Manufacturer: Ortho McNeil Janssen
Date approved: December 20, 1996
Status: Prescription Only with a Black Box Warning
Approved uses: Antibiotic used to treat anthrax, pneumonia; chronic bronchitis; and sinus, urinary tract, kidney, prostate (a male reproductive gland), and skin infections.
Off-Label uses: Plague and Tuberculosis (TB)
• Spontaneous Tendon Rupture
• Irreversible Nerve Damage
• Toxic Epidermal Necrolysis
• Stevens Johnson Syndrome
Common Misspellings: Levequin, Leviquin, Levofloxacin, Levoflaxacin
Levaquin (levofloxacin)is a 3rd-generation fluoroquinolone antibiotic, manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson. Doctors prescribe Levaquin as an antibiotic to treat bacterial infections in many different parts of the body. It does not work for viral infections (for example, the common cold).
While patients takin Levaquin have reported a variety of minor side-effects, common with any medication, the most serious Levaquin side effect reported has been an increased risk of Achilles tendonitis among current and former patients. Several studies published in accredited medical journals have cited case studies in which individuals who have taken Levaquin have been adversely affected by levofloxacin-induced tendonopathy and tendon rupture.
Most recently in July 2008, the FDA announced plans to require a “black box” warning on all prescriptions of Levaquin after the consumer group Public Citizen sued the FDA to require the agency to add black-box warnings to all fluoroquinolone antibiotics. The warning will caution patients of the risk of tendonitis and tendon rupture associated with use of the drugs. Such ruptures most frequently involves the Achilles tendon, but can also include ruptures of the shoulder, hand, biceps, and thumbs, according to the FDA.
Levaquin Issued Black Box Warning by FDA
Levaquin (levofloxacin), maufactured by Ortho-McNeil, is among a family of drugs that has been issued a “black box” warning from the FDA – the most severe warning given to medications on the market – due to an increased risk of tendon rupture and tendonitis.
Levaquin Side Effects Reported to FDA
The U.S. Food and Drug Administration (FDA) will require certain popular antibiotics to carry a “black box” warning on all labels alerting patients and doctors of potential tendon ruptures and tendonitis. This is the harshest warning the FDA can issue without demanding a recall.
All fluoroquinolone drugs, which include the popular medications Cipro, Levaquin, Avelox, Noroxin and Floxin, will be required to carry warning labels and distribute a medication guide alerting patients of possible risks.
The warning came after the FDA was sued by consumer watch group Public Citizen, which had previously asked in 2006 that the medications carry the black box warning.
Although the organization is pleased with the FDA requirement, they are concerned the FDA may not be protecting consumers to the best of its ability from unnecessary tendon rupture.
Tendon rupture and tendonitis can occur once in about 100,000 patients, however fluoroquinolone drugs can increase the risk three to four times according the FDA. Patients who are over 60, or who have had a kidney, lung or heart transplants are more at risk, however ruptures have occurred in all ages groups.
Ruptures most frequently involve the Achilles tendon, although ruptures have been reported in the biceps, shoulder, hand and thumbs, according to the FDA. Often patients do not have symptoms prior to a rupture.
The FDA has advised patients to quit taking the antibiotics if they show signs of tendon pain, avoid exercise and contact their doctor.
Do You Need Legal Advice Regarding Levaquin?
Oftentimes, patients pursue a Levaquin lawsuit to seek monetary compensation to cover medical treatments due to tendon rupture or tendonitis. If you or a loved one has questions regarding a potential Levaquin law suit, you may contact one of our experienced Levaquin law firms. A Levaquin lawyer can provide you with updates on Levaquin side effects or a possible Levaquin recall. Contact a Levaquin attorney using the form at the top of the page.
Reports Surface Detailing Levaquin Risks
Levaquin, also know as levofloxacin, is an anti-bacterial treatment for adults, and was recently approved by the U.S. Food and Drug Administration (FDA) for children. Levaquin levofloxacin is part of the fluoroquinolone group of oral medications prescribed to treat acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, noscocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections, mild to moderate uncomplicated skin and skin structure infections, chronic bacterial prostates, urinary tract infections and acute pyelonephritis caused by Escherichia coli, also known as E. coli, which is an infection affecting the lower intestines of humans and highly associated with food poisonings in the United States.
