Regulators in Europe have recommended that the shelf life of Roche's Tamiflu should be extended to seven years from five years due to the outbreak of the new H1N1 virus, or swine flu.

The European Medicines Agency says that the change would apply to newly manufactured Tamiflu (oseltamivir) and in the event of a pandemic, capsules of the antiviral already on the market could be used for an additional two years after their current five-year expiry date. However the agency noted that the recommendations “will only apply if a pandemic has been declared by the World Health Organisation".

The EMEA added that patients who have Tamiflu capsules that have recently expired should not dispose of them because they might be needed during a pandemic. The agency also issued guidance that in a declared pandemic children under the age of one should receive the antiviral because the benefits would outweigh the risks.

The agency said it also concluded after a review of available data for Tamiflu and GlaxoSmithKline’s Relenza (zanamivir) that pregnant and breastfeeding women should also be prescribed the antivirals if needed during a pandemic.

Warnings on Tarceva label
Meantime, Roche unit Genentech and partner OSI Pharmaceuticals have added new safety warnings to the prescribing information of the lung cancer blockbuster Tarceva (erlotinib).

The US Food and Drug Administration noted that the label on Tarceva now includes warnings about gastrointestinal perforation, which has caused fatalities, as well as "bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders”.

Tarceva is indicated in the US as a monotherapy for patients with locally advanced or metastatic non-small-cell lung cancer in whom prior chemotherapy has failed, as well as for the first-line treatment of locally advanced, unresectable or metastatic pancreatic cancer, in combination with Eli Lilly's Gemzar (gemcitabine).