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Why GPC must harness public's respect for GPs

As statins are made available OTC I feel it is important to make everyone aware of the serious risks to the unborn child of taking statins during pregnancy.

While it is true that statins are contraindicated during pregnancy, this warning is made about a whole range of drugs, many of which may cause only minor problems.

However, a review of first-trimester statin exposure in the NEJM in April this year1 made it clear statins cause severe developmental abnormalities ranging from spina bifida to duplication of the spinal cord, holoprosencephaly (defective septum separating lateral cerebral ventricles) and aplasia of all distal structures.

Simvastatin, which is lipophilic and thus crossed the placental barrier, was implicated in several cases.

In addition, a recent review of adverse effects of simvastain from the FDA reveals that from 1996 to 2004 simvastatin was implicated in 416 deaths and 49,350 severe adverse drug reactions2.

It seems remarkable the Government has allowed such powerful and potentially dangerous drugs to be made available OTC and I believe warnings on side-effects, and the serious teratogenicity of statins, need to be highlighted.

The current view on statins is that they are among the safest drugs ever discovered and this seems to have led to dangerous complacency about their use which will be compounded when they can be bought over the counter.

Dr Malcolm Kendrick



1 NEJM 2004 April. 350(15) 1579-1582

2 Information on adverse drug reactions can be obtained from Harold D. Stepper (FDA) at 001-301-443-2414 by referring to File No. F04-172 dated May 14, 2004

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