Discussion in 'Fibromyalgia Main Forum' started by 3gs, Mar 31, 2009.

  1. 3gs

    3gs New Member

    Local news just reported FDA has told pharmacies they have 90 days to pull drugs for pain.

    some are the following morphine sulfate,hydromorphone,oxycodone and hydrocodone(im screwed). also a long lasting guafiensen drug and others. said no prior approval was gotten before drugs released on market.

    Have a bad feeling things are going to get really tough out there for meds. Like its not already.
  2. luckyman

    luckyman New Member

    There are way too many people with serious pain for this to happen. I'm keeping my eyes and eyes open on this one. Do you have links to verify this?

    On a completely other absurdity, I read today that CARB, no not the kind we eat, but as an acronym for California Air Resourses Board has enacted a law that will become effective in a couple of years BANNING the sale of black or dark colored cars and trucks in CA. Many other states follow CARB's legislation. It seems that dark cars require greater use of air conditioning, thus leaving a larger carbon footprint because of the extra power to run the air cond. I have links! Paint manufacturers are scrambling to make their paint more reflective and hopefully sidestep the law. As of now, all they can make is "mud puddle brown"

    It's really hard to believe what's going on in this country. Please update if you hear any more.
  3. TeaBisqit

    TeaBisqit Member

    I heard about the drug pulls, it's on the AP.

    I don't understand what's happening or why. They are removing anything that helps us. It makes no sense. Are they trying to get people to be forced to buy from drug dealers on a corner??? I just don't get it.
  4. TropicalGirl

    TropicalGirl New Member

    I just went to CNN news and got the scoop! Yes, they are pulling over 100 drugs that do have the morphine base...BUT, they are NOT taking our pain medications off of the market! They are sending out "warning letters" to pharmacies that are distributing pain medications from these "off brand" pharmaceutical manufacturers. They are giving the pharmacy 60 days to obtain "legalized FDA approved" narcotics from REAL suppliers.

    This is actually good for all of us, because it is forcing the pharmacies that we go to, to give us medications that have the standard medication amount that has been approved by the FDA.


    I hope this helps!

    Tropical Girl ;)
    [This Message was Edited on 04/01/2009]
  5. luckyman

    luckyman New Member

    FDA to Step Up Regulation of Extended-Release Opioids
    By John Gever, Senior Editor, MedPage Today
    Published: February 09, 2009

    ROCKVILLE, Md., Feb. 9 -- The FDA has begun a "massive new program" to stem abuse of opioid painkillers, putting the onus on manufacturers to develop new misuse-prevention programs.

    The effort is likely to set up new hoops that physicians must jump through in prescribing these agents, currently used by millions of Americans.

    On Friday, the agency sent letters to 16 companies that make 24 extended-release and patch formulations of opioid drugs, informing them that they will have to develop formal risk evaluation and mitigation strategies for the products.

    Among the drugs covered by the letters are Purdue Pharma's extended-release oxycodone (OxyContin), Ortho McNeil Janssen's fentanyl patch (Duragesic), and Endo Pharma's extended-release oxymorphone tablet (Opana), along with generic versions.

    Generic and branded versions of morphine, methadone, and hydromorphone are also included.

    "This will be a relatively massive new program," said John Jenkins, M.D., director of new drugs in the FDA's Center for Drug Evaluation and Research, in a press briefing today.

    He estimated that some 21 million prescriptions are written annually for products covered by the letters.

    Dr. Jenkins said clinicians would likely see new procedures for writing prescriptions for these painkillers and patients would face hurdles in filling them, although the specifics remain to be worked out and may vary by product.

    The plans will take several months to unfold, Dr. Jenkins said.

    The first step will be a March 3 meeting between FDA staff and the 16 manufacturers.

    Additional steps will include discussions with other federal agencies -- such as the Drug Enforcement Administration -- patient and consumer advocates, representatives of the pain and addiction treatment communities, and other healthcare professionals.

    Dr. Jenkins said a public meeting would be held in late spring or early summer to allow for broader public input and participation.

    "Nothing is changing immediately," he emphasized. "This is obviously a very complex undertaking, so it will take some time."

    He said that the programs would likely include a training element for physicians to educate them on the risks of extended-release opioids and how to minimize them for individual patients.

    The move represents the FDA's most significant use yet of authority it was granted under the Food and Drug Administration Amendments Act of 2007.

    Previous risk evaluation and mitigation programs have put significant paperwork responsibilities on physicians and patients.

