When Was Fentanyl Approved By The FDA?

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 for breakthrough pain in people who are already on around-the-clock narcotics and are opioid resistant. Before prescribing, it doctors are supposed to 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, as well as the fact that it’s still not a major part of most people’s understanding of drugs, it’s actually a painkiller that’s been around for decades. People often wonder what the history of fentanyl is and when was fentanyl approved by the FDA, and are surprised to find out how long it’s been in use.

To begin, fentanyl, which is a synthetic opiate, was first developed in 1959 by someone named Dr. Paul Janssen. The patent was obtained under his company name, Janssen Pharmaceutica. Fentanyl, because of just how powerful it is, has a history that began by offering a painless death experience, and its implications weren’t ever to manage pain in everyday life. Along with being extremely powerful, more so than heroin, fentanyl acts quickly but also wears off fast. Unfortunately, despite instructions to physicians as to how it should very carefully be prescribed, over the years it’s been given to patients for things it was never meant for, such as the short-term pain of recovering from a knee surgery. It was introduced to the marketplace in 1960 as an analog for Demerol, with, as was touched on above, plans that it would be only for palliative care.

By the 1960s there was an intravenous anesthetic version of fentanyl called Sublimaze, and in the mid-1990s Janssen Pharmaceutical began working on clinical trials for the Duragesic patch. This is a skin patch that includes an alcohol gel with certain doses of fentanyl. After the patch came a flavored lollipop version of fentanyl that was introduced under the brand name Actiq, and it was the first rapid-action version of fentanyl intended for dealing with chronic breakthrough pain. Following that, an effervescent tab was introduced, and a buccal spray device is currently being worked on. Also recently approved by the FDA was something called Onsolis. 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 in the mouth and it can’t be abused by taking the medicine and inhaling or crushing it. So, to answer when was fentanyl approved by the FDA, it was in 1959, but since then many new products using fentanyl have been introduced. Since the introduction of fentanyl over 50 years ago, it has become a source of controversy, and the patch has been available since the beginning of the 1990s. When was fentanyl approved by the FDA is an important question to understand the role the drug has played in healthcare and pain management for so long, but there have been public health warnings related to the drug issued 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. They highlighted the fact that deaths and overdoses were happening from 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 and deadly side effects for people using the fentanyl patch, and the warning went on to say that physicians were inappropriately prescribing it.

While it was 1959 when Fentanyl was approved by the FDA, it wasn’t until the 1970s that illicit use of the drug really started happening. 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 heroin even. 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, leading to unintentional overdoses and deaths.