Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance.

Unlabelled: The collection and assessment of individual case safety reports (ICSRs) is important to detect unknown adverse drug reactions particularly in the first decade after approval of new chemical entities. However, regulations require that these activities are routinely undertaken for all medicinal products, including older medicines such as generic medicinal products with a well-established safety profile. For the latter, the risk management plans no longer contain important risks, considered important safety concerns, on the basis that routine pharmacovigilance activity would not allow their further characterisation.

Pharmacovigilance of medicines for rare and ultrarare diseases.

The assessment of the safety of medicines for rare diseases during the development phase is often limited by the few data available from small numbers of patients. This also applies to a lesser extent during the postmarketing phase of the lifecycle of a medicine. By using all available sources of data for rare diseases drugs, and by carefully assessing these data, the most informed safety profile can be obtained.

Safety and tolerability of pioglitazone, metformin, and gliclazide in the treatment of type 2 diabetes.

This analysis compares the safety and tolerability of pioglitazone (a thiazolidinedione), metformin (a biguanide), and gliclazide (a sulfonylurea). Data collected from four 1-year, double-blind studies comparing treatment of over 3700 patients with type 2 diabetes with pioglitazone, metformin, or gliclazide have been combined to provide comparative tolerability and safety profiles. All treatments were well tolerated with approximately 6% of patients withdrawing from treatment because of side-effects.