Insys Therapeutics, Inc., Illegally Marketing Subsys for Off-label Use

From January to June of 2015, after being in the market for only three years, Subsys has already earned for Insys Therapeutics, Inc., $147.2 million. Up until now, this drug continues to be one of the biggest selling opioid (narcotic) pain medicines in the United States.

Subsys, a federally controlled substance (CII), is the first and only sublingual prescription pain medication that contains fentanyl (fentanyl is an opioid agonist Schedule II controlled substance that is 80 to 100 times more powerful than morphin). Subsys has been approved by the U.S. Food and Drug Administration as treatment for breakthrough pain in adult cancer patients who have become opioid tolerant (these are people, whose long term treatment with opioid has resulted to tolerance with this addictive pain medicine).

Like any other fentanyl-containing medication, Subsys has side-effects which include nausea, vomiting, somnolence, constipation,respiratory depression (which can lead to apnea),circulatory depression, hypotension, shock, slow heart rate, feeling like passing out, loss of appetite, dizziness, worsening tiredness or weakness, and fatal breathing problems.

Though Subsys is intended only for opioid tolerant patients, a study by Symphony Health found out that it has often been prescribed by dentists, neurologists and even podiatrists – those who should have nothing to do with the drug. Despite this off-label use of Subsys due to doctors’ recommendations, it cannot be legally stopped since marketing a drug for off-label use is only prohibited of drugmakers.

With more than 200 deaths (due to adverse effects linked to Subsys) reported to the FDA’s Adverse Events Reporting System, however, this drug may be availed only after registering with the Transmucosal Immediate-Release Fentanyl (TIRF) Risk Evaluation and Mitigation Strategy (REMS) Access program.

According to a Subsys spray lawsuit attorney of Williams Kherkher, reports have found that the drug’s manufacturer, Insys Therapeutics, has encouraged doctors to prescribe Subsys oral spray to patients who do not really need it. These prescriptions are issued despite the risk of death associated with the drug, which is directly written on its label. There have even been instances where the company helped patients who had no signs of cancer falsify cancer diagnoses in order to receive Subsys and thereby increase its sales.

Subsys oral sprays should never be prescribed to patients who do not have terminal cancer. Having a member of a family being hospitalized after being given Subsys oral spray for a non-cancerous condition, the victim’s family members may be able to hold the drug’s manufacturer accountable for whatever damages they may suffer.