The European Medicines Evaluation Agency said today that GlaxoSmithKline's anti-smoking drug Zyban has cleared a safety review.
The agency was asked by Germany to review the drug after reports that a number of people using it to quit smoking had died.
But in a statement the EMEA said it scientific committee had concluded that the "balance of risk and benefits (of Zyban) remains favourable."
It said however that the drug should be used in accordance with smoking cessation guidelines and would be kept under review by regulatory agencies across Europe.
The German concerns follow reported deaths in patients taking Zyban since it was launched in 2000.
Britain's Medicines Control Agency said in January it had received 6,975 reports of suspected adverse drug reactions, including 57 deaths.
However, drug regulators have stressed that the drug's contribution to the deaths is "unproven" and that in most cases the individual's underlying condition might have been responsible.
It is suspected that many of the reported side effects have occurred in patients who should not have been prescribed the drug.
Last year, Britain’s Committee on Safety of Medicines issued a statement to doctors ordering changes to the starting dosages of Zyban and warning that patients at risk of a seizure should take the drug only if there were compelling reasons to do so.