Reassurance over unsafe drug

There are no registered drugs in Malta containing the ingredient phenylpropanolamine (PPA), considered unsafe by the US Food and Drug Administration (FDA), the Medicines Authority said yesterday.

Contacted by The Times, Sarah Spiteri, a quality assessor within the authority's Post-Licensing Directorate, said no medicines containing PPA are registered for marketing in Malta.

Ms Spiteri explained that PPA is found internationally in several over-the-counter cough and cold medicines as a decongestant, and is also available internationally in over-the-counter weight-loss products. The latter were not available on the local market.

An e-mail is currently circulating urging people to stop taking any products containing PPA.

The controversy surrounding PPA started in 2000 when a study conducted at Yale University showed that the ingredient increased the risk of haemorrhagic stroke, particularly in women.

However, the UK's Committee on Safety of Medicines said the US data did not apply to British products since the compound used in Europe was different to that used in the US, and was available in lower doses. Ms Spiteri said back then it was not considered necessary to withdraw products containing PPA in Europe, including in Malta.

"But over the years patients became increasingly alarmed by repeated warnings by the FDA about the safe use of PPA and the use of such product dropped dramatically," Ms Spiteri explained, adding that most pharmaceutical companies decided to discontinue them voluntarily.

Just before Christmas the FDA issued a warning and classified PPA as something that is not considered safe and effective. Ms Spiteri pointed out that in the same warning the authority said it was taking steps to remove PPA from all drug products, and had also requested all companies to discontinue marketing products containing the compound.