Generic Prozac: Can You Trust It?
Aug. 28, 2001 -- Since the new generic Prozac got FDA approval, the WebMD message boards have been buzzing with consumer questions and comments:
lucia18: "My health plan just sent a note that they'd like for me to switch to the new form of generic Prozac. I'm very hesitant to switch. Am I foolish? Are they truly the same thing? How can they be the same thing (did the Prozac fellows send the recipe to the generic fellows)?"
iberne: "On an emotional level, I can understand a general discomfort with 'generic' medications. Name brand does mean quality with many consumer products. Personally I like my Coca-Cola, and lots of name brand cereals taste better to me. But a better analogy is table salt. The difference between brands is virtually nil for the most part, and quality isn't so much an issue."
murray500: "My mother-in-law swears that generic ibuprofen is not as good as her Motrin. I can't tell any difference except a lot less $$$."
Is the active ingredient in generic Prozac really the same as the name-brand version? Can different inactive ingredients -- binders and fillers -- affect the drug's quality?
For answers, WebMD turned to Bob West, RPh, acting deputy director of the FDA's Office of Generic Drugs.
"We want to assure the public that through rigorous testing, generic Prozac has been proven to be as safe and effective as the Lilly product," West tells WebMD. Drugmaker Eli Lilly and Co. manufactures Prozac.
"When you swallow the capsule or tablet, it dissolves in a manner similar to the Lilly product," he says. "The active ingredient is absorbed by the body in a manner comparable to the Lilly product, so the blood levels obtained are comparable to those obtained with the Lilly product."
What sort of rigorous testing is West talking about? FDA regulations require that generic drugs:
- Contain the same active ingredients as the brand-name drug (the binders and fillers may vary, however).
- Must be the same in strength and dosage (whether pill or capsule) as brand-name drugs.
- Be manufactured under the same strict standards as brand-name products. Meet batch requirements for, among other things, strength, purity, and quality.
- Be bioequivalent to the name-brand drug.
Translation: If two drugs are "bioequivalent," it means that the active ingredient in one drug works the same as in the other drug.
As with other generic drugs, generic Prozac's bioequivalency study was conducted over a month's time, with 40-50 people taking the generic version, then switching to the name-brand drug. Each patient's blood was analyzed multiple times each day to observe the amount of drug that had been absorbed, how long it took the drug to be absorbed, and the total amount of drug that was absorbed.