Scientific research demonstrates Zinc Gluconate Safety
Oct 5 news release:
On September 29, 2004, Matrixx Initiatives, Inc., the manufacturer of Zicam® Cold Remedy zinc gluconate nasal gel, completed a two-day meeting of its Scientific Advisory Board to review the findings of studies initiated in the first quarter of 2004. Members of the Scientific Advisory Board presented the results of their studies on the epidemiology, anatomy, and physiology of smell disorders.
It was the unanimous opinion of the Scientific Advisory Board that the cumulative scientific evidence does not support the contention that Zicam® Cold Remedy zinc gluconate nasal gel is associated with disorders of smell.
Study findings included the following:
• Anatomic and behavioral data obtained in animal studies showed no detrimental effects on smell associated with single doses of Zicam intranasal zinc gluconate gel equivalent to between three and six times the recommended dose for humans.
• Human in vivo and cadaver studies using the current dosage form and nasal pump delivery device confirmed that Zicam intranasal zinc gluconate gel does not reach the upper area of the nasal cavity where smell reception occurs.
• The epidemiologic study demonstrates that three of the most common conditions associated with anosmia are the common cold, sinusitis, and nasal injury. This population study in 3.7 million patients demonstrated statistically significant associations between anosmia and numerous medical conditions, and multiple classes of drugs. These factors confound any attempt to attribute an association of anosmia with Zicam.® Cold Remedy zinc gluconate nasal gel.
A more rigorous evaluation of the epidemiologic data will be performed. The Scientific Advisory Board also plans to do further testing of the zinc gluconate nasal gel on human volunteers and animal models. Panel members will reconvene in approximately six months to review the findings of the additional research.
Panel members included Lawrence DeSanto, M.D., Mayo Clinic, Scottsdale; Joseph E. Dohar, M.D., Children's Hospital of Pittsburgh; Aiden L. Doyle, M.D., FACS, Pharmaceutical Consultant, Central Nervous System; Kathleen M. Guthrie, Ph.D., Department of Biomedical Science, Florida Atlantic University; Judith K. Jones, M.D., Ph.D., Pharmacoepidemiologist; Bao-Anh Nguyen-Khoa, Pharm. D., M.P.H., Pharmacoepidemiologist; Burton M. Slotnick, Ph.D., Department of Psychology, University of South Florida; and Michael Zmuda, Ph.D., Regulatory Consultant. |
