NEW YORK • A Pfizer unit that makes the life-saving allergy shot EpiPen failed to investigate hundreds of complaints about defects in the auto-injecting pens, including in cases where patients were hurt or had died, according to the United States Food and Drug Administration (FDA).
In a warning letter sent to Pfizer's Meridian Medical Technologies division, the FDA said the firm "failed to thoroughly investigate multiple serious component and product failures for your EpiPen products, including failures associated with patient deaths and severe illness".
Bloomberg has reported that in some cases, the epinephrine in the EpiPens had leaked out, meaning there was no drug left when patients needed it. In other cases, the injectors did not work properly.
Pfizer also did not initially remove potentially defective products from the market even after identifying a faulty part that was causing the problems, according to the agency.
It later recalled some EpiPens after being pushed by the FDA.
Ms Theresa Eisenman, an FDA spokesman, did not provide further details on the number of deaths, according to Bloomberg.
Pfizer manufactures the EpiPens for Mylan, which sells the injectors and has come under criticism over the product's price. Last year, Pfizer made US$386 million (S$519 million) from the product.
In Singapore, EpiPens are distributed by pharmaceutical sales and marketing firm Good Pharmaceutical. Its managing director Jason Humphries said there were a few thousand users in Singapore. The company has not received complaints about EpiPens so far.
"EpiPens are given by prescription and if patients encounter issues, they will usually go back to their doctors who (give) feedback to us," said Mr Humphries.
"If there's any problem, we will immediately inform the Health Sciences Authority (HSA)."
Mr Humphries said there are stringent checks and protocols in Singapore to ensure that products are safe and fit within HSA prescriptions before they are given to patients.
"Pharmaceutical products are strictly regulated here," he said. "We keep HSA abreast of any warnings or cautions that we receive from manufacturers. We also submit any complaints we receive to them."
When contacted, the Consumers Association of Singapore said it has not received any complaints involving EpiPens, Pfizer or Mylan since 2014.
• Additional reporting by Sue-Ann Tan