Claritin/loratadine 
Author Message
 Claritin/loratadine

While at my allergist's office today, I mentioned to him that, for me
anyway, Seldane doesn't seem all that effective.  So he gave me some
samples of Claritin to try, to see if it works better for me.  He mentioned
that it's a newer drug.

Now, I'm not a chicken-little or a Luddite when it comes to things that
modern medical science invent to make my life better, but I do try to
stay informed about what I'm putting into my body.  The samples included
the standard, very long drug information sheet, which I read.  One part
of it concerned me, but I'm not medically literate enough to interpret
it properly, so I'm putting it out here to ask for feedback.  (Note -
recommended dose is 10 mg/day for {*filter*}s.  I weigh approximately 70 kg).

"Carcinogenesis, Mutagenesis, and Impairment of Fertility:  In an 18-month
oncogenicity study in mice and a 2-year studin in rats, loratadine was
administered in the diet at doses up to 40 mg/kg (mice) and 25 mg/kg (rats).
In the carcinogenicity studies, pharmacokinetic assessments were carried
out to determin animal exposure to the drug.  AUC data demonstrated that
the exposure of mice given 40 mg/kg of loratadine was 3.6 (loratadine)
and 18 (active metabolite) times higher than a human given 10 mg/day.
Exposure of rats given 25 mg/kg of loratadine was 28 (loratadine) and
67 (active metabolite) times higher than a human given 10 mg/day.  Male
mice given 40 mg/kg had a significantly higher incidence of hepatocellular
tumors (combined adenomas and carcinomas) than concurrent controls.
In rats, a significantly higher incidence of hepatocellular tumors
(combined adenomas and carcinomas) was observed in males given 10 mg/kg
and males and females given 25 mg/kg.  The clinical significance of
these findings during long-term use of CLARITAN Tablets is not known."

It goes on to talk about mutagenicity and decreased fertility in male rats
given 64 mg/kg.  Also, "produced hepatic microsomal enzyme induction in
the mouse at 40 mg/kg and rat at 25 mg/kg, but not at lower doses."

Now, I know that these tests were done at much greater doses than in
humans, and I also take some comfort in the fact that this drug was
approved by the FDA (should I?).  But it seems to me that this data
indicates that there are some real potential problems with this drug
in its effect on the liver.  It may be relevant that the elimination
half-life of this drug is 8.4 hours (loratadine) and 28 hours (metabolites),
and that these numbers go up significantly for people with liver damage.
In other words, the body eliminates it slowly, and it seems like the liver
is the main organ that does so.

My allergies are not bad enough that I want to risk liver cancer.
Am I being alarmist?  Thanks for any perspective that you can shed on this.

--
--------------------------------------------------------------
Bob Herlien
MBARI (Monterey Bay Aquarium Research Institute)



Tue, 01 Oct 1996 08:49:39 GMT
 
 [ 1 post ] 

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