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 to 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 the brand name comes in at each strength. Their product contains the same amount of active ingredients. Generic drugs must also match the form and route of administration of the original or “innovator” medicine, whether it’s a tablet, capsule, liquid, or injection.
Also, 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 taking the new medication. If the blood levels 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. 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 sensitive to dyes. An adhesive compound called a “binder” is also added to help the powder press together into a tablet. 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 complicated than duplicating a simple tablet. This makes it more tricky.
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, significant differences showed up in how the generic was absorbed into the body. 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 Taking Generic Medicines:
- 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 branded version’s appearance, the color or shape can change whenever your pharmacy uses a different manufacturer. Check for and challenge any changes in your medicine’s form or color to make sure you have the correct medication in your pill bottle.
- 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, 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.
- Ask your doctor to order the brand name product.
If you’ve had a bad experience with a generic product, ask your doctor to document it in your medical record. When ordering the brand name medicine, make sure your doctor adds the comment DO NOT SUBSTITUTE. 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.
- Report it to the FDA.
If you notice a significant difference when switching from a brand name medicine to its generic equivalent, ask your doctor to report it. The MedWatch program run by the FDA tracks side effects and other medication-related problems.
