The Medicines and Healthcare products Regulatory Agency (MHRA) is
strengthening safety warnings for all botulinum toxin type A
products, following reports of rare cases of botulism linked to
their use.
Botulinum toxin medicines are widely used in both medical
treatments and cosmetic procedures. However, in very rare cases,
the toxin's effect may spread beyond the injection site, causing
botulism, a serious and potentially life-threatening condition.
The MHRA has worked with manufacturers to update product
information, including patient leaflets, to more clearly
highlight the risk of iatrogenic botulism (botulism caused by
medical treatment).
Patients are advised to seek immediate medical attention if they
experience symptoms after treatment, including difficulty
swallowing, slurred speech, breathing difficulties, or muscle
weakness. These symptoms can occur within days or up to four
weeks after treatment.
Dr Alison Cave, MHRA Chief Safety Officer said:
Botulinum toxin products are effective for a number of different
medical and cosmetic purposes when used correctly. However, these
strengthened warnings are an important reminder that, in rare
cases, serious side effects can occur.
It is vital that healthcare professionals and patients are aware
of the symptoms of botulism and act quickly if they arise as this
is a medical emergency. We also strongly urge the public to avoid
unlicensed products and seek treatment only from appropriately qualified
practitioners.
The MHRA continuously monitors the safety of these medicines,
including side effects and emerging evidence.
Dr Martin Bewley, Consultant in Health Protection from
UKHSA said:
While botulism is a rare infection, it can be serious.
There are effective treatments available and we recommend seeking
immediate medical advice if you have had a recent treatment and
are having symptoms such as difficulty swallowing.
Contact NHS 111 (or local equivalent in Northern Ireland) for
further advice and seek immediate medical attention. It is
important to get checked out so you can have peace of mind and
treatment if needed. Given the risks, it is also important to go
to a licensed practitioner.
If you will be having botulinum toxin administered for a cosmetic
procedure, the NHS has information that can help assist you with
choosing an
appropriate prescriber.
The risk of adverse reactions may be higher in certain
circumstances, including;
- in patients with certain underlying conditions such as
neurological disorders, a history of dysphagia (difficult
swallowing) or a history of aspiration (breathing in a foreign
material)
- where high doses are used
- where products are used outside of their licensed indications
or into an unapproved site.
The MHRA is also warning about the dangers of unlicensed
and counterfeit botulinum toxin products. Products obtained
outside regulated supply chains do not meet UK safety and quality
standards and can significantly increase the risk of serious side
effects.
The MHRA's Criminal Enforcement Unit has launched a number of
investigations linked to the use of unlicensed botulinum toxin
products following a spike in hospital admissions seen last year.
Anyone considering treatment should ensure their practitioner is
appropriately qualified and confirm that the product being used
is authorised for use in the UK. Suspected side effects should be
reported through the MHRA's
Yellow Card scheme.
Notes to editors
-
Please see MHRA'sDrug Safety
Update (DSU)for further information.
-
Botulinum toxin type A is
a prescription-only medicine (POM) in the
UK. It is authorised to treat a
number of conditions including muscle spasms,
hyperhidrosis (excess sweating from armpits),
and overactive bladder.
