Quebec's pregnant women taking dangerous drugs

- The Gazette

11/18/2009 - Physicians have long known that anti-acne drug Accutane increases by 10 times the risk of a congenital malformation if taken by pregnant women.

At least six per cent of pregnant women in Quebec take prescription medications that are known to harm the fetus, raising questions about the medical judgment of some of their physicians, especially general practitioners, suggests a new study by Université de Montréal researchers.

To the surprise of the researchers, they found that one of the medications, the anti-acne drug Accutane, is still available on the market without a “proper risk-management program.”

The researchers also concluded that some drugs are being over-prescribed, especially benzodiazepine, used in the treatment of anxiety. This class of drugs has been linked to breathing problems and withdrawal symptoms in newborns.

“Clearly, the physician has a responsibility to warn pregnant patients about the risks of congenital malformations associated with certain drugs,” said lead researcher Anick Bérard, a professor at the U de M’s faculty of pharmacy.

More than two decades after Accutane was approved for the treatment of severe acne, the researchers discovered that 71 pregnant women took it from 1998 to 2002 – the period under study. Physicians have long known that the drug increases by 10 times the risk of a congenital malformation.

Bérard conceded that some young women might be sharing the drug without the knowledge of their physician, but she urged doctors to be more rigorous and careful in prescribing medications to pregnant women. The study noted that 73 per cent of the prescriptions were written by GPs.

In contrast, obstetrician-gynecologists tend to take a more prudent approach. The Society of Obstetricians and Gynaecologists of Canada regularly informs its members about the risks of some prescription medications. For example, in a November 2007 article on statins, the society warned that “statins should be avoided during pregnancy, and pregnant women exposed to cholesterol-lowering drugs should be monitored closely.”

The researchers examined the medical records of 109,344 women gleaned from the Quebec Pregnancy Registry.

They found that 56 per cent of the women filled at least one prescription for any medication during pregnancy. Of the total number of women, 6.3 per cent took at least one drug with recognized embryo-toxic or feto-toxic effects.

Of those who took the harmful medications, 47 per cent ended up having an abortion and six per cent had miscarriages. This compares with 36.2 per cent of abortions and 4.7 per cent of miscarriages for all the women in the registry.

Among the infants whose mothers took the harmful medications, 8.2 per cent were diagnosed with a major congenital malformation. That compares with 7.1 per cent of malformations in infants whose mothers were not exposed to those medications.

Among the medications that are known to be feto-toxic are isotretinoin for severe acne, anxiolytic benzodiazepines, anti-epileptics as well as drugs for hypertension, statins and anti-coagulants.

Bérard urged pregnant women to stay more informed and ask their doctors detailed questions. She also criticized the drug industry for “sticking its head in the stand” as it aggressively markets anti-anxiety medications.

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