When Was Fentanyl Approved By The FDA?

In many ways, fentanyl is a massive part of the current opioid crisis in the U.S. Despite the fact that fentanyl is one of the most powerful and most-abused opioids, as well as one of the more deadly prescription drugs currently available, it wasn’t until music legend Prince’s was ruled in part due to a fentanyl overdose that this drug took over the national spotlight.

What is Fentanyl?

Fentanyl is a Schedule II prescription opioid painkiller that’s 50 to 100 times more powerful than morphine. It’s intended for use in people suffering from severe, long-term pain, primarily in cancer situations. Fentanyl is used to treat breakthrough pain in people who are already on around-the-clock narcotics and are opioid resistant.

Before prescribing fentanyl, doctors should assess whether or not a patient is a good fit for the drug based on their history of potential drug or alcohol abuse, and whether there are other options available.

Despite the extreme potency and dangers associated with this drug, it’s actually a painkiller that’s been around for decades. People who wonder what the history of fentanyl is and when was fentanyl approved by the FDA may be surprised to find out how long it’s been in use.

What Is the History of Fentanyl?

Fentanyl is a synthetic opioid that was first developed in 1960 by Belgian chemist Dr. Paul Janssen. The patent for fentanyl was obtained under his company name, Janssen Pharmaceutica.

Fentanyl was first approved by the Food and Drug Administration (FDA) in 1968 and introduced to the marketplace as an analog for Demerol with plans that it would be only for palliative care.

Along with being extremely potent (even more so than heroin) fentanyl acts quickly but also wears off fast. Despite instructions to physicians as to how it should be prescribed, fentanyl has been given to patients for uses it was never meant for, such as the short-term pain of recovering from knee surgery.

Different Ways to Take Fentanyl

By the 1960s, there was an intravenous anesthetic version of fentanyl called Sublimaze, and in the mid-1990s, Janssen Pharmaceutica began working on clinical trials for Duragesic patches. These skin patches include an alcohol gel with specific doses of fentanyl.

After the patch was produced, a flavored lollipop version of fentanyl was introduced under the brand name Actiq, and it was the first rapid-action version of fentanyl intended for treating breakthrough pain. Following the fentanyl lollipop, a fentanyl effervescent tab was introduced, and a buccal spray device is now available.

Onsolis was another drug recently approved by the FDA. This is a fentanyl product specifically designed for cancer breakthrough pain, and it uses a fentanyl buccal soluble film. It’s different from other fentanyl products because it’s given by a small disc for oral use and it can’t be abused by inhaling or crushing it.

To answer, “When was fentanyl approved by the FDA?” fentanyl was approved in 1968, but since then many new fentanyl products have been introduced.

“When was fentanyl approved by the FDA?” is important to know the answer to in understanding the role the drug has played in health care and pain management for so long. There have been public health warnings related to fentanyl as well, despite the fact that it is approved and classified as a Schedule II drug.

For example, in 2005, the FDA issued a public health warning related to potential dangers of the fentanyl patch. The warning highlighted the fact that deaths and overdoses were happening among people using both the brand-name Duragesic and the generic version of the patch.

In 2007, a second public health advisory was issued, stating that there continued to be reports of deadly side effects for people using the fentanyl patch. The warning stated that physicians were inappropriately prescribing fentanyl patches.

Illegal Use of Fentanyl

While it was 1968 when fentanyl was approved by the FDA, it wasn’t until the 1970s that illicit use of the drug started occurring on a large scale. There are many identified analogs of the drug, making it relatively easy to get, and these can be up to hundreds of times more powerful than other opioids like heroin.

Unfortunately, fentanyl is sold on the black market in various forms, and even people who think they’re getting heroin may actually be buying fentanyl, which could lead to unintentional overdoses.

By – Camille Renzoni

Cami Renzoni is a creative writer and editor for The Recovery Village. As an advocate for behavioral health, Cami is certified in mental health first aid and encourages people who face substance use disorders to ask for the help they deserve. Read more

Medically Reviewed By – Christina Caplinger, RPh

Christina Caplinger is a licensed pharmacist in both Colorado and Idaho and is also a board-certified pharmacotherapy specialist. Read more