Epipen warning issued

Regulator warns of safety issues after reports from pharmacies

The TGA has issued a safety alert about an EpiPen Adrenaline Auto-injector produced by Alphapharm following reports from pharmacies in a small area of Victoria that expiry dates on some actual devices do not match those on the carton.

The product is used for the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, drugs or other allergens.

The head of the TGA, Professor John Skerritt, said that as a precautionary measure, Alphapharm has been required to inform users, their carers and pharmacists of the EpiPen issue and to urge them to check that the expiry date on each EpiPen device is the same as that on the carton.

“In consultation with the TGA the company has contacted all pharmacies in the small area of Victoria they distribute to and are investigating the discrepancy.”

In a seperate warning, the TGA said “a small number of reports have been received of discrepancies being noted between the batch numbers and expiry dates on EpiPen Adrenaline Auto-Injector cartons and the batch numbers and expiry dates on the EpiPen devices inside the cartons. The reports have come from pharmacies in a small area of Victoria”.

As a precautionary measure the product’s sponsor, Alphapharm, in consultation with the TGA is urging users of EpiPen Adrenaline Auto-Injectors to check that the expiry date on each EpiPen device is the same as that on the carton, along with a timely reminder that EpiPen devices must not be used beyond the expiry date.

Professor Skerritt said at the current time there is no evidence of broader issues but people who use an EpiPen or somebody you care for uses EpiPen Adrenaline Auto-Injectors, people should check the expiry date on each EpiPen device and compare it with the information on the carton. If these dates do not match, return the product to the place of purchase for replacement.

“EpiPen Adrenaline Auto-Injectors must not be used beyond its expiry date,” Professor Skerritt said.

“If you have an expired EpiPen, you must replace it with an EpiPen which is within its expiry date.”

Professor Skerritt said that consumers and health professionals are encouraged to report problems with medicines to the TGA through the contacts available on the TGA website or by phoning 1800 044 144 (business hours).

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