Category Archives: opiates

FDA Panel Urges Ban on Vicodin, Percocet

“Also recommends dosing limits for OTC painkillers that contain acetaminophen, like Tylenol or Excedrin, because of link to liver damage.”

“TUESDAY, June 30 (HealthDay News) — The popular prescription painkillers Vicodin and Percocet, which combine acetaminophen with an opiate narcotic, should be banned, and the maximum dose of over-the-counter painkillers with acetaminophen, like Tylenol or Excedrin, should be lowered, a U.S. Food and Drug Administration advisory panel urged Tuesday.

The panel’s recommendations followed the release of an FDA report last month that found severe liver damage, and even death, can result from a lack of consumer awareness that acetaminophen — which is easier on the stomach than such painkillers as aspirin and ibuprofen — can cause such injury.

The dangers from use or abuse of Vicodin and Percocet may be even more concerning, one key panelist said.

"It seems to me that problems with opiate combinations are clearly more prevalent," Dr. Lewis S. Nelson, chairman of the FDA’s Drug Safety and Risk Management Advisory Committee, said during a Tuesday press conference held after the two-day meeting.

Explaining the panel’s 20-17 vote to ban prescription acetaminophen/opiate drugs, Nelson said, "There are many deaths that relate to problems with prescription opiate combination acetaminophen products, whereas the number of deaths clearly related to the over-the-counter products are much more limited."

But the FDA advisers also took aim at over-the-counter (OTC) acetaminophen products. The agency’s report found that many people may consume more than the recommended dose of these pain relievers in the mistaken belief that taking more will prove more effective against pain without posing health risks. Consumers may also not know that acetaminophen is present in many over-the-counter products, including remedies for colds, headaches and fevers, making it possible to exceed the recommended acetaminophen dose, the report said.

Based on that, the FDA advisory panel voted 21-16 to lower the maximum daily dose of nonprescription acetaminophen, which is currently 4 grams — equal to eight pills of a drug such as Extra Strength Tylenol. The panel was not asked to recommend another maximum daily dose.

The panel also voted 24-13 to limit the maximum single dose of acetaminophen to 650 milligrams. The current single dose of Extra Strength Tylenol, for instance, is 1,000 milligrams.

The panel also voted 26-11 to make the 1,000-milligram dose of acetaminophen available only by prescription.

The advisers voted against other safety restrictions for other over-the-counter drugs such as NyQuil or Theraflu, which contain acetaminophen and other ingredients that treat cough and runny nose. Patients often mix the cold medications with pure acetaminophen drugs, like Tylenol, leaving them vulnerable to dangerously high levels of acetaminophen.

The FDA is not obligated to follow the recommendations of its advisory panels, but it typically does so.

Dr. Sandra L. Kweder, deputy director of the FDA’s Office of New Drugs at the Center for Drug Evaluation and Research, gave a strong hint of what the agency might do with the advisory panel’s recommendations.

"I think the top recommendation of this committee was that the agency needs to do something to address and decrease the usual dose of acetaminophen, both for over-the-counter products and also prescription combination products," Kweder said during the press conference.

She added, "There was a clear message that there is a high likelihood of overdose from prescription narcotic/acetaminophen combination products. If we don’t eliminate these combination products, we should certainly at least lower the usual acetaminophen dose patients receive in those prescription combination products."

At the very least the agency should require new warning labels on these prescription combinations that alert patients to the potential of liver damage if they take too much acetaminophen, she said.

Speaking for the OTC drug industry, Lynda A. Suydam, of the Consumer Healthcare Products Association (CHPA), said her group was "pleased the committee did not recommend eliminating these important nonprescription products."

However, in a statement, she added that CHPA was "disappointed in [the panel’s] divided vote to lower the maximum daily dose and the single dose of 1000 mg acetaminophen. There was a notable lack of data referenced by the committee to support these recommendations and overwhelmingly strong data affirming the efficacy and safety of acetaminophen in its current dosage forms."

Another expert took a different view. Dr. John H. Klippel, chief executive officer of the Arthritis Foundation, said Tuesday’s votes were very important to "people with arthritis because acetaminophen is a very commonly used medication to control pain."

"Lowering the maximum dose, providing that kind of guidance to patients, if it increases safety, would be something the arthritis community would support," he said. "Every person who takes this drug sees it as valuable, but they want clear guidance so they won’t be harmed by the drug."

Dr. Lewis W. Teperman, director of transplant surgery and vice chairman of surgery at New York University School of Medicine, said he also supported the panel’s decision to recommend lowering doses of acetaminophen.

"It’s not that the doses can get you in trouble, but the very young and the very old can get into trouble easily," he said. Also if you are sick, there is the danger of taking cold remedies that contain acetaminophen plus taking pure acetaminophen drugs as well, he noted.

