The US Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate- and extended-release opioid tramadol hydrochloride (ConZip).
ConZip is an opioid agonist indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
In a warning letter to Cipher President and CEO Robert Tessarolo, the FDA said marketing materials for ConZip directed at healthcare providers are “false or misleading” because they omit “important risk information” regarding use of ConZip and because of other “material facts.”
The FDA said the promotional materials for ConZip make claims about its efficacy, such as “All Day Pain Relief,” but fail to mention any of its risks, which include addiction and the potential for abuse and life-threatening respiratory depression.
The materials also fail to communicate any information about risks associated with use of the product. “By omitting the risks associated with ConZip, including serious and potentially fatal risks, 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 heightened by the serious public health impacts of opioid addiction, abuse and misuse,” the letter reads.
The FDA also says the promotional materials leave out important parts of ConZip’s indication, which specifies that the drug should be reserved for patients for whom alternative treatment options, such as nonopioid analgesics or immediate-release opioids, are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain relief.
The FDA has asked the company to stop distributing the promotional materials, provide the agency with a list of all other materials that make similar representations of the drug, and develop a 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.”
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