The drugLevaquin, which is manufactured by from pharmaceutical firm Ortho-McNeil, was approved in 1996, but the oral solution was introduced in 2004 and this was followed by a 750-milligram (mg) five-day oral treatment becoming widely available in 2005, although the Levaquin is also available intravenously as well.
While Levaquin is prescribed for an array of bacterial infections, it has also been approved to treat the effects of airborne anthrax. It was also recently approved for the use by in treating children as an anti-bacterial component and as a treatment of anthrax contamination. The drug is absorbed quickly, particularly after oral consumption and is usually allotted in 500 mg to 750 mg doses.
According to manufacturers, individuals who have kidney disease, diabetes, spinal or brain cord conditions are highly recommended to avoid the drug as it could cause serious side eaffects including:
• slow absorption of in kidney disease patients
• blood level spikes and irregularities of in diabetes patients
• uncontrollable seizures among spinal and brain injury patients
According to manufacturers, the most common adverse drug reactions Levaquin side effects that occurred in U.S. clinical trials of Levaquin included headache, nausea and diarrhea, constipation, dizziness and insomnia. Additionally, the list of side effects continues to grow and patients that exude any of the following symptoms should stop taking the medication and seek medical assistance immediately:
• abdominal tenderness, cramping or severe pain
• confusion, hallucinations or psychosis
• diarrhea (which may be bloody)
• blisters, redness and swelling of the skin
• sensation of burning skin
• trembling or seizures
• easy bruising or bleeding
• numbness in limbs, tingling in fingers
• swelling, pain in legs/muscles
Recent studies have also suggested that individuals with preexisting conditions (previously mentioned) as well as individuals taking specific types of medicine may find an increased risk of Levaquin side effects causing, which cause severe medical trauma.
The following medications that can cause complications, according to an article from the Mayo Clinic, include:
• blood thinners (warfarin/coumadin)
• aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs)
• heart rhythm medications (Cordarone, Pacerone, etc.)
• antacids (Tums, Rolaids)
• ulcer medication (Carafate)
• didanosine (Videx)
• vitamins or supplements containing iron or zinc
Levaquin Tendon Rupture Risks
The most serious Levaquin side effect is the risk of Achilles tendonitis among current and former patients of Levaquin levofloxacin. Several studies published in accredited medical journals including the Journal of Antimicrobial Chemotherapy, The Journal of the American Board of Family Medicine, The Annals of Pharmacotherapy and The Journal of Orthopaedics and Traumatology have all cited case studies in which individuals who have taken Levaquin have been adversely affected by levofloxacin-induced tendonopathy and tendon rupture.
According to the report from The Journal of American Board of Family Medicine, the onset of tendon ruptures among patients characteristically is abrupt in onset causing extreme sharp pains and swelling of legs when walking. The study also reports that while most of the tendonitis among Levaquin patients occurs within the first two weeks of taking the drug, it can occur in patients long after the drug’s cycle has been completed. In some patients, the Levaquin tendon ruptures occurred longer than six months after treatment administration of the drug. The study noted that the U.S. Food and Drug Administration (FDA ) first cited the link of tendon rupture to drugs in the quinolone drug class in 1991.
Although it wasn’t until 1996 when the FDA issued its first Report of Adverse Effects on the fluoroquinolones. Since then, however, it has been recorded that at least 200 reports of tendon rupture occurred through the class of drugs was reported within a 10-year period and no recall or major investigation has occurred to increase warning labels on the drugs, especially Levaquin. Additionally, a report from the United Kingdom found that levofloxacin-induced tendonitis potentially affects approximately 3.2 out of every 1,000 patients who have taken Levaquin.
Victims of Levaquin Risks
Individuals who have previously been exposed to Levaquin, whether through intravenous or oral methods, should speak with their physician to asses any potential risk. Additionally, patients may want to consult with an experienced Levaquin lawyer especially if any of the previous symptoms have occurred. Additionally, because of the severity of tendonitis and potential long-term damage, it is important for an individual to consider seeking out compensation in the form of a Levaquin Lawsuit that may provide monetary relief from the extensive surgical and medical procedures likely associated with solving or easing the pain of tendonitis caused through a prescription of Levaquin.