Some powerful Extended Release and Long Acting pain medicines get a risk plan from the FDA

Risk and a new language and plan for Extended release and long acting opioid medicines-What on earth does this mean? Language in medicines is always complicated. The FDA has approved a REMS for 12 important pain medicines and it’s important to understand what this means. The medicines that come under this FDA Risk Evaluation and Mediation Strategy include:

  • Avinza (morphine sulfate extended release capsules)
  • Butrans (buprenorphine transdermal tablets)
  • Dolophine (methadone hydrochloride tablets)
  • Duragesic (fentanyl transdermal)
  • **Embeda (morphine sulfate and naltrexone extended release capsules)
  • Exalgo (hydromorphone hydrochloride extended release tablets)
  • Kadian (morphine sulfate extended release capsules)
  • MS Contin (morphine sulfate controlled release tablets)
  • Nucynta ER (tapentadol extended release oral tablets)
  • Opana ER (oxymorphone hydrochloride extended release tablets)
  • OxyContin (oxycodone hydrochloride controlled release tablets)
  • *Palladone (hydromorphone extended release capsules)

*No longer marketed but still approved

**not currently available because of a voluntary recall

The FDA has decided to undertake this Risk lowering approach for these medicines because it thinks that there is a “disproportionate safety problem” associated with the medicines listed. The FDA says that it realizes that these medicines can offer effective pain management when they are used as directed, but they see serious risks associated with people taking these drugs who should NOT take them and also see risk with improper use (accidental or intentional).

Part of the problem comes from the fact that there are medicines that go to work immediately and for much of the dose which are known as IR medicines and they work for shorter amounts of time.

  • ER (extended Release) medicines are designed (formulated) to give pain relief for a longer time (provide longer drug release) so that they also have to be taken less often (decreased dosing frequency).
  • LA or Long Acting medicines like methadone work for a longer time because of the nature of the medicine itself, not because of the way it is made (design feature).

Does this announcement mean that these are bad drugs? ABSOLUTELY NOT. What this announcement means is that the FDA wants to alert health professionals and patients about how important it is to have these medicines properly prescribed and properly used. Additionally, companies that make these products will need to offer continuing education for prescribers and dispencers of these products. All prescribers are encouraged to thoroughly talk with patients about the risks and benefits of these medicines with their patients. This editor would encourage prescribers to talk with patients and their families as patient and family-centered care is an important way to get strong results from medicines. People who are worried about problems or who have questions about these new FDA steps should talk to their doctor and pharmacist to get the answers they need.

There is actually an FDA blueprint for Prescriber Education and the full release on this important issue can be seen at

More information can be found by looking at the specific medicine you have questions about. For example, this editor visited I found a very complete site with many documents including a 20-page health care professional education document. My understanding is that education on these new REMS will have to be offered to prescribers by March 1, 2013. As always, take care of yourself and know your medicines. There will be information on REMS in the new Essential Guide to Prescription Drugs next year. The Essential Guide to Prescription Drugs, 12 Top Meds for 2012 was published before these REMS, but includes information on other REMS (for example, on Ipilimumab (Yervoy).

Contact Us