THE Irish Medicines Board has issued an urgent safety notice about the potential danger of various sexual enhancement products marketed as dietary supplements by a US manufacturer.
The IMB claimed six products sold in capsule form to boost an individual’s sex-drive could place patients at risk.
The Florida-based manufacturer, Atlas Operations Inc, has made a voluntary nationwide recall of its products in the US as a result of tests by the US Food and Drug Administration which found they contained an ingredient not listed on the product label.
It discovered that certain batches of the products were adulterated with sulfoaildenafil – a compound of sildenafil which is more commonly known as Viagra. Sildenafil is authorised to treat erectile dysfunction and is a prescription-only medicine.
The products are – Staminil, Sexual Surge, 72 Hours, Rockhard, Vierect and Finally on Demand. Details of the affected batch numbers are contained on the IMB’s website on www.imb.ie.
The IMB said it was possible that some of the affected products were available in Ireland from retailers or had been bought by Irish consumers over the internet.
The IMB considers the adulterated products to be illegal medicine as they are not authorised for marketing here as medicinal products. It also pointed out that the products are not being supplied in accordance with applicable regulations.
Members of the public who are using any of the products are being advised by the IMB to immediately discontinue taking them and to consult their doctor if they have any concerns.
Anyone in possession of such products including retailers and suppliers are also being asked to notify the IMB.
Atlas Operations insisted that it did not “in any way knowingly or intentionally violate the law with regard to distribution”.
Meanwhile, the European Medicines Agency has issued an interim safety notice about the health risks associated with medicines containing sibutramine.
The EMA is reviewing data that indicates that there is an increased risk of a stroke or heart attack from taking medicines with sibutramine as a major international study examined the use of the drug in 10,000 patients over a six-year period.
In Ireland, sibutramine is found in Reductil – a medicine used by obese and overweight patients who also have other risk factors such as type-2 diabetes or dyslipidaemia. Reductil is manufactured by Abbott Laboratories.
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