PETALING JAYA: The Health Ministry and the National Pharmaceutical Regulatory Agency (NPRA) has revoked the product registration of a traditional male sex enhancement capsule, as it contains a harmful scheduled poison, adding that it warned the public to stop taking or purchasing it.
Health director-general Datuk Dr Noor Hisham Abdullah (pic) said the Nan Bao traditional product capsule, with the registration number MAL19962457T, was found to contain sildenafil, a scheduled poison.
Dr Noor Hisham said the product registration holder was Sinma Medical Products (M) Sdn Bhd and was produced by Lisheng Pharm Fty Tianjin in China.
"The registration of this product has been revoked by the Drug Control Authority (DCA) at its 331th meeting following the detection of sildenafil, a scheduled poison, in the product which is not allowed in traditional product formulations," he said in a statement on Tuesday (Feb 12).
Dr Noor Hisham said sildenafil was a type of medication used to treat erectile dysfunction or impotence, adding that such drugs could only be supplied by a doctor or obtained from a pharmacy with a doctor's prescription.
Hence, he said the use of sildenafil without a doctor's supervision can result in adverse effects such as reduction or loss of vision and hearing, sudden drop in blood pressure to dangerous levels, and the impact on cardiovascular systems, such as a stroke or heart attack.
Dr Noor Hisham added that sildenafil and its analogues were not allowed in drugs classified as traditional medicine as the usage of the drug posed a danger to the public, especially those who are high risk to its adverse effects such as heart patients.
Dr Noor Hisham also warned all sellers and distributors to halt the distribution and sale of the product with immediate effect.
He said the selling or distribution of the product would be in violation of the Sale Of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984.
Dr Noor Hisham pointed out that any individual who commit an offence under these regulations will be liable to a fine not exceeding RM25,000, or imprisonment not more than three years or both on the first offence, adding that a fine not exceeding RM50,000 or imprisonment not exceeding 5 years or both for the subsequent offence.
He added that companies violating these regulations can be fined up to RM50,000 for the first offence, and fined up to RM100,000 for the subsequent offences.
"The public who are using this product are advised to stop using it and to get professional medical help if they are experiencing any discomfort or adverse effects," he said.
Dr Noor Hisham added that the public can check a product registration status through https//:npra.moh.gov.my or call the NPRA at 03-7883 5400.
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