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Last Updated: Monday, 16 January 2006, 00:40 GMT
Pregnancy drug use 'too cautious'
By Nick Triggle
BBC News health reporter

Pregnant woman
Drug firms are cautious because of the thalidomide case
Drug companies are being overly cautious in advising pregnant women to avoid using many of their most useful medicines, a leading doctor says.

Dr Jim Kennedy, the Royal College of GPs head of prescribing, said expectant mothers were told not to take many drugs when there was no proof of harm.

He called for a rethink as some women were actually risking their health more by not being treated in the best way.

The industry said it was cautious after the thalidomide tragedy 50 years ago.

Thalidomide use by pregnant women resulted in more than 400 disabled babies being born in the UK in the late 1950s and early 1960s before the drug was withdrawn.

It is a very tricky issue that leaves women and families in difficult situations
Rosie Dodds, of the National Childbirth Trust

Most drugs on the market carry warnings about use during pregnancy even though in many cases there is no evidence of harm, said Dr Kennedy.

He said the situation had become so bad that many women refused to take paracetamol even though the majority of over-the-counter drugs are safe to use.

"Women are being denied use of drugs for everything from headaches and depression to infections.

"For some drugs such as statins for cholesterol and some anti-epilepsy drugs, the risk of not taking medicine may be greater than the risk of taking them.

"But the problem is that the industry, because of thalidomide, is perhaps too quick to put warnings on it.


"I can understand why they do it, but I think maybe we could look at whether the warnings are always needed.

"We should also encourage women to consult with their doctors about whether they could be taking drugs.

"Women are being ghettoised over treatment, if this was happening to an ethnic group there would be outrage and quite rightly."

Drug manufactures have to submit medicines to the regulator, the Medicines and Healthcare Regulatory products Agency, for licensing.

It is almost routine to add caveats about use during pregnancy even though clinical trials hardly ever include expectant mothers.

Richard Ley, of the Association of the British Pharmaceutical Industry, said: "You just do not carry out trial on pregnant women or women of child-bearing ages because of the obvious reasons.

"Therefore, it is impossible to get proof. We probably do err on the side of caution, but patient safety is paramount and, of course, you always have an eye on thalidomide"

And Rosie Dodds, policy officer at the National Childbirth Trust, added: "It is a very tricky issue that leaves women and families in difficult situations. It is one of those topics we receive a lot of calls about.

"But is not just a problem for pregnant women, many of the warnings also apply to breastfeeding mothers and when you consider some of these drugs are licensed for children, in some ways it doesn't make sense."

Fears over premature birth drug
19 Jan 06 |  Health

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