Comment · Fri, November 29, 2013 · Ceretropic
Cerebral Health Pyritinol (New Test Results)
Original post in this thread
MisterYouAreSoDumb · 137 points
We have finally identified the substance that Cerebral Health was selling as pyritinol, which has sent one person to the hospital, and caused adverse reactions in half a dozen other people so far. The results are very surprising, as I never would have guessed it. It turns out the substance is diphenhydramine, also known as Benadryl. Diphenhydramine has anticholinergic and serotonergic effects, and has been known to cause seizures in higher doses. So essentially people were overdosing on a deliriant. You can read reports of people taking large doses of it online, and it does not seem like a very pleasurable experience.
So far Cerebral Health has not taken any steps to address the issue. I've gone back and forth with the owner Doug on Longecity for a while now, and the exchange has pretty much been a PR disaster for him. Not only has he been rude and dismissive, but he has threatened myself and the lab manager of the first lab we used to do the testing with litigation. On top of that, he insulted the lab managers education, and generally has been a total asshole throughout this whole incident. It's definitely not the…
What they were answering
[deleted] · 0 points
"To Whom It May Concern,
Thank you for writing the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER).
The Federal Food, Drug, and Cosmetic Act generally requires that drugs marketed in the United States be shown to be both safe and effective prior to marketing and widespread use in the general population. Drugs that are marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling.
Please know that the Agency has serious concerns that drugs marketed without required FDA approval may not meet modern standards for safety, effectiveness, quality, and labeling. The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. Furthermore, FDA's review of the applicant's labeling insures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.
We are concerned about the public health implications of Internet drug sales and are working actively with other State and Federal agencies to ensure that the safeguards Congress has enacted over the years serves its purpose to protect the public health and safety of the American public.
Please also forward information to the Drug Enforcement Agency (DEA) about sus…
u/MisterYouAreSoDumb · Ceretropic
I will be giving the FDA a call today. It's better that we get in front of this, rather than let them find it out on their own.