FDA Calls On Drugmaker To Pull A Powerful Opioid Off The Market

U.S. Senator Joe Donnelly released the following statement after the U.S. Food and Drug Administration (FDA) requested Endo Pharmaceuticals remove its prescription opioid pain medication, Opana ER from the market. The FDA's reasoning was simple: the risks of the medication Opana ER outweigh the benefits, the agency said Thursday in a statement.

FDA Commissioner Scott Gottlieb, who has pledged to take "more forceful" steps to curb the nation's opioid epidemic, said the agency's action reflects its increased focus on the risks posed by the illicit use of opioids.

The medication was approved in 2006 for moderate-to-severe pain when a round-the-clock painkiller is needed.

Endo officials did not immediately respond.

"The FDA's decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product's reformulation", it said. The medication is meant to release over time, but addicts had been crushing it to get a massive high all at once.

The drug was reformulated in 2012 in an attempt to make the medication more hard for people to abuse; specifically, the drug makers sought to make it hard for users to snort or inject the drug. In the IN case, the shared needles helped spread the HIV infection to over 142 people.

If the company declines to remove the product, the FDA will take steps to formally require its removal by withdrawing agency approval. But many users dissolved and injected the drug, which has led to an outbreak of HIV and hepatitis C, according to the FDA.

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He is accompanied by senior Congress leaders including Kamal Nath, who is touted to become the next chief of the state Congress. The whole reason behind this situation is "Congress" who needs to be blamed as they are grabbing focus in this violence.

It remains to be seen whether Endo will comply with the FDA's request.

As public health authorities and the FDA became increasingly concerned about the nation's epidemic of opioid abuse and overdoses, the company reformulated the drug in 2012, by adding a coating that was meant to make it harder to snort or inject the medicine.

The FDA didn't agree, refusing to let Endo market the new formulation as abuse deterrent when it granted approval for sales several years ago.

The United States in in the midst of an opioid overdose epidemic, according to the US Centers for Disease Control and Prevention. Almost half of all such deaths involved a prescription drug, the state agency added.

In a written statement, Endo says the company is "reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward".

"When we determined that the product had unsafe unintended consequences, we made a decision to request its withdrawal from the market", says Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

Endo's shares fell 12.2 percent to $12.10 in extended trading.

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