Posted 05 September 2017
By Michael Mezher
The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate and extended release opioid ConZip (tramadol hydrochloride).
The warning letter, only the second sent from OPDP in 2017, comes as the US grapples with an ongoing opioid epidemic that has brought increased scrutiny on opioid makers and their marketing practices.
According to FDA, marketing materials for ConZip aimed at a professional audience and distributed by Vertical Pharmaceuticals, which holds an exclusive license to market and sell the drug in the US, completely left out risk information and key details about the drug's indication.
Specifically, FDA says that the detail aid for ConZip made claims about its efficacy, such as "All Day Pain Relief," but did not mention any of its risks, which include addiction and abuse potential and life-threatening respiratory depression.
"The detail aid fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug's safety, a concern highlighted by the serious public health impacts of opioid addiction, abuse and misuse," FDA writes.
FDA also says the promotional materials left out critical parts of ConZip's indication, which specifies that ConZip should only be used when other alternatives would be inadequate to manage a patient's long-term pain and that ConZip is not indicated for as-needed pain management.
As a result of these violations, FDA requests that Cipher immediately stop distributing the promotional materials, provide the agency with a list of all others that make similar representations of the drug and create a "a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in [the warning] letter to the audience(s) that received the violative promotional materials."
If the company does not comply with the request, FDA says it will need to stop distributing the misbranded drug in the US. The company did not respond to a request for comment.