Dear FDA,

When I go to my Pharmacy I am under the impression that the medications I am getting will not cause me harm. I expect some side effects that my Doctor has warned me about but nothing beyond that. I didn’t expect to see the FDA admit they can’t regulate Generic Medications adequately.

A Generic Medication must deliver the same amount of active ingredients into a patients bloodstream in the same amount of time as the Brand Name drug. Even with guidelines problems are not detected until after a drug is approved. The FDA admits concerns about Extended Release generics and their lack of therapeutic effect. They are “evaluating the issue”.

Irish company Mallinckrodt confirmed that it’s generic version of Concerta was suspected by the FDA to “Not be equivalent to Concerta”. They reclassified it and it’s still on the market. Mallinckrodt could be pressed to “voluntarily” withdraw the medication but that’s it.

The reason I’m going over this is because I take several Generics. One is Amphetamine Salts 30mg. Generic for Adderall. I was getting the brand Teva which was fine. At one point I was switched to another brand and noticed a difference right away. CVS was kind enough to switch them for me. I have Celiac Disease and some generics use gluten as a binder/filler. They won’t admit it but they do. I can’t afford to get glutened right now with my kidneys in danger and other health problems.

This last time I had my prescription filled I didn’t even think to look or say anything because there is a note on my file that I only do well with Teva. I get home and open the bag and see that they are different. The company is Aurobindo Pharma a company in India that has already had several sanctions from the FDA and thousands of complaints from patients. FDA has done nothing. CVS is only dealing with them now. I took them because I really didn’t have a choice. I was right. I’m more depressed, I don’t want to go anywhere, I feel the exact opposite of when I was taking the Teva. My crying and stuttering has increased to the point where I can’t talk to anyone until around 3:00 p.m. It’s horrible. The 29th I go back to the Urologist. I really do not want to be a mess in front of him again. He’s going to be going over some difficult stuff and I have to be able to handle it. He’ll be scheduling my biopsy and going over the procedure which is risky. I can’t fall apart. He already thinks I’m unstable and annoying. Hopefully my sister being there will help.

This is what the drug companies and the FDA don’t understand. If just one of my medications is off it effects everything. If there is gluten in one of them it effects my entire body and brain. As an example I now have Vitamin D resistant Rickets. Who the hell gets Rickets anymore? But because of the Celiac and my immune system I’m at risk for all sorts of odd things. Gluten is in the most unexpected places. It is irresponsible to not let a consumer know that their medication contains something harmful to them because it’s cheaper for the company to make.

I don’t see things changing anytime soon. It will take time. If consumers keep complaining and stand up for their rights maybe something will be done.