An article posted on WorstPills.org this month details new FDA warnings to consumers and health care professionals about the adverse effects of pain managing drug methadone.
Deaths and life-threatening changes in heart beat and breathing have been reported in association with methadone.
The professional product label, also known as a package insert, for methadone carries a black-box warning about respiratory depression and fatal heart rhythm disturbances. That warning accompanies this article. A black-box warning is the strongest type of warning that the FDA can request from a drug manufacturer and is usually reserved for those drugs that have caused death or serious injury to patients.The full text of the FDA's public health advisory is available on the agency's Web site at http://www.fda.gov/cder/drug/advisory/methadone.htm.
The full text of the FDA's public health advisory is available on the agency's Web site at http://www.fda.gov/cder/drug/advisory/methadone.htm.
Have an opinion about this post? Please consider leaving a comment or subscribing to the feed to have future articles delivered to your feed reader.
I'm writing to you about the methadone epidemic taking place in the United States . I am writing on behalf of HARMD (Helping America Reduce Methadone Deaths). We are the families of victims and those yet to be victims of methadone. More ... I have come together with many other families throughout the United States who have lost loved ones to methadone. On June 24th 2006 I lost my fiancé (Ron) to methadone prescribed by a physician with a combination of other medications that acted as additives to the Methadone. He was a professional Jai Alai player at Hamilton Downs Jai Alai in Jasper, FL and had knee surgery after an injury on the court. He became addicted to the percocet he was prescribed. He checked hi mself into Greenleaf in Valdosta , GA (part of South Georgia Medical Center ) for detoxification. Upon entering the facility he was drug tested and did not come up positive for opiates or any other drugs (he had stopped taking the percocet 4 days before entering the facility). He was prescribed by a Dr. excessive amounts of methadone (for a person without a known tolerence) with valium and Klonopin. On the fourth day in detox he died sometime between 2am and 1pm in the afternoon (he was never checked on in all of those hours). When hi s body was found at 1pm he was already in rigor mortis. He was extremely neglected bordering abusive considering he was supposed to be monitored every 1/2 hour according to hi s medical charts. The night before he died he was complaining of migraines and vomiting, apparently the staff thought he was still experiencing withdrawals (but again he had NO drugs in hi s system upon entering the facility) and was not concerned about these symptoms. The symptoms of methadone toxicity mimic withdrawal symptoms; physicians and staff must be very cognizant of the complex properties and metabolization of methadone. There were many errors made in my fiancé's death including the fact that he was given numerous amounts of additive medications such as benzodiazepines (valium and klonapin). He had only been taking percocet for about 4 months and according to the DSM IV he wouldn't be an appropriate candidate methadone maintenance treatment. We are asking government agencies to enact stricter guidelines in prescribing methadone for any reason. It must be mandatory that all doctors be certified and trained in the pharmacology of methadone; inpatient stays must be required during induction to methadone; all staff be extensively trained in monitoring methadone patients for symptoms of toxicity. Clinic patients should be tested for legal and illegal drugs that are taken with methadone to get "high" or experience "euphoria" such as benzodiazepines, alcohol, cocaine, heroin, marijuana etc... and face severe consequences / mandatory detoxification from methadone program. When presenting inebriated at clinic, clinic should also document such activity as well as prevent client from driving. Take home doses for all patients receiving methadone should be eliminated thus preventing the risk of diversion or precautions such as pill safe should be implemented. More ... Current statistics show that nearly 4000 people a year die from methadone. These deaths are mostly happening to pain management and detoxification patients within the first 10 days of taking initial dose. Most of these deaths are related to methadone prescribed with other medications that react as additives with the methadone. Diversion of methadone is a serious problem because it lands this most deadly drug on streets. Statistics also state that methadone is contributing to more deaths nationwide then heroine and only second to cocaine deaths. The government did take notice after the 2003 record number of deaths associated with methadone and the Bush administration responded by gathering the top experts on drug overdoses, doctors, researchers, and medical examiners, as well as representatives from the federal Drug Enforcement Administration, Food and Drug Administration, and Substance Abuse and Mental Health Association. Finn and Tuckwiller (2006) report that "the man hired to research and write the report based on the conference, as well as background paper for conference participants, was Stewart B. Leavitt, and addiction specialist whose work is funded by the makers of methadone". Stewart B. Leavitt PhD served as researcher/writer for A National Assessment of Methadone-Associated Mortality: Background Briefing Report from the U.S. Department of Health and Human Services. Stewart B Leavitt also writes Addiction Treatment Forum Methadone Dosing & Safety in the Treatment of Opioid Addiction which is funded by Mallinckrodt, Inc. a manufacturer of methadone. My question is why hasn't a team of independent researchers not funded by pharmaceutical companies; a person or group of people that stand to gain no financial benefit on the outcome of the studies been hired to conduct the research? Finn and Tuckwiller (2006) report that "the man hired to research and write the report based on the conference, as well as background paper for conference participants, was Stewart B. Leavitt, and addiction specialist