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    Friday, November 19, 2004

    Caveat Emptor: Drug company stocks took a dive this week, as an FDA regulator spoke publicly about five drugs he considers unsafe:

    The slides followed a claim by Dr David Graham, a regulator at the US Food and Drug Administration, of safety concerns surrounding AstraZeneca's Crestor anti-cholesterol drug and Serevent, an asthma treatment made by GSK.

    "I can tell you right now there are at least five drugs on the market today that need to be looked at quite seriously to see if they belong there," Dr Graham told a committee of US senators.

    The other drugs were Meridia, a weight-loss drug made by Abbott Laboratories, Bextra, a painkiller made by Pfizer, and Accutane, Roche's treatment for acne.

    He said that the FDA, the US watchdog responsible for ensuring drug safety, had "case reports of people dying clutching their Serevent inhalers.

    Dr Graham added that the FDA, as currently configured, was "incapable of protecting Americans against another Vioxx".

    "It is important that the American people understand that what happened with Vioxx can happen again," he said. "We are virtually defenceless."

    The cholesterol lowering drug Crestor has become a new favorite of our local cardiologists, and more than one patient has brought in ads for it asking me for the "best cholesterol medicine." But questions have been raised by the British medical establishment in the past about its safety. (Even though it's The Lancet, they make valid points. If it's safety profile is worse than other statins, why have it?)

    Serevent is a problem because many patients with asthma forget or fail to understand that it isn't to be used as an emergency inhaler, but rather as a maintenance medicine that provides long-term, slow-acting asthma relief. I don't know why it's so hard to get that through to people, but I had too many experiences of patients who were using it inappropriately despite my best efforts at patient education, that I gave up on it soon after its introduction.

    Meridia is a stimulant for weight loss. It's side effect profile is similar to other stimulants. I've always been wary that it could have the potential for side effects similar to other stimulants such as Redux and Fen-Phen which were removed from the market. (Not to mention, that once a person stops the drugs, they tend to regain their weight.) Long term use is definitely not recommended.

    Bextra may end up having the same problems with clotting as Vioxx. (Although you can still make the argument that patients should be given the option of its use if it helps their pain, given the small risk of clotting associated with the class.)

    Accutane, we know, has some serious side effects - among them birth defects. Most dermatologists who use it are extremely scrupulous about monitoring for side effects. They make girls go on birth control pills before they'll prescribe it, and they monitor lipid levels and liver enzymes very closely. It is a wonderful drug for treating recalcitrant, cystic acne, a condition which can leave devastating physical and emotional scars. I've never seen it used irresponsibly in any of the communities in which I've practiced. I have seen it used to great effect and with appropriate caution.

    UPDATE: Comments from a Serevent user:

    I was shocked to read that serevent has been attacked because some people can't, or won't, learn to use it properly. It was added to my preventive routine of albuterol and azmacort several months ago and has been very successful. My doctor wanted to get me off intermittent courses of prednisone in allergy season (suggested by prior physician.) Do you have the same problem with patients on azmacort? That doesn't stop attacks either. Are you suggesting that nobody should get preventive treatment for asthma because some people can't use it properly? That doesn't make sense to me.

    No, but I'm suggesting that inhaled steroids are favored over Serevent for preventive therapy. For some reason, people don't mistake inhaled steroids for their rescue inhalers. Perhaps it's because Serevent is a bronchodilator, as are the rescue inhalers, and many people just carelessly figure one bronchodilator is pretty much like any other, despite warnings to the contrary. Acutally, the most popular - although expensive - preventive therapy seems to be Advair, a combination of inhaled steroids and Serevent. People don't mistake that one for a rescue inhaler, either.


    posted by Sydney on 11/19/2004 07:22:00 AM 1 comments


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