USA. The US FDA has raised objections that the web advertising or the product information in print for botulinum A toxin preparation (Botox) as posted by the company (Allergan) has insufficient information on the unwanted side effects that could result in patients treated with the product for cosmetic purposes. FDA is of the opinion that the advertisements pertaining to the product are false and misleading because they falsely identify the product as a cosmetic treatment, fail to reveal material facts about the product use and minimise the risk information presented. The advertising does not make it clear that more than four in ten people treated with the product suffer some form of side effect. The most common side effects of the treatment are headache and nausea; the product has also been linked with respiratory infection and ‘flu syndrome’, as well as temporary drooping of the eyelids.
News & Updates, 27 Jun 2003. Available from URL: http://www.druginfozone.nhs.uk