Sunday, February 25, 2024

Generic medicines are considered equivalent to their brand name counterparts, but they are not identical


Q: My insurance forced me to switch to a generic version of my medicine, but my symptoms started coming back. My doctor insists it’s the exact same medicine, so why doesn’t it work as well?
Generic medicines are considered equivalent to their brand name counterparts, but they are not identical. Although the Food And Drug Administration (FDA) requires all generic drugs meet the same standards as brand name products, they don’t have to match them in every way.
Before they can sell a generic version of any medicine, its manufacturer must show the FDA that at each strength that the brand name comes in, their product contains the same amount of active ingredients. Generic medicines must also match the form and route of administration of the original or “innovator” medicine, whether it’s a tablet, capsule, liquid or injection.
In addition, the manufacturing processes, quality control and testing for generics must meet the same standards as branded medicines. Surprisingly, many generics are made in the exact same facility as their branded versions.
Generic drug manufacturers must prove to the FDA that their generic is equivalent to the branded medicine by testing the blood of human volunteers who take each one at a time. If the levels in the blood from the generic and brand are similar, the FDA assumes the generic will work the same in your body.
The active ingredients of generics must be equivalent but the inactive ingredients don’t have to be. Sometimes those differences change the way you absorb your medicine. Just like meatballs contain more than just meat, tablets and capsules can contain more than just their active ingredient. Diluents or fillers are added to provide bulk, as the active ingredient may only be a small amount of powder, with lactose, sucrose, kaolin, powdered starches and cellulose commonly used as fillers for tablets and capsules.
Food coloring may also be mixed into the powder, causing reactions in people who are sensitive to dyes. An adhesive compound called a “binder” is also added to help the powder press together into a tablet, like adding an egg to a meatball recipe helps the meat and rice “stick” together when formed into a ball.
Generic manufacturers use less expensive versions of fillers, dyes and binders, allowable by the FDA as long as the active ingredient is the same concentration as the original medicine. Making generic versions of extended-release or long-acting forms is more complex than duplicating a simple tablet, making it trickier to get the generic versions to act the same as the original.
The FDA received complaints about one generic version of Wellbutrin® XL that caused headaches, nausea and a return of depressive symptoms in some people. After investigation, important differences showed up in how the generic was absorbed into the body and in October 2012 the FDA reversed its approval of generic Wellbutrin® XL, instructing its manufacturer, Teva, to take it off the market.
Here are 4 Tips on How To Take Generic Medicines:
1. Check your pills BEFORE you leave the pharmacy.
Don’t assume a different shape or color is “just another generic”. Because generic medicines don’t have to match the appearance of the branded version, the color or shape can change whenever your pharmacy uses a different manufacturer. Check for and challenge any changes in the shape or color of your medicine, to make sure you have the correct medicine in your pill bottle.
2. Ask Google.
If you get your pills by mail, you can check what’s in your pill bottle yourself. In Google, type in the shape (round or oblong), color, and any markings you see on the pill. If there is a line across the tablet, type in the word “scored”. Most of the time there’s only one result plus a photo, but if you see more than one, check with your pharmacy FIRST before taking it.
3. Ask your doctor for brand name only.
If you have a bad experience with a generic product, ask your doctor to document the problem and prescribe the brand you did well on, adding  DO NOT SUBSTITUTE to the prescription. With documentation, an insurance company will usually cover the brand name product for you instead of the generic, though sometimes you will have a higher copayment.
4. Report it to the FDA.
If you notice a significant difference when switching to a generic medicine, ask your doctor to report it to the MedWatch program that is run by the FDA, which tracks adverse events caused by medicines.

Dr. Louise Achey, Doctor of Pharmacy is a 40-year veteran of pharmacology and author of Why Dogs Can’t Eat Chocolate: How Medicines Work and How YOU Can Take Them Safely. Check out her NEW website for daily tips on how to take your medicine safely. ®2020 Louise Achey


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