But Klippel added that the vote to make the 1,000-milligram dose of acetaminophen available by prescription only would overburden the health-care system. "Given the massive number of people who rely on this drug for pain control, making the maximum dose requiring a prescription, I think, is going to place undo burden on the health-care system," he said.

Teperman disagreed.

"The 1,000 milligram pill should never be at the patient’s discretion. It should only be prescribed by a physician," Teperman said. "If you took an entire bottle of Tylenol Extra Strength, three days later you would be in a coma and needing a liver transplant."

For more on acetaminophen, visit the U.S. National Library of Medicine.

SOURCES: June 30, 2009, press conference with Sandra L. Kweder, M.D., deputy director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, and Lewis S. Nelson, M.D., chairman, FDA Drug Safety and Risk Management Advisory Committee, and associate professor, department of emergency medicine, NYU Langone Medical Center; John H. Klippel, M.D., CEO, Arthritis Foundation; Lewis W. Teperman, M.D., director of transplant surgery, vice chairman of surgery, New York University School of Medicine, New York City; June 30, 2009, news release, Consumer Healthcare Products Association; May 28, 2009, news release, U.S. Food and Drug Administration”

 

I wonder what this will do to the millions of people who are in pain consistently.  Conversely what about those in acute pain? The extremely numerous Rx’s written daily for hydrocodone/APAP will not be available… then maybe they should be put over the counter.  Civilized people should be treated as though they have a brain and not looked at in a biblical or moral controlled light which hurts so many due to the prohibition and lack of health care providing adequate pain relief.  I will try and stay on this story… interesting.

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THE MEDICAL – Mis-MANAGEMENT OF PAIN

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Quotations:

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All types of pain in all parts of the world are inadequately treated…” C. S. Hill, MD. JAMA 1995: 274: P. 1881-1882

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“We all must die. But if I can save someone from days of torture, that is what I feel is my great and ever new privilege. Pain is a more terrible lord of mankind than even death itself.” Albert Schweitzer, humanitarian, physician, theologian and composer.

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The United States is the only advanced industrial society in the world where a patient’s ability to pay determines access to health care.” D. E. Joranson, MSSW, Pain Research Group, University of Wisconsin Medical School

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Overview:

Many terminally ill patients experience severe pain. Some forms of cancer are notorious causes of pain in dying patients. A statement from a NIH Consensus Development Conference suggested that:

  • …there is no ‘magic bullet’ or universally accepted treatment for the relief of pain and suffering.
  • Contemporary science and clinical practice cannot assure the full relief of all pain.”
  • The data indicate that there remains a proportion of patients whose pain presents difficult, and so far unsolved, problems for successful management.
  • Concerns are focused on reported undermedication of individuals with acute pain and chronic pain associated with malignant diseases as well as reported overmedication of people with chronic pain not associated with malignant disease.

There are barriers to pain relief. They include:

  • Some types of pain in some individuals cannot be adequately controlled with current technology and medications that are now available.
  • Some patients and their physicians are concerned about the possible side effects of pain medication, including addiction.
  • Inadequate training of medical professionals.
  • Pain management is not universally available, particularly to the over 40 million Americans who lack health insurance, and as many as 80 million who are under-insured.

Dr. Robin Bernhoft comments:

Experience consistently shows that patients often want to die because of undertreated pain. Yet with good medical care their pain is almost always manageable, and they almost always regain their desire to live. Pain relief typically can be achieved without impairing mental ability…” 8

Referring to doctors who “simply don’t know how to treat depression and pain.” Dr Bernhoft states:

According to many studies, between 50 and 70 percent of U.S. doctors fit that description.8

Dr Bernhoft, and many others, believe that if terminally ill people were given access to adequate pain management, then requests for physician assisted suicide would be greatly reduced.

