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# ConZip Professional Aid Omits Risk Info: FDA
- URL: https://www.fdaweb.com/conzip-professional-aid-omits-risk-info-fda/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139549

The CDER Office of Prescription Drug Promotion (OPDP) says that a Cipher Pharmaceuticals professional detail aid for ConZip (tramadol hydrochloride) extended-release capsules for oral use is false or misleading because it omits important risk information associated with using ConZip and other material facts. In an 8/24 [Warning Letter](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM574480.pdf?ref=fdaweb.com), OPDP says that ConZip is an opioid agonist indicated for managing pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The drug’s labeling contains Boxed Warnings about addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; neonatal opioid withdrawal syndrome; interactions with drugs affecting cytochrome P450 isoenzymes, and risks from concomitant use with benzodiazepines or other central nervous system depressants. There also are Contraindications and Warnings and Precautions.

The letter says the detail aid makes several representations and suggestions about ConZip efficacy but fails to communicate any risk information about it. “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 Warning Letter says. It says the detail aid also is misleading because it fails to provide material information about ConZip’s full FDA-approved indication, including important limitations of use.

The letter tells Cipher to immediately stop misbranding ConZip and/or cease introducing the misbranded drug into interstate commerce. It is to reply with a list of all promotional materials containing representations described in the letter and explaining its plan to discontinue using such materials or ceasing distribution of the drug. The company also is to submit a comprehensive plan to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in the letter to the audiences that received the violative promotional materials.