Diane 35 manufacturer seeks permission to update leaflet

ABU DHABI — In an attempt to dispel fears following reports on marketed Diane 35 pills, which allegedly caused serious depression and mood swings in some patients, the manufacturing German company of the product used to treat acne and hirsutism 'Schering', has approached the Ministry of Health to obtain permission for updating leaflet on side effects, cautions and interactions of the medicine.

By Nada S. Mussallam

Published: Sun 14 May 2006, 10:43 AM

Last updated: Wed 8 Nov 2023, 9:17 AM

Speaking to Khaleej Times yesterday, Dr Issa bin Jakkha Al Mansouri, Director of the Central Drug Control Department (DCD) at the ministry said the updated leaflet aims to ensure patients in the UAE are well aware of side effects of the medicine, which is only dispensed under medical prescription.

'Diane 35', is used for treating androgen dependant disorders in women and androgenetic alopecia or (loss of hair due to a genetic disease).

"There are still some missing documents from the side of the company that are required to grant them approval to import 'Diane 35' with new leaflet, which was sanctioned by the country of origin", said Dr Mansouri.

He said the updated leaflet will also include countermeasures patient should undertaken against undersirable side effects, as well as advisable usage duration.

He noted indications of the pills are the same and the difference is that the old leaflet does not contain precise details about side effects and cautions.

It had been reported that reports from 100 women claiming serious depression and mood swings while on the drug prompted Britain's Medicines and Healthcare Products Regulatory Authority to review the medicine.

Dr Mansouri said Diane 35', which is scientifically known as 'ethinylstradiol' and used as contraceptives has been registered with the ministry since 1990.

"The DCD hasn't received any complaints regarding the side effects of the drug. All medicines have side effects. However, is the event of reported serious side effects it is mandatory for the manufacturing company to immediately inform the ministry", said Dr Mansouri.