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Scope of the problem:
  • Pain management appears to be in a state of chaos in North America
  • Medical writer John Horgan cited an article in the Journal of the American Medical Association for 1995-NOV which described the results of a study called “Study to Understand Prognoses and Preferences for Outcomes and risks of treatments (SUPPORT).” The study involved over 9,000 patients in five hospitals. They reported “substantial shortcomings in care for seriously ill hospitalized adults.” Horgan commented: “More often than not, patients died in pain, their desires concerning treatment neglected, after spending 10 days or more in an intensive care unit.1 A Massachusetts legislature subcommittee report on pain management mentioned that the SUPPORT study “found that half of patients who died in the hospital experienced moderate or severe pain at least half the time during their last three days of life.
  • The American Pain Society (APS) issued a news release in 1999-FEB concerning individuals with chronic pain. They found that over 40% “with moderate to severe chronic pain have yet to find adequate relief, saying their pain is out of control…” The study found that “only 22% had been referred to a specialized pain treatment program or clinic.”  APS president, Dr. Russell Portenoy, said “This survey suggests that there are millions of people living with severe uncontrolled pain. This is a great tragedy. Although not everyone can be helped, it is very likely that most of these patients could benefit if provided with state-of-the-art therapies and improved access to pain specialists when needed.” (This study may not be indicative of the problems of the terminally ill; patients with cancer were not included in the study.) 2
  • A 1997 study of cancer patients receiving oral medication for their pain showed that two concerns prevented them from accepting pain medication:
  • inadequate information about how to manage pain, and
  • exaggerated concern about addiction and side effects. 3
  • A 1997 article reported that too many cancer patients continue to experience unrelieved pain. Roadblocks to treatment include:
  • lack of knowledge of modern pain medications among doctors and nurses, and
  • government regulations concerning some important pain medications in many jurisdictions. 4
  • Another 1997 article found  that only 35% of members of ethnic minorities received pain medication at recommended dosage strengths. This was compared to 50% of Caucasian patients. 5
  • A survey of 48 families of deceased cancer patients in a comprehensive cancer center revealed that 10 families (21%) considered pain treatment to be incomplete or inefficient. 6
  • Patient’s rating of pain is often different from caregivers’ impression. Using a pain scale of 0 to 10 (0 = no pain; 10 being the most severe pain) only 64% of caregivers at one hospital matched their patients’ scores within 2 points. 7

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Physician ignorance:

Everyone is aware of the extremely addictive properties of drugs such as morphine and heroin. But what is less known is that these drugs’ addictive properties are primarily seen among healthy people who are not in pain. They become addicted when they use these drugs illegally for the feeling of euphoria that they generate. If a person who is in severe pain properly uses these narcotics for the relief of pain, they do not feel euphoria; they do not become addicted; they simply have relief from intense pain. A wide range of people are in need of such medication; they include from individuals who are suffering from advanced cancer, untreatable back pain, and limb amputations.

Unfortunately, most physicians are not trained in the use of opioid therapy for the relief of intense chronic pain. Even worse, the members of some state medical boards are also unaware of the need for this use of narcotics. When they review physicians in their jurisdiction who specialize in the relief of pain, all they see is “oversubscription” of controlled substances. They have put pressure on physicians to prescribe lower quantities of these narcotics, thus causing their patients to live in continuous pain. Some boards have pulled the medical licenses of physicians specializing in this field. Each time this happens, the pain management of dozens of patients is terminated. Without narcotics, at least some probably commit suicide; with narcotics, they can lead productive lives.

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Sponsored link:

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The money trail:

David E. Joranson, of the Pain Research Group, at the University of Wisconsin Medical School wrote in 1994: “Access to professional services, prescription drugs, and medical equipment is critical to obtaining effective pain management and to restoring quality of life. The US is one of the few countries in the world where access to these products and services is based on the ability of a person to pay for them, either through personal resources or third-party private or government health insurance.” 11 He estimated about 34 million Americans under the age of 65 have no health insurance. By 2002, this had grown to over 45 million; it continues to increase at about 1 million a year. On top of that group are others — perhaps as many as 80 million. These are individuals who have limited insurance, and cannot afford to pay the extra costs associated with their illness. Racial minorities comprise a disproportionately large share of these groups. 12 According to the American Cancer Society, low income Americans suffer greater pain from cancer than average. 13

Many people over the age of 65 have less ability to pay for prescription drugs because they are on fixed and low incomes. Yet these are the individuals who are most likely to need pain medication due to age-related degenerative diseases like arthritis and terminal illnesses like cancer. 14

Some pharmaceutical manufacturers have limited programs to make their medication available to indigent patients. The American Cancer Society is one referral source for these programs for cancer patients.

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The Pain Relief Promotion Act

In 1999-OCT, the federal Pain Relief Promotion Act (PRPA) was passed by the House, by a vote of 271 to 156. If the bill had been passed by the Senate and signed into law by the president, it would have prevented the use of federally regulated drugs in cases of physician-assisted suicide. It would have prohibited the U.S. Attorney General from making exceptions. Its effect would have been to overrule the Oregon Death-With-Dignity Law which allows physicians to assist terminally ill people to commit suicide. The constitutionality of such a Federal law is highly doubtful. The U.S. Supreme Court decision of 1997 implied that states can pass laws which permit physician assisted suicide, and that individuals have a right to take advantage of these laws if they wish. The Federal Government can hardly prevent such access.

