FDA Takes Regulatory Action Against 21 Websites Selling Unapproved Opioids

FDA Takes Regulatory Action Against 21 Websites Selling Unapproved Opioids

September 21st, 2018 // 3:07 pm @

FDA announced in August that it had warned four online networks operating 21 websites that they were illegally marketing dangerous, misbranded and unapproved opioids. One of them was tramadol. The FDA warning letters to each network stated that they must cease selling the products to consumers.

According to FDA Commissioner Scott Gottlieb, selling opioids online illegally is a serious risk to American consumers and is helping to spread the use of opioids that leads to many injuries and deaths each year. Reducing the flow of illegal opioid sales online is important, and FDA is going to continue to enforce regulations to stop these dangerous sales. He also said that the effort that FDA is making continues to build upon its earlier actions against illicit sale of opioids. There have been 13 warning letters sent out to 70 websites just in the summer of 2018.

FDA also noted in its announcement that patients who purchase these illegal opioids online could put their health in danger because the products could be fake, contaminated, expired and generally unsafe. The illegal sale of these drugs is a major concern for FDA especially because tramadol has a black box warning, which is FDA’s most important warning. It states that the drug has a higher risk of life-threatening adverse effects.

FDA has been aggressive in fighting the illegal online sale of opioids for years. In June, FDA stated that it was sending out a similar round of warning letters to illegal online pharmacies. On June 27, FDA had a meeting of Internet stakeholders at an Online Opioid Summit to talk about ways to take more aggressive actions to fight illegal opioid sales. The summit discussed ways to make it harder to buy these illegal drugs online, as well as how to find gaps in regulations and how to improve them. FDA will continue to take aggressive action against illegal marketers of opioids in 2018 and beyond.

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