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FDA: Antibiotics raise tendon rupture risk 7-9-08
The U.S.Food and Drug Administration (FDA) issued a letter to the
manufacturers of certain antibiotics to request that a Boxed Warning in the
product labeling be printed to highlight the increased risk of tendinitis and
tendon rupture among patients taking these medications.
The affected antibiotics include Bayer AG's Cipro and Avelox, Oscient
Pharmaceuticals Corp's Factive, Depomed Inc's Proquin XR, Johnson & Johnson's
Levaquin and Floxin and Merck & Co Inc's Noroxin. The generic form of Cipro,
ciprofloxacin and the generic form of Floxin, ofloxaci are also affected. These
drugs belong to a class known as fluoroquinolones.
The request was based on the agency’s new authority under the Food and Drug
Administration Amendments Act of 2007 and the FDA action was triggered by its
findings that these drugs have some serious safety issues that patients and
doctors need to know.
The FDA conducted a new analysis of the literature and post marketing data on
adverse reports and confirmed that use of fluoroquinolones is associated with an
increased risk of tendon rupture. Additionally, despite the current warning of
tendon rupture in the product labeling, large numbers of tendon related adverse
events continue to be reported to the agency.
The risk of developing fluoroquinolone-linked tendonitis and tendon rupture is
particularly high in people older than 60 and in those who are taking
corticosteroid drugs and in kidney, heart and lung transplant patients, the FDA
says in its public statement.
Dr. Renata Albrecht, a top health official at the FDA said cited by Reuters that
the estimated risk of tendon rupture is about three times higher among patients
who used the concerned antibiotics. The general population has a rate of tendon
rupture of 1 in 100,000.
Most cases of tendon rupture occurred to the Archilles tendon, and some to
shoulders, biceps, hands and elsewhere. Rupture may be avoided if patients act
early enough. But some patients can’t recover.
The FDA also sent a notice to Health Care Professionals today to alert them to
the increased risk of tendinitis and tendon rupture in patients who are taking
these antibiotics and to highlight new concerns about the risk.
"Patients experiencing pain, swelling, inflammation of a tendon or tendon
rupture should be advised to stop taking their fluoroquinolone medication and to
contact their health care professional promptly about changing their
antimicrobial therapy," the FDA advised in its statement.
"Patients should also avoid exercise and using the affected area at the first
sign of tendon pain, swelling, or inflammation."
These drugs are approved for treatment or prevention of certain bacterial
infections. They can't be used to treat or prevent viral infections such as
colds or flu.
"Fluoroquinolones are effective in treating certain bacterial infections, but
health care professionals and patients need to be aware of the increased risk
associated with the use of these drugs of developing tendinitis and tendon
rupture, particularly for certain patient populations," said Edward Cox, M.D.,
director, Office of Antimicrobial Products, Center for Drug Evaluation and
Research.
"The FDA believes it is important to highlight and strengthen information
regarding possible side effects of fluoroquinolones because it may affect
decisions about the relative risks and benefits associated with these products."
The FDA requires a systemic or uniform updated warning language to be used in
the product labeling. However, the warning is valid only for systemic use of
fluoroquinolones, pills, tablets, capsules and injectable formulations, but not
for topical applications.
The manufacturers have 30 days to respond or submit the safety labeling changes
including the Boxed Warning and the Medication Guide.
Because of the magnitude of the side effects of these medications, the FDA also
requests that the patient medication guide be updated to reflect the increased
risk of tendinitis and tendon rupture.
Most patients can tolerate the antibiotics of concern, but some will develop
other serious adverse reactions including convulsions, hallucinations,
depression, abnormalities in heart rhythm or severe diarrhea, the FDA says.
The severe adverse effects of these antibiotics have been known for quite a long
time. In 2006, Public Citizen sued the FDA to have the boxed warnings carried on
the product labeling because of the reporting of 262 cases of tendon ruptures,
258 cases of tendonitis and 274 cases of other tendon problems through the end
of 2005.
Sidney Wolfe, health head of Public Citizen's Health Research Group, told
Reuters that roughly 100 more cases were reported after that time.
The consumer group actually was calling for tendon warnings early in 1996 and
sued the FDA to force companies to notify physicians about the risk.