The Swiss drugmaker notified the US Food and Drug Administration (FDA) of the likely shortage late yesterday, telling the agency that its Genentech subsidiary “is experiencing temporary delays in manufacturing of Oral suspension.”
This was confirmed by a Roche spokesman who told in-Pharmatechnologist.com that: “The packaging delay is generalised and not regarding specific plants,” adding that the firm does not disclose the location of sites at which it produces particular drugs.
He also set out Roche’s response to the shortage, explaining that: “We are asking distributors to prioritize new shipments of Tamiflu from their existing inventories to pharmacies in those regions hardest hit by flu.”
The spokesman also stressed that capsule formulations of the antiviral are still available and repeated the official Roche guidance that pharmacists unable to source the oral suspension version can mix the pills into a liquid for patients who need it.
He added that: “To ensure that enough Tamiflu Oral Suspension is getting to where it’s needed, we will carefully manage inventory of Tamiflu OS throughout the flu season so that we can meet demand across the network of distributors who supply retail pharmacies in the US.”
According to the US Centers for Disease Control and Prevention (CDC) the incidence of flu this year has been widespread.
Earlier this week it announced that: “Twenty-five states are now reporting widespread levels of activity” and predicted “additional increases across the country are expected in the coming weeks.”
The oral suspension version of Tamiflu is usually given to children under age 13 or to people who have trouble swallowing and is approved for babies as young as 2 weeks old.
According to CDC data six children have died as a result of infection by the dominant form of flu virus - pH1N1 - that is circulating this season.
Patients unable to find the liquid form of the antiviral have few options. GSK's competitior produce Relenza is not approved for use by people who are less than seven years old.