The FDA recently released a Drug Safety Announcement regarding the use of codeine in young children after tonsillectomy/adenoidectomy surgery for obstructive sleep apnea. I was somewhat surprised to see a safety announcement on a medication that has been in use for decades, but the release underscores our improved knowledge of drug metabolism, and the broadening demographics of the United States.
Codeine has little activity at opioid receptors. The analgesic effects of codeine are actually caused by morphine, after the conversion of codeine to morphine at the liver. The conversion is catalyzed by an enzyme called CYP2D6, part of the cytochrome system of enzymes that are involved in the breakdown of a number of compounds.
I have written about the addictiveness of narcotic pain medications. People addicted to opioids often go to significant lengths to obtain prescriptions for narcotic pain relievers from healthcare practitioners. Emergency room physicians and nurses become aware of the efforts of ‘narcotic-seekers’, which range from faking pain symptoms or dental injuries to self-catheterization and instilling blood into the bladder to fake kidney stones. Distinguishing those with real pain from those who are addicted and not experiencing pain is a serious situation, but doctors roll their eyes at some of the more-typical presentations. One such situation is the patient who reports an ‘allergy’ to all of the weaker narcotics, and claims that ‘the only drug that works is (insert Dilaudid, morphine, oxycodone, or another potent opioid here).
Codeine is one drug that is commonly rejected as ‘ineffective’ as part of a request for something stronger. When I was a medical student, we assumed that requests for something other than codeine were disingenuous. But at some point, maybe 15 years ago, I remember reading an article that described the conversion of codeine to morphine by the liver. The article reported that the enzyme that performs the conversion exists in varying forms across the population, with some ethnic groups having more active forms of the enzyme than others. Some people have very low levels of CYP2D6, and therefore get very little analgesia from codeine. In …
A couple weeks ago the manufacturer of Suboxone, Reckitt-Benckiser, filed a Citizens Petition with the FDA, announcing a voluntary recall of one of the company’s signature products, Suboxone Tablets. Suboxone was sold in tablet form for almost ten years, and the patent ran out on Suboxone Tablets last year. A couple years ago the same company began making Suboxone Film; a rapidly-dissolving form of the medication that comes with each dose individually packaged.
Suboxone is used to treat opioid dependence, and the medication has been a vital, albeit expensive, tool for saving the lives of patients addicted to narcotic pain medications or heroin.
Last week I expressed anger at the company for their actions. Uninsured patients treated for opioid dependence pay a high cost for the medication that helps keep them safe, and have been looking forward to a generic form of the medication for years. It appeared to me that Reckitt Benckiser was trying to tarnish the tablets, perhaps to reduce insurance or Medicaid coverage of the tablets when they inevitably (?) hit the market.
I have carefully read through the entire Citizens Petition, and I now have a better understanding of what, exactly, was accomplished by that action by the manufacturer of Suboxone. It turn out that I underestimated the people at Reckitt-Benckiser.
The Citizens Petition explains that Reckitt-Benckiser (RB) hired an independent group, RADARS (Researched Abuse, Diversion, and Addiction-Related Surveillance), to investigate the exposure of small children to Suboxone tabs and Suboxone Film. The results of the RADARS findings are spelled out in detail in the Petition.
RADARS showed an increase in exposure to Suboxone Tabs over the past ten years. They also show an increased rate of exposure, i.e. number of exposures, divided by the number of tabs prescribed. Reckitt-Benckiser wrote that they instituted REMS over the past few years to counter that increase. What are REMS, you ask?
From the FDA site: The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from manufacturers to ensure that the benefits of a drug …
Message from a reader:
I am trying to determine what my best course of action might be in dealing with protracted withdrawals from a number of drugs, including benzodiazepines.
My history is as follows: I was snorting Oxycontin for about 6 months and went into treatment to stop. Before entering the rehab hospital they put me on Clonidine .2 mgs, Ambien 12.5 mg and Sertraline 50mgs for about 1-2 weeks. Once hospitalized they switched me to Mirtazapine 15 mg, Clonazepam 1 mg and Cymbalta 20 mg., and I was on these for 5-6 months.
I took myself off all three of the last meds over a week or two, becoming free from all drugs. I believe stopping these medications cold turkey affected my CNS. I don’t drink alcohol or smoke pot. I basically stopped interacting with all of my friends to stay away from all drugs and alcohol.
I still feel awful. My primary symptoms are anxiety, depression, foggy-headed and depersonalization.
I have read posts from a woman who goes by username “Polenta,” from a site called benzo buddies, who is nearly 80 and has been in withdrawal for 20 years.
Will I fully heal? Does everybody heal no matter how far out they are? This Polenta woman says she knows of people who are as far out as her, or farther. My big question that plagues me is whether these people recover mentally? I’m aware there are physical and mental symptoms; I only suffer from mental symptoms. Polenta said in another post that Una had said there were people out even farther out who recovered, even a person 25 yrs. out. I’m wondering if that person was like Polenta and suffered from mental issues and still recovered to have quality of life.
Would I benefit from starting a low dose of an antidepressant and then tapering very slowly off to help stabilize my CNS? I greatly appreciate any advice that you can offer me. I’ve been in a lot of pain these last couple years and believe that someone with your professional and personal experiences can help me find some answers.
I hear similar complaints frequently. Just today I saw …
I’ve described the ongoing debate over the use of opioids to treat chronic pain. To catch new readers up to speed, the country is in the midst of an epidemic of deaths due to overdose on pain medications or heroin. The epidemic is evident to anyone who spends even a few minutes searching the internet using the keywords ‘overdose deaths.’ Another increasing phenomenon is the prosecution of physicians whose patients have died from overdose. Physicians have been found guilty of manslaughter, even when people used the prescribed medication inappropriately, far outside of prescribed guidelines. It is no surprise that in response, many doctors have stopped treating pain with opioids altogether.
I’ve described one group of physicians, Physicians for Responsible Opioid Prescribing or PROP, who have taken a position seen as extreme by some other physician groups, particularly groups involved in advocating for pain relief. The latest efforts by PROP have resulted in a direct conflict with pain advocacy groups. Readers of this blog who are interested in the issue can have a direct impact on the outcome of the situation.
Medications approved by the FDA have been shown through scientific study to be effective and safe enough to justify their use. At present, opioid pain medications are indicated for moderate or severe pain. There are no other restrictions on the use of pain medications from the FDA, but use of all medications, including opioids, must be within the ‘standard of care,’ a general pattern of practice in a given area that is sometimes difficult to pinpoint.
PROP has asked the FDA to change the indications to state that opioid pain medications are to be used only for severe pain. They also asked that opioids be recommended for use for a maximum of 90 days, and never in doses greater than the equivalent of 100 mg of morphine. They base their request on studies that have shown that some patients develop a condition of increased pain, when maintained on opioids for a prolonged period of time. They are also concerned about the large numbers of deaths from opioids, …