The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events - including death - associated with the misuse and inappropriate use of this potent cough medication.

The European Medicines Agency (EMEA) has been formally notified by Wyeth Europa Ltd of its decision to withdraw the application for a centralised marketing authorisation for the medicine Pristiqs (desvenlafaxine) 50mg and 100mg prolonged release tablets.

The European Medicines Agency (EMEA) has been formally notified by Actelion of its decision to withdraw its application for an extension of indication for the centrally authorised medicine Zavesca (miglustat).

The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended that new warnings be included in the product information for Sebivo (telbivudine), from Novartis Europharm Ltd. This warning is intended to inform doctors about the risk of peripheral neuropathy in patients with chronic hepatitis B who are being treated with Sebivo.

The European Medicines Agency (EMEA) has recommended updating the product information for rosiglitazone-containing antidiabetic medicines. Rosiglitazone is available in the European Union as Avandia (rosiglitazone maleate), Avandamet (rosiglitazone maleate/metformin) and Avaglim (rosiglitazone maleate/glimepiride).

Finalising a review of the safety of clobutinol-containing cough medicines in the European Union (EU), the European Medicines Agency (EMEA) concluded that the risks of these medicines are greater than their benefits and recommended that the marketing authorisations for these medicines be withdrawn throughout the EU.