    For example, the program governing the acne treatment isotretinoin (Accutane) required that women of child-bearing age provide proof of a negative pregnancy test before they could receive the drug, a known teratogen.

    Bob Rappaport, director of the FDA unit overseeing anesthesia and analgesic drugs, said new survey data indicate that "non-medical" use of pain medications is growing in children as well as several adult age groups.

    Primary source: FDA
    Source reference: http://www.fda.gov/cder/drug/infopage/opioids/default.htm

  6. luckyman

    luckyman New Member

    New Guidelines on Opioids for Chronic Pain Include Caution on Methadone

    By John Gever, Senior Editor, MedPage Today
    Published: February 12, 2009
    Reviewed by Zalman S. Agus, MD; Emeritus Professor
    University of Pennsylvania School of Medicine.

    PORTLAND, Ore., Feb. 12 -- Although methadone has become an increasingly popular option for treating chronic pain, it is one of the most unpredictable opioids and should be used cautiously, according to new guidelines issued this week. Action Points
    Explain to interested patients that opioids reduce chronic pain in most patients but seldom eliminate it altogether. Breakthrough pain is common even in patients taking maximal safe doses.

    Explain that long-term use of opioids can have a variety of adverse effects and that the prescribed dosing schedule should be followed exactly.
    The methadone caution was one of 25 recommendations in the guidelines, developed by the American Pain Society and the American Academy of Pain Medicine and published in the February issue of the Journal of Pain.

    The guidelines were based on an extensive literature review and analysis, published as separate papers in the journal. They are the first joint guideline effort of the two societies.

    "Use of methadone for chronic noncancer pain has increased dramatically," wrote Roger Chou, M.D., of Oregon Health and Science University here, and colleagues on the guideline panel.

    But they noted that its pharmacokinetics and clinical effects are highly variable, and the drug has been associated with prolonged QTc, arrhythmias, and an increasing number of deaths.

    For these reasons, the guidelines recommend that clinicians start with low doses of methadone -- 2.5 mg every eight hours in opioid-naive patients -- and titrate slowly. Some patients may need 12 days to achieve a steady state, the authors said.

    They also recommended that methadone never be used for breakthrough pain or be prescribed "as needed."

    The guideline writers said the methadone recommendation was backed by moderate-quality evidence -- making it among the best-supported in the entire guideline.

    They lamented the generally poor state of research on the use of opioids for chronic noncancer pain.

    "The panel identified numerous research gaps," they wrote. "In fact, the panel did not rate any of its 25 recommendations as supported by high quality evidence. Only four recommendations were viewed as supported by even moderate quality evidence."

    Nevertheless, the authors said there was little dissent on the panel about any of the recommendations.

    Among the strongest:

    Patient selection and risk stratification at the beginning of opioid therapy is vital.
    Clinicians should counsel patients on realistic expectations from therapy and on the precautions necessary to avoid diversion or other misuse.
    Doses need to be carefully titrated.
    Frequent monitoring and re-evaluation is necessary.
    Additional therapies targeting psychosocial factors should be considered.
    Patients should have a medical home to ensure that treatment of pain, the underlying condition, and comorbidities is coordinated.

    The authors also said that research is most urgently needed on methods for obtaining informed consent, the best makeup of management plans worked out with patients, approaches to high-dose opioid therapy, usefulness of rotating different opioids, and treatment of breakthrough pain.

    They added that much remains unknown about how regulations and policies restricting opioid prescription and dispensing affects clinical outcomes.

    "Surveys show that clinicians have a poor or limited understanding of the laws, regulations, and other policies" governing opioid distribution and usage, Dr. Chou and colleagues said.

    How much this lack of knowledge affects healthcare practices and patient care has received little formal study, they said.

    The guidelines are available at Clinical Guidelines for Use of Chronic Opioid Therapy in Chronic Noncancer Pain.

    The review and guideline preparation was funded by the American Pain Society.

    Other authors reported a wide range of relationships with commercial entities including pharmaceutical companies marketing opioid pain medications.

    Primary source: Journal of Pain
    Source reference:
    Chou R, et al "Opioid treatment guidelines: clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain" J Pain 2009; 10: 113-30.

  7. TigerLilea

    TigerLilea Active Member

    My understanding is that it is the "over-sized" pills that are being pulled from the market. The FDA approved 5 mg and 10 mg amounts, however, the pharmacutical companies were selling 40 mg and 50 mg sizes, which weren't FDA approved for pain.