I have been on generic Subutex since 2003. I was detoxed from methadone by my choice to begin Suboxone/Subutex in 2003. I was not able to tolerate Suboxone so I’ve been on generic Subutex. I’M writing to inform you that the quality of the generic brands are increasingly poor. Initially I was on the Roxane brand. I had been on the same brand for the entire time. Recently West ward Pharmaceutical bought them out to Hikma. I contacted the customer service and reported the poor quality of the medication. I will follow up with a complaint to the FDA. Thank you for your time and consideration of this as it effects many people.
Answer:
Sorry to hear of your troubles with generic buprenorphine preparations, you are quite correct in complaining and discontinuing a product that is not working for you. This actually happens more often than reported or admitted to in medication practices. Generic drugs have to be tested by the FDA which certifies that the product does contain the appropriate medication and dosage as labeled but the FDA does not test the generic for bio-availability, impact of non-biologic tablet fillers, dyes, etc. Therein lies the potential for problems. Although a generic may contain the right medication at the right dose, the way a generic company prepares their own dosing form of formally patented trade medication may greatly affect its actions in the body. E.g. a different tableting machine may compress a tablet too hard or too loose that will affect the drugs absorption in the body. Buprenorphine is usually tableted in 2,4, 6, or 8 mg. per tablet or sublingual tape and that size is much too physically small to be practical. So fillers (starches, powders, “inert” substances, et al.) are used to make practical dosage forms. Sometimes those may actually interfere with bioavailability or even cause allergic and other reactions in certain uses. Thus the amount of medication that gets taken up by generic drug may be very different from the original trade mark drug. This has been a very critical issue with heart, blood thinner and other medications that operate on a very narrow dosing regimes. Then, though more rarely, there are some very sloppy generic drug providers who do sloppy work and it is therefore good that you reported this and I hope the FDA will follow up to ensure that they at least have the right medication and right dosage form as they have labeled their generic dosage form to contain. Thank you for bringing this to our attention, it is the first I have heard of it with buprenorphine and now with generic Suboxone coming into the market along with previous Subutex, it will be important to follow what happens when the FDA responds to your report especially if other similar reports begin to pop up.
Dr. Darryl S. Inaba, PharmD, CATC V, CADC III
Director of Clinical and Behavioral Health Service, Addictions Recovery Center
Director of Research and Education, CNS Productions