FDA BLACK BOX
The Food and Drug Administration imposed the government's
most urgent safety warning on Cipro, Levaquin, Avelox and many other
flouroquinolone antibiotics. The FDA orders a prominent "black box"
warning and the development of new literature for patients emphasizing the
risks. The most prominent risk is tendon rupture causing long term disability,
possibly permanent.
This is an important first step to ensuring these
antibiotics are only used when the patient faces a potential fatal outcome, and
only after the use of all other antibiotics have been ruled out. This is not
due to the probability of risk, but rather severity.
To those who have been affected, prognosis is normally not
good. There is no cure. Often repeat exposure through food and water cause a
continual never ending cycle of symptoms. Many victims face the fact that their
lives have been completely destroyed. Many face loss of job and income, some
face breakup of the family. Some have even committed suicide because of the
pain inflicted by these drugs.
Unfortunately, physicians currently give these prescriptions
out like candy. To emphasize the ignorance of physicians, Cipro is often
prescribed post-op for tendon repair surgery. The physician will often
prescribe a drug known to cause tendon rupture as a preventive to infection
after tendon repair surgery. There is an obvious neglect on the part of the
physicians who simply do not known the potential dangers of the drugs they
prescribe. So where is the breakdown of information? Unfortunately many
physicians mistakenly rely on pharmaceutical drug reps to point out any
potential side effects rather than investigating it themselves. Further
implicating the physicians, they accept gifts from drug companies and in return
will prescribe unnecessary and dangerous substances. Drug Reps, paid on
commission, find themselves making more sales by not disclosing the dangers, or
make light of potential side effects. Making the problem worse, the drug
manufactures trivialize and distort the potential risks.
A pending U.S. Senate bill would require drug companies to
report gifts to doctors of more than $25. New York State's legislature plans to
hold hearings this year on the relationship between doctors and drug companies.
One congressional critic has even compared the drug industry with the tobacco
industry, and Senator John McCain has called drug makers the "bad
guys."
Antibiotics known as flouroquinolones have been associated
with some or all of the following adverse drug reactions:
Tendonitis, Tendon Rupture, Tendon, Ligament, Joint and
Muscle Damage
Vision Damage, Hearing Loss, Taste Perversion
Peripheral Neuropathy (Tingling, burning sensation)
Insomnia, Nightmares, Anxiety Attacks, Depersonalization,
Cognitive Disorders
Brain, Heart, Liver, Kidney, Pancreas, Blood and Endocrine
Disorders
Severe Psychotic Reactions, Suicidal Thoughts or Actions
Gastrointestinal Damage
Compounding the problem, there are numerous drugs which
should not be taken in combination with this class of antibiotics. There are
increased risks of injury when they are taken in combination with
corticosteroids (e.g.: Prednisone, Flovent, Nasarel, Azmacort, Advair Disku,
Methylprednisolone Dospak, Elocon Cream, Desoximetasone Cream, and Sterapred)
and when taken in combinations with non-steroidal anti-inflammatory drugs
(NSAIDs) (e.g.: Motrin, Pamprin, Aleve, Advil, and Ibuprofen, among others).
Physicians are frequently not aware of these contraindications and prescribe
dangerous combinations of drugs which cause severe injuries to their patients.
Physicians may also not be able to identify that their patient is suffering an
adverse reaction and instruct them to continue to take more of the antibiotic
resulting in very serious and perhaps preventable injuries.
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