UPDATE 1-FDA strengthens pain drugs warnings in face of abuse epidemic
Sept 10 (Reuters) - The U.S. Food and Drug Administration said it would require stronger safety language on labels of long-acting and extended-release opioids in response to an epidemic of overdoses and deaths from the widely-used pain medicines.
The FDA will highlight on labels the dangers of abuse and possible death, as well as risks to newborns of mothers taking the medicines, it said in a release on Tuesday.
The agency will require extra studies of the drugs to assess known risks of abuse, overdose and death.
FDA Officials noted the number of fatalities from the powerful pills has have more than tripled over the past decade. In a conference call, officials said opioids have played a "disproportionate role" in drug abuse and deaths.
The FDA said the drug labels currently are indicated for patients with moderate to severe pain and would in future indicate they should only be used for severe pain.
Updated language in the drug labels will stress the medicines are meant for pain severe enough to require daily, round the clock, long-term opioid treatment, and only for those who have not had adequate pain relief from alternative medicines.
The labels, when given final approval, will also include prominent boxed warnings that chronic maternal use of the drugs can result in potentially fatal opioid withdrawal syndrome in newborns.
"The FDA is invoking its authority to require safety labeling changes and postmarket studies to combat the misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities," FDA Commissioner Margaret Hamburg said in a release.
The agency said the changes to language in package insert labels for the drugs, when final, will better enable doctors to tailor use of the potentially addictive medicines to individual patients.