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Levaquin Approved for Children Despite the Potential Link to Severe Tendon Ruptures Among Patients

Jun 17, 2008
The U.S. Food and Drug Administration (FDA) recently approved an antibiotic known as Levaquin (levofloxacin), part of the fluoroquinolone antibiotic group of drugs used to fight infections, for use by children even though the drug's potential link to severe side effects remains uncertain.

Potential Serious Levaquin Side Effects

Levaquin, from makers Ortho-McNeil, was released to the market in 2004. The drug is used to treat a wide range of bacterial infections including pneumonia, bronchitis, skin infections, urinary tract and prostate infections, Chlamydia and gonorrhea.

The FDA has also approved Levaquin for use against anthrax inhalation for both adults and, recently, children as well. However, several studies have been published recently the antibiotic to severe and spontaneous Achilles tendon rupture among patients treated with Levaquin.

Studies of Levaquin Risks

The Journal of Antimicrobial Chemotherapy published a study conducted by the Department of Microbiology at The University Hospital Lewisham, of several patients being treated with Levaquin, although all were elderly in age, the report found that the link to Achilles tendonitis and rupture may be more common adverse effects of levofloxacin than previously thought.

Despite the fact that this risk has surfaced among adult patients, the FDA continued to approve the drug for use in children under the age or 18. Some researchers believe that the use of the drug for children should be further studied prior to approval, but the FDA has done nothing to block or slow the drugs availability on the market. Another study reflecting the same sentiment involving risks of tendonitis was published in The Journal of the American Board of Family Medicine. Here medical researchers noted that there has been a rise in tendon rupture incidence since the 1980s when the first cases of the effects of fluoroquinolones on tendons were documented.

The study concluded that as more individuals are prescribed levofloxacin, the risk of tendon rupture would continue to rise as well.

Additionally, the study noted that individuals who are showing signs of joint swelling and tenderness that had previously been prescribed the drug, as far back as six months or more, may be at risk for tendon rupture and should seek medical help right away.

The study noted that the risks of tendonitis are severe among patients of levofloxacins and the outcome can range from minor discomfort to death. The only way to reduce the morbidity rate of patients associated with the drug-induced tendonitis or rupture is with prevention of prescribing the drug or intervention of patients taking the drug. Child Risks of Levaquin Consumption

While most of the previous studies were conducted on elderly patients, the Mayo Clinic released an article on the potential risks of prescribing Levaquin to patients younger than 18 years of age. According to the article, published in mid-2007, the use of levofloxacins for children can potentially disrupt bone development.

This information derives from testing of the medication on young animals that were found to have developmental issues after use of the drug. The Mayo Clinic expressed caution when prescribing the drug to young individuals and extreme care must be taken to ensure the proper dosage is prescribed and consumed.

Additional Risks of Levaquin Side Effects

In addition to the risk of tendon rupture among patients, Levaquin may cause other discomforting side effects including sensitivity to sunlight, which is caused through levofloxacin mixing improperly with other medications like antacids containing aluminum, calcium or magnesium; abdominal tenderness or stomach cramping; blisters; diarrhea; confusion; agitation; fever; trembling; sensation of the skin burning; and psychosis and hallucinations.

The Mayo Clinic recommends immediate medical attention if any of the above side effects occur in patients.

Individuals who also have preexisting medical conditions are also advised to avoid the medication because of serious complications that can occur. For example, studies have found that individuals suffering from brain or spinal cord disease taking the drug may have an increase of seizures, while diabetic patients taking Levaquin may find uncontrollable changes in blood sugar levels.

Also, the effects of kidney disease are increased among patients with kidney-related issues because of the slow removal of levofloxacin from the body, according to the Mayo Clinic.

What To Do if Levaquin Tendon Rupture Occurs

Patients who have taken Levaquin and suffer from tendon rupture or who have signs of tendon swelling or pain should seek medical attention immediately, as the severity of the incidence may increase if medical assistance is not sought.

Individuals may be prescribed the use of a cane, splinting, crutches or casting to manage the tendonitis, according to Michael Rudzinski, PA-C, RPh, a practicing physicians assist in orthopedics and pain management in the VA Medical Center in New York. However, if the condition is severe, surgery may be required to repair torn tendons.

Those with Levaquin-induced tendonitis are also advised to contact an experienced Levaquin attorney who can offer assistance with developing a Levaquin lawsuit. Because the risks of the drug have surfaced and can be considered preventable, becoming involved with a potential Levaquin class action lawsuit may be an option to seek monetary compensation for pain and suffering caused.
About the Author
For more information on Levaquin, visit http://levaquin.legalview.com/. Learn about similar legal and pharmaceutical issues like the Digitek digoxin toxicity. Also, find other information on the LegalView site such as the revamped traumatic brain injury portal at http://brain-injury.legalview.com/.
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