A generic drug, a teenager and blindness

This is about a sad case in which the pharmaceutical company Teva, which manufactures generic drugs, started producing an acne drug but failed to update safety information about the drug causing blindness in some. Now, admittedly, blindness as a side effect is not very marketable and from a profit point of view who could blame Teva for failing to include the information.

Anyway, an unfortunate teenager took the drug and became blind. Subsequently, Teva was sued and part of its defense was that it was not legally required to update safety warnings.

Is a suitable punishment for this kind of behavior included in one of the circles in Dante’s Inferno?

Shockingly, we discover that the world of generic drugs have more than a few problems.

Here is a report on the matter from Jim Edward’s PharmaBlog on BNET

A settlement between Teva Pharmaceuticals (TEVA) and a Georgia teenager rendered blind by the company’s acne drug indicates that life for generic drug companies is about to get a whole lot harder — they’ll actually have to start caring about safety.

The settlement came because Teva did what all generic drug companies do: It copied the original drug, right down its patient information label, but it didn’t test its product for safety and it didn’t add new safety warnings once new evidence emerged…

…Teva did know of an association, Weilbrenner alleged, but didn’t do anything about it:

Defendant (Teva) has admitted it was aware of the reported association between the use of minocycline and the potential development of pseudotumor cerebri in adolescent patients well before the incident leading to Ms. Weilbrenner’s permanent loss of vision.

Nevertheless, Defendant also admits it has never mailed any information to any physicians in the United States informing them of this association, nor advised them of the need to routinely check patients for papilledema (i.e., swelling of the optic nerve, a hallmark of PTC) while taking minocycline.

Moreover, Teva has not undertaken to provide such information to physicians since this incident causing legal blindness to Ms. Weilbrenner…

much more at Pharmablog BNET


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