FDA Needs Drug Safety Office, Say Doctors

Monitor Wire Services

"Overall, 52 percent of approved drugs have serious adverse effects not detected prior to approval" by the FDA, says a commentary in the mid-May Journal of the American Medical Association.

They say in the commentary that the FDA's focus is on approving new drugs and not on monitoring drugs after they have already entered the marketplace. "Merely recording adverse effects is not by itself sufficient to protect the public.

"Each year, prescription drugs injure approximately 1.5 million people so severely they require hospitalization, and 100,000 die." One major job of the new national office, the authors say, should be first to develop "reliable estimates of deaths and serious injuries from prescription drugs," and second to implement procedures to reduce the number of drug-related injuries.

"Without [good] data, it is impossible to tell whether serious injuries associated with prescription drug adverse effects are declining or whether an epidemic of drug-induced injury may be occurring," they write.

This new office should estimate the number and cause of serious injuries and death -- no one at the FDA is routinely collecting such information, nor is anyone else in the government.

"It makes no more sense to monitor drug safety without knowing the extent of serious injuries than to have a National Highway Transportation Safety Administration that operated without information about automobile accidents or a Federal Aviation Administration (FAA) that does not know how many airplane crashes have occurred."

Also missing is a way to track new serious adverse reactions: The reports of adverse reactions are handicapped by limited physician participation, they say.

The FDA estimates that only 1 percent of adverse events are ever reported. For example, an average of 82 adverse reactions are reported each year for digoxin toxicity, which includes serious arrhythmias, but a systematic study of Medicare records found 202,211 hospitalizations in a seven-year period for digoxin-adverse reactions. Digoxin is prescribed for heart failure.

Some adverse reactions are disguised because an event might naturally be expected with the disease being treated. For example, it was hard to detect that flecainide -- a drug given for life-threatening ventricular tachycardia or fibrillation -- itself caused cardiac arrest.

The physicians also called for efforts to monitor effectiveness of previous safety alerts. The FDA has no organized program to be sure that important warning messages are being communicated to doctors and the general public -- and whether they are being heeded. Even boxed warning labels have little effect.

"Safety monitoring should include surveillance of the most important known and expected risks and regular public reporting on the response of the public and prescribing physicians."

Urgently needed, say the authors, is an early warning system that would focus on medical problems that are most commonly induced by drugs, such as birth defects, aplastic anemia, and certain irregular heart rhythms.

The authors also say that the new office should identify the priority targets for prevention efforts. "Are preventable drug-related injuries occurring because of inadequate initial testing, a breakdown in post-market surveillance, physician prescribing errors or a lack of patient compliance?" they ask.

"The nation needs an office of drug safety with the authority, independence, funds and legal mandate to undertake all four of the major tasks that define a basic drug safety monitoring program," the three conclude. "The funds to pay for this expanded safety program should come from user fees collected from pharmaceutical companies."

They contend that just one penny per prescription would yield approximately $24 million for an enhanced drug safety monitoring program. Additional funds raised the same way "could finance other needed initiatives in long-term drug testing, safety research and education at the nation's medical centers."

They add, "This investment in drug safety has the potential to save thousands of lives and prevent tens of thousands of serious injuries each year."