Cams

Saturday, August 18, 2012

UPDATED:FDA ALERT METHADONE: WHAT YOU SHOULD KNOW

WHAT TO KNOW BEFORE GOING FOR A MARCHMAN ACT






Methadone (also known as Symoron, Dolophine, Amidone, Methadose, Physeptone, Heptadon, Phy and many other names) is a synthetic opioid, used medically as an analgesic and a maintenance anti-addictive for use in patients with opioid dependency. It was developed in Germany in 1937. Because it is an acyclic analog of morphine or heroin, methadone acts on the same opioid receptors as these drugs, and thus has many of the same effects. Methadone is also used in managing severe chronic pain, owing to its long duration of action, extremely powerful effects, and very low cost. Methadone was introduced into the United States in 1947 by Eli Lilly and Company.
 
 
 
 
 

 
FDA ALERT [11/2006]: Death, Narcotic Overdose, and Serious Cardiac Arrhythmias
 
 
 
FDA has reviewed reports of death and life-threatening adverse events such as respiratory depression and cardiac arrhythmias in patients receiving methadone. These adverse events are the possible result of unintentional methadone overdoses, drug interactions, and methadone’s cardiac toxicities (QT prolongation and Torsades de Pointes). Physicians prescribing methadone should be familiar with methadone’s toxicities and unique pharmacologic properties. Methadone’s elimination half-life (8-59 hours) is longer than its duration of analgesic action (4-8 hours). Methadone doses for pain should be carefully selected and slowly titrated to analgesic effect even in patients who are opioid-tolerant. Physicians should closely monitor patients when converting them from other opioids and changing the methadone dose, and thoroughly instruct patients how to take methadone. Healthcare professionals should tell patients to take no more methadone than has been prescribed without first talking to their physician.
This information reflects FDA’s current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.



