Orlaam is the trade name for levacetylmethadol, a synthetic opioid similar in structure to methadone. It has a long duration of action due to its active metabolites. It is used to treat and manage opioid addiction if a patient has failed to respond to other treatments, such as methadone or buprenorphine. Orlaam was used between 1993 and 2003 to relieve the many unpleasant symptoms of opioid withdrawal.
Orlaam is no longer sold in the U.S. but is a Schedule II controlled substance under the Federal Controlled Substances Act. One of the main problems with Orlaam is that it produces dependence, as does morphine, and has the potential for abuse. If it is used repeatedly, it could produce tolerance, which would limit its effectiveness. It could also produce physical dependence. Like methadone, it could be diverted by a user and sold on the illegal drug market.
What Are Opioids?
Opioids comprise a class of drugs used medically to relieve pain. Some are made from natural substances, some are synthetic, and some are semi-synthetic. They work by interacting with opioid receptors in brain cells in the human body.
Some opioids are made from the seed pods of opium poppy plants, e.g., morphine and heroin. These are sometimes referred to as “opiates.” Morphine is a natural substance taken from the seed pods of various opium poppy plants, and heroin is made from morphine. Heroin is sold on the black market for drugs as a white or brown powder or a sticky black substance referred to as “black tar heroin.”
Morphine is a Schedule II controlled substance because it has a high potential for abuse, i.e., addiction. It is sold by prescription under MS Contin, Roxanol, Kadian, and others. Heroin is a Schedule I controlled substance, meaning it has no currently accepted medical use. It is considered unsafe to use even under the supervision of a doctor. That is because of the high risk of becoming addicted to it. It is not available legally at all.
Some opioids can be synthesized in a laboratory, e.g., fentanyl. Fentanyl is sold under the brand names Actiq, Duragesic, and others. Fentanyl is also a controlled substance. It is available by prescription and on the illegal market for controlled substances.
The problem with all opioids is that they are addictive. In addition to relieving pain and making a person sleepy at low doses, they induce intense euphoria. This makes a person want to continue feeling the euphoria or feel it again with increasing frequency. This is part of what leads a person to addiction. Once people find they are addicted, they must use the substance regularly or suffer withdrawal symptoms.
Unfortunately, at higher doses, opioids slow a person’s breathing and heartbeat. This is the other major risk of opioid use; a sufficiently high dose can cause death. This is one of the reasons why addiction to opioids is so harmful. It comes with a high risk that a person will take too large a dose and die.
What Went Wrong with Orlaam?
The federal Food and Drug Administration approved Orlaam in 1993. It was approved for use in the treatment of opioid addiction. It was taken off European markets in 2001 because it was reported to cause life-threatening cardiac rhythm disorders. In 2003, Roxane Laboratories, Inc., the manufacturer of Orlaam, voluntarily took Orlaam off the market in the U.S. It is no longer prescribed here.
Many reports have been made that Orlaam was discontinued because it presented a high risk of addiction. However, the FDA issued a notice in June 2011 that it was not removed from the market for reasons of safety or effectiveness.
What Are the Side-Effects of Orlaam?
Nonetheless, Orlaam has a long list of side effects, and its use is restricted. It could only be dispensed by Opioid Treatment Programs (OTPs) certified by the Substance Abuse and Mental Health Services Administration (SAMHSA), a part of the U.S. Public Health Service. Orlaam had no recommended medical uses other than the treatment of opioid addiction.
One of Orlaam’s possibly life-threatening side effects is the risk of proarrhythmic effects, which causes cardiac arrhythmias. For this reason, it could only be used to treat opiate-addicted patients who did not respond to other treatments for opioid addiction because other treatments were not effective enough. Or other treatments were not helpful because they could not be used in an effective dose due to side effects that were not tolerable.
Cases of QT prolongation and serious arrhythmia were observed during treatment with Orlaam. Because of these reports, all patients had to undergo a 12-lead electrocardiogram before Orlaam was administered. This assessment aimed to determine if the patient had a prolonged QT interval. If a patient did have a prolonged QT interval, they were not allowed to take Orlaam.
If the potential benefit of taking Orlaam outweighed a patient’s risk of developing arrhythmias, an electrocardiogram was to be performed before treatment started, 12 to 14 days after treatment was started, and then periodically. The reason for this was to eliminate any changes in the QT interval.
Orlaam was to be administered with extreme caution to patients at risk for developing prolonged QT syndrome, e.g., congestive heart failure, atrial fibrillation, use of a diuretic medication, cardiac hypertrophy, hypokalemia, or hypomagnesemia.
There were numerous other side effects as well, including the following:
- Hives;
- Difficulty breathing;
- Swelling of face, lips, tongue, or throat;
- Breathing that stopped while a person was asleep;
- Severe dizziness;
- Pale skin;
- Thin or thready pulse;
- Rapid or shallow breathing;
- Low blood pressure;
- Shortness of breath.
A person was directed to seek immediate medical attention if they suffered any side effects. This list is not complete. There were about 40 other side effects also.
What Are My Remedies If I Have Been Injured by Orlaam?
Orlaam has not been used medically since 2003. So, a person should not have been given Orlaam by a medical professional for quite some time. If they have been treated with Orlam, they would want to consider finding another doctor.
If a person took Orlaam when it was still on the market and believes they were injured by taking the drug, they should consult a personal injury lawyer. A lawyer would review their case thoroughly to determine if Orlaam caused the person’s injuries and whether a lawsuit for medical malpractice, pharmacy malpractice, or strict product liability would be an option.
If successful, any of these lawsuits for personal injury would lead to an award of compensatory damages. Damages would reimburse a person for both their economic and non-economic damages, such as the cost of medical care, pain and suffering, and lost salary.
It is possible that a lawsuit for strict product liability against the manufacturer and distributors of Orlaam would be challenging at best because the drug would be found to be unavoidably unsafe, and a person who had a life-threatening illness, e.g., opioid addiction, would risk the dangerous side-effects to seek relief from their underlying life-threatening condition.
Do I Need the Help of a Lawyer for My Orlaam Issue?
If you believe you were injured by taking Orlaam, consult a class action attorney. Your attorney will have a medical expert review your case and determine if you have a claim. Your attorney could advise you on your next steps and protect your rights.
