A Texas man has filed a lawsuit against Cephalon over its Actiq fentanyl lollipop, saying the sugary painkiller rotted his teeth. The Actiq lollipops, which contain a powerful pain medication in a lozenge on the end of a stick, have also been connected with a number of fentanyl overdose deaths.
The Actiq lawsuit was filed earlier this month by Greg Lee Minckley, in the District Court for the 419 Judicial District of Travis County, Texas. The complaint alleges that the sugar in the Actiq fentanyl lollipops destroyed his teeth and resulted in $37,000 in extensive dental treatment, according to Courthouse News Service. Minckley was prescribed the fentanly lollipops to treat pain caused by pancreatitis, which is not an approved use for the strong painkiller.
Actiq lollipops (fentanyl citrate) are designed to slowly release the potent drug over time as the patient holds the lollipop in their mouth. Minckley alleges that Cephalon developed a sugar-free version of the lollipops, but decided not to market it.
Actiq side effects have also been linked to other serious and potentially fatal fentany injuries, beyond causing tooth decay. As a result of the candy-like nature of the lollipops, there have been a number of fentanyl overdoses and deaths, including users who took too much of the medication and young children who found the fentanyl lollipops and mistook them for candy.
Although Actiq is only approved for the treatment of cancer pain in patients who have already grown tolerant to other opioids, Cephalon has been criticized for marketing the drug in a way that led to off-label sales.
Earlier this month, a federal judge dismissed a lawsuit brought by a Cephalon shareholder, which alleged the company illegally promoted the drug off-label. According to a story by BNET Pharma Blog, the company did not dispute the off-label marketing charges, which claimed that sales reps aggressively marketed the drug for other uses, but got the lawsuit dismissed because the shareholder, Jerald King, was unable to tie the actions of Cephalon marketing staff to the company’s board members.
It has been estimated that more than 80% of Actiq users received the medication “off-label” and do not have cancer. The FDA was concerned enough about the power of the lollipops and the potential of abuse that it is requiring Cephalon to alert the agency if any group of physicians who represent potential off-label use, such as doctors who are not oncologists or pain specialists, account for more than 15% of its sales.