Warning: Not All Boxed Warnings Are Equal

• Report this Comment On March 15, 2010, at 2:23 PM, TMFKris wrote:

  How interesting that the FDA would do something to help patients (alert them to a drug that might be ineffective because of their genetic makeup), at the expense of drug companies (who would lose money.)

  Kris (TMF copyeditor)

• Report this Comment On March 15, 2010, at 6:06 PM, KateSeattle wrote:

  I find this article lacking in insight. Plavix could, in effect, be deadly for a person who has been prescribed the medication if it doesn't work. I imagine someone who is taking it, forms a clot and dies from the resulting cardiac incident would have preferred that black box warning. You make it sound like some over the counter heart burn medication. Bummer that the tums didn't work.

  In contrast, Tysabri has issues in people who take a variety of immunosuppresents, as many MS patients do. Having a black box warning on both allows patients and doctors to make the best health care decision for the individual situation.

  The issue here is informed choice. Empowering doctors and patients is good, even if it happens to inconvenience investors.

• Report this Comment On March 16, 2010, at 9:12 AM, hengstrom wrote:

  Tysabri does cause a fatal brain infection, but in some patients with pre-existing JC virus and weaker immune systems (a rare group of MS patients), Tysabri's mechanism of action allows JCV to progress to PML. Tysabri inhibits some T cells to prevent them from destroying an MS patient's own myelin sheath, the fatty protective covering surrounding nerves.

  It should be noted that the number of serious adverse events for Tysabri patients is probably 20% that of SAEs of patients who are subjected to interferon treatment (the current standard of care) while simultaneously Tysabri prevents 75% of the lesions that still occur while on this interferon therapy.

  Black box warnings are indeed not all the same. In Tysabri's case, it is warranted but the severity of MS should result in most patients and neurologists determining that the risk/reward is well justified.

• Report this Comment On March 16, 2010, at 4:35 PM, sssscooter wrote:

  My wife has had 36 infusions of Tysabri and while there is certainly the risk of PML, her doctors are almost hyper-cautious in watching for it, so it is unlikely to reach a point at where it is untreatable. Also, there has been little discussion related to the greater success rates when treating those who do contract PML. It is not the death sentence it once was. All in all, she could be the poster child for the drug's effectiveness. Not only is the incidence of flare-up of MS symptoms almost nil, there has actually been evidence of repair of the nerves that had lesions on them- an unexpected result for her doctor. When we consider the negative trajectory that her disease was following, this medicine has surpassed our greatest expectations.

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