A consumer group asked a U.S. court on Thursday to act and force regulators
to make a decision concerning stronger warnings for the commonly used antibiotics
that are members of a class called fluoroquinolones. to alert doctors and patients
about the risks of tendon rupture.
The antibiotics -- widely prescribed for gastrointestinal, respiratory and urinary
tract infections -- include Levaquin, Cipro, and Avelox. Cipro is also sold
under its generic name -- ciprofloxacin.
In August 2006, consumer group Public Citizen petitioned the Food and Drug Administration
to add a "black box" warning, the strongest type available for prescription
drugs, to fluoroquinolones about the risk of tendon injury and rupture.
The possibility of tendon rupture is now mentioned in the drug's prescribing
instructions, but the warning "is buried in a long list of possible adverse
reactions and is far too easy to miss," said Dr. Sidney Wolfe, director
of Public Citizen's Health Research Group.
Stronger warnings could lead patients to switch to other antibiotics soon after
tendon pain develops and before the tendon ruptures, the group argued in a complaint
filed with the U.S. District Court for the District of Columbia.
Public Citizen also argued that the FDA was violating federal law by not ruling
on the petition. The agency said in February 2007 it had not yet reached a decision
because the petition raised complex issues requiring extensive review, according
to Public Citizen.
"While the FDA sits idly by and ignores the problem, more people will suffer
serious tendon ruptures that could have been prevented," Wolfe said. The FDA has received 336 reports of tendon rupture in patients treated with
fluoroquinolones from November 1997 through March 2007, Public Citizen
said. The actual number is likely higher because only a fraction of potential
side effects are typically reported to the agency.
Chicago Survey: Nearly Half of Doctors Have Given Patients Dummy Pills
or Other Placebos
A recently released survey shows that many doctors give dummy pills or other
placebos to their patients, furthering the debate about a practice that some
experts consider unethical.
Nearly half the doctors surveyed at three Chicago-area medical institutions
reported that they have used placebos in medical practice. While the survey
was confined to about 230 doctors, the results closely track those of similar
Doctors said they had administered a variety of placebos to patients, including
in some cases simple sugar tablets. Almost 20% of doctors said they had used
the pills to calm patients, 15% said they used placebos to satisfy patients'
"unjustified" demands for treatment, and 6% to get patients to "stop
Placebos are widely used in research trials as a way to control for the influence
of the placebo effect. In the case of drug trials, one study group may be given
an active drug while another group gets identical treatment with only the active
ingredient missing. In theory this lets researchers study only the active ingredient
while canceling out the placebo effect.
But the use of placebos also raises questions. While study volunteers are usually
told they could receive a placebo as part of the experiment's design, few patients
are informed in this way. That's mainly because the mere knowledge that a pill
is a placebo is usually enough to cancel out the placebo effect. And that lack
of information could undermine a patient's right to informed consent, some experts
say. Commentary by Jerry Hickey, R.Ph.; it is interesting that giving
patients the illusion of control via prescribing a placebo pill may help relieve
symptoms. But is the placebo also given to support the illusion that the physician
is in control.
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