To report serious adverse events associated with the use of these drugs, please contact the FDA MedWatch program using the contact information at the bottom of this sheet.
Considerations
Methadone is an effective analgesic and may provide pain relief when other analgesics are ineffective. However, methadone can cause significant toxicities. We are highlighting important safety information from the new label about using methadone for pain. See the methadone label2 (Dolophine) for more details.
Methadone’s elimination half-life (8-59 hours) is longer than its duration of analgesic action (4-8 hours). Methadone’s peak respiratory depressant effects typically occur later, and persist longer than its peak analgesic effects. During treatment initiation, methadone’s full analgesic effect is usually not attained until 3-5 days of dosing. Initiation and titration to analgesic effect and dose adjustments should be done cautiously and in consideration of these properties. In chronic use, methadone may be retained in the liver and then slowly released, prolonging the duration of action despite low plasma concentrations.
Cross-tolerance between methadone and other opioids is incomplete. This incomplete cross-tolerance makes the conversion of patients on other opioids to methadone complex and does not eliminate the possibility of methadone overdose, even in patients tolerant to other opioids. Deaths have been reported during conversion from chronic, high-dose treatment with other opioid agonists to methadone. It is critical to understand the pharmacokinetics of methadone when converting patients from other opioids to methadone. Particular vigilance is necessary during treatment initiation, during conversion from one opioid to another, and during dose adjustments.
Methadone can cause serious cardiac conduction effects, including QT interval prolongation and Torsades de Pointes.
There are pharmacokinetic and pharmacodynamic drug interactions between methadone and many other drugs. Drugs administered concomitantly with methadone should be evaluated for interaction potential.
Methadone is secreted into human milk.
What should physicians do?
Read and follow the prescribing information for methadone.
Carefully weigh methadone’s risks with its potential benefits before prescribing methadone.
Avoid prescribing methadone 40 mg dispersible tablets for pain. This product is only FDA-approved for detoxification and maintenance treatment of narcotic addition.
Closely monitor patients who receive methadone, especially during treatment initiation and dose adjustments.
What should healthcare professionals tell patients when prescribing methadone for pain?
Pain relief from methadone does not last as long as methadone stays in your body. Therefore, do not to take more methadone than prescribed because methadone could build up in your body and cause death.
Methadone can cause life-threatening changes in breathing (it may slow or stop).
Methadone can cause life-threatening changes to the heart beat that may not be felt.
Seek medical attention right away if you experience symptoms suggestive of an arrhythmia such as palpitations, dizziness, lightheadedness, or fainting or if you experience symptoms suggestive of a methadone overdose such as slow or shallow breathing; extreme tiredness or sleepiness; blurred vision; inability to think, talk or walk normally; and feeling faint, dizzy or confused.
Directions you should follow if your pain is not controlled after taking the prescribed amount of methadone.
Pain relief from methadone should last longer after you have taken it for awhile.
Tell your doctor if you start or stop other medicines because other medicines can interact with methadone and possibly cause death or life threatening side effects, or result in less pain relief from methadone.
Tell your doctor if you are breastfeeding because methadone is secreted into human milk. Babies can experience the same serious side effects from methadone as the mother.
Data and Background Information
There have been reports of serious adverse events such as death, respiratory depression, and serious cardiac arrhythmias in patients receiving methadone. Fatalities have been reported in patients who were switched from chronic, high-dose treatment with other opioids to methadone and in patients initiating treatment with methadone. These adverse events may have resulted from unintentional methadone overdoses, drug interactions, and/or methadone’s cardiac toxicities (QT prolongation and Torsades de Pointes). Some of the unintentional overdoses were due to prescribers not being aware of methadone’s pharmacokinetics and potential adverse effects.
FDA recently updated the methadone label following an extensive review of the medical literature and other available information. The new label provides new information on methadone’s pharmacology, drug interactions, and instructions on converting patients from other opioids to methadone and dosing methadone based on a synthesis of recommendations from several palliative care organizations and treatment centers.
References
Goodman F., Jones W., Glassman P. Methadone Dosing Recommendations for Treatment of Chronic Pain, Pharmacy Benefits Management Strategic Healthcare Group, United States Department of Veterans Affairs, December 2001.
Pain Management at the End of Life. A Physician's Self-Study Packet. For physicians with prescribing privileges. A Collaborative Project of the Main Hospice Council, Maine Pain Initiative, University of Southern Maine, Muskie School of Public Service, 2006. (accessed 10/20/06)
Pereira J, Lawlor P, Vigano A, Dorgan M, Bruera E. Equianalgesic dose ratios for opioids. a critical review and proposals for long-term dosing. J Pain Symptom Manage. 2001 Aug;22(2): 672-87.
Report serious adverse events to
FDA’s MedWatch reporting system by completing a form on line at
http://www.fda.gov/medwatch/report.htm3, by faxing (1-800-FDA-0178),
by mail using the postage-paid address form provided online
(5600 Fishers Lane, Rockville, MD 20852-9787),
or by telephone (1-800-FDA-1088).


References
  • Goodman F., Jones W., Glassman P. Methadone Dosing Recommendations for Treatment of Chronic Pain, Pharmacy Benefits Management Strategic Healthcare Group, United States Department of Veterans Affairs, December 2001.
  • Pain Management at the End of Life. A Physician's Self-Study Packet. For physicians with prescribing privileges. A Collaborative Project of the Main Hospice Council, Maine Pain Initiative, University of Southern Maine, Muskie School of Public Service, 2006. (accessed 10/20/06)
  • Pereira J, Lawlor P, Vigano A, Dorgan M, Bruera E. Equianalgesic dose ratios for opioids. a critical review and proposals for long-term dosing. J Pain Symptom Manage. 2001 Aug;22(2): 672-87.
Report serious adverse events to
FDA’s MedWatch reporting system by completing a form on line at
http://www.fda.gov/medwatch/report.htm3, by faxing (1-800-FDA-0178),
by mail using the postage-paid address form provided online
(5600 Fishers Lane, Rockville, MD 20852-9787),
or by telephone (1-800-FDA-1088).



