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Public Alert No. 0030/2020 – Warning on use of Tafrodol Manufactured by Deep Pharmaceutical, India

November 16, 2020,

The National Agency for Food and Drug Administration and Control (NAFDAC) alerts the members of the public against the use of a drug marketed on the internet under the brand name Tafrodol by Deep Pharmaceutical, Mumbai, Maharashtra, India.

The active ingredients for Tafrodol declared by the manufacturer are Tapentadol Hcl 100mg and Carisoprodol 125mg

Tapentadol is an opioid analgesic and Carisoprodol is a muscle relaxant with Central Nervous System(CNS) depressing properties. Tafrodol contains two groups of drugs that should not be routinely used together. Using them together can result in serious side effects including profound sedation, respiratory depression, coma, and/or death.

The picture below show packet of tafrodol:

NAFDAC has not authorised Tafrodol for sale in Nigeria.

Purchase of drugs that are not authorised by NAFDAC exposes consumers to the risk of purchasing substandard/ falsified medicines or medicines which are not safe for use. Use of such medicines may worsen the disease condition or cause other harm.

Recommendations

  • Members of the public are encouraged to consult their healthcare providers if they have moderate to severe pain that require analgesics that are not sold over the counter (without a prescription). Your healthcare provider will only prescribe opioid analgesics with benzodiazepines or other CNS depressants concomitantly for a short term in patients for whom alternative treatment options are inadequate. Such patients will be kept under close monitoring by their Healthcare provider.
  • NAFDAC implores the public to purchase drugs and other medical products only from genuine and trusted pharmacies. Purchase of drugs on the internet exposes consumers to the risk of purchasing substandard and falsified medicines.
  • NAFDAC implores importers, distributors, retailers, healthcare providers and consumers to exercise caution and vigilance to avoid the importation, distribution, sale and use of Tafrodol

Consumers are advised to report adverse events related to the use of medicines to the nearest NAFDAC office, NAFDAC PRASCOR ( 20543 TOLL FREE for all Network ) via pharmacovigilance@nafdac.gov.ng, the e-reporting platform available on the NAFDAC website or via the Med safety app available for download on android and IOS stores.

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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