WOMEN of childbearing age may be at risk from using rimonabant, the
latest weight-loss "wonder drug", leading scientists have said.
The alert comes after evidence that a key chemical that is affected by
the drug is needed for embryos to implant normally in the womb. It is
feared that even small variations in the level of anandamide, which
governs the development and implantation of the embryo, could have
disastrous consequences.

The weight-loss pill was introduced in Britain under the brand name
Acomplia this summer as a drug that can help a person to lose 10 per
cent of their weight in a year. It works by interacting with
anandamide to reduce appetite and, it has also been claimed, helps
smokers to give up by reducing their cravings.

Test results for rimonabant were quite impressive. In trials involving
more than 6,000 patients in the US and Europe, about a quarter of
those taking it lost more than 10 per cent of their weight after a
year.

But research sponsored by the US Government and published in the The
Journal of Clinical Investigation suggests that the drug may also be
able to alter levels of anandamide. Experiments with mice have shown
catastrophic effects on the development of embryos.

The researchers believe that potential adverse effects could include
ectopic pregnancy — in which an embryo fails to move to the womb for
correct implantation. This could occur very early in pregnancy,
possibly before a woman even knew she had conceived.

Sudhansu Dey, director of reproductive and developmental biology at
Vanderbilt University Medical Centre, Nashville, said that his work
raised real concerns about the safety of rimonabant in women of
child-bearing age.

For example, women might use the drug in the hope that it would help
them to quit smoking before they conceived, not realising the
potential risks.

Professor Dey said that he had spoken to the manufacturer of
rimonabant, the French drug company Sanofi-Aventis, about his
concerns. "I gave a talk to them to explain the problems, but I didn't
hear from them again," he said. "At least they should consider putting
a warning on the packets."

The potential market is huge. Some analysts have predicted that
Acomplia alone could generate worldwide sales in excess of £3 billion.
The drug was given official European Union marketing approval in June.
Sanofi-Aventis also hopes to win a licence in the US, where the Food
and Drug Administration has asked for more information.

Herbert Schuel, an expert in reproductive biology at the State
University of New York, in Buffalo, said: "Given the results presented
by Professor Dey's study, we need to be very sure that rimonabant
doesn't have unwanted effects on women of reproductive age."

A spokeswoman for Sanofi-Aventis said that existing packages advised
women who were pregnant to consult their GP before continuing with
medication. "Sanofi-Aventis takes the safety of all its medicines
seriously and will report any adverse events to regulatory
authorities," she said. "We do not recommend the use of rimonabant
during pregnancy."

The study does not address the effects of rimonabant directly but
looks at marijuana, which also affects levels of anandamide. Professor
Dey's team showed that very precise levels were required for healthy
pregnancies in mice.

THE DANGER

Ectopic pregnancies are one of the most dangerous complications faced
by women expecting babies

They occur when an egg fertilised in the Fallopian tubes fails to
reach the womb

The embryo can implant in the Fallopian tubes, ovaries, abdomen or cervix

Anything that slows the movement of the egg can increase the risk.
Research suggests that Acomplia may have that effect

Ectopic pregnancies, which are becoming more common, can cause
rupturing of the Fallopian tubes and internal bleeding and kill the
mother

A woman who has had an ectopic pregnancy is more likely to have
another, and her fertility is likely to be reduced.

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