If the law had been passed, it would have have a profound effect on the management of pain:

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On the positive side, some patients who are currently unmedicated or severely undermedicated may have their pain relieved, to a degree. The law would allow doctors to prescribe narcotics for the relief of pain, even if the drugs have the side effect of shortening a patient’s life. Passage of the law would legalize this very common method of pain control; it is currently on shaky legal ground in some jurisdictions. Some physicians currently leave their patients in agony out of fear of prosecution. They could theoretically be charged with murder in some states if they shorten the patient’s life by even a small amount. If the bill becomes law, doctors would be able to prescribe some level of medication, and reduce their patient’s agony, without endangering the doctor’s safety.

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On the negative side, many physicians would fear giving adequate levels of narcotics to manage properly their patients’ pain. If the physician misjudged the dose and give the patient too much medication, they could cause that patient’s quick death. The physician may be charged under the act, and end up with a 20 year jail sentence. Each physician who prescribes a narcotic for pain relief will have an army of DEA investigators looking over their shoulders, evaluating each dose and trying to assess the doctor’s intent. The tendency will be for many doctors to err on the side of their own safety and prescribe inadequate medication to control the pain. This way, they will make certain that the patient’s death will not be accelerated sufficiently to attract the attention of the DEA. Compassion in Dying ®  comments: “…study after study reveals that doctors usually under-treat pain. They often use mild, ineffective drugs when morphine or another opiate would be appropriate. The reason often given is fear of scrutiny or discipline from state and federal authorities.15 This law would greatly aggravate this situation.

It is ironic that a bill called the “Pain Relief Promotion Act” will result in leaving countless patients in severe, continuous pain, if it becomes law. In addition, the main purpose of the bill is to prevent Oregon citizens who are dying in pain from taking advantage of their state’s assisted suicide law.

The bill became stalled in the Senate, and died.

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References used:

The following information sources were used to prepare and update the above essay. The hyperlinks are not necessarily still active today.

  1. Journal of the American Medical Association (JAMA), 1995-NOV. Cited in John Horgan, “Right to Die,” Scientific American, 1996-MAY.
  2. American Pain Society, “New survey of people with chronic pain reveals out-of-control symptoms, impaired daily lives,” 1999-FEB-17. Available at: http://www.ampainsoc.org/whatsnew/release030499.htm
  3. A. Riddell, article, Oncology Nurse Forum, 1997; 24: Pages 1775 to 1784.
  4. K. Redmond, article, Support Care in Cancer, 1997; 5: Pages 451 to 456.
  5. C.S. Cleeland et al., article, Ann. Intern. Med., 1997; 127: Pages 813 to 816.
  6. Y. Merrouche, et al., “Quality of final care for terminal cancer patients in a comprehensive cancer centre [sic] from the point of view of patients’ families,” Support Care in Cancer, 1996; 4: Pages 163 to 168.
  7. E. au, et al., “Regular use of a verbal pain scale improves the understanding of oncology inpatient pain intensity,” Journal of Clinical Oncology, 1994, 12: 2751 to 2755.
  8. Robin Bernhoft, MD, “How we can win the compassion debate,” Focus on the Family, Citizen Magazine, 1996-JUN-24.
  9. The integrated approach to the management of pain,” National Institutes of Health: Consensus Development Conference Statement, 1986-MAY 19-21. Available at
  10. Report of the special subcommittee on the management of acute and terminal pain: Joint committee on health care,” 1997-JAN-8. at: http://www.magnet.state.ma.us/dph/dcp/pnrep2.htm
  11. David Joranson, “Are Health-Care Reimbursement Policies a Barrier to Acute and Cancer Pain Management?Journal of Pain & Symptom Management, 1994, 9(4): Pages 244 to 253. Available at: http://www.medsch.wisc.edu/painpolicy/publicat/94jpsma.htm
  12. M. Earnest, “Access to health care in the United States: barriers for neurologic patients, challenges for neurologic physicians,” Neurology 1990; 40: Pages 1815 to 1819
  13. Cancer and the poor: a report to the nation.” American Cancer Society, 1989.
  14. M.E. Gluck, “A Medicare prescription drug benefit,” National Academy of Social Insurance, at: http://www.nasi.org/Medicare/Briefs/medbr1.htm
  15. Advocating for better pain management,” Compassion in Dying ® at: http://www.compassionindying.org/pain/pain.html

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Support and advocacy groups

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An Internet support group exists for pain sufferers and their relatives. You can join PAIN-L by sending an Email to listserv@sjuvm.stjohns.edu with a message: subscribe pain-l [your name]

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MedSupport Pain Forum offers 24 hour online pain support. See: http://www.medsupport.org/pforum/pain2.html

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Compassion in Dying ® is an Oregon-based agency that is concerned about the under-treatment of pain in terminally ill people. They offer a no-cost review of patients’ pain management from a clinical and legal perspective. They are “challenging the states with unreasonable legal barriers to good pain management.” See: http://www.compassionindying.org/

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