Cohen Pieter A, Avula Bharathi, Wang Yan Hong, Zakharevich Igor, Khan Ikhlas
Department of Medicine (PAC), Cambridge Health Alliance, Somerville, MA, Harvard Medical School, Boston, MA; National Center for Natural Products Research (BA, YHW, IK), School of Pharmacy, University of Mississippi, University, MS; and Department of Biochemistry and Molecular Genetics (IZ), University of Colorado Denver-Anschutz Medical Campus, Aurora.
Neurol Clin Pract. 2021 Jun;11(3):e303-e307. doi: 10.1212/CPJ.0000000000000960.
To identify the presence of unapproved pharmaceutical drugs in over-the-counter dietary supplements marketed to improve memory and cognitive function.
Supplements were identified by searching 2 supplement databases for products labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam, 4 drugs not approved for human use in the United States. Products were purchased online and analyzed using nontargeted liquid chromatography-quadrupole time-of-flight mass spectrometry methods.
In the 10 products tested, omberacetam and aniracetam were detected along with 3 additional unapproved drugs (i.e., phenibut, vinpocetine and picamilon). By consuming recommended serving sizes, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 ± 0.4 mg omberacetam (typical pharmacologic dose of 10 mg), 502 ± 0.8 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 ± 0.3 mg of phenibut (typical pharmacologic dose 250-500 mg), 4.3 ± 0.1 mg of vinpocetine (typical pharmacologic dose 5-40 mg), and 90.1 ± 0.7 mg of picamilon (typical pharmacologic dose 50-200 mg). Several detected drugs were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, 75% (9/12) of declared quantities were inaccurate. Consumers could be exposed to up to four-fold greater than pharmaceutical dosages and as many as 4 unapproved drugs when using individual products.
Over-the-counter cognitive enhancement supplements may contain multiple unapproved drugs. The health effects of consuming untested combinations of unapproved drugs at unpredictable dosages without clinician oversight in supplements are unknown.
确定在市场上销售的用于改善记忆力和认知功能的非处方膳食补充剂中是否存在未经批准的药品。
通过搜索2个补充剂数据库来识别补充剂，查找标签上标明含有奥拉西坦、阿尼西坦、苯乙拉西坦或奥西拉西坦的产品，这4种药物在美国未被批准用于人类。产品通过在线购买，并使用非靶向液相色谱 - 四极杆飞行时间质谱法进行分析。
在测试的10种产品中，检测到了奥拉西坦和阿尼西坦以及另外3种未经批准的药物（即苯丁胺、长春西汀和匹卡米隆）。按照推荐服用量，消费者可能会接触到药物水平剂量的药物，包括最高40.6±0.4毫克的奥拉西坦（典型药理剂量为10毫克）、502±0.8毫克的阿尼西坦（典型药理剂量为200 - 750毫克）、15.4±0.3毫克的苯丁胺（典型药理剂量为250 - 500毫克）、4.3±0.1毫克的长春西汀（典型药理剂量为5 - 40毫克）以及90.1±0.7毫克的匹卡米隆（典型药理剂量为50 - 200毫克）。几种检测到的药物未在标签上声明，而标签上声明的几种药物在产品中未被检测到。对于那些标签上提供了药物含量的产品，75%（9/12）的声明含量不准确。消费者在使用单个产品时，接触到的药物剂量可能比药物剂量高出四倍，并且可能接触到多达4种未经批准的药物。
非处方认知增强补充剂可能含有多种未经批准的药物。在没有临床医生监督的情况下，在补充剂中以不可预测的剂量服用未经测试的未经批准药物组合对健康的影响尚不清楚。
