OTC drugs face review after safety queries

The Committee on the Safety of Medicines was due to meet yesterday to review the packaging and advertising rules relating to products containing phenylpropanol amine (PPA), a drug that has been linked to strokes in the US.

In the UK, over-the-counter cold and flu medicines containing PPA include SmithKline Beecham’s Contac-400 and Day Nurse; Pfizer’s Benylin Day & Night and Sinutab; and Novartis’ Mucron.

The CSM is made up of members of the Department of Health’s Medicine Control Agency (MCA).

The decision to review the situation in the UK follows action taken by the Food & Drug Administration (FDA) in the US, which has reported that medicines using PPA should no longer be considered safe since the drug can trigger haemorrhagic strokes, especially in younger women.

SmithKline Beecham has already removed Contac from sale in the US but is still waiting for the results of the CSM meeting in the UK.

A spokesman for SmithKline Beecham explains: “In the UK, we are still discussing the situation with the regulatory bodies and are working with them to supply them with all the information needed for a possible review.”

He adds that the amount of PPA used in cold remedies in Britain is much lower than in the US and that appetite suppressants containing the drug are not available here.


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