The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an alert over batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API) for trace contamination of histamine.
The situation is reportedly not serious enough to warrant a recall.
Gentamicin is a bactericidal used an as active ingredient for antibiotics. The MHRA was made aware that testing of the finished products has uncovered higher levels of histamine than expected. The unwanted histamine is thought to be a residual from the manufacturing process, with the potentially affected range between July 2014 and June 2017.
While a recall has not been deemed necessary, healthcare professionals still need to keep the alert in mind. This may be especially important when using a Gentamicin drug along with medicines that cause histamine release, like opioids and muscle relaxants. It has been reported that the combination of Gentamicin with non-polarising muscle relaxants could cause neuromuscular blockage and respiratory paralysis.
If you have an allergy, you may be aware of anti-histamines. Histamines initiate our bodies to react and repel allergens by sneezing it out or getting it off your skin by making you itchy. However, our bodies can overreact to a point where we need to take antihistamines to calm the histamines down.
In this case, increased levels of histamines may cause similar reactions. Patients taking the Gentamicin products with heightened levels of histamines may therefore experience the following adverse reactions:
- Flushing
- Itching
- Urticaria (rashes or hives)
- Shortness of breath
- Hypotensive reactions
- Increased heart rate
- Increased blood pressure
Those who suffer from kidney problems may reportedly be more susceptible to adverse effects so these patients must be closely monitored.
The below chart contains information from the MGRA on the products that may be affected by the alert:
| Marketing Authorisation Holder | Product | PL Number |
|---|---|---|
| B Braun Melsungen AG | Gentamicin 1mg/ml Solution for Infusion | 03551/0116 |
| B Braun Melsungen AG | Gentamicin 3mg/ml Solution for Infusion | 03551/0117 |
| Sanofi | Cidomycin (Gentamicin) 80mg/2ml Solution for Injection | 04425/0672 |
| Hospira UK Limited | Gentamicin40mg/ml Injection | 04515/0037 |
| Zentiva | Gentamicin Intrathecal 5mg/ml Solution for Injection | 17780/0506 |
| Zentiva | Gentamicin Paediatric 20mg/2ml Solution for Injection | 17780/0507 |
| Amdipharm UK Limited | Gentamicin 40mg/ml Solution for Injection | 20072/0056 |
| Wockhardt UK Limited | Gentamicin 10mg/ml Solution for Injection or Infusion | 29831/0659 |
| Wockhardt UK Limited | Gentamicin 40mg/ml Solution for Injection or Infusion | 29831/0660 |
The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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