E-DRUG: Norgestrel and combined contraceptive pills (cont'd)

[Gaut Gadeholt <gaut@online.no>]

E-drug: Norgestrel and combined contraceptive pills (cont'd)
---------------------------------------------

I think the Norwegian market has examples of both. If I am
not mistaken, Schering's high-dose pill Eugynon contains
ethinyl oestradiol (EE) 50 micrograms and 500 micrograms
DL-norgestrel (DLNG). This is an old product, and there is
lots of red tape to change composition of an established
product. In Sweden, which always was an exacting country
(apologies to the Swedes) I think Eugynon contains 50 EE + 
250 micrograms levonorgestrel (LNG). In Norway as well as
elsewhere the low-dose pill Microgynon contains 30
micrograms EE and 150 micrograms LNG. The morning after pill
Tetragynon - a new product - contains 4 times (50EE + 250
LNG).

I never heard that this difference was of clinical
importance. But I agree with everybody who says that
racemates should be avoided if one of the components is
inactive. The question is whether this matter should be
given regulatory priority from a health perspective - for
example because of a difference in thrombosis or
hepatotoxicity. If anyone has hard facts based on controlled
studies, or a good reason for suspicion based on spontaneous
reporting, I would love to know about it. 

As for the labetalol - dilevalol case, I think even
labetalol is unacceptable from a hepatotoxicity point of
view. Just look at the product monograph - and compare with
for example atenolol or propranolol or metoprolol. The drug
may have a place in the therapy of hypertension, but I think
it should be small.

Gaut Gadeholt (MD)
National Insurance Administration
Norway
gaut@online.no
  
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