HR  

safety of herbal medicines, which are widely used on the basis of scant scientific evidence, is to be investigated

<<< Back to Europe Health Regulatory History

Thu Sep 23,11:14 AM ET
LONDON (Reuters) - The safety of herbal medicines, which are widely used on the basis of scant scientific evidence, is to be investigated by a new panel of European experts.

The Committee on Herbal Medicinal Products held its inaugural meeting in London on Thursday and will meet every two months under new EU legislation designed to protect consumers.

Not everything natural is risk free, and the use of herbal remedies is a growing concern worldwide.

The World Health Organization (news - web sites) warned in June that adverse drug reactions to herbal and other alternative medicines had more than doubled in three years and urged governments to tighten controls.

Thomas Lonngren, executive director of the London-based European Medicines Agency, said the watchdog's new panel would harmonize regulation of the industry across the European Union (news - web sites).

Until now, rules have varied from country to country, with some states including Germany, the biggest user, having tight controls, but oversight in some markets proving lax.

More than 4,500 herbal medicines and preparations are sold across the EU, although 300-400 make up 90 percent of sales.

Konstantin Keller, chairman of the new herbal medicines committee, said the range of products available and their widespread use made effective scrutiny of side effects imperative, even though serious problems were rare.

"The main problem relates to chronic toxicity, such as carcinogenicity, because it may take 10 years to make a connection between cancer and use of a herbal medicine," he told reporters.

Concerns about the safety of natural treatments was highlighted recently when weight-loss product ephedra was pulled from the market following evidence that it could increase risks of heart attacks, strokes and deaths.

Another worry is that herbal medicines sold over-the-counter may interact dangerously with prescription drugs. Keller said this problem was exacerbated because many people taking alternative medicines did not tell their doctors.

Ginkgo, for example, may intensify the effects of the blood-thinning drug warfarin, raising the risk of serious bleeding, while St John's Wort speeds up the rate at which conventional drugs are metabolized, lessening their effect.

Because of the long history of herbal medicine, the new EU system will not require full clinical trials to prove safety. But manufacturers will have to prove that products have been in medical use for at least 30 years, including 15 years in the EU.

That could exclude some herbal medicines introduced recently into Europe from China or elsewhere in Asia, as well as South America or Africa.




Back to top of document