 





The History of Methadone

Ralf Gerlach©: A Brief Overview on the Discovery of Methadone. INDRO e.V. Münster 2004

[pdf-download]

Methadone was first synthetized in 1939 at the pharmaceutical laboratories of the I.G. Farbenkonzern, a subsidiary of the Farbwerke Hoechst, Frankfurt am Main, Germany. It was the product of a long and continuous research chain in the area of synthetic antipyretics and analgetics that had already been initiated in the early 1880s (e.g. Antipyrin® 1884, Pyramidon® 1897, and Novalgin® 1921). At the end of the 1920s the Hoechst scientists had focussed their research on the development of medications with both painkilling and spasmolytic properties (MOLL 1990; HOECHST AG 1992) and a first major progress in research was made in 1937 when the Hoechst chemists Eisleb and Schaumann discovered Pethidin/pethidine (1-methyl-4-phenyl-4-carbaethoxypiperidin), an effective opioid analgesic drug which was launched in Germany in 1939 under the trade name Dolantin® (SCHAUMANN 1952). In the course of ongoing research on synthetic opioids the Hoechst scientists Bockmühl and Ehrhart discovered a number of basically substituted diphenylmethanes acting both analgesically and spasmolytically. One of these compounds was 2-dimethylamino-4,4-diphenylheptanon-(5), which they numbered Va 10820 (BOCKMÜHL/EHRHART 1949; SCHAUMANN 1952). Va 10820 was to become known as methadone no sooner than 1947.



Due to the huge number of compounds discovered in 1939 Ehrhart started pharmacological tests with Va 10820 only in early 1942 (after a lot of other compounds had already been tested). Clinical tests still followed in the autumn of the same year (SCHAUMANN 1952). Compound Va 10820 was also provided to the military, the German Wehrmacht, for additional testing under the code name Amidon (PRESTON 1996). To date, there is no evidence that Amidon was handed over to the Wehrmacht in appreciable quantities. Since at Hoechst the production level of Amidon was very low, the top priority of opioid production lay with Pethidin, only an insignificant quantity could have been handed over to the military. All known sources clearly indicate, that after the first clinical tests had been completed, Amidon was not used during World War II - most likely, both the Hoechst scientists and the Wehrmacht doctors used inadequate doses in the experiments causing undesirable side effects: There is no evidence that Amidon had been used as a painkiller in casualty clearing stations or military hospitals. Further, the drug had not been approved for commercial production. Thus, the civic medical sector had also been excluded from being supplied with Amidon.



For the reasons given above, it is dishonest to state that “methadone” had widely been used during the war as a painkiller and a substitute for morphine under the trade name Dolophin (Dolophine), allegedly derived from Hitler’s first name Adolf. Also, stating that Amidon had been called Adolfin (Adolphine) among soldiers and civilian people is entirely unfounded. In fact, the name Adolphine was created in the US in the early 1970s:“The invention of the term ‘Adolphine’ by New York City street linguists in the 1970s was an apparent attempt to discredit methadone treatment by those unsympathetic to it, using the Hitler association” (BYRNE 1995, 20; see also KLEBER 2002).




The discovery of Pethidin (pethidine), Amidon and several other synthetic opioid analgesics must not be seen isolated from Hitler’s attempt to achieve in Germany a state of economic and industrial independence of other countries (autarchy), as pronounced in 1936 when Hitler introduced his war-preparatory Four-Year-Plan (KÜHNL 1977; PIEPER 2002).

As a consequence of the re-organisation and re-structuring of the German trade and industry there was also a stepping up of efforts to become independent on the import of opium needed for the production of morphine.Of course, the discovery of medications cannot be ordered by politicians or military forces. Acting together were both intensified research activities within the scope of the Four-Year-Plan as well as decades of research in the field of analgesics. The more financial support and manpower, the more intensive research is possible and the more chances are there to make discoveries.After the war, all German patents, trade names and research records were requisitioned and expropriated by the allied forces.

The records on the research work of the I.G. Farbenkonzern at the Farbwerke Hoechst were confiscated by the U.S. Department of Commerce Intelligence, investigated by a Technical Industrial Committee of the U.S. Department of State and then brought to the US.

