Commonly used antibiotics cause tendon ruptures; Group sues US in push for antibiotic warning

January 18, 2008

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 studies.
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 complaining."
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.