The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland.

The U.S. Food and Drug Administration proposed to withdraw approval of the drug midodrine hydrochloride, used to treat the low blood pressure condition orthostatic hypotension, because required post-approval studies that verify the clinical benefit of the drug have not been done.

The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products.

The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile.

The U.S. Food and Drug Administration unveiled a new source of information for patients and health care professionals on the safety of recently approved drugs and biologics.

The U.S. Food and Drug Administration advised consumers and health care professionals about potential rare occurrences of severe liver injury in patients taking the weight-loss medication orlistat, marketed as Xenical and Alli.

The U.S. Food and Drug Administration announced today that it will collaborate with the Web site Drugs.com to expand access to the FDA's consumer health information. Drugs.com seeks to provide patients with information to better manage their own health care and to assist in the reduction of medication errors.