Fentanyl is a powerful opioid painkiller. Because of its incredibly addictive nature, it is important for Fentanyl to only be marketed and used as approved by the U.S. Food and Drug Administration (FDA). Unfortunately, the manufacturers of a fast-acting form of Fentanyl have been marketing it for off label uses, exposing thousands of patients to serious risks and even death.
The class of drugs — quick-absorbing fentanyl sprays, tablets and lozenges called T.I.R.F.s (for transmucosal immediate-release fentanyl) is only approved for use in terminal cancer patients with a high opioid tolerance. T.I.R.F.s have to be taken on a strict around the clock schedule. Without a regular routine, the body’s tolerance to the drug dramatically decreases, increasing the risk of accidental overdose and other complications.
Improper Marketing of Fast-Acting Fentanyl
Makers of Fentanyl have improperly marketed the drug to treat other types of pain, and patients weren’t warned of the increased risk of accidental overdose. Unfortunately, many patients were completely unaware T.I.R.F.s were not approved for use treating chronic pain unrelated to cancer treatment. Improper marketing has been so widespread that several companies have been fined millions of dollars for misleading the public. Common brand names of transmucosal immediate-release fentanyl medications include Actiq and Fentora made by Cephalon, and Subsys made by Insys Therapeutics.
In 2008, Cephalon paid over $400 million in fines for falsely advertising its products, including a Fentanyl lollipop called Actiq. Cephalon illegally marketed Actiq for the treatment of migraines. In the same year, McKesson Corporation paid $13.25 million in fines for not reporting suspicious orders of opioids. Just nine years later, McKesson was again accused of failing to report suspicious opioid orders and eventually agreed to pay $150 million in fines.
Patients have the right to know all risks associated with their medications. Instead of warning patients, Fentanyl manufactures blatantly ignored regulations to maximize profits. Off-label promotion of medications is illegal, and manufacturers need to be held responsible for the injuries and deaths they have caused.
The pharmaceutical lawyers at Blizzard Law PLLC have seen too often how drug companies put profits before people. That’s why we advocate aggressively for our clients to protect their rights and help them obtain compensation for their injuries. If you or someone you love was prescribed fast-acting Fentanyl off-label and suffered a serious injury or death, do not wait to call us. We only work on a contingency fee basis, meaning you won’t owe us anything unless we help you obtain compensation. Call us today to schedule a free consultation.