The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier.
The agency also told the company, Cipher Pharmaceuticals, of Mississauga, Ontario, to cease circulation of the incomplete promotional materials for the extended-release drug, ConZip (tramadol hydrochloride).
At issue is a two-page flyer, or “detail aid,” for the drug, which is exclusively marketed in the United States by Vertical Pharmaceuticals, of Sayreville, New Jersey.
“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 FDA Office of Prescription Drug Promotion said in a warning letter to Cipher.
Left out of the detail aid, although included in the prescription information approved by the FDA in 2016, is that ConZip is “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,” the letter said.
Also missing is that ConZip is not indicated as an as-needed analgesic, the letter said.