A Case of Hepatotoxicity Induced by Adulterated "Tiger King", a Chinese Herbal Medicine Containing Sildenafil.

Detection of Phosphodiesterase Type 5 (PDE-5) inhibitors and their analogues in "100% natural" or "herbal" supplements have been described in numerous reports. However, few reports have been published in relation to actual harm caused by counterfeit erectile dysfunction herbal supplements. We describe a case of a 65-year old male admitted to a tertiary hospital with acute liver toxicity, possibly induced by adulterated "Chinese herbal" supplement "Tiger King" for sexual enhancement. Chemical analysis of the tablets discovered the presence of therapeutic doses of sildenafil with no other herbal components. Other medications were excluded as potential causes of the hepatic impairment. According to the Naranjo adverse drug reaction scale and the Roussel Uclaf Causality Assessment Method (RUCAM) the probability of association of Hepatotoxicity with Sildenafil was "possible" and "probable" respectively (Naranjo score of 4, RUCAM score of 7). Within three days of admission, the patient's clinical status and liver function improved without any specific treatment. His liver function tests normalized 30 days post discharge. Further pharmacovigilance actions should be taken by regulatory authorities and pharmaceutical companies in order to determine the relation between sildenafil and hepatotoxicity. This case emphasizes the importance of raising public awareness on the potential dangers of "Tiger king" in particular, and other counterfeit medications or herbal supplements of unknown origin.

[Synthetic cannabinoids--the new "legal high" drugs].

Recently, a new Law, named the "derivative law" (first addition, schedule drug change--2010), was accepted in the Israeli parliament. It will mean that dangerous substances that are closely related structurally to a drug that is listed in the dangerous drugs ordinance will automatically enter the dangerous drugs ordinance. The dangerous drugs that were sold in kiosks were related to 4 major groups: Amphetamines, methamphetamines, cathinone and methcathinone. Over 90% of the substances known as "legal highs" or "hagigat" belong to these groups. Before the law was accepted, merchandisers and clandestine Laboratories took advantage of a state in which every small molecular change in a controlled substance of amphetamines, methamphetamines, cathinone and methcathinone required a long legal process in order to include the new substance in the controlled substance law. During this process, we believe that public health was endangered. The chemists and merchandisers found a new solution to "legally" bypass the "derivative law", by marketing a new group of substances named "synthetic cannabinoids". The synthetic cannabinoids do not resemble the chemical structure of tetrahydrocannabinol (THC] which appears in marijuana or hashish, but affects the body in the same manner and according to the literature, are five times more potent. The synthetic cannabinoids are sold in Israel under different nicknames such as: "Mabsuton", "Mr. Nice Guy", "Spice", "Sabbaba" and "Lemon Grass". The substance can be used in different ways such as smoking, inhaling or swallowing. The use of synthetic cannabinoids causes side effects that include: euphoria, dizziness, headache, thirst, paranoia, insomnia, fatigue and disturbed vision. Cases of hospital admission in Israel due to the use of these substances have been reported. The symptoms included psychiatric disturbances. In an urgent meeting of the multi-ministry committee on psychotropic substances held in December 2010 in the Israel Anti-Drug Authority, it was decided to recommend to the Minister of Health to insert an inclusive group of "synthetic cannabinoids" into the control drug list in Israel. On April 5, 2011, after receiving the approval of the health and welfare committee in the Israeli parliament, the dangerous drugs ordinance (new version)--5732-1973 was amended with the addition of an inclusive group of "synthetic cannabinoids". These include: JWH-018, JWH-133, JWH-073, CP 47, 497, CP 55, 940, HU-331, HU-210, HU-211, HU-250.

[Counterfeit drugs in Israel and worldwide. Part I: the extent of occurrence and impending threats].

A counterfeit drug is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeit drugs can be found worldwide, both in deveLoped and developing countries, and their dissemination is a major threat to public health and safety, and has major economic effects on the consumers, the pharmaceutical industry, and society at Large. One of the first measures in confronting this problem is bringing it to the awareness of medical staff and public. This review aims to describe the extent of the problem, to discuss its negative effect, and to present actual and possible consequences.

[Counterfeit drugs in Israel and worldwide. Part II: distribution profile and anti-counterfeiting strategies and actions].

Counterfeit drugs are a major threat to public health and safety around the world. This review describes the various distribution methods and channels of counterfeit drugs, including the growing use of the internet. National, regional and international efforts to confront this problem are presented, as well as a wide range of technologies that may assist in detection and enforcement. Finally, the Israeli perspective and actions are illustrated.