It was only in 1947 that Amidon was given the generic name “methadone” by the Council on Pharmacy and Chemistry of the American Medical Association (COUNCIL...1947). 

Since the patent rights of the I.G. Farbenkonzern and Farbwerke Hoechst were no longer protected each pharmaceutical company interested in the formula could purchase the rights for commercial production of methadone for just one dollar (MOLL 1990). Commercial production was first introduced in 1947 by the US company Eli-Lilly. Only then methadone was given the trade name Dolophine, derived from the Latin dolor (pain) and finis (end). Many companies in other countries soon followed and methadone was given many trade names, some of which still exist: Adanon®, Adolan®, Althose®, Amidone®, AN-148®, Anadon®, Biodone®, Butalgin®, Diskets®, Dolamid®, Dolophine®, Dopridol®, Eptadone®, Heptadon®, Heptalgin®, Heptanal®, Heptanon®, Ketalgin®, Mephenon®, Metasedin®, Methadone®, Methadose®, Methox, Miadone®, Pallidone®, Petalgin®, Phenadone®, Physeptone®, Sedo Rapide®, Symoron®, Tussol®, Westadone® (SCHAUMANN 1952; GERLACH/SCHNEIDER 1994).
As a consequence of post-war events (e.g. the I.G. Farbenindustrie was broken up by the allies) the newly founded Hoechst AG could only in January 1949 launch methadone on the German pharmaceutical market under the protected trade name “Polamidon”. The patent approval of Polamidon was given on February 2, 1953. It took four years to have the patent problems clarified with the relevant US authorities.
As a consequence of post-war events (e.g. the I.G. Farbenindustrie was broken up by the allies) the newly founded Hoechst AG could only in January 1949 launch methadone on the German pharmaceutical market under the protected trade name “Polamidon”. The patent approval of Polamidon was given on February 2, 1953. It took four years to have the patent problems clarified with the relevant US authorities.


As a consequence of post-war events (e.g. the I.G. Farbenindustrie was broken up by the allies) the newly founded Hoechst AG could only in January 1949 launch methadone on the German pharmaceutical market under the protected trade name “Polamidon”. The patent approval of Polamidon was given on February 2, 1953. It took four years to have the patent problems clarified with the relevant US authorities.


My Spin on the matter of methadone treatment is that, if your loved one or person of concern is highly addicted to opiates and has been for many years, chances are that when asked if they would want to get on methadone in order for them not to go through withdrawal, they will always say yes.

Think of it; what addict wants to face physically painful and emotionally mind altering withdrawal?



Symptoms

Early symptoms of withdrawal include:

  • Agitation

  • Anxiety

  • Muscle aches

  • Increased tearing

  • Insomnia

  • Runny nose

  • Sweating

  • Yawning

Late symptoms of withdrawal include:

  • Abdominal cramping

  • Diarrhea

  • Dilated pupils

  • Goose bumps

  • Nausea

  • Vomiting

 

For long-term users, the symptoms of methadone use include:

  • Abdominal pain

  • Constipation

  • Increased sweating

  • Irregular menstrual periods

  • Itching

  • Lowered sex drive

  • Nausea

  • Skin rashes

  • Sore muscles and joints

  • Tooth decay

  • Vomiting

 



 


 

Below right is a picture of liquid methadone


40mg methadone tablets. Developed in Germany in 1937, methadone is used medically as an analgesic, antitussive and a maintenance anti-addictive for use in patients on opioids.

Methadone

methadone dissolved and in liquid form

Overview

Methadone is a synthetic (man-made) narcotic.

What are the street names?

Amidone, Chocolate Chip Cookies, Fizzies, Maria, Pastora, Salvia, Street Methadone, Wafer

What does this drug look like?

Methadone is available as a tablet, disc, oral solution, or injectable liquid. Tablets are available in 5 mg and 10 mg formulations. As of January 1, 2008, manufacturers of methadone hydrochloride tablets 40 mg (dispersible) have voluntarily agreed to restrict distribution of this formulation to only those facilities authorized for detoxification and maintenance treatment of opioid addiction, and hospitals. Manufacturers will instruct their wholesale distributors to discontinue supplying this formulation to any facility not meeting the above criteria.


