14
    • anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormal
  • Postmarketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with LEVAQUIN®
  • Convulsions, toxic psychoses, increased intracranial pressure (including pseudotumor cerebri) have been reported in patients receiving fluoroquinolones, including LEVAQUIN®. Fluoroquinolones may also cause central nervous system stimulation, which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose
  • Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including LEVAQUIN®, and may range in severity from mild diarrhea to fatal colitis.
  • Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported in patients receiving fluoroquinolones, including LEVAQUIN®. Symptoms may occur soon after initiation of LEVAQUIN® and may be irreversible.
  • An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving LEVAQUIN®.
  • As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper-and hypoglycemia, have been reported with LEVAQUIN®,
  • Prescribing LEVAQUIN® in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria

Lable Changes – More Adverse Black Box Warnings

In July 2008, fluoroquinolone warning labels were changed, adding, “Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture.”

August 2013 – Fluoroquinolone warning labels were changed, adding  “risk for possibly permanent nerve damage” – Drug Safety Communication

May 2016 –  Fluoroquinolone warning labels were changed  adding – disabling side effects” – Drug Safety Communication

They state:

We have determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risk of these serious side effects generally outweighs the benefits in these patients.

In July 2016, fluoroquinolone warning labels were changed, adding –  disabling side effects that can occur together” – Drug Safety Communication.

In July 2018, fluoroquinolone warning labels were changed to note that, “Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects” – Drug Safety Communication.

Mental health disturbances : Disturbances in attention, disorientation, agitation, nervousness, memory impairment, and serious disturbances in mental abilities called delirium.

December 2018 – The FDA issued a Drug Safety Communication warning about the risk of aortic aneurysm and dissection with fluoroquinolones.

or the record, the affected drugs are

  • ciprofloxacin (Cipro)
  • ciprofloxacin extended-release (Cipro extended-release)
  • gemifloxacin (Factive)
  • levofloxacin (Levaquin)
  • moxifloxacin (Avelox)
  • norfloxacin (Noroxin) and
  • ofloxacin (Floxin).

Fluoroquinolones are only a fraction as effective as minocycline in killing intracellular bacteria. 1)

Another researched issue is retinal detachment 3) 4) 5) 6) 7) 8) 9) 10) 11) 12)

WARNINGS AND PRECAUTIONS———————

  • Risk of tendinitis and tendon rupture is increased.
  • Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.3 )
  • Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.4 )
  • Hepatotoxicity: Severe, and sometimes fatal, hepatoxicity has been reported.
  • Central nervous system effects, including convulsions, anxiety, confusion, depression, and insomnia may occur after the first dose. Use with caution in patients with known or suspected disorders that may predispose them to seizures or lower the seizure threshold. Increased intracranial pressure (pseudotumor cerebri) has been reported (5.6)
  • Clostridium difficile-associated colitis: evaluate if diarrhea occurs (5.7 )
  • Peripheral neuropathy: discontinue immediately if symptoms occur in order to prevent irreversibility (5.8 )
  • Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval

Peripheral Neuropathy Associated with Fluoroquinolones

These cases suggest a possible association between fluoroquinolone antibiotics and severe, long-term adverse effects involving the PNS as well as other organ systems. The severity of these cases may reflect a different population than typically reported to drug companies or MedWatch, which often originate from healthcare providers.

A

  • Alatrofloxacin
  • Amifloxacin

B

  • Balofloxacin
  • Besifloxacin

C

  • Cadazolid
  • Ciprofloxacin
  • Clinafloxacin

D

  • Danofloxacin
  • Delafloxacin
  • Difloxacin

E

  • Enoxacin
  • Enrofloxacin

F

  • Finafloxacin
  • Fleroxacin
  • Flumequine

G

  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin

J

  • JNJ-Q2

L

  • Levofloxacin
  • Lomefloxacin

M

  • Marbofloxacin
  • Moxifloxacin

N

  • Norfloxacin

O

  • Ofloxacin
  • Orbifloxacin

P

  • Pazufloxacin
  • Pefloxacin
  • Pradofloxacin
  • Prulifloxacin

R

  • Rufloxacin

S

  • Sarafloxacin
  • Sitafloxacin
  • Sparfloxacin

T

  • Temafloxacin
  • Tosufloxacin
  • Trovafloxacin

Z

  • Zabofloxacin

Side Effects of Levaquin

Other serious side effects of LEVAQUIN® include:

Liver damage (hepatotoxicity):

Liver damage (hepatotoxicity) can happen in people who take LEVAQUIN®. Call your healthcare provider right away if you have unexplained symptoms such as: •nausea or vomiting, •stomach pain, •fever, •weakness, •abdominal pain or tenderness, •itching, •unusual tiredness, •loss of appetite, •light colored bowel movements, •dark colored urine or yellowing of your skin or the whites of your eyes.

Central Nervous System Effects: Seizures have been reported in people who take fluoroquinolone antibiotics, including LEVAQUIN®. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking LEVAQUIN®will change your risk of having a seizure. Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of LEVAQUIN®. Talk to your healthcare provider right away if you get any of these side effects or other changes in mood or behavior:

seizures, hear voices, see things, or sense things that are not there (hallucinations) feel restless, tremors, feel anxious or nervous, confusion, depression, trouble sleeping, nightmares, feel lightheaded, feel more suspicious (paranoia), suicidal thoughts or acts Serious allergic reactions.

Allergic reactions can happen in people taking fluoroquinolones, including LEVAQUIN®, even after only one dose. Stop taking LEVAQUIN® and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction:

•hives

•trouble breathing or swallowing

•swelling of the lips, tongue, face

•throat tightness, hoarseness

•rapid heartbeat

•faint

•Yellowing of the skin or eyes.

Stop taking LEVAQUIN® and tell your healthcare provider right away if you get yellowing of your skin or white part of your eyes, or if

•••••••you have dark urine. These can be signs of a serious reaction to LEVAQUIN® (a liver problem).

Skin rash may happen in people taking LEVAQUIN®, even after only one dose. Stop taking LEVAQUIN® at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to LEVAQUIN®.

Intestine infection (Pseudomembranous colitis) Pseudomembranous colitis can happen with most antibiotics, including LEVAQUIN®. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever.

Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Changes in sensation and possible nerve damage (Peripheral Neuropathy) Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including LEVAQUIN®. Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: •pain •burning •tingling •numbness •weakness LEVAQUIN® may need to be stopped to prevent permanent nerve damage.

Serious heart rhythm changes (QT prolongation and torsades de pointes) Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. LEVAQUIN® may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous.

The chances of this happening are higher in people:

•who are elderly

•with a family history of prolonged QT interval

•with low blood potassium (hypokalemia)

•who take certain medicines to control heart rhythm(antiarrhythmics)

Changes in blood sugar [low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia)] People who take LEVAQUIN® and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking LEVAQUIN®, stop taking LEVAQUIN® and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

Sensitivity to sunlight (photosensitivity)See “What should I avoid while taking LEVAQUIN®?”

Joint Problems Increased chance of problems with joints and tissues around joints in children. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with LEVAQUIN®

SOURCE

This website is for information purposes only; we are not diagnosing, treating, curing, mitigating, or preventing any disease or medical condition by providing the information contained herein. Before beginning any natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional.