Levofloxacin and FDA Information
Levofloxacin is an antibiotic of a drug class called fluoroquinolones. It is used to treat severe bacterial infections. It is sold under the brand name of Levaquin and Tavanic. This drug is helpful in a way but damaging in many ways as it causes a number of severe serious side effects.
A subsidiary of Johnson & Johnson- Ortho-McNeil manufactures Levaquin or levofloxacin. It is also considered a remedy for patients suffering from anthrax.
The Food and Drug Administration (FDA) approved it in 1996. But it came under scanner since its side effects were too huge to be ignored. Therefore, in 2002 and 2007, FDA ordered the manufacturers to add a label that warns against the side effects of using this drug. Again in July 2008 a package insert was added i.e. inclusion of black box warning which highlights the risk of tendinitis and tendon rupture that usage of this drug can cause to all age groups, particularly to those who crossed their sixties and are also taking corticosteroids. In the same year, FDA notifies that a medication guide should be developed for the patients about fluoroquinolone antimicrobial drugs such as levofloxacin or Levaquin. It will inform people more about the pros and cons of the fluoroquinolone drugs.
In addition to tendinitis and tendon rupture, the risk further increases in the people of over 60 years of age who might also happen to have some heart, kidney or lung transplant. Doctors should be immediately consulted only at the start of appearing of the first sign of pain in tendon, swelling or inflammation.
FDA can be informed about any problems you faced due to the intake of this drug, by either reporting online to the FDA MedWatch Adverse Event Reporting program or by e-mail or fax.
Healthcare Professionals are recommended to inform general masses about fluoroquinolones as they are linked with an increase in tendinitis and tendon rupture. In case of kidney, heart, and lung transplant recipients in 60s, the risk is even greater. If the patient experiences pain or inflammation in a tendon or tendon ruptures the treatment must be discontinued. Patients should be advised to stop any exercise, even stop taking the fluoroquinolone and contact a specialist immediately if any sign of tendon pain, swelling, or inflammation occurs.
Before prescribing a fluoroquinolone drug, the healthcare professional s should bear in mind the pros and cons of suggesting this drug to the patient. Some people tolerate this drug while many others develop severe health issues. Depression, torsade de pointes, or Clostridium difficile, convulsions, hallucinations, diarrhea, in some serious cases damage to the liver, alterations in glucose homeostasis, kidneys or bone marrow may occur.
Viral infections such as common cold or influenza are not and should not be treated by fluoroquinolones. They only cure infections caused by bacteria.
Patients taking fluoroquinolone antibiotics may also have inflammation, pain, and swelling, tears of tendons of Achilles, shoulder or hand. Some medicines interfere in functioning of others. Therefore, it is advisable to inform your healthcare professional about that particular medicine you take.