Posted by bubblegumchewer on August 2, 2002, at 12:31:05
In reply to Re: FDA is the DMV in the pharm world » pharmrep, posted by Geezer on July 31, 2002, at 14:29:20
This is of special interest to me, because I am pregnant. In 1981 all approved prescription medication for nausea of pregnancy ceased being available because of some (unsuccessful) lawsuits against the makers of Bendectin. Bendectin's maker could not support the costs of defending itself and found it cheaper to stop production. Anyone familiar with pregnancy will know that there is a fixed incidence of birth defects that is fairly constant: about 6% I think, (the figure changes depending on what birth defects are counted, major or minor and what kind.)
Anyway, in our lawsuit-happy country, of course a certain number of parents of children born with "defects" are going to sue whomever they can, and the maker of a medicine taken during pregnancy would be a prime target. Bendectin was a combination of doxylamine, and old common antihistamine, and vitamin B6. It was never found to be responsible for any birth defects.
In fact, it has been the most widely studied drug during pregnancy and has found to have no correlation whatsoever with birth defects. Apparently every other country in the world markets this drug; in Canada for example it is called Diclectin. My doctor who is from Australia told me to go get ahold of the stuff over the counter. Doxylamine is sold as Unisom and of course, vitamin B6 is sold as vitamin B6.
Pregnancy of nausea can be debilitating and cause massive misery. Sure, some women are lucky and get only mild cases or none at all. But I have read (sorry, any source freaks; I don't have sources at hand) that voluntary terminations of pregnancy were found to increase when/where this effective anti-nauseant was not available, and in fact I've seen a graph that shows the rising # of hospitalizations (yes, it can be severe enough to require IV and other measures) for nvp (nausea and vomiting of pregnancy) right after 1981 when America's prescription access to Bendectin was cut off. In contrast, with the subsequent availability of Diclectin (the same stuff, remember) in Canada, hospitalizations dropped dramatically. (Canada had also been without anything for a while as Bendectin was not available in Canada, either, in 1981 and shortly thereafter until they "created" Diclectin.)
Well, there's my rant, and I'm sure you already got the point. Sometimes it makes me pretty mad that in this country people suffer while other countries seem more sensible. I can't give a profound comment on the source of this discrepancy except that I think there is so much liability-consciousness here that we pay for it one way or another. Either in money or in personal suffering.
poster:bubblegumchewer
thread:110928
URL: http://www.dr-bob.org/babble/20020731/msgs/114949.html