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Tainted Generic Drugs Recalled

By Jeralyn, Section Off Topic
Posted on Wed Jul 15, 2009 at 07:16:00 AM EST
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I've never fully trusted generic drugs. I know they are supposed to be the same as the real deal, but there are some that just don't seem the same to me.

In the wake of Michael Jackson's death, comes this news about diprivan, a generic form of propofol, one of the drugs he may have taken:

Two tainted lots of a generic version of a drug reportedly taken by Michael Jackson have been recalled by the drug maker.... The CDC issued a health advisory Monday, saying two lots of a generic version of the drug had tested positive for endotoxin, a contaminant. The drug maker, Teva Pharmaceuticals, voluntarily recalled the lots.

Srinivasan said the agency received 40 reports of patients around the country developing high fevers and muscle aches after being injected with the drug.

So if someone famous hadn't died while taking the drug, would we ever have found out and would there have been a recall? (Note, the article says no link has been established between Jackson's death and the tainted drug. But that's not my point.) Have there been other instances of generic drugs being tainted or recalled? [More...]

The discovery doesn't sound like a coincidence:
"I can say the DEA did contact us about a specific lot number, and that lot number is not from the two we are recalling," said spokeswoman Denise Bradley.She would not say whether the contact was related to the Jackson investigation.
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    Tainted Generic Drugs Recalled | 35 comments (35 topical)

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    The big problem in generics is with pills, (5.00 / 3) (#2)
    by andgarden on Wed Jul 15, 2009 at 12:24:28 AM EST
    and in particular, timed release pills. For various medications, patients often say that the generic just doesn't release in the same way.

    But for contamination in an injected drug like this, I don't think there's any reason to trust the generic less than the name brand. However, I would feel better if we had a better FDA. (Maybe funding could be drawn away from the DEA. . .).

    Active ingredients (none / 0) (#20)
    by gyrfalcon on Wed Jul 15, 2009 at 08:47:15 AM EST
    Have to be identical.  It's the inactive ingredients that sometimes cause a problem because they do vary.  This is a particular problem with timed-release formulations, but it exists in other things, too.  Every body reacts differently to different substances, and something that has no effect on one person can have a noticeable effect on the next.

    I don't know how patent law works on this, but it seems that a company can keep the total formulation proprietary, even if the core active ingredient becomes public after a number of years.  Coca-Cola, for instance, keeps its formula a tightly held secret after how many years?

    I also think of the garden chemical Round-Up.  Its active ingredient, glycophosphate, is now available from a number of other companies besides Monsanto, but if you've ever tried to use one of those, they simply are nowhere near as effective an herbicide as Round-Up, even with the same concentration of the active ingredient glycophosphate.  Monsanto has worked out some sort of combination that delivers the herbicide far more effectively than anybody has been able to duplicate, and it's apparently allowed to keep that formula entirely to itself.

    The trick with generics is to give them a try and see how they work.  With the vast majority of drugs and the vast majority of people, they work just fine and there's no need to pay the outrageous price of the brand name.  Caution and careful observation is definitely necessary with anything timed-release, and particularly with drugs that affect the neurological system or have a psychoactive component.

    Parent

    propofol is the generic (5.00 / 1) (#4)
    by Fabian on Wed Jul 15, 2009 at 12:38:33 AM EST
    Diprivan is the brand name.

    Propofol is prone to microbial growth due to its formulation.  The common formulation includes small amounts of lecithin and vegetable oil, so an open vial of the drug needs to be refrigerated and used promptly.

    Quality control and testing to ensure sterility should be standard.

    (There is a new formulation without the oil and lecithin, but it was only FDA approved in December of last year.)

    Uh Oh (