FDA Announces New Warnings on Opioid Painkillers

FDA Announces New Warnings on Opioid Painkillers

September 11th, 2013 // 12:25 am @

Source: Pharmalot

Due to the concerns about the frequent abuse of many types of prescription painkillers, FDA now is going to require major  label safety changes and several types of new post market study requirements for many types of long acting and extended release opioids. Their hope is to cut down on the incidents of improper prescribing. This drug group, which already has a Risk Evaluation Mitigation Strategy in place (REMS), does include Opana ER and OxyContin.

This new move by FDA is the latest attempt by the agency to slow down a serious problem of deaths and addictions that are caused by the increasing use of such drugs. Back in 2010, CDC stated that the increase in deaths by overdose in the US was directly caused by a 300% increase in the prescription of such drugs since 1999. That is why the US Senate Finance Committee did a probe last year into drugmaker promotions for the drugs that have seemed to fuel the increased usage.

New Labels Required by FDA for Opioid Painkillers

FDA has been under a lot of public pressure to take more steps to fight this problem. In early 2013, FDA started by releasing a new draft guidance that tried to help drug companies to figure out which studies need to be conducted to come up with drugs that can reduce abuse and which labeling claims FDA may approve.

However, FDA was chastised by some stakeholders for their approved labeling. Physicians for Responsible Opioid Prescribing petitioned FDA to improve the wording of the labels, which said that the drugs were used for moderate or severe pain. This group said that this was too broad of a definition. It implied, they said, that the drugs are safe for use in the long term.

Now the labels will state that the drugs are designed to deal with pain that is of enough severity to require daily opioid treatment for the long term, and the alternatives are not sufficient. Due to risks of addiction, abuse and overdose, these drugs only can be used by patients who find that the other treatments are not tolerable or are ineffective. The word ‘moderate’ does not now appear on the label.

According to Douglas Throckmorton, deputy director for regulatory programs in CDER, the new labeling changes offer better descriptions of the risks and safety problems that are associated with opioids, and these labels should encourage better prescribing and monitoring.

FDA also is mandating a new warning in a box to remind patients that long term use during pregnancy may result in neonatal opioid withdrawal syndrome or NOWS

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