Medsafe recalls two products

6 October 2011 Media Release

Medsafe recalls two products with undeclared prescription medicines

Director-General of Health Kevin Woods today advised consumers to immediately stop taking two products for erectile dysfunction or the enhancement of sexual performance which contain undeclared prescription medicines, citing significant health risks from their use. The warning, issued under Section 98 of the Medicines Act 1981, followed Medsafe's order for the immediate recall of all batches of the following products : Get Stiff and Maxi Mize. Medsafe is the New Zealand Medicines and Medical Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand. Investigations by Medsafe found that the products contained one or more of the following undeclared prescription medicines tadalafil, vardenafil, yohimbine, hydroxyhomosildenafil and hydroxythiohomosildenafil.

Consumers should immediately stop taking these products and seek medical advice if they have felt unwell when taking any of these products or if they are also taking other medicines,” Mr Woods said. The two products are being promoted and sold in New Zealand by various retailers, including “adult” shops, and over the Internet as products that could enhance sexual performance or treat erectile dysfunction. The Institute of Environmental Science and Research tested samples of the products and found them to contain significant quantities of prescription medicines. Product name Undeclared medicine (dose) Get Stiff Vardenafil (6mg) Yohimbine (2mg) Maxi Mize Hydroxyhomosildenafil (2mg) Hydroxythiohomosildenafil (130mg)

Both products also contain trace amounts of tadalafil, the active ingredient in the prescription medicine Cialis, which is used to treat erectile dysfunction. Vardenafil is the active ingredient in the prescription medicine Levitra, which is also prescribed for erectile dysfunction. Both taladalafil and vardenafil are known to interfere with certain heart medications. Their inappropriate use can be harmful and even fatal for some people. Hydroxyhomosildenafil and hydroxythiohomosildenafil are compounds similar in structure to sildenafil. The safety and efficacy of yohimbine hydroxyhomosildenafil and hydroxythiohomosildenafil have not been established. "Since July 2009, Medsafe has identified 65 ostensibly herbal supplements to enhance sexual performance which have been adulterated with similar prescription medicines. The practice of adulterating this type of product with prescription medicines is common," Mr Woods cited. "I advise consumers to treat with extreme caution products purportedly for the treatment of erectile dysfunction or to improve sexual performance offered for sale without a prescription. They should seek medical advice before using them." Sponsors, distributors, retailers and importers are responsible for the products they sell. They are required under the Medicines Act 1981 to be aware of all the active ingredients contained in their products and to seek approval prior to selling them.

ENDS