Active ingredients in med.

[Allie501]

Has anyone read or heard about DEA regulations regarding amounts of active ingredients in ADHD medications for 2023? I did but tbh I don't understand it all. I know they limit how many can be manufactured and sold. But I hadn't heard they are beginning to regulate amounts of chemicals or ingredients in them. Which, if true, would mean weaker meds.

[BlessedLady]

The DEA has been regulating the amount of Schedule II ingredients manufacturers receive for years. In recent years they have been steadily reducing the amount. It only pertains to the amount manufacturers are allotted for a year

[Allie501 in reply to BlessedLady]

Ok. I didn't know that. I thought they regulated how many they can make. Wow that's upsetting for we who have ADHD and need our meds to function. Not just to stay up to study or clean the house. Which that does help with but some of us can barely get out of bed in the morning without it. Thanks for enlightening me

[BlessedLady in reply to Allie501]

Technically, the DEA does regulate how much of a Schedule II drug can be made. The allotment is for the entire year.

There can be a difference in the amount of active ingredients in genetic drugs compared to the brand. Also inactive ingredients can vary. For example if a brand contains 10 mg active ingredients. The generic has to contain 8 mg-12 mg active ingredients. The difference in inactive ingredients can impact how a drug in absorbed in the body

[Allie501 in reply to BlessedLady]

Thanks for the info. My Dr. prescribed brand. I'm finally able to get a refill today.

[HCStymie in reply to BlessedLady]

That range of active ingredients in a drug is a very common misunderstanding. The +/- 20% rule is in regards to the blood concentration of the Active Pharmaceutical Ingredient (API) within each person of a study at different time intervals relative to the brand. The average and the entire 90% (technically can be argued to be 95%) Confidence Interval must also be within that 20%.

That is the short version, I'll spare the more technical aspects, it can be looked up online quite easily for a detailed explanation. What is important is that almost all medications API are within 2.5 to 5% of the blood concentration of the brand name. That is the bioequivalence that needs to be shown to be approved by the FDA. Proving bioequivalence by that standard, they assume it to be therapeutically equivalent. In reality, there can be a huge difference based on the inactive ingredients effects. And quality control is a factor since manufactures are left to self regulate with spot inspections for a few of them each year. FDA has caught manufactures cheating when batches came up short etc.

Inactive Ingredients (excipients) often have their own drug profile and themselves could actually be a minor stimulant or assist the medication in some way, Sometimes they can actually work against the API. FDA regulates the amount of each excipient that can be in a medication too.

As an example, an excipient may help adderall get through the blood brain barrier where it does it's job. If you have 2 drugs with identical blood concentrations, but only 1 has the blood brain barrier assistance effects from an excipient, that one would be more likely to produce a real therapeutic effect than the other. Also, could be possible for a drug to fail the bioequivalence tests, yet be more therapeutic than the name brand because it had better excipients that assist the drug or have additional benefits on their own.

Bioavailability is how much of the API is absorbed and available to the body. Some excipients assist APIs in the first pass through the liver after absorbed from the gut. Higher bioavailability. It may take more API for a different brand without those excipients to make the same blood concentration as the brand name. So actual API in the medication does not matter at all as long as it results in a bioequivalent blood concentration. Even if there was double the API in a pill, if it results in the same blood concentration, it is considered equivalent.

The FDA regulates the actual meds, the DEA just screws the prescribers by limiting the total amount manufacturers can make by restricting the API.

[Allie501 in reply to HCStymie]

Thank you for your response. Although I can't totally understand all of it, I'm wondering how to know if our prescribed med's API is too low. Or if other factors related to the individual person can affect how well a med works. Like certain foods or lack of exercise. Or less hormones related to post menopause.

[HCStymie in reply to Allie501]

The best bet is the API is probably at an ok level. Different people do react differently to different drugs. Example, for me Evekeo is weak and useless. but for 15% of people, they respond well to it, or better than Adderall or Zenzedi.

Some people respond better to the amphetamine based drugs, others to the methylphenidate based drugs, and others to the non stimulant atomoxetine.

If you find a med that works well for you, then go with it. If you get the name brand, most likely you are getting one of the best. If it still doesn't work well, either you need a higher dose or different med prescribed.

If you get a generic version of a drug that doesn't work relative to other generic brands or the name brand, it is most likely due to cheap inactive ingredients. Even among the good brands of generic Adderall, I was able to notice a difference. But still useful. But as I recall, crappy brands can sometimes feel like you took nothing.

Certain foods can interact, but not usually on a large difference. I know I take 4 Lovaza daily (Omega-3, ie concentrated purified fish oil) and can notice a difference if I forget to take it the next day. Less focus, alertness, and energy. But not a huge difference. Or if I drink a can of soda with lunch my meds wear off a little faster (due to making urine more acidic thereby eliminating more amphetamine (weak base).

Can't say for sure as far as hormones affecting medication for ADHD. My guess is probably not. I do know ADHD meds effect dopamine levels. And dopamine does have an effect on hormones. So I think the opposite is more likely. In my case, Adderall has devastated my endocrine system. But I am more sensitive to it than most people.