whose work is funded by the makers of methadone". Stewart B. Leavitt PhD served as researcher/writer for A National Assessment of Methadone-Associated Mortality: Background Briefing Report from the U.S. Department of Health and Human Services. Stewart B Leavitt also writes Addiction Treatment Forum Methadone Dosing & Safety in the Treatment of Opioid Addiction which is funded by Mallinckrodt, Inc. a manufacturer of methadone. On the forum associated with his website several of the clinic participants speak of diverting, misusing, stockpiling, selling, and potentiating methadone and other prescription drugs. This methadone epidemic and deaths associated with it are not going away. It's only getting worse; I get contacted by families on a daily basis who have lost someone to this drug. At what point do we value human life over the convenience of others? Methadone patients, whether they are pain or clinic pose a risk to themselves and society as a whole if they are not monitored, dosed, and assessed correctly. Clinic patients getting into cars after being dosed who are using benzodiazepines, alcohol, marijuana or other opiates are killing innocent people on the road. This type of harm reduction is not saving lives it's taking them. The government cannot continue to be a legal drug dealer in order for its citizens to "behave". I know the rules are in place for the clinics but they are NOT being followed. Patients sell take homes outside the clinics. In one news article a man died in the parking lot of a clinic after taking his brothers take home. This drug is too dangerous to be allowed in medicine cabinets! There is A LOT of money to be made from methadone but what expense is that money being made at? When do the risks outweigh the benefits of this drug? How many more people must die before changes are made that actually save lives?I have called several methadone clinics and have found out that many do not test for marijuana and are not open 7 days a week. These two things are of special concern to my organization because all methadone patients will receive a take home bottle of methadone on Saturday for Sunday (the day they are closed) whether they are new to the program or have been abusing other drugs. Marijuana and methadone have an effect on the user very similar to heroin. Many clinics do not test for marijuana because it is not believed to be a drug of choice or a "hard drug", I beg to differ because of the effect when combining the two have the potential to be more dangerous then the user/staff is aware. This poses a serious public health risk to those on the road innocently driving to work or school. The state of Delaware has just added Methadone to the list of medications covered under the Medicaid program that require prior authorization for pain treatment. The potential of abuse, diversion, and overdose to new patients being prescribed methadone is overwhelming. The unique properties of methadone, it's long half life, short analgesic properties, cardiac risks and it's negative interaction with numerous drugs make it an optimal choice as a last result treatment for chronic pain. Thank you for taking the time to read this letter. Sincerely Melissa Zuppardi
Keep up with the latest updates using your favorite RSS reader
Your question will be referred to an attorney near you. If your question is of a legal nature, then by submitting this form you agree you are not forming a formal attorney / client relationship. Read our full privacy policy.
Looking for an InjuryBoard attorney closer to home? Click here.
Enter your email address if you would like to receive email notifications when comments are made on this post.
Colorado Personal Injury Lawyers
Drug Injury Watch
Ernie The Attorney
Mealey's Legal News
Products Liability Prof Blog
Find an InjuryBoard Blog in your area:
Alabama
Birmingham
Gadsden
Huntsville
Mobile
Montgomery
Alaska
Anchorage
Fairbanks
Arizona
Chandler
Phoenix
Scottsdale
Tucson
Arkansas
Bentonville
El Dorado
Jonesboro
Little Rock
Mountain Home
California
Bakersfield
Chico
Fresno
Glendale
Huntington Beach
Lancaster
Long Beach
Los Angeles
Modesto
Novato
Oakland
Orange County
Redding
Sacramento
San Diego
San Diego County
San Francisco
San Jose
San Luis Obispo
Santa Clarita
Stockton
Ventura
Colorado
Colorado Springs
Denver
Fort Collins
Grand Junction
Connecticut
Hartford
New Haven
Waterbury
District of Columbia
Metro D.C.
Washington
Florida
Central Florida
Fort Lauderdale
Ft. Myers
Gainesville, Ocala & Daytona Beach
Jacksonville
Melbourne
Miami
Orlando
Pensacola
Sarasota
Tallahassee
Tampa Bay
West Palm Beach
Georgia
Atlanta
Hawaii
Honolulu
Idaho
Boise
Illinois
Chicago
Chicago-Land
Cook County
Rockford & Moline
Springfield
Indiana
Bloomington
Indianapolis
Iowa
Council Bluffs
Davenport
Des Moines
Fort Dodge
Waterloo
Kansas
Topeka
Wichita
Kentucky
Bowling Green
Louisville
Paducah
Louisiana
Baton Rouge
Lafayette
New Orleans
Maine
Bangor & Augusta
Maryland
Baltimore
Massachusetts
Boston
Cape Cod
Stoughton / Canton
Michigan
Detroit
Grand Rapids
Lansing
Traverse City
Minnesota
Minneapolis
St. Cloud
Mississippi
Biloxi & Gulfport
Tupelo
Missouri
Jefferson City
Kansas City
St. Louis
Montana
Missoula
Nebraska
Lincoln
Omaha
Nevada
Las Vegas
Reno
New Hampshire
New Jersey
Bergen County
Cherry Hill
Jersey City
Newark
Trenton
New York
Buffalo
Long Island
New York City
Northern New York
Syracuse
North Carolina
Charlotte
Fayetteville
Greensboro
Greenville, OBX & Rocky Mount
Raleigh
Wilmington
Ohio
Akron
Cincinnati
Cleveland
Columbus
Dayton
Findlay
Sandusky
Toledo
Oklahoma
Oklahoma City
Tulsa
Oregon
Portland
Pennsylvania
Philadelphia
Rhode Island
Providence
South Carolina
Charleston
Columbia
Florence / Myrtle Beach
Greenville
Spartanburg
Tennessee
Chattanooga
Nashville
Texas
Austin
Beaumont
Brownsville
Corpus Christi
Dallas
Galveston Bay
Houston
Laredo
McAllen
North Dallas
San Antonio
Tyler
Victoria
Waco
Utah
Salt Lake City
Vermont
Virginia
Charlottesville
Fairfax, Leesburg & Loudoun
Norfolk, Portsmouth & Hampton
Northern Virginia
Richmond
Roanoke
Virginia Beach, Chesapeake & Suffolk
Everett
King County
Olympia
Seattle
Tacoma
Vancouver
West Virginia
Wisconsin
Milwaukee
Wyoming
Cheyenne
Wheaton Personal Injury
New York City Auto Recall
Carter Lake Motorcycle Accident Victims