Why was Flexeril discontinued?
Flexeril is one of the most popularly prescribed muscle relaxants. It is typically used to help alleviate muscle spasms and treat pain and tenderness related to musculoskeletal conditions. But why was Flexeril discontinued? Despite its popularity, the brand name has now been discontinued due to a variety of reasons not related to drug safety.
Flexeril is manufactured by Merck & Co. Inc. The company decided to discontinue the product in 2023. According to the National Library of Medicine, the drug was first synthesized in 1960 and FDA approved for use in human medicine in 1977. It is often used in conjunction with physical therapy and a comprehensive treatment plan to help relieve pain associated with muscle-related pain or injury.
Cyclobenzaprine is the generic form of the drug. However, despite no longer being on the market, most forms of cyclobenzaprine medication are still often referred to as Flexeril.
Why was Flexeril Discontinued?
Flexeril was discontinued in 2023 primarily due to economic reasons. It was not discontinued for safety reasons. The company never officially stated the reasons for discontinuation; however, it was widely believed to be because of product profitability. The growth in the availability of cheaper generic alternatives of cyclobenzaprine made it more difficult for the brand to compete in the market. It was no longer financially lucrative to keep producing the brand-name drug.
Flexeril became one of the most popular brands for treating muscle-related injuries. Even today, as the brand no longer exists, the generic versions available are still generally referred to as Flexeril.
Economic decisions can heavily influence drug availability. Research and analysis show the recent changes in the dynamics of pharmaceutical supply and demand. These changes weighed heavily on the presence of Flexeril on the drug market. Most pharmaceutical companies will pivot towards more profitable or innovative products. Because of the widespread availability and access to much cheaper alternatives to cyclobenzaprine, it contributed to the decision to discontinue Flexeril.
A drug patent generally lasts for about 20 years. Generic versions of cyclobenzaprine began emerging as early as 1986. This led to various legal battles regarding the drug. Merck sued another drug manufacturer, Danbury Pharmacal Inc., for patent infringement. Danbury went on to countersue, arguing that Merck’s patent for Flexeril was invalid due to a number of misrepresentations about the drug.
Ultimately, the court upheld the patent’s validity, but ruled in favor of Danbury in two key points. The first was that Merck failed to disclose the similarity between Flexeril and the existing drug Amitriptyline. The second, Merck inaccurately claimed that Flexeril did not cause drowsiness. These legal challenges Merck faced eventually opened the doors for the availability of generic cyclobenzaprine drugs to flood the market.
What is Flexeril?
Flexeril belongs to the class of drugs called muscle relaxants. It works on the central nervous system and blocks pain sensations from traveling to the brain. This helps to provide pain relief from muscle spasms and muscle tenderness. This type of muscle relaxant drug works directly on the brain rather than on the muscles. Because of its impact on the central nervous system, there are risks of developing a dependence and addiction to the drug.
The drug is typically prescribed for short-term between 2-3 weeks to help manage pain from acute musculoskeletal conditions. It can help relax tense muscles, relieve pain, relieve stiffness and relax muscle spasms.
Flexeril is not a controlled substance. It is often prescribed for off-label uses such as the treatment of fibromyalgia, temporomandibular disorders and PTSD. The skeletal muscle relaxant works directly on the brain. Because it directly affects the central nervous system, this can cause a risk of dependence and addiction. The risk for drug abuse increases if the medication is used alongside other drugs that impact the central nervous system such as alcohol and opioids.
One dose of Flexeril can last anywhere between 6-24 hours, depending on the formulation. An immediate release formulation works quickly within the hour and can reach its maximum effect within 4 hours. But it can take about 1-2 days of medication to fully feel the effects of the drug. The formulation is usually taken 3 times per day. An extended-release formulation reaches its maximum effects within 7-8 hours. It is designed to slowly release the medication into the body over a period of time and can last up to 24 hours. The average half-life of Flexeril is anywhere between 8 to 37 hours.
Side effects
- Drowsiness
- Dry mouth
- Fatigue
- Headaches
- Dizziness
- Nausea
- Constipation
- Blurred vision
- Confusion
- Abdominal pain
- Nervousness
- Heart palpitations
- Difficulty speaking
- Numbness
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Risks and Dangers of Flexeril Use
- Serotonin Syndrome – This condition occurs when there is too much serotonin in the body and can cause symptoms such as agitation, hallucinations, seizures and nausea.
- Muscle relaxant toxicity – It can cause changes in blood pressure, elevated heart rate and increased muscle activity.
- Central Nervous System Depression – It can cause symptoms such as slurred speech, lethargy, respiratory arrest and lack of coordination.
- Can cause aggressive behavior, paranoia and delusions when taken at high doses.
Cyclobenzaprine medications and Flexeril alternatives
Now that the brand Flexeril is off the market, scientists and researchers are developing new drugs with fewer adverse side effects while still holding maximum effectiveness. New research has led to the development of muscle relaxants that target a different pathway to improve and alleviate pain. The newer muscle relaxant drugs are created with reduced side effects and a more effective formulation that minimizes dangerous side effects such as sedation.
Other alternative cyclobenzaprine medications include Amrix, which is an extended-release capsule available in doses from 15 to 30mg. And Fexmid, a cyclobenzaprine medication that was the direct competition and alternative to Flexeril.
Muscle Relaxant Abuse
Muscle relaxants are generally not addictive and pose very little risk for abuse. However, because Flexeril works directly on the central nervous system, there is a higher risk of dependence and developing an addiction.
The National Institute on Drug Abuse estimates that more than 50 million Americans over the age of 12 have abused prescription drugs such as Flexeril at least once in their lives. In 2011, US doctors wrote an estimated 25.2 million prescriptions for Flexeril and other medications that contained the drug cyclobenzaprine. Flexeril totaled about 30 million prescriptions annually in recent years. The widespread availability and recommendation of use of the drug have led to abuse.
Flexeril does not necessarily produce a euphoric high. However, people still misuse the drug to induce relaxation and continue to increase the dosage to intensify feelings of relaxation and sedation. Misuse of the drug can cause symptoms such as cardiac arrest, low blood pressure, seizures, heart attack, and central nervous system depression. The risk of these effects is increased when combined with other drugs like alcohol and benzodiazepines.
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Flexeril is a muscle relaxant prescribed for short-term pain relief and discomfort from muscle injuries. The brand name of the drug has been discontinued. But there are still various generic forms of cyclobenzaprine on the market at similar or more cost-effective prices. It is not considered an addictive drug, but there is a risk of developing a physical dependence and addiction. Behavioral health treatment programs such as Hotel California by the Sea, provide substance use disorder treatment.
We offer treatment at all levels of care including detox, residential, PHP and IOP. We utilize evidence-based treatment methods including CBT, DBT, group therapy and family therapy. Hotel California by the Sea is dedicated to helping clients reach their goals of sobriety and overcome their substance addiction.
References:
https://www.greenmatters.com/health-and-wellness/why-was-flexeril-discontinued
https://www.addictioncenter.com/antidepressants/flexeril
https://www.medicalnewstoday.com/articles/cyclobenzaprine-oral-tablet
https://www.verywellhealth.com/effects-of-cyclobenzaprine-how-long-will-they-last-8576669
https://www.help.org/flexeril-addiction
https://livefreerecoverynh.com/why-was-flexeril-discontinued/
https://heartfeltrecoverycenters.com/blog/why-was-flexeril-discontinued/