FDA Orders More Stringent Labeling For Opioid Drugs
The US Food and Drug Administration has recently announced safety labeling changes and post-market study requirements for extended-release and long-acting opioid analgesics.
Earlier this year the Center for Disease Control’s Vital Signs report showed that prescription painkiller overdoses killed nearly 48,000 women between 1999 and 2010. The new regulations aim to cut the number of deaths per year from opioid dependence.
“The FDA is invoking its authority to require safety labeling changes and post-market studies to combat the crisis of misuse, abuse, addiction, overdose and death from these potent drugs that have harmed too many patients and devastated too many families and communities. Today’s action demonstrates the FDA’s resolve to reduce the serious risks of long-acting and extended release opioids while still seeking to preserve appropriate access for those patients who rely on these medications to manage their pain,"FDA Commissioner Margaret Hamburg said.
Oxycontin, Opana ER, Embeda, Palladone and MS Contin fall into this class of drugs. The medications contain narcotics such as oxycodone or morphine.
One warning restricts the use of these painkillers to those who need it on daily basis, long-term pain management and for whom non-narcotic drugs haven’t worked.
A second warning targets pregnant women to the danger of narcotic withdrawal syndrome in their newborns.
The FDA is requiring the drug companies that make these product to conduct further studies and clinical trials as more informations is needed to assess the serious risks associated with long term use of ER/LA opioids.
“The FDA remains committed to improving the safety of opioids and to continuing to engage in efforts to evaluate and mitigate the risks associated with opioid use,” said Dr Douglas Throckmorton, deputy director for regulatory programs in the FDA’s Center for Drug Evaluation and Research.