Propoxyphene is an opioid pain reliever used to treat mild to moderate pain. In 19 November 2010, FDA notified healthcare professionals that dextropropoxyphene has been withdrawn from the US market after new data showed that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. For the same reason, in 2011, Healthcare Canada and Paladin Labs Inc announced that the company has decided to voluntarily recall and withdraw dextropropoxyphene (Darvon-N) on the Canadian market and discontinue the sale of the product.

In Europe, on 25 June 2009 the EMEA recommended a gradual withdrawal throughout the European Union. The EMEA's conclusion was based on evidence that dextropropoxyphene-containing medicines were weak painkillers, the combination of propoxyphene and paracetamol was no more effective than paracetamol on its own, and that the difference between the dose needed for treatment and a harmful dose (the "therapeutic index") was too small. Propoxyphene has also been withdrawn in Sweden (March 2011) and New Zealand (February 2011).

Following a review of the available safety data, the Authority has decided that the safety risks of propoxyphene outweigh its benefits for pain releif at recommended doses.

The MCAZ agreed to intend to cancel the registration of Dextropropoxyphene containing products and implement a phased-out approach in consultation with the manufacturers to allow availability of alternative medicines on the market such as morphine tablets.

Recategorisation of Ibuprofen 200mg tablets in pack sizes of 20 or less dosage units from Pharmacist Initiated Medicine (PIM) category of distribution to Household Remedy (HR)

Following a request by a manufacturer of ibuprofen 200mg tablets, and an in-depth review of available evidence, the Authority has approved the recategorisation of ibuprofen 200mg in pack sizes of 20 dosage units or less from PIM to HR category of distribution.

Following a request by the Ministry of Health and Child Welfare, and after extensive consultations with stakeholders, the Authority has approved the categorisation the following anti-malarial preparations:

The use of Rapid Diagnostic Tests (RDTs) to confirm the malaria diagnosis is recommended before initiating a person on ACTs where possible.

Recategorisation of Cimetidine 200mg tablets in pack sizes of 20 or less dosage units from Prescription Preparations (PP) to Pharmacist Initiated Medicine (PIM) category of distribution.

Following a request by a manufacturer of cimetidine 200mg tablets, and an in-depth review of available evidence, the Authority has approved the recategorisation of cimetidine 200mg in pack sizes of 20 dosage units or less from PP to PIM category of distribution.

Please note that 400mg tablets remains a Prescription preparation (PP) irrespective of the pack size.