I am sorry about the spell check and the Hydrophone. Does sound like a sound device
I just checked in the PDR.net and the correct product name is zohydro ER. If it is listed in the PDR.net that they must be selling enough to llist it there. Once again sorry for the misspelling.
Regards Eddie
They put out this letter in July 2016. I bought some stock hoping it would go up in 2012
July 2016
FDA-Required REMS Program for Serious Drug Risks
Subject: Risk Evaluation and Mitigation Strategy (REMS) for all extended-release/long-acting opioid
analgesic drug products due to their risks of misuse, abuse, addiction, and overdose
Dear DEA-Registered Prescriber:
You are receiving this letter because you recently registered with DEA to prescribe Schedule II or III drugs. The
purpose of this letter is to inform you about a Risk Evaluation and Mitigation Strategy (REMS) that has been
required by the U.S. Food and Drug Administration (FDA) for all extended-release and long-acting (ER/LA) opioid
analgesic drug products.
ER/LA opioid analgesics are used for the management of pain severe enough to require daily, around-the-clock,
long-term opioid treatment and for which alternative treatment options are inadequate. Because of the risks of
addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of
overdose and death with extended-release formulations, reserve ER/LA opioid analgesics for use in patients for
whom alternative treatment options (e.g. non-opioid analgesics or immediate-release opioids) are ineffective, not
tolerated, or would be otherwise inadequate to provide sufficient management of pain.
They can be safe and effective in appropriately selected patients when used as directed. However, opioid analgesics
are also associated with serious risks and are at the center of a major public health crisis of increased misuse,
abuse, addiction, overdose, and death.
FDA determined that a REMS was necessary to ensure that the benefits of ER/LA opioid analgesics continue to
outweigh their risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate
prescribing, abuse, and misuse. A REMS is a strategy to manage a known or potential serious risk associated with
a drug product. In the interest of public health and to minimize the burden on the healthcare delivery system of
having multiple unique REMS programs, the pharmaceutical companies subject to this REMS have joined together
to implement the REMS for all ER/LA opioid analgesic drug products.
The ER/LA Opioid Analgesic REMS has three principal components:
a) Prescriber training on all ER/LA opioid analgesics,
b) a Patient Counseling Document on Extended-Release/Long-Acting Opioid Analgesics (PCD), and
c) a unique Medication Guide for each ER/LA opioid analgesic drug product.
The branded and generic drug products subject to this REMS include all:
• extended-release, oral-dosage forms containing
- hydrocodone,
- hydromorphone,
- morphine,
- oxycodone,
- oxymorphone, or
- tapentadol;
• fentanyl and buprenorphine-containing transdermal delivery systems; and
• methadone tablets and solutions as well as buprenorphine-containing buccal films that are indicated for use as
analgesics.
Prescriber Action
Under the REMS, you are strongly encouraged to do all of the following:
• Train (Educate Yourself) — Complete REMS-compliant training on the ER/LA opioid analgesics offered by an
accredited provider of continuing education (CE) for your discipline. REMS-compliant training will: (a) be delivered
by accredited CE providers; (b) cover all elements of the FDA Blueprint for Prescriber Education for Extended-
Release and Long-Acting Opioid Analgesics (“FDA Blueprint”); © include a knowledge assessment; and (d) be
subject to independent audit of content and compliance with applicable accrediting standards.
PO Box 1730 • West Caldwell, NJ 07007
I just checked in the PDR.net and the correct product name is zohydro ER. If it is listed in the PDR.net that they must be selling enough to llist it there. Once again sorry for the misspelling.
Regards Eddie
They put out this letter in July 2016. I bought some stock hoping it would go up in 2012
July 2016
FDA-Required REMS Program for Serious Drug Risks
Subject: Risk Evaluation and Mitigation Strategy (REMS) for all extended-release/long-acting opioid
analgesic drug products due to their risks of misuse, abuse, addiction, and overdose
Dear DEA-Registered Prescriber:
You are receiving this letter because you recently registered with DEA to prescribe Schedule II or III drugs. The
purpose of this letter is to inform you about a Risk Evaluation and Mitigation Strategy (REMS) that has been
required by the U.S. Food and Drug Administration (FDA) for all extended-release and long-acting (ER/LA) opioid
analgesic drug products.
ER/LA opioid analgesics are used for the management of pain severe enough to require daily, around-the-clock,
long-term opioid treatment and for which alternative treatment options are inadequate. Because of the risks of
addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of
overdose and death with extended-release formulations, reserve ER/LA opioid analgesics for use in patients for
whom alternative treatment options (e.g. non-opioid analgesics or immediate-release opioids) are ineffective, not
tolerated, or would be otherwise inadequate to provide sufficient management of pain.
They can be safe and effective in appropriately selected patients when used as directed. However, opioid analgesics
are also associated with serious risks and are at the center of a major public health crisis of increased misuse,
abuse, addiction, overdose, and death.
FDA determined that a REMS was necessary to ensure that the benefits of ER/LA opioid analgesics continue to
outweigh their risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate
prescribing, abuse, and misuse. A REMS is a strategy to manage a known or potential serious risk associated with
a drug product. In the interest of public health and to minimize the burden on the healthcare delivery system of
having multiple unique REMS programs, the pharmaceutical companies subject to this REMS have joined together
to implement the REMS for all ER/LA opioid analgesic drug products.
The ER/LA Opioid Analgesic REMS has three principal components:
a) Prescriber training on all ER/LA opioid analgesics,
b) a Patient Counseling Document on Extended-Release/Long-Acting Opioid Analgesics (PCD), and
c) a unique Medication Guide for each ER/LA opioid analgesic drug product.
The branded and generic drug products subject to this REMS include all:
• extended-release, oral-dosage forms containing
- hydrocodone,
- hydromorphone,
- morphine,
- oxycodone,
- oxymorphone, or
- tapentadol;
• fentanyl and buprenorphine-containing transdermal delivery systems; and
• methadone tablets and solutions as well as buprenorphine-containing buccal films that are indicated for use as
analgesics.
Prescriber Action
Under the REMS, you are strongly encouraged to do all of the following:
• Train (Educate Yourself) — Complete REMS-compliant training on the ER/LA opioid analgesics offered by an
accredited provider of continuing education (CE) for your discipline. REMS-compliant training will: (a) be delivered
by accredited CE providers; (b) cover all elements of the FDA Blueprint for Prescriber Education for Extended-
Release and Long-Acting Opioid Analgesics (“FDA Blueprint”); © include a knowledge assessment; and (d) be
subject to independent audit of content and compliance with applicable accrediting standards.
PO Box 1730 • West Caldwell, NJ 07007