其 他 安 全 警 示
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| The United States: FDA and DEA warn website operators illegally selling opioids (English only) |
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The US Food and Drug Administration (FDA) announces that the FDA and the US Drug Enforcement Administration (DEA) have issued joint warning letters to four online networks, operating a total of 10 websites, illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol, that are potentially dangerous. The warning letters issued to each of the networks state that they must immediately stop illegally selling these opioids to American consumers.
Patients who buy prescription medicines, including opioids, from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired or otherwise unsafe. Additionally, several of these websites offer opioids online without a prescription, posing significant risks to patients. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol, in violation of the Federal Food, Drug, and Cosmetic Act.
The illegal sale of these opioids is particularly concerning because the FDA-approved tramadol carries a boxed warning, the agency’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening side effects. The boxed warning for tramadol addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems) and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn babies). In addition, when taken with other central nervous system depressants, including alcohol, tramadol’s use may result in coma or death.
The networks receiving warning letters include:
- Divyata (offers tramadol, marketed as “Tramadol (Ultram) 100mg” manufactured by “Dimedics”)
- Euphoria Healthcare Pvt Ltd. (offers tapentadol 100mg, marketed as “Aspadol Tab”)
- JCM Dropship (offers tramadol, marketed as “Top-Tram”)
- Meds4U (offers tramadol, marketed as “Tramadol 200mg Tablets” manufactured by “Livealth”)
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/fda-and-dea-warn-website-operators-illegally-selling-opioids
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Oct 2, 2019
Issued at HKT 16:00
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