"This new indication, once finalized, will remind prescribers that immediate-release opioids are also powerful drugs with important safety concerns, " said Dr. Doug Throckmorton, a deputy director in the FDA's drug center. The FDA will provide new cautions about dosing and "a warning not to abruptly stop treatment in a physically dependent patient".
As part of the boxed warning on IR opioid analgesics, the FDA now requires a precaution that chronic maternal use of opioids during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated using protocols developed by neonatology experts.
The extensions of these warnings apply particularly to the immediate-release painkillers; the FDA already upped labeling restrictions for extended-release painkillers in 2013.
The FDA added similar warnings to long-acting drugs - such as OxyContin, which release their dosage slowly, over 12 hours or more - almost three years ago. Those are given for pain severe enough to require daily, round-the-clock treatment and contain more drug per tablet than immediate-release tablets. The labels "may have an impact on people using opioids for chronic pain - it's a reminder to them - but it's not going to impact the people that are really caught up in the heroin craze", Merrigan said. The new warnings include the risks of abuse, addiction, overdose and death. Ninety percent of all opioid prescriptions are for these fast-acting, or immediate-release, formulations.
"Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids", Califf says in a release about the new requirements. When prescribing opioids for short-term pain, the agency said doctors should prescribe a 3-day supply, whenever possible.
The move by FDA was praised by Dr. Leana Wen, Baltimore City health commissioner, for informing prescribers and patients about the risks. As per the announcement by the FDA, when a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug, reported Fox 8.
Califf added the new warnings will help, but the FDA can't regulate how doctors practice medicine.
Yesterday's announcement comes as pressures have mounted in Washington for officials to take action on what increasingly is being spotlighted as a public health crisis after being in the shadows for years.
According to the Centers for Disease Control and Prevention, overdose deaths involving prescription drugs have quadrupled since 1999, and has followed an increase in prescribing.
In light of the prescription drug abuse epidemic, the Food and Drug Administration (FDA) is cracking down on the labeling of opioid painkillers.
"The main driver of our opioid epidemic is addiction, and the immediate-release products are just as addictive... that's why they should be prescribed more cautiously", said the group's founder, Dr. Andrew Kolodny, an addiction therapist.
The FDA's label change came as a House panel held a hearing March 22 on opioid abuse.
However, critics of the FDA - such as the group Physicians for Responsible Opioid Prescribing - called on the agency to add the warnings years ago.
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Source: Opioid Medications to Get New Boxed Warnings
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