Risk of Serious Adverse Drug Events Associated with the Use of Botulinum Toxin Products (Botox)

The Medicines and Healthcare products Regulatory Agency (MHRA), the British equivalent of the Saudi Food and Drug Authority (SFDA), announced that reports have been received of serious adverse drug reactions, including deaths, associated with the use of botulinum toxin products. Botox is the only brand name product registered by the Ministry of Health in Saudi Arabia.

There have been reports, some fatal, of muscle weakness, dysphagia (difficulty in swallowing), and aspiration (taking of foreign matter into the lungs) that can lead to pneumonia in patients receiving botulinum toxin product injections.

Botulinum toxin is produced by the bacterium Clostridium botulinum that may grow in improperly prepared foods. Botulinum toxins act by preventing the release of a nerve transmitting chemical that produces paralysis of the injected muscles or glands. Paralysis of muscles makes skin wrinkles less noticeable.

The most popular use for Botox is as a cosmetic to lessen wrinkles in certain areas of the face. Botox is also used medically in people with severe sweating (hyperhydrosis); a condition that effects the muscles of the neck (cervical dystonia); and strabismus and blepharospasm which are disorders of the eye muscles

These adverse reactions apparently resulted from the spread of the botulinum toxin from the intended injection site to other surrounding areas that resulted in muscle weakness, dysphagia, or aspiration.

Botulinum toxin products were first approved in Saudi Arabia in 1998 for sale.

Actions that the Public and Health Professionals Should Follow

· Patients considering botulinum toxin treatment should only consult a qualified physician experienced in the administration of these products.

· Patients and their family members should be warned about the risk of the spread of botulinum toxin to surrounding areas and seek immediate medical attention if swallowing , speech or respiratory difficulties develop.

· Botulinum toxin products are not interchangeable.

· The administration and dosing recommendations for the botulinum products contained in the prescribing information should be followed.

Report Adverse Drug Reactions to the Saudi FDA

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at