FDA asks drug maker to remove powerful opioid from market

Amid the rising concern over opioid epidemic lashing the country, the Food and Drug Administration (FDA) has urged a pharmaceutical company to withdraw its powerful opioid drug from the market completely.

The FDA requested drugmaker Endo Pharmaceuticals to stop selling Opana ER, an extended-release version of Opana. In view of the “public health consequences of opioid abuse,” this is the first time that the agency has asked an opioid manufacturer to pull off its highly addictive opioid from the market.

The FDA has taken cognizance of the gravity of the situation arising from the opioid pandemic, because of which an increasing number of people are abusing the painkillers in different ways. People are using them by crushing, dissolving or injecting. Another problem area is the sharing of needles by drug users. Shared needles have led to a rapid spread of associated infectious diseases like HIV, hepatitis C and others.

While announcing the move, FDA Commissioner Dr. Scott Gottlieb, said, “We are facing an opioid epidemic — a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse.” The FDA will continue to take regulatory steps whenever any opioid outweighs its benefits, Gottlieb added.

The company in question, on the other hand, has decided to defend its product, citing the effectiveness of the opioid in alleviating pain and Endo’s efforts in preventing abuse. In a written statement, the company said they were “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.”

The company has taken a stance, projecting its continued commitment to the improvement of pain management and fostering a sense of responsibility while helping patients in easing their pain. They also mentioned in the statement the efforts they are making in curbing any potential misuse of opioids.

However, it remains to be seen, whether such efforts from both the pharmaceutical companies and the agencies tightening the noose bear any fruits. There has to a collective effort from everyone to limp back to normalcy and save the future.

Other efforts by FDA

Along with this, the FDA is also involved in apprising healthcare professionals about the risks associated with the abuse of this product. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said FDA’s Center for Drug Evaluation and Research Director Dr. Janet Woodcock. The FDA is confident this action will protect the public from any future misuse of this particular drug.

Dealing with opioid abuse

The entire nation is under the grip of an opioid crisis, where thousands have perished to drug overdoses. The best way to deal with opioid addiction or any other substance abuse is treatment at the right juncture. Hence, always seek immediate treatment whenever you or a loved one is struggling with a substance use disorder. Timely treatment can help prevent things from getting out of hand.

One should always seek the help of professional organizations for addiction treatment as they have skilled individuals and medical staff to handle such treatment plans. Sovereign Health is a leading provider of substance abuse treatment with many specialized programs for children like our teenage rehabilitation center San Diego, which is among the best in the country. If a teen is abusing any substance, you may look for our rehab for teens in Rancho San Diego. Whether it is our teen addiction rehab in San Diego or in your vicinity, we offer comprehensive treatment for substance abuse. Just call at our 24/7 helpline number or chat online for further information.