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Millions of Americans may be getting cancer-causing chemical in generic cold medicine

AILSA CHANG, HOST:

Generic over-the-counter medicines can cost significantly less than their name-brand counterparts. Most consumers see generics as a good bargain, the same medicine with the same ingredients for less money. But millions of Americans who purchase a generic version of extended-release Mucinex could be getting a drug that contains benzene. That's a chemical that causes cancer. Benzene is found in store brands from CVS, Walmart and other major retailers. Anna Edney reports on healthcare for Bloomberg News, and she's been following this story and joins us now. Welcome.

ANNA EDNEY: Thank you for having me.

CHANG: Well, thanks for being with us. So, I mean, I think pretty much everyone, including myself, has at some point bought a generic drug. So this does raise a lot of questions. Can you just first explain what is benzene? And how did a cancer-causing chemical end up in the generic version of a very popular cold medicine?

EDNEY: Yeah. Benzene is - it's a potent carcinogen. It's something that is usually - you might find it in gasoline. It's essentially a byproduct of, you know, petroleum products. You know, it's known to cause, as you mentioned, cancer, specifically leukemia or lymphoma. What it also can be used as, which I think a lot of people don't know, is a solvent. Essentially, when you're making drugs, you have a lot of dry ingredients that are going together. You need to sort of get them to come together - solvents that can be used. And what I did find was that there are some store brands, as you mentioned - they are buying from a company that makes this generic Mucinex that uses an ingredient that has benzene as the solvent. And the Food and Drug Administration has said, like, we need to move away from this because that could risk...

CHANG: Yeah.

EDNEY: ...Leaving benzene in the product for consumers.

CHANG: Well, how much benzene are we talking about in these cases? Like, Is it enough to be dangerous? I'm assuming yes.

EDNEY: Really, we just don't know because the Food and Drug Administration hasn't shared that information. I've also filed Freedom of Information Act requests to get some of the results of the testing that they've done but have - so far have not gotten any answers.

CHANG: Wow. And all this time, how would a consumer know that benzene is in their generic-brand drug? Like, is it on the label, written there explicitly? How did you figure this out?

EDNEY: Definitely it is - benzene is not on the label. You can sometimes find this ingredient, the carbomer, on the label, and that would be in the inactive ingredients. So usually way up top on the label, there's the active ingredient. But go lower down. There's all these words you can't pronounce. Carbomer would be in there.

CHANG: OK, I have a really basic question. If Benzene...

EDNEY: Yeah.

CHANG: ...Is not part of the active ingredients and if it doesn't...

EDNEY: Right.

CHANG: ...Have to be in the carbomer that is used in these generic drugs, why don't companies just make generics without benzene?

EDNEY: There is a significant price difference. A carbomer made with benzene is a lot cheaper than one made without.

CHANG: Well, it sounds like the FDA is sort of trying to crack down on this. They said that benzene would be phased out of pharmaceutical drugs next year, but then that's been extended to 2026 after manufacturers complained. But why has the U.S. allowed use of a known cancer-causing chemical for the past decades?

EDNEY: Yeah. I think, you know, international guidelines say Benzene should not be used in drug-making unless, you know, there's some lifesaving drug that absolutely can't be made without it, which - I don't know that, you know, we really have come across that. But it's kind of opened this loophole for the Food and Drug Administration to allow it. The companies have been able to use it and kind of get away with it under this loophole, and the FDA has not cracked down on that.

CHANG: Anna Edney reports on health care for Bloomberg News. Thank you so much for your reporting.

EDNEY: Thank you for having me on. Transcript provided by NPR, Copyright NPR.

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Ailsa Chang is an award-winning journalist who hosts All Things Considered along with Ari Shapiro, Audie Cornish, and Mary Louise Kelly. She landed in public radio after practicing law for a few years.