January 12th, 2017
FDA is warning consumers not to purchase or use PNC-27, a product promoted and sold through http://PNC27.com, as a treatment or cure for cancer. An FDA laboratory discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inhalation.
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Consumers at higher risk include vulnerable populations, such as young children, elderly people, pregnant women, and individuals with weakened immune systems.
BACKGROUND: PNC-27 may be available in various dosage forms, such as a nebulized solution, intravenous solution, vaginal suppository, or rectal suppository. FDA has not evaluated or approved PNC-27 as safe and effective to treat any disease, including any form of cancer. The agency has not received reports of illnesses or serious adverse events related to PNC-27.
RECOMMENDATION: FDA recommends patients with cancer discuss treatment options with a licensed health care professional. Patients who have used any PNC-27 product and have concerns should contact their health care provider as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: http://www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Warning statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536763.htm back...
Consumers who use a contaminated product are at risk for serious, potentially life-threatening infections. Consumers at higher risk include vulnerable populations, such as young children, elderly people, pregnant women, and individuals with weakened immune systems.
BACKGROUND: PNC-27 may be available in various dosage forms, such as a nebulized solution, intravenous solution, vaginal suppository, or rectal suppository. FDA has not evaluated or approved PNC-27 as safe and effective to treat any disease, including any form of cancer. The agency has not received reports of illnesses or serious adverse events related to PNC-27.
RECOMMENDATION: FDA recommends patients with cancer discuss treatment options with a licensed health care professional. Patients who have used any PNC-27 product and have concerns should contact their health care provider as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: http://www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the FDA Warning statement, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm536763.htm back...
