FDA To Change Prescription Warnings

Friday, December 22nd 2000, 12:00 am

By: News On 6

WASHINGTON (AP) â€” Hoping to combat the dangerous problem of doctors prescribing the wrong drug for the wrong patient, the government said Thursday it would overhaul the fine-print drug warnings doctors are supposed to read so they can quickly spot hazards and keep risky medicines away from people they might kill.

Admitting that too few doctors today even read vital drug warnings, the Food and Drug Administration said the change will let busy physicians spot in 30 seconds a medicine's biggest danger.

It's the FDA's latest effort to improve drug safety in the wake of a string of banned drugs that killed dozens of Americans.

``I think we'll see a real difference,'' said FDA Commissioner Jane Henney. Patients ``will have a greater assurance that the drug prescribed will be the right one.''

Every medicine, even aspirin, comes with side effects. A drug that's safe for one person can kill the next. Indeed, studies estimate 2 million Americans are hospitalized annually with drug side effects, and 100,000 die.

So each new prescription drug comes with pages of complex warnings, written in fine print, that tell doctors how to match each patient's risk factors with each drug's side effects.

But few doctors read these labels, instead learning about new drugs from pharmaceutical salesmen unlikely to emphasize the risks.

In fact, seven of the 11 drugs pulled off the market for safety problems since 1997 were banned in part because doctors kept prescribing them to the wrong patients despite label warnings. The FDA recently announced in the Journal of the American Medical Association that if things don't improve, it will ban even more drugs.

Thursday, the FDA proposed regulations to make the labels of newer drugs easier for doctors to use, with at-a-glance sections of the most important safe-prescribing information. Among the changes:

â€”Each label will begin with a ``highlights'' section, leading with the most important warning. Take the blood pressure drug Capoten. Its label would state up front, in bold print, that use in the second or third trimester of pregnancy can kill a fetus.

â€”Next, doctors learn if additional warnings have been added in the last year, so they can check an update they might have missed.

â€”Then comes the proper dose.

â€”Next come other important side effects and, in bold print, the FDA's phone number to report suspected problems in patients. This is a major change. The FDA depends on doctors voluntarily reporting their patients' problems to uncover previously unknown drug risks, yet few do.

â€”Doctors can then read the label's old-fashioned details, using a new index to each topic instead of slogging through all the tiny type.

â€”The label ends with a special ``patient counseling'' section, a checklist of everything patients should know before filling the prescription.

The change is ``a great step, a badly needed step,'' said drug safety expert Dr. Jay Cohen of the University of California, San Diego.

He recounts patients who wound up in the emergency room with illnesses doctors insisted couldn't be due to their medication, only to discover later that those doctors had missed warnings buried in the label.

But Cohen cautioned that FDA can't depend just on user-friendly drug labels to deal with risky medications. For example, new drugs are tested on only several hundred to several thousand people, meaning side effects thought rare can crop up when millions use the pills. FDA then adds new warnings â€” but even doctors who read the labels of newly approved drugs seldom check for updates.

Nor will new labels satisfy critics who say the FDA glosses over early danger signs because of congressional and industry pressure to approve new drugs quickly.

Henney says FDA is working on other drug-safety improvements, including limiting which doctors can prescribe certain medicines when they first hit the market.

But the new labels ``will hit physicians all across the board,'' she said. ``There's no guarantee,'' but in FDA meetings with doctors around the country, ``what physicians told us is if they were presented with information in a clear and useful way, they would read the label.''

The FDA will mandate the label change for all newly approved drugs and some older ones, but not old medicines posing few problems. The agency will accept public comment on the proposed change through March before finalizing the rules.