New Warnings About Methadone Poisoning

New Warnings About Methadone Poisoning

The dangers associated with overuse, overdose and unintended deaths due to methadone poisoning have long been known. But recent increases in the numbers of methadone-related deaths have prompted new warnings about methadone poisoning.

How Bad Is It?

Data from the National Center for Health Statistics (NCHS), NCHS Data Brief No. 22, September 2009, of the Centers for Disease Control and Prevention (CDC) show that death rates involving opioid analgesics (painkillers) more than tripled in the U.S. since 1999. During that period (1999-2006), poisoning deaths involving methadone increased the most.

NCHS data suggests that multiple drugs were involved in at least one-half of the opioid analgesic-related poisoning deaths. The fact that benzodiazepines (sedatives prescribed for anxiety, insomnia and seizures) were involved was particularly troubling due to previous studies which showed that people who were prescribed both methadone and benzodiazepines were at greater risk of overdose than those prescribed only one of the drugs.

The number of methadone-related deaths rose from 799 in 1999 to almost 5,420 in 2006 – a nearly sevenfold increase. In another report for the year 2003, some 2,000 deaths were attributed to methadone poisoning. That year, more than 2 million prescriptions were filled for methadone.

According to the CDC, during one month in 2007 an estimated 5.2 million people age 12 or older used prescription medication for nonmedical purposes. In 2006, an estimated 57,000 emergency department visits for nonmedical use of hydrocodone (or hydrocodone combinations), 65,000 for nonmedical use of oxycodone (or oxycodone combinations), and 45,000 for the nonmedical use of methadone.

State statistics from the NCHS for 2005 show the following five states had the highest numbers of methadone-related poisoning deaths: Florida (430), North Carolina (299), Washington (269), California (214), and Texas (199).

Any way you look at it, the increase in methadone-related poisoning deaths is a troubling trend.

What Is Methadone?

Methadone is a long-acting opioid used in the treatment of pain and in the treatment of opioid dependence, specifically heroin dependence. It does, however, require a complex dosing schedule. When used for pain relief, the drug relieves pain for 4 to 8 hours, but the methadone stays in the body for up to 59 hours.

Patients taking the drug for pain relief may feel the need for more medication when the drug is still in their body. Methadone may build up to toxic levels in the body if it is taken too often, if too much is taken, or if it is taken in combination with certain other medicines or supplements.

Opioid analgesics are drugs that are usually prescribed to relieve pain and include methadone, which is also used to treat opioid dependency, other opioids such as oxycodone and hydrocodone, and synthetic narcotics such as fentanyl and propoxyphene.
Poisoning deaths include those involving intentional or accidental overdoses of a drug, taking the wrong drug in error, taking the drug inadvertently, or being given the wrong drug.

Methadone for Treatment of Opioid Dependence

According to the Code of Federal Regulations (Title 42, Section 8), methadone for the treatment of opioid dependence can only be dispensed by opioid treatment programs (and agencies, practitioners or institutions by formal agreement with the program sponsor), certified by the Substance Abuse and Mental Health Services Administration (SAMSHA) and approved by the designated state authority.

Methadone may only be dispensed and used in oral form for the treatment of opioid dependence by such certified treatment programs, and only in accordance with treatment requirements stipulated in the Federal Opioid Treatment Standards (42 CFR 8.12).

Failure to abide by the regulation requirements may result in seizure of the drug supply, criminal prosecution, revocation of the program approval, and injunction precluding program operation.

When used in methadone maintenance treatment for heroin addiction, methadone:

• Blocks cravings for opioids that is the major cause of relapse
• Suppresses opioid withdrawal symptoms for 24 to 36 hours
• Blocks effects of administered heroin
• Does not cause euphoria, intoxication, or sedation

FDA Advisory on Methadone

The number of unintended deaths due to methadone-related poisoning prompted the U.S. Food and Drug Administration (FDA) to issue a health advisory in late 2006 warning patients of potential problems if their methadone intake wasn’t strictly monitored.
The advisory noted that side effects and deaths associated with improper methadone dosing occurred in patients who had newly started methadone for pain control and in patients who switched to methadone after being treated for pain with other strong narcotic pain relievers.

Methadone may cause shallow or slow breathing and changes in heartbeat that the patient may not be aware of.

Signs of methadone overdose include:

• Breathing that is shallow or slow
• Blurred vision and pinpoint pupils
• Blue fingernails and lips
• Cold, clammy skin
• Coma
• Constipation
• Disorientation
• Extreme tiredness or sleepiness
• Feelings of confusion, dizziness or faintness
• Inability to think, talk, or walk normally
• Low blood pressure
• Muscle twitches or spasms
• Nausea
• Vomiting
• Weak pulse

FDA Programs and Initiatives on Pain Medications and Risks

The FDA has introduced a number of specific programs and initiatives in order to strike the right balance between patients’ access to important pain medications while mitigating the risks.

