News

09 January 2008 /Side effects and trials

Safety regarding use of corticosteroids

Synthetic corticosteroids are used to treat a variety of disesaes. For some reason, some patient cannot produce the vital corticosteroid hormone (cortisol) naturally, and they therefore need to be given this hormone.

01 August 2007 /Side effects and trials

Guideline for first-in-man clinical trials

EMEA has published a guideline for first-in-man clinical trials.

06 June 2007 /Side effects and trials

The Danish Medicines Agency monitors adverse reactions

During the first two years of a medicinal product's life on the market, adverse reactions are monitored closely. Doctors must report adverse reactions.

08 February 2007 /Side effects and trials

New recommendations on the use of MRI contrast agents in patients with impaired renal function

The CHMP-Pharmacovigilance Working Party has considered the safety of gadolinium-containing MRI contrast agents. The Committee has concluded that the recommendations on the use of these contrast agents should be amended for patients with impaired renal function.

15 December 2006 /Side effects and trials

The European Commission publishes Volume 10 – clinical trials

The European Commission has gathered all relevant guidances, guidelines, legislaten, frequently asked questions, etc. concerning clinical trials in a Volume 10 in Eudralex.

07 November 2006 /Side effects and trials

Steps towards improved consumer safety

Every year, mistakes and unintended incidents within the healthcare system, hereunder incorrect medication, cause patients and society great human and economic costs.

29 May 2006 /Side effects and trials

Investigation of the safety of MRI contrast medium Omniscan®

It has come to the attention of the Danish Medicines Agency that over a four year period 20 patients in Denmark and 5 patients in Austria have developed a very rare disease called 'Nephrogenic Fibrosing Dermopathy' or 'Nephrogenic Systemic Fibrosis' after the administration of Omniscan®.

11 April 2006 /Side effects and trials

First adverse drug reaction report about Therma Power

In March, the Danish Medicines Agency warned about the sale of illegal diet pills with a risk of serious adverse drug reactions, please see the fact box to the right.

12 July 2005 /Side effects and trials

Warning on adverse reactions from Coleus Forskolii Briq

The Italian pharmaceutical authority has discovered that specific products containing the substance Foskolin may cause adverse reactions. The adverse reactions are similar to those arising from treatment with atropine.