When Was Fentanyl Approved By The FDA?

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.

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.

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.

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.