[Update: 3/27/2017] An FDA laboratory tested another sample of PNC-27 solution for inhalation and found the bacteria Ralstonia insidiosa.
[1/10/2017] The Food and Drug Administration 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.
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.
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.
The agency has not received reports of illnesses or serious adverse events related to PNC-27. FDA encourages health care professionals and consumers to report any adverse events possibly related to the use of a PNC-27 product to FDA’s MedWatch Adverse Event Reporting Program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.