Thalassemia Patients and Friends

Discussion Forums => Iron Chelation Corner => Topic started by: Manal on October 28, 2007, 12:12:44 AM

Title: Two or Six years
Post by: Manal on October 28, 2007, 12:12:44 AM

Hi

I have noticed that the starting age to use exjade differs from a country to another. For example, in Australia it not allowed to be taken for children under six years. On the contrary, in Egypt i know a girl who has been on exjade and she is 4 years. Other countries allow it at the age of 2. Shouldn't the age be unified? Who control this Novartis or countries?

Manal

Title: Re: Two or Six years
Post by: Andy Battaglia on October 28, 2007, 02:04:14 AM

The age is determined by the drug regulating organization of each country. In the US it is determined by the FDA. Each country may have different rules and procedures for determining drug safety, both in  general and for children. In the US, Novartis has provided sufficient testing results to get FDA approval. In other countries with differing standards, Novartis has not yet provided sufficient information to get approval for use by younger patients. As further evidence is gathered by Novartis, you can expect the age limit to be reduced in many countries regarding the use of exjade, as long as these trials demonstrate that the drug is safe for long term use.