MHRA reports rise in botulism cases in Europe

The Medicines and Healthcare Products Regulatory Agency (MHRA) has alerted the Joint Council for Cosmetic Practitioners (JCCP) to a rise in botulism cases in Europe. It has been linked to two hospitals in Turkey.

The JCCP has advised the need for practitioners to be vigilant regarding members of the public who have recently undergone medical procedures in Turkey using botulinum toxin, and who may exhibit symptoms of botulism.

Specifically, on March 7, 2023, the National IHR Focal Point (NFP) for Germany notified WHO of five cases of iatrogenic botulism in individuals who underwent medical procedures with the injection of botulinum neurotoxin type A (BoNT/A) in health institutions in Turkey.

As of March 17, 2023, a total of 71 cases have been reported in four countries in the European Region; 53 cases in Turkey, 16 in Germany, one in Austria, and one in Switzerland. All cases are adults, and the majority are middle-aged women.

Among the 69 cases for which the treatment location information is known, two private hospitals in two locations in Turkey were identified, with 66 cases linked to one hospital and three cases to the other.

Investigations carried out by the Turkish authorities reported that licensed BoNT products were administered for a different purpose other than for which the products were approved (off-label use). The relevant departments of both hospitals had their activities suspended on 1 March 2023 and the products used for the treatment were seized and taken for examination and evaluation.

Botulism outbreaks are rare, but outbreaks require rapid recognition to identify the source of the disease, distinguish between types of outbreaks (natural, accidental, or potentially deliberate), prevent additional cases, and effectively administer treatment to affected patients. Successful treatment depends significantly on early diagnosis.

In the reported cases, the clinical presentation ranged from mild to severe. Clinical signs of BoNT intoxication were observed, including fatigue, headache, blurred and/or double vision, dizziness, ptosis, dysphagia, dyspnea, neck weakness, generalized muscle weakness, and swollen tongue.

Several cases were hospitalised, some cases were treated with botulinum antitoxin, and at least five cases were admitted to intensive care units. There are no reported deaths and no new symptomatic cases have been reported since March 8, 2023.

WHO is collaborating with the European Centre for Disease Prevention and Control (ECDC), and the affected IHR State Parties. Although the source of the outbreak may have been removed, WHO Member States are advised to remain vigilant.

Specifically, the JCCP is advising registrants to screen their clients for those who have visited Turkey for any treatment with botulinum toxin, and who may exhibit symptoms of botulism, which may be mild. Should it be required, the JCCP requests that practitioners take the necessary steps for the protection of the individual and report the matter to the relevant authorities. The JCCP is also available for further guidance where required.