Cyclobenzaprine

Why Was Flexeril Discontinued?

The muscle relaxant Flexeril (cyclobenzaprine) offered relief to many people, including athletes dealing with acute pain. The prescription drug was a go-to treatment for painful musculoskeletal conditions like sprains, fractures, and overuse injuries.

In 2023, it vanished from pharmacies, leaving a lot of patients asking, “Why was Flexeril discontinued?”

If you’re someone who relied on Flexeril for pain relief, you’re likely searching for answers and other options.

Below, we uncover the reason behind Flexeril’s discontinuation and whether concerns about its side effects or potential for substance abuse played a role.

What Is Flexeril?

Until recently, Flexeril was a popular brand name for the prescription drug cyclobenzaprine. When combined with ample rest and physical therapy, it effectively treats painful muscle spasms caused by direct injuries to the muscles, tendons, or bones.

Flexeril acts on the central nervous system, blocking pain sensations from reaching the brain. This action helps relax muscles without affecting their mobility.

Originally, Flexeril was pitched as a muscle relaxant that wouldn’t make you drowsy or sleepy. That claim wasn’t 100’% true, but we’ll get to that in a bit.

Flexeril has also been used off-label for other medical conditions, including:

Why Flexeril Was Discontinued

Merck, the maker of Flexeril, hasn’t given an official explanation for its discontinuation. However, many believed money was the main reason.

Nowadays, generic cyclobenzaprine is everywhere and way cheaper, making it hard for Flexeril to stay profitable. This happens a lot when drug patents expire, although Flexeril didn’t exactly play out that way.

Merck got FDA approval to sell cyclobenzaprine as Flexeril in 1977, following its patent grant in 1975. A US patent normally lasts about 20 years, but by 1986, generic versions of Flexeril were already underway.

As you can imagine, legal battles quickly followed. For instance, Merck sued Danbury Pharmacal for trying to sell their own generic cyclobenzaprine, which was a clear breach of their patent.

Danbury fired back, claiming Merck’s patent was invalid because they hadn’t been completely honest about Flexeril. In the end, the court upheld the validity of the patent but sided with Danbury on two points:

  • Merck didn’t disclose how similar Flexeril was to the existing drug amitriptyline, in both chemical makeup and usage. The only difference was a double bond in cyclobenzaprine, which didn’t make it a unique invention.
  • They claimed Flexeril didn’t cause drowsiness or sedative effects when it actually could.

Long story short, Merck misrepresented Flexeril and could not enforce their patent. That opened the door for more generic versions of cyclobenzaprine to hit the market.

Is Flexeril Addictive?

Flexeril, or the generic cyclobenzaprine, is considered non-addictive when used as intended, no longer than three weeks. The Food and Drug Administration advises against prolonged therapy since muscle spasms clear up pretty quickly with proper treatment.

However, evidence suggests cyclobenzaprine addiction isn’t that far-fetched.

Cyclobenzaprine slows down your central nervous system, which can have soothing effects some people find irresistible. Chronic use or high doses can lead to addiction or substance abuse.

Below are signs that someone is building up a tolerance and dependence on cyclobenzaprine:

  • Taking it longer than prescribed
  • Needing larger doses for the same effect
  • Using it in ways other than prescribed, like chewing or snorting
  • Preoccupation with the drug
  • Changes in appearance or behavior

People with mental health issues trying to quiet down their thoughts are more likely to get hooked on cyclobenzaprine. Some may abuse the drug to experience a different kind of calm or ease off the hard stuff like cocaine or Adderall.

Chronic, high-dose users may experience withdrawal symptoms upon quitting. They’re usually mild but may include headaches, nausea, fatigue, and intense cravings.

The Dangers of Combining Flexeril With Other Drugs

Cyclobenzaprine is dangerous when mixed with other drugs. In the worst cases, this could lead to a life-threatening overdose, leading to:

  • Severe muscle stiffness
  • Changing consciousness
  • High fever
  • High blood pressure
  • Heart attack or cardiac arrest
  • Seizures

Whitney Houston, for example, who tragically died in 2012, had traces of cocaine, Flexeril, and other drugs in her system.

Like other muscle relaxants, you should never take cyclobenzaprine with alcohol and other CNS depressants (barbiturates and benzodiazepines). This combination can make you extremely sleepy and even slow your breathing and heart rate to dangerous levels.

Taking Flexeril with certain antidepressants that boost serotonin levels is also risky. This can lead to a condition called serotonin syndrome, which can cause tremors, sweating, agitation, and, in severe cases, high blood pressure.

Plus, Flexeril can make seizures more likely when combined with MAO inhibitors, a more potent class of antidepressants.

Lastly, it can worsen side effects like dry mouth, dry eyes, and constipation when taken with other anticholinergics.

Given these serious risks, inform your healthcare provider about all the medications and supplements you’re taking before starting cyclobenzaprine. This way, they can screen for drug interactions and ensure your safety.

What Is a Substitute for Flexeril?

The generic cyclobenzaprine is the same as Flexeril, so you’re not left without options.

You can also consider branded options Fexmid and Amrix (an extended-release capsule), which are hydrochloride forms of cyclobenzaprine like Flexeril.

Is Flexeril an Opioid?

Flexeril is not an opioid. It works on your central nervous system differently than opioids do.

Cyclobenzaprine reduces pain signals to the brain by limiting serotonin transmission at the spinal cord. Meanwhile, opioids activate opioid receptors all over your body, including the brain’s pain and reward centers.

Is Flexeril a Controlled Substance?

Since Flexeril isn’t an opioid or narcotic, it’s not considered a controlled substance by the Drug Enforcement Administration (DEA). Still, you need a prescription to get it.

Final Thoughts

Flexeril might have disappeared from the market, but cyclobenzaprine remains available in a more affordable generic form.

Talk with your doctor about alternative treatments and explore other options that may be just as effective but a lot safer than Flexeril.

References

Published on: 2024-07-10
Updated on: 2024-08-17

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