Patients died from contaminated Benzathine Penicillin injections - FDA

The Food and Drugs Authority (FDA) has stated that its preliminary investigations discovered that three patients of the New Senchi Health Centre at Akrade in the Asuogyaman District in the Eastern region died as a result of being injected with Benzathine Penicillin.

The FDA said the three people suffered serious adverse reactions described as injection site abscess, skin necrosis and ulcers leading to their deaths.

The Benzathine Penicillin is presented as powder for Injection and should be reconstituted with STERILE water for injection and also used immediately to avoid contamination.

But in a statement issued by the FDA, it said, ‘The 0.9% Normal Saline Solution was reported to have been opened and used repeatedly for several days which might have resulted in the contamination’.

It assured that it has dispatched the Pharmacovigilance team from the Eastern Regional Office to Akradie to investigate the issue in collaboration with the Ghana Health Service.

The FDA advised healthcare professionals and consumers to be vigilant and report untoward effects of medicines.

Meanwhile, the two medical personnel James Yeboah, 65, and Simon Tarkrama, 42, who administered the injection have been arrested to assist in investigations.

Read details of FDA’s statement:

SERIOUS ADVERSE REACTION REPORTS, NEW SENCHI HEALTH CENTRE, AKRADE

The Food and Drugs Authority (FDA) has become aware of serious adverse reactions described as injection site abscess, skin necrosis and ulcers leading to the deaths of three (3) patients who had injections of Benzathine Penicillin from the New Senchi Health Centre at Akrade in the Asuogyaman District in the Eastern region. These serious adverse reactions were reported during the 3rd week of March 2018.

Preliminary investigations revealed that these reactions may be due to contaminated 0.9% Normal Saline, the solution which was used to reconstitute (mix) the Benzathine Penicillin Powder for Injection. The 0.9% Normal Saline Solution was reported to have been opened and used repeatedly for several days which might have resulted in the contamination.

Benzathine Penicillin is presented as powder for Injection and should be reconstituted with STERILE water for injection and also used immediately to avoid contamination.

The FDA has dispatched the Pharmacovigilance team from the Eastern Regional Office to Akradie to investigate the issue in collaboration with the Ghana Health Service and will keep you updated as more information becomes available.

Meanwhile, healthcare professionals and consumers are encouraged to be vigilant and report untoward effects of medicines and health products to the FDA by completing adverse reaction reporting forms provided in hospitals and Community Pharmacies designated as Patient Safety Centres across the country or through the contacts below:

HOTLINES – 0299802932, 0299802933,

TOLL FREE NUMBER – 0800151000 (free only on Airtel and Vodafone)

SMS SHORTCODE – 4015

SIGNED

CHIEF EXECUTIVE OFFICER