US FDA Issues Initial Drug Safety Newsletter
-resized%20-%20-.jpg "The FDA's newsletter will focus on risk factors associated with presciption drugs")
On the 18th September 2007, a new report was issued by the US Food and Drug Administration in which it highlighted the potential dangers of a number of drugs currently on the market. The report follows the ever-intensifying criticism levelled at the primary American drug regulatory body that it is failing to properly monitor the medicines it approves once they enter the public domain.
Entitled the Drug Safety Newsletter, the report is targeted at professionals within the healthcare industry. It focuses on the risk associated with four drugs: Rituxan, Provigil, Temodar, and Exjade.
When, in 2006, the Institute of Medicine (IOM) published a damning report against the US FDA, the regulator pledged to produce a report in which it would highlight potential safety issues – which it has now done. In conclusion, said the IOM a year ago, the US FDA’s “dysfunctional” framework was a barrier to it effectively protecting the public.
The US FDA’s newsletter details possible risks linked to Exjade in a section called “early safety findings”. Exjade, manufactured by Novartis AG, acts in treating excessive iron when blood transfusions are performed. Four months ago, Exjade – generically known as deferasirox – was linked to instances of kidney failure and, in some patients, death. The depth of this association, however, was “uncertain”, said the US FDA.
In the Drug Safety Newsletter, the US FDA reports on 115 cases of hospitalisation and death. Exjade’s part in these is described as “suspected”, although the deaths are attributed to the principal disease within the patients concerned, rather than the medication prescribed.
So far, no comment has been provided by Exjade’s producer – Novartis AG.
The newsletter additionally highlights instances of extreme skin reactions connected to Provigil (a sleep disorder treatment made by Cephalon), deadly aplastic anaemia linked to Temodar (made by Schering Plough), and, to Rituxan (manufactured by Biogen Idec and Genentech), it associates a lethal disorder affecting the central nervous system.
While spokespersons from Biogen and Cephalon were not available for commentary purposes, Schering Plough’s Katherine Cantone highlighted how, on the notes accompanying Temodar, the chance of aplastic anaemia developing in patients with advanced brain cancer is mentioned.
According to one industry analyst – Public Citizen’s Peter Laurie – if the US FDA’s newsletter draws attention to new side effects, it offers the potential to act as “a real service”.
The Drug Safety Newsletter will be produced every three months.
Source – Pharmaceutical International’s US Reporter
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