Popular for its wrinkle-banishing product Botox, healthcare company Allergan has sought to calm fears of local doctors, in the face of Botox-related caution sounded recently by the US regulatory authority.
The United States Food and Drug Administration (US FDA) had notified the public on adverse reactions linked to the use of Botox. The reactions included respiratory failure and death, following treatment of a variety of conditions using a wide range of doses, a USFDA note said.
The adverse effects found across FDA approved and non-approved usages were seen to be severe in children treated for spasticity in their limbs associated with cerebral palsy.
Allergan India has sought to allay fears of cosmetic surgeons and neuro-physicians who use Botox to treat cerebral palsy, a company representative told Business Line. It is safe to use Botox for both cosmetic and therapeutic purposes, he said.
Juvenile cerebral palsy (JCP) is an approved indication of Botox in India and 61 other countries, he said.
There may have been improper patient selection or over-dosing in the US by some physicians, he clarified.
While the USFDA review is ongoing, it has not yet asked for additional labelling.
In India, physicians have been using Botox to treat JCP/spasticity for about five years and they are aware of the risk/benefit profile, the company official said.
Botox grosses over $1 billion globally. In India, over 25,000 procedures are done per year, divided almost equally between cosmetic and therapeutic usages.
Imported from Allergan’s factory in Ireland, Botox is priced locally at Rs 16,500 for a 100 unit vial compared with $450 in the US for a similar product.