Australia: EpiPen recall, girl with tetanus update, 3rd M. chimaera infection

EpiPen 300 recall

The Therapeutics Goods Adminstration (TGA) in Australia announced the recall of four batches of Alphapharm EpiPen 300 microgram adrenaline injection syringe auto-injectors. It has been identified that EpiPens from the four affected batches may contain a defective part that could result in the auto-injector failing to activate or a need to apply more force than normal to activate.

The affected batch numbers are:

EpiPen is used in emergency situations to treat people who are having a severe allergic reaction (also known as anaphylaxis). There have been two confirmed reports of auto-injectors from these batches failing to activate correctly world-wide from approximately 80,000 devices distributed. The proportion of these auto-injectors that have been used is not known.

EpiPens from affected batches can be returned to pharmacies for a refund or exchanged for one from a different, unaffected batch free of charge.

Tetanus update

In a follow-up on the 7-year-old unvaccinated girl who contracted tetanus, the Australian Associated Press reports today that the girl from NSW diagnosed with tetanus is on the mend but it’s likely she’ll remain in an intensive care unit for the next few weeks.

She has since responded well to treatment and is now in a stable condition, a hospital spokesman told AAP on Monday.

“I understand it will be a couple of weeks before she’s released as it’s quite a nasty infection,” he said.

Mycobacterium chimaera

A third heart surgery patient in NSW – a man in his 80s – has been confirmed with Mycobacterium chimaera infection following exposure to the rare bacteria from open heart surgery equipment used worldwide.

All three M chimaera cases in NSW underwent open heart surgery, which included a valve replacement, at Prince of Wales Hospital in 2015.

Altogether four NSW public hospitals used the affected equipment – Prince of Wales, St George, The Children’s Hospital at Westmead and Sydney Children’s Hospital Randwick.

NSW Chief Health Officer, Dr Kerry Chant, said the overall risk of M chimaera infections after cardiac surgery is very low but experience overseas had shown that when an M chimaera case is reported in a facility it could mean other patients who had heart surgery in that facility were also at risk, particularly if the surgery included implants, such as valves.

“Since we were first notified of the international risk posed by contaminated heater-cooler units last August we have been responding to international advice and communicating with heart surgery patients at the four NSW public hospitals that used the affected equipment,” Dr Chant said.

“Patients have been asked to watch for M chimaera symptoms – persistent fevers, increasing or unusual shortness of breath, and unexplained weight loss.

Related: 

• Los Angeles: Post-surgical Mycobacterium chimaera cases confirmed
• British health officials investigate Mycobacterium chimaera infections in cardiac surgery patients