FDA Urges Studies on Safer Formulations of Narcotic Painkillers01/10/13
WEDNESDAY, Jan. 9 (HealthDay News) -- As part of an effort to
control the misuse of prescription narcotic painkillers, the U.S.
Food and Drug Administration is calling on drug makers to study
formulations of the medications that would deter people from
"Opioid drugs provide significant benefits for patients when used properly," Dr. Douglas Throckmorton, deputy director for regulatory programs at the FDA's Center for Drug Evaluation and Research, said during an afternoon press conference Wednesday.
However, "opioids also carry a risk of abuse, misuse and death,"
he said. In 2009, there were nearly 425,000 emergency department
visits involving inappropriate use of narcotic painkillers and an
estimated 15,600 deaths involving these drugs, Throckmorton
The draft guidance the FDA issued Wednesday is designed to let
drug makers know what kinds of studies to conduct to measure the
effectiveness of the new formulations, and how the agency will
evaluate safety claims pharmaceutical companies make about their
One issue yet to be dealt with is whether the makers of cheaper
generic versions of narcotic painkillers will also be asked to try
to produce tamper-free versions of their product.
"This guidance doesn't address generics," Throckmorton said. "What future action we might take with regards to generics in requiring they have abuse- deterrent technologies I simply can't comment on today."
Narcotic painkillers can be abused in many ways, including
crushing pills to make them easier to dissolve and inject, the
The FDA pointed out, however, that the science of abuse
deterrence is relatively new, and ways of making drugs harder to
abuse are quickly developing and changing.
If the new formulations meet the requirements for being deemed
tamperproof, the drug maker could label its product as being safer,
according to the agency.
"Our decision-making will be based on the scientific data that are submitted to us," Throckmorton said. "The FDA intends to take a flexible approach to the evaluation and labeling of these products as the new science evolves."
The FDA is looking for public comments on the draft guidance,
and will make its final recommendations later in the year.
"Drug companies are looking at new ways to make it very hard to use a drug [in ways other] than what is intended," said Peter Delany, director of the Center for Behavioral Health Statistics and Quality at the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA).
It will take a combined effort from federal and state
governments, doctors and other health care professionals to stop
the misuse of these drugs, Delany said.
SAMHSA recently released a report that highlights the extent of
the prescription-drug-abuse problem state by state. According to
that report, some 22 million Americans abused prescription
painkillers in 2002.
Pooled data from 2010 and 2011 shows the rates of prescription
painkiller abuse for those aged 12 or older ranged from 3.6 percent
in Iowa to 6.4 percent in Oregon.
For more on prescription drug abuse, visit the
U.S. National Library of Medicine.
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