4 replies to this topic

[zevogaz]

Hi

ProbaBLY this kind of topic has been discussed already, but I could not find it.

I am interested in how to to establish a border between pharmaceuticals, nootropics and dietary supplements?

What is the scope of nootropics and dietary supplements vs. pharmaceuticals?

Thank you for your assistance,
zevogaz

[exigentsky]

These terms are not exclusive. For example, many nootropics are pharmaceuticals.

[mitkat]

Read LifeMirage's Q+A about nootropics, he sets out some guidelines for what makes a nootropic what it is. One of those main points is that it must be relatively non-toxic.

And yeah, a lot of nootropics (racetam's, for example) are pharmaceuticals.

[dopamine]

Nootropics usually aren't considered pharmaceuticals in the "political" sense in that they do not carry the weight of evidence that other, FDA approved drugs, carry with them in the regulatory process. Many argue that their is a conspiracy or agenda against the development of nootropics into effective prescription drugs in the U.S., as many nootropics are prescription drugs intended to treat specific conditions in other countries.

There is some weight to the argument that in order for a substance to be a true "nootropic", it must posses certain properties outlined by the original developers of Piracetam, which among others includes the lack of toxicity in in vitro as well as in in vivo experimental conditions. However, some nootropics, like Nefiracetam, show toxicity in some enviroments, most disturbingly in the testicles of dogs in a recent experient (Reprod Toxicol. 2004 May;18(3):423-30):

Testicular toxicity induced in dogs by nefiracetam, a neutrotransmission enhancer.

Shimomura K, Shimada M, Hagiwara M, Harada S, Kato M, Furuhama K.

Drug Safety Research Laboratory, Daiichi Pharmaceutical Co, Ltd, 1-16-13 Kitakasai, Edogawa-ku, Tokyo 134-8630, Japan. shimop7x@daiichipharm.co.jp

To investigate mechanisms of the testicular toxicity of nefiracetam and to find sensitive parameters to predict the toxicity, male beagle dogs were orally administered 180 or 300 mg/kg per day of the drug once and for 1 and 4 weeks. Time-course changes in serum and/or testicular hormone levels and semen parameters, and testicular morphology were examined. The testicular testosterone level was decreased 4 h after single administration of nefiracetam at 300 mg/kg per day, but the progesterone level showed no change at that time. The serum testosterone level was decreased after single, 1-week or 2-week treatment. In contrast, the serum estradiol level was increased from 1- to 4-week treatment. No changes in serum LH, FSH and inhibin B levels were observed throughout the experimental period. Decreased sperm motility and increased number of malformed sperms were first observed in semen after 4-week treatment. Histopathological examination of the testis revealed moderate and severe seminiferous atrophy with multinucleated giant cell formation at 180 and 300 mg/kg per day, respectively, after 4-week treatment, but not 1-week treatment. These results show that nefiracetam decreases testicular testosterone level in dogs following single oral administration of a high dose, and induces severe morphologic changes after 4-week treatment. This reduction is shown to be a sensitive parameter to detect the toxicity, and is suggested to be induced by the impaired conversion of progesterone to testosterone in Leydig cells.

There is also some concern that Nefiracetam has adverse effects on the bladder and kidney (Toxicol Pathol. 1996 Sep-Oct;24(5):549-57):

Examination of lesions in the urinary bladder and kidney of dogs induced by nefiracetam, a new nootropic agent.

Kashida Y, Yoshida M, Ishii Y, Nomura M, Kato M.

Drug Safety Research Laboratory, Daiichi Pharmaceutical Co., Ltd., Tokyo, Japan.

Toxic lesions induced by nefiracetam, a nootropic drug, in the urinary bladder and kidney were examined by repeated oral administration of 300 mg/kg/day for 1, 2, 3, 4, or 11 wk to male and female beagle dogs. Each dog was sacrificed after each treatment period, and urinalysis and serum biochemistry were performed for surviving dogs at several time points. One male and 2 females died during week 10 or 11. Degeneration and desquamation of epithelial cells and edema and hemorrhage in the lamina propria were observed in the urinary bladder after 1 wk of treatment. These changes became severe as time progressed and were reflected in the clinical abnormalities of hematuria and increased protein excretion in urine. However, epithelial regeneration and hyperplasia were seen thereafter, and almost no change was seen in the urinary bladder after treatment for 11 wk. Instead of recovery as in the urinary bladder, the kidney showed epithelial degeneration and hyperplasia in the papilla and collecting duct and interstitial congestion and hemorrhage after treatment for 11 wk. Extensive hemorrhage and papillary necrosis were seen in animals that died during week 10 or 11 of dosing. These kidney changes were associated with increased urinary volume and decreased osmotic pressure. The lesions are thought to have a common etiopathogenesis and to be initiated by the epithelial damage with a time lag between expression of injury in the urinary bladder and the kidney.

So, not all nootropics are entirely "safe", even within the boundaries of pyrrolidone derivatives.

[kevink]

Dopamine - Thanks for posting that info. That's exactly why I pass on the newer
racetams in favor of Piracetam.

Please continue to post anything else you come across. We all can't read everything, so if people giving a heads up is greatly appreciated.