Safe Use Initiative – The FDA’s mission with the Safe Use Initiative is to both create and facilitate public and private collaborations within the healthcare community. The agency believes that collaboration is essential for drugs such as opioids, given the diverse factors influencing their use as well as the number of stakeholders working to make sure they are used correctly and safely. With the Safe Use Initiative, the FDA seeks to reduce preventable harm by:

• Identifying specific and preventable medication risks

• Implementing and evaluating cross-sector interventions with partners who are committed to safe medication use
Risk Evaluation and Mitigation Strategies for Opioid Drugs – In 2007, Congress gave the FDA authority to require Risk Evaluation and Mitigation Strategies (REMS) for opioid drugs – if that was necessary to ensure that the drug’s benefits outweigh the risks. Practically speaking, this can include requirements for the prescriber, pharmacist and patient information about the appropriate use and risks of a particular drug as well as tools to better manage a drug’s risks. In February 2009, the FDA sent letters to the manufacturers of certain opioid drug products indicating that they would require REMS. The affected drugs included long-acting and extended-release brand name and generic products containing the ingredients, fentanyl, methadone, hydromorphone, morphine, oxycodone and oxymorphone. After holding a number of public stakeholder meetings in 2009 and opening a docket to receive public comments, the agency continues to accept public comments on the approach to opioid REMS. In the summer of 2010, the FDA plans to hold a public advisory meeting to discuss proposals for this important safety program.

Strategies for Safe Disposal of Drugs – Every year, thousands of unintended deaths are caused by accidental dosing of drugs left lying around. Many drugs have harmful, even potentially fatal, effects if they are taken in high doses or by persons for whom they are not intended. The FDA lists 26 drugs, many of which are potent opioids, which require special disposal instructions when they are no longer useful or required. This includes the requirement to flush them down a toilet or sink – so they cannot be accidently used by children, pets or anyone else.

Evaluation of Abuse Potential of Drugs – The FDA has entered into research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs that have a high potential for abuse. The FDA makes the research results available to the Drug Enforcement Agency (DEA).

Efforts to Identify Safer Pain Medications – Recognizing that pain medication should be accessible to people who require it, while also trying to manage the variety of risks posed by such pain medications, the FDA is trying to strike the right balance. In addition to the other strategies and initiatives, the FDA is also exploring ways to improve the development of new pain-relieving medication. This is primarily through research into better designs for pain trials, with the hope that new drugs will be developed that are highly effective yet have better managed risks.

With Precautions in Place – Why the Increase in Deaths?

Despite the precautions, warnings and educational outreach in place by the FDA and others, poisoning deaths attributed to morphine continue to rise. What could be causing this increase?

Greater availability of methadone leads to the increase in deaths. One theory that seems to have credence involves diverting, a common practice involving opioid drugs. What happens is that one person has a prescription for the opioid drug – in this case, methadone – and then sells it or gives it to another.

In one recent study of opioid-related deaths, less than half the people who died from accidental drug overdose had actually been prescribed the drug by a physician.

But in most of the deaths, the reason for the overdose is unclear. Patients overdosing may have been taking their medications as prescribed, or they may have accidentally or intentionally taken more than prescribed.

New warnings which may help reduce the number of deaths include encouraging doctors to require patient contracts in which they pledge not to share their opioid prescription drugs with others and to only use the drugs as necessary. In addition, patients need to exercise more diligence and responsibility about storage and proper use of these strong medications.

According to information from the NIDA International Program, even though methadone can be diverted for oral or intravenous use, the rate of overdose is low for patients enrolled in methadone maintenance programs (for the treatment of opioid dependence). Methadone maintenance treatment has been successfully used to treat heroin addiction in the United States for the past 46 years (since 1964).

The website resource on methadone abuse states that with the increase use of methadone as a treatment for chronic pain the majority of the methadone-related deaths in the United States is believed to be associated with the use of this medication for pain treatment rather than for treatment of opioid dependence.

What Should You Do?

Patients already taking pain medication or other medications should be extremely cautious when also taking methadone. This is a very strong painkiller which may produce unintended harmful and potentially fatal effects if taken in the wrong doses, in combination with other medications, or taken inadvertently.

Methadone overdose can occur if you take methadone when you are also taking certain other painkillers such as OxyContin, Vicodin, or morphine.

If you, or someone you know, are experiencing any of the symptoms of methadone overdose, call the National Poison Control Center immediately at 1-800-222-1222. You can call toll-free from anywhere in the United States. The other important thing to know about this national hotline is that you can also call even if it is not an emergency. So, call if you have any questions about poisoning or need information about methadone poisoning. It is a confidential service that is provided to everyone and is available 24 hours a day, 7 days a week.

If you are directed to go to the hospital emergency department, take the methadone container with you.

At the hospital emergency room, your vital signs will be measured and monitored, including blood pressure, breathing rate, pulse and temperature. Treatment will proceed as appropriate for your symptoms. Such treatment may include activated charcoal, breathing tube, intravenous fluids (IV), laxative, antidote medication to reverse the effects of the methadone, or a tube through the mouth into the stomach to wash out the stomach (known as gastric lavage).

The outlook, or prognosis, depends on how much methadone you took, and how quickly you got treatment. Obviously, the sooner you receive treatment, the better your prognosis. If an antidote is not received quickly enough, some of the complications that may occur include brain damage or respiratory arrest.

Medical experts say that if an antidote can be given for an acute overdose, recovery begins immediately. However, since methadone remains in the body for a couple of days, you may need to stay in the hospital overnight, and you may receive repeated doses of the antidote.

Bottom line: Only take methadone if it has been prescribed for you. Only take it in the doses and at the times your physician prescribes. Store the medication in a locked cabinet or one that is not accessible to children or others. Safely discard medication when no longer needed by flushing it down a sink or toilet. Never giver or sell methadone to others. It is illegal and could result in accidental or intentional methadone poisoning.

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