Published: 10 December 2020

Safety Information

Monitoring

Antiseptic Soothing Cream: review of the benefits and risks requested under section 36 of the Medicines Act 1981

Antiseptic Soothing Cream (bufexamac 50 mg/g, chlorhexidine gluconate 1 mg/g, and lidocaine hydrochloride 10 mg/g) topical cream is a General Sale medicine indicated for the treatment of insect bites, stings and itches, and minor burns and sunburn.

Serious skin reactions have been reported overseas following the use of bufexamac-containing products.

On 27 October 2020, Medsafe issued a notice under section 36 of the Medicines Act 1981 requesting the sponsor to provide evidence of the safety and efficacy of Antiseptic Soothing Cream within 60 days.

Products affected

Product name Sponsor
Antiseptic Soothing Cream Multichem NZ Limited

Additional information

The Australian Therapeutic Goods Administration (TGA) removed bufexamac-containing products from the Australian Register of Therapeutic Goods on 18 September 2020. The TGA determined that the benefit-risk balance of bufexamac-containing products is unacceptable due to a risk of serious skin reactions and inadequate evidence that bufexamac is effective.

Due to the serious nature of the actions taken in Australia, Medsafe has decided to conduct a benefit-risk review for bufexamac-containing products.

Under section 36(1) of the Medicines Act 1981, Medsafe may request the sponsor to provide evidence that a product is safe and effective for the therapeutic purpose for which it is sold. If the sponsor is unable to satisfy Medsafe that the product is safe and effective for its therapeutic purpose, conditions on the use of the medicine may be imposed or the consent for distribution of the product may be revoked.

Medsafe previously reviewed the benefit-risk balance for bufexamac in 2011, after products containing bufexamac were withdrawn from the European market due to concerns of allergic contact dermatitis. Information provided by the sponsor under section 36(1) of the Medicines Act did not support the continued consent for distribution of bufexamac (single ingredient product) for the relief of dermatitis, rash and hives. The matter was referred to the Medicines Adverse Reactions Committee (MARC) under section 36(2) of the Medicines Act 1981 and was discussed at the 145th MARC meeting on 10 March 2011. The Committee recommended that the consents to distribute bufexamac-containing medicines indicated for the relief of dermatitis, rash and hives should be revoked.

Reporting

Consumers and healthcare professionals are encouraged to report suspected adverse reactions to medicines to the Centre for Adverse Reactions Monitoring (CARM).

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