How is this drug abused?

Methodone can be swallowed or injected.

How does this drug affect the mind?

Abuse of methadone can lead to psychological dependence.


How does this drug affect the body?

When an individual uses methadone, he/she may experience physical symptoms like sweating, itchy skin, or sleepiness. Individuals who abuse methadone risk becoming tolerant of and physically dependent on the drug. When use is stopped, individuals may experience withdrawal symptoms including: anxiety, muscle tremors, nausea, diarrhea, vomiting, and abdominal cramps.

What drugs cause similar effects?

Although chemically unlike morphine or heroin, methadone produces many of the same effects.

What are the overdose effects?

The effects of a methadone overdose are: slow and shallow breathing, blue fingernails and lips, stomach spasms, clammy skin, convulsions, weak pulse, coma, and possible death.

What is the legal status in the United States?

Methadone is a Schedule II drug under the Controlled Substances Act. While it may legally be used under a doctor’s supervision, its non-medical use is illegal.

What are the common places of origin?

German scientists synthesized methadone during World War II because of a shortage of morphine. Methadone was introduced into the United States in 1947 as an analgesic (Dolophinel).




Source: Many medications, over the counter and prescription, have the potential of reacting badly with methadone. The risk of trading one addiction for another is high; the side effects of methadone, though it may lessen withdrawal symptoms from other narcotics to begin with, don’t seem to be worth the new addiction or dependence in the long run.

 

 

My own daughter would come home after 5 hours in DACCO and under the influence of 35mgs. of Methadone, agitated, twitching, her hands and back were clammy and extremely angry until finally throwing herself on the bed to sleep for about 5 hours; during that time asleep, she seemed to have a weak pulse although the reader I have may not have gauged it correctly...but still.  On top of that, I was horrified to see that her twitching had seemed to become more violent; throwing her head backwards over her left as her mouth distorted towards the same upward movement towards her left hand side.  Sometimes she would repeat her words, like "yeah yeah: and she would use the F word for no apparent reason.  Other times she would let out a sort of squeaking sound; it was similar to Tourette's Syndrome.  I was extremely concerned that the methadone dose that DACCO was giving her daily was simply to keep her alert during her 5 hour classes at the treatment facility and that once the 5 hours were over and I picked her up to drive her home, the second phase of the methadone would kick in.  Why on earth would any parent believe that this drug was doing their child any good?  What good is it if your loved one is in bed asleep from 12 noon until 5 pm and be experiencing violent changes in their body?  Granted, upon awaking, she was well enough to agree to attend her Narcotics Anonymous meeting but she was still not the daughter I had prior to her drug use or the methadone treatment.  It seemed to me that she had turned into some sort of a puppet manipulated by this new drug (methadone) whose puppet master was now, DACCO in lieu of her once drug dealers.  It seemed that upon Marchman Acting her, that I had pushed her from the frying pan into the fire.



                                           

  Methadone Can Kill 





_______________________________________________________________________________________________________________________________




Print this info up and share it with those who are considering Marchman Acting someone.





1 comment:

  1. I need a methadone attorney in Tampa! Why? After long term treatment and progressing all the way up to level 4,(highest level) and only requiring a once a month appearance at the treatment center for my meds, I was clean and I was doing great. I moved from another state and my counselor was told by management of DACCO I would maintain my level 4 that I had worked up to so I had my paperwork transfered, etc., to DACCO in Tampa and then moved to a town closeby. Once moved, the head honcho refused me my level 4, saying I had to start my level all over. My out of state counselor called on my behalf but he refused to change it for me. I had to drive back and forth for 2 hours every day for the next month and then once a week every week thereafter. I almost relapsed and wanted to go back to drugs and say F it! I have not been the same since. I am angry about it and I want to suit them!!If you know a good attorney to take a methadone case please post it and I will continue to check the boards or e me at alhendrix78734@aol.com Thanks for the help.

    ReplyDelete