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Is it safe to take Pregnidoxin during pregnancy?

Saturday, 01 March 2008
Answered by: Dr. Chandra M. Gulhati
Editor,
MIMS,
New Delhi
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Q. I am a 25 years old pregnant woman. My doctor prescribed me Pregnidoxin, about which I am confused. Please see the following two links about safety of pregnidoxin in pregnancy. Don't you think the information given here is contradictory? Please confirm.

A.  It is true that the two responses are contradictory to some extent. Pregnidox is the brand name; the name of the medicine is meclizine. In advanced countries such as America and Great Britain, meclizine is approved for Motion sickness prophylaxis, vertigo of vestibular origin by the U. S. Food and Drug Administration (USFDA) and the British Medicines and Healthcare products Regulatory Authority (MHRA). It is NOT approved for prevention of nausea and vomiting of pregnancy because no adequate human controlled clinical trials have been done to establish its safety and efficacy due to ethical reasons. At least one observational study in Britain (Watson GI - Meclizine and foetal abnormalities: Preliminary report by the epidemic observation unit of the College of General Practitioners) published in the British Medical Journal claimed that 10 cases of congenital malformation had occured where mothers had taken the drug during pregnancy. However some other observational studies have not shown similar results. Studies have however shown that the drug causes cleft palate (hare lip) in offspring of female, experimental animals. It is not known if animal experiment is relevant to humans in this particular case but the results certainly cast doubt. Using a drug for unapproved indications (in the United States and elsewhere) means that no one is legally responsible should there be adverse effects. In good, safe clinical practice while using drugs, it is always better to stick to approved indications and observe abundant precaution while dealing with cases of pregnancy. Should one take even 1 in a thousand risk? If nausea and vomiting of pregnancy is so severe that it needs to be controlled by drugs, then doxylamine 10mg with vitamin B-6 (sold in India as Queezy) 2 tablets at bedtime, followed by one more tab in the morning and afternoon is preferable.

A.  It is true that the two responses are contradictory to some extent. Pregnidox is the brand name; the name of the medicine is meclizine. In advanced countries such as America and Great Britain, meclizine is approved for Motion sickness prophylaxis, vertigo of vestibular origin by the U. S. Food and Drug Administration (USFDA) and the British Medicines and Healthcare products Regulatory Authority (MHRA). It is NOT approved for prevention of nausea and vomiting of pregnancy because no adequate human controlled clinical trials have been done to establish its safety and efficacy due to ethical reasons. At least one observational study in Britain (Watson GI - Meclizine and foetal abnormalities: Preliminary report by the epidemic observation unit of the College of General Practitioners) published in the British Medical Journal claimed that 10 cases of congenital malformation had occured where mothers had taken the drug during pregnancy. However some other observational studies have not shown similar results. Studies have however shown that the drug causes cleft palate (hare lip) in offspring of female, experimental animals. It is not known if animal experiment is relevant to humans in this particular case but the results certainly cast doubt. Using a drug for unapproved indications (in the United States and elsewhere) means that no one is legally responsible should there be adverse effects. In good, safe clinical practice while using drugs, it is always better to stick to approved indications and observe abundant precaution while dealing with cases of pregnancy. Should one take even 1 in a thousand risk? If nausea and vomiting of pregnancy is so severe that it needs to be controlled by drugs, then doxylamine 10mg with vitamin B-6 (sold in India as Queezy) 2 tablets at bedtime, followed by one more tab in the morning and afternoon is preferable.

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