April

β0ToxinA® - The truth about news on allergy reactions.

The facts

A couple of months ago the British daily tabloid "The Sun" reported 16 deaths of children below 16 suffering from cerebral palsy and treated for limb spasms with botulinum toxin and the hospitalization of 87 people for severe adverse effects of the toxin used to treat several conditions, cosmetic and otherwise.

An American consumer advocacy group, Public Citizen, petitioned the FDA to carefully review safety data of Botox® (Botulinum toxin Type A) and Myobloc® (Botulinum toxin Type B) and requested a black-box warning to be printed on all labels of BTA, a warning letter to be sent doctors, and consumer-friendly explanation on all adverse reactions of the drug to be released.

Collecting 9 years of data, the group reported 16 deaths for cerebral palsy treatment (a use not approved by FDA, but common in the States and approved in several other countries) and 180 cases of adults experiencing diverse adverse effects, such as muscle weakness, difficulty swallowing or aspiration pneumonia related to the spread of the toxin to areas distant from the site of injection.

As usual, when dramatic news are reported, tabloids, journalists looking for scoops and word-of-mouth of emotional people increase the alarm. Although we certainly do not want to minimize the gravity of what happened, we believe that especially at this time clarity and objectivity is needed. Doctors and patients have the right to know the truth.

That is why we have decided to devote this month's newsletter to some words of caution.

So far, FDA has been probing reports and has issued a communication with background information and advice, but yet no conclusive word on the issue as no evidence of the deaths being caused by BTA exists.

See our next month newsletter on the supposed botulinum spread to central- and moto-neurons.

To be kept in mind

The following aspects should be kept in special consideration, remembering that problems may have diverse causes:

WHO injects the BTA - Unfortunately, given BTA popularity, the substance is often offered by beauty centres, and sometimes injected by nurses, beauty therapists, and other non health care professionals. Only experienced physicians, specialized in the cosmetic field, and having attended a specific approved training course should administer it.

WHAT is injected - Physicians should be aware that many counterfeit products are available on the market, mainly made in China or Korea. Such products may not be safe for several reasons: they are not certified by any reputable health institutions, may not contain purified botulinum toxin, may also contain additives that may cause allergic reactions.

Moreover, even with the safe certified products, some patients may be allergic to bovine gelatine, which is an excipient of many may botulinum toxin products In such cases, we recommend the use of Neo β0ToxinA® containing albumin.

Moreover, β0ToxinA® Instant can be used instead of regular saline in the countries where its sale is allowed by law. We remind physicians that β0ToxinA® Instant is compatible with all formulations of botulinum toxin.

HOW - a sterile, disposable syringe should be used, storage instructions and expiration date should be carefully observed. The medication should be correctly reconstituted.

WHERE - consider the site carefully as an injection misplaced even of just a millimeter may paralyze a muscle different from the one intended and cause serious problems.

HOW MUCH - Dosage should be decided with the utmost care and the lowest possible should be used. Obviously, patients suffering from neuromuscular diseases are injected dosages tenfold or more than those used in the cosmetic field to fight wrinkles.

Also, don't forget that Units of the different formulation present on the market are not equivalent.

IN WHAT SITUATION - patients suffering from eyebrow hyperplasia and neurological disorders such as ALS, myasthenia gravis, or Eaton-Lambert syndrome should not receive BTA treatment.

WHAT TO DO in case one suspects the onset of an adverse reaction. β0ToxinA® is a safe, thoroughly tested product. No cases of serious adverse reactions have occurred so far. However, the fact that it is a neurotoxin should not be overlooked. Moreover, like any other medication and even most natural substances, allergies, intolerance are possible in few individuals. In such cases, oedema may appear in the first 72 hours.

If a reaction seems to be developing administer a small dose of 1:100,000 adrenalin should be administered. The patient should be kept under observation for a short time and, if oedema is suspected, an ice pack should be applied on the area injected and cortisone should be administered.

The few, temporary, side effects of BTA are well-known in the literature and by physicians. The most common are usually correlated to the local injection of the solutions. Patients face the chance of a contusion at the site of the injection. On extremely rare occasions, a sore may develop on the white of the eye (corneal ulceration). In less than 1% of the cases patients may suffer slight temporary eyelid droop.

One positive side effect of this turmoil is that physicians will beware of cheaper and unknown products offered to them, and people will become more aware of who they entrust their health and beauty to.

It is always advisable to have patients sign an informed consent form. We provide a downloadable one specifically conceived for the members of our association.

The valued members of our association can access our detailed step-by-step online "How to effectively use β0ToxinA®" manual, rich in vital information on correct procedures that will minimize the risk of side effects.

"How to effectively use β0ToxinA®" - Step-by-step manual

Contatti

SeaLab Europe LLP - Suite 36, 88-90 Hatton Garden, Holborn, EC1N 8PN, Londra (Regno Unito)

Telefono: +44 7077073252

Fax: +44 7077077606

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