Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that inhibits appetite by acting on the central nervous system. The drug was developed by Arena Pharmaceuticals.
In Brazil, APIs are registered independently of the drug products that contain them. API approval is needed to apply for marketing authorization of pharmaceutical products including them. (you can find here an overview of API registration) In this case, the API Lorcaserin had been approved by ANVISA in July 2013, but no commercial pharmaceutical products containing it were registered. The drug substance was being marketed only in customized compounded prescription medication, formulations prepared in pharmacy labs for individual patients.
Lorcaserin (commercialized as Belviq) was registered in the European Union until May 2013, but the marketing authorization was cancelled then, after the Committee of Drug Products for Human Use of the European Medicine Agency, expressed that the product should have never been approved for the treatment of overweight and obesity. In lab tests, the product showed potential risk of cancer, especially with the long-term use.
The drug is approved in the USA, where is is classified as a Schedule IV drug under the Controlled Substances Act, meaning that is a controlled substance but that has a low potential for abuse relative to the drugs or other substances in schedule III, that has a currently accepted medical use in treatment in the USA, and that abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. Prescriptions for Schedule IV drugs may be refilled up to five times within a six-month period.
Is there any update regarding this article? I am curious where the information you posted here are coming from. Cancer risk? Is there a study out there that corroborates your story?
Hi Michael! Thanks for your engagement. This is where I found the information on the withdrawal of application from EMA and related information: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2013/05/WC500143811.pdf
To be honest, I haven’t followed up on the topics. Do you have any new information on whether ANVISA has reaccepted Lorcaserin as an API?
Have a nice day!
No, I don’t have new information regarding this but I am researching if that has changed.
What is interesting though is that information is now all over that says the concerns for valvulopathy and drug addiction are not true. And that Lorcaserin itself is being looked as a potential drug for helping smoking cessation, drug addiction, etc now.
Another plus is that the price of Belviq is not $75 and not the original $200+ 🙂
I will get back to you as soon as I get more information.