Hello Friends. This is disturbing news. Do you want the FDA to regulate your medications? Well, they are trying to do just that. So, Please read.......
Background on Opioid REMS........
On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks (Opioid REMS Meeting Invitation Template (PDF - 18KB); Opioids Products Chart). The affected opioid drugs include long-acting and extended-release brand name and generic products and are formulated with the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone.
Under the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85), FDA has the authority to require persons submitting certain drug approval applications to submit a proposed REMS as part of the application. FDA may require a REMS when necessary to ensure that the benefits of a drug outweigh its risks. FDAAA also authorizes FDA to require holders of certain drug applications approved without a REMS to submit a proposed REMS if the agency becomes aware of new safety information and makes a determination that a REMS is necessary to ensure the benefits of the drug outweigh its risks.
Opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients. Opioid drugs have serious risks when used improperly. In the past, FDA, drug manufacturers, and others have taken a number of steps to prevent misuse, abuse and accidental overdose of these drugs, including providing additional warnings in product labeling, implementing risk management plans, conducting inter-agency collaborations and issuing direct communications to both prescribers and patients. Despite these efforts, the rates of misuse and abuse, and of accidental overdose of opioids, have risen over the past decade. FDA believes that establishing a REMS for opioids will reduce these risks while ensuring that patients with legitimate need for these drugs will continue to have appropriate access.
FDA recognizes the need to achieve balance between appropriate access and risk mitigation and believes an effective risk management strategy would benefit from input from industry, patient advocacy groups, the pain and addiction treatment communities, the general public, and other stakeholders. Through this process, FDA hopes to gain valuable information that will lead to practical and effective solutions for developing a REMS and for appropriate use of these opioid drug products.
CURRENT STATE OF OPIOID DRUG APPROVALS.........
In July and August 2009, FDA approved two new opioid drugs with REMS. Onsolis, a short-acting opioid to manage breakthrough pain, was approved for patients with cancer who already use pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. FDA required a REMS with Onsolis, because it is a drug that can lead to overdose, sudden serious breathing difficulties, and death. The REMS for Onsolis was specifically tailored to the drug and is not intended to be a model for the long-acting opioid REMS.
FDA also approved Embeda in August with a REMS that includes a Medication Guide. Embeda is a long-acting opioid for the management of moderate to severe pain when a continuous, around-the-clock opioid is needed for an extended period of time. Once FDA determines what REMS elements should be implemented across the class of modified-release opioids, Embeda's REMS will be modified to incorporate those elements. FDA will continue to review new drug applications for opioids while developing the requirements for REMS for long-acting opioids.
OPIOIDS PRODUCT CHART.......
Opioid Products That May Be Required to Have Risk Evaluation and Mitigation Strategies (REMS)
Brand Name Products
Generic Name Trade Name Applicant/Sponsors
Fentanyl Duragesic Extended Release Transdermal System Ortho McNeil Janssen
Hydromorphone *Palladone Extended Release Capsules Purdue Pharma
Methadone Dolophine Tablets Roxanne
Morphine Avinza Extended Release Capsules King Pharms
Morphine Kadian Extended Release Capsules Actavis
Morphine MS Contin Extended Release Tablets Purdue Pharma
Morphine Oramorph Extended Release Tablets Xanodyne Pharms
Oxycodone OxyContin Extended Release Tablets Purdue Pharma
Oxymorphone Opana Extended Release Tablets Endo Pharma
Do you want the FDA to be the ones who decide what prescription Pain Medication you will be allowed to take???
I know for a fact that none of us want this. I urge you to go to the FDA's REMS web site and give them your comment. I also have the address available. Please contact me and I will be more than happy to give it to you. The more members that we can get to speak out, the better. THIS IS OUR LIVES THAT THEY ARE FOOLING WITH. We must ban together NOW.
My very best,