Levaquin Pulled From the Market
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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, but we will do it anyway. Levaquin has been killing people for over twenty years.
A report discloses that Johnson & Johnson’s Janssen Pharmaceuticals subsidiary ceased Levaquin’s production very quietly last year. This came ahead of new label warnings required by federal regulators to add to the numerous warnings. The new 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
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.
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;
•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
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).
- 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
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.