New FDA Warnings For Two Psychiatric Medications

In the past week, the FDA has come out with warnings for two psychiatric medications, citalopram (a common antidepressant) and asenapine (a newer antipsychotic). The warning for citalopram (otherwise known by the brand name Celexa) can be found here, and states that higher doses of the medication may be associated with some heart abnormalities. The warning for asenapine (known by its brand name Saphris) can be found here, and warns of possible allergic reaction. Now, as I’ve mentioned in previous posts, I work in a veteran’s hospital, where medications are limited by what is provided in the pharmacy there. So I’ve never prescribed asenapine, because it’s new and still very expensive; therefore I can’t speak to how well it works, or what its side effects are. I do, however, prescribe citalopram quite frequently, however, and have gotten to high doses. The FDA will tell you that there is no evidence (no published trials) that it works better at higher doses, but plenty of psychiatrists can tell you from clinical experience that it potentially can work better for some patients at higher doses. The FDA is now saying, though, that it should not be prescribed at higher doses. This is a new way of wording its warnings–it is not saying, be careful, check an EKG, monitor carefully. The FDA is saying to not prescribe altogether.

When the FDA says something like this, and you work in a federal hospital, you have to listen. However, the FDA does not tell us what the clinical consequences of these heart abnormalities are. As far as I know, no one has had sudden cardiac death from this medication (which is ultimately what could happen from these type of heart abnormalities). They also do not comment on other antidepressants in the same class. Why citalopram and not escitalopram (brand name Lexapro)? The suspicious part of me wonders if it is because escitalopram is still on patent, and more expensive and profitable for the company that makes both medications. Also, I wonder who sponsored the data, which has yet to be published.

So what does this mean for patients? Well, unfortunately for patients who were doing well on higher doses of citalopram, they may have to try going back to lower doses, or try an alternative medication. Ultimately every medication will have potential risks to it, but sometimes when you weigh the risks against the benefits, the benefits win. For people who have been through the devastating effects of depression, it may be worth it.

I also don’t think this trend will stop with these two medications. There are many new psychiatric medications coming out, and only time will tell how safe they are to use.

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4 Comments on “New FDA Warnings For Two Psychiatric Medications”

  1. YMO Says:

    So, what do you do with the pts that are on Celexa above 40mg- taper them down, get EKG’s (looking for what exactly???), leave them alone?
    Just like you, I don’t really use Saphris with my population, but Celexa is huge, especially since, as of this spring, Lexapro is no longer covered by medicaid. The timing is indeed, extremely “interesting.”

  2. Dr. G Says:

    You’re right, it’s a big deal. Citalopram was usually my first choice in the hospital because it’s “cleaner” than other medications in terms of drug-drug interaction. My understanding of the warning is you have to use your judgment to either get someone down to 40mg or switch medications, or augment, perhaps. (And it’s 20mg max for those over 60 years old; and I’m not sure what it would be for children). The EKG issue–the warning states “consider more frequent EKGs in those with cardiac issues” presumably looking for QTC prolongation. Clinically, if there is prolongation, what does that mean exactly, is not explained.

  3. L Says:

    Thanks Dr. G! This is great up-to-date info! We use Citalopram in our clinic all the time too. Do you think medicaid will pay for Lexepro if Citalopram at a lower dose is not viable for the patients? Do you know when Lexepro will go off patent and have a generic form?

    • Dr. G Says:

      Great questions. I think this issue will affect a lot of providers and patients unfortunately.

      I believe the generic version of Lexapro will come out not until 2012 which is when the patent will expire. A lot of times companies will make an XR (extended release), ER (extended release), SR (sustained release), etc. when the regular form will run out. The thing is, while the drugs claim to “last longer” in the blood stream, the efficacy is usually the same. Sometimes this happens for drugs that have to be taken more than once a day, which can be hard for some people to remember. That being said, everyone is trying to cut costs, including Medicare/Medicaid (and the VA where I work) so these are usually not places to get the newest drugs. What’s important to remember is that while most of the medications work similarly in terms of efficacy, a lot of factors go into why one medication works better than another for certain people (metabolism, side effects, and so on). Substituting one for another may seem intuitive but does not always work.


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