“I was not aware of the prescription drug epidemic until it appeared on my front door and entered my house,” the Louisville, Kentucky, resident told an FDA advisory committee in March. “I was forced to wake up and confront this assault on my family head on. ”

Walden says her son, TJ, began abusing drugs about 10 years ago, when he was 17. He was at a party when friends offered him the prescription narcotic OxyContin. “I know that within several weeks, things started to fall apart, and he quickly moved to Opana,” she said. “These drugs were readily available.”

Her intuition told her something was wrong. She had him tested for drugs, and he passed — but it didn’t test for opiates.

Things weren’t adding up. TJ wasn’t the same kid. “It wasn’t long after that, he lied to me about something stupid, but I pushed it and kept pushing it, and then he confessed to me what was going on,” Walden said.

Unknown opioid found in counterfeit pain pills

She did everything she could to help him. She sent him to rehab, but he kept being pulled back in. “He told me, ‘I don’t want to die from this,’ ” she said.

At 18, he knew that he wanted to join the National Guard. “He loved it. That’s what he wanted his entire life. He was a member of the Kentucky National Guard. His life’s dream was to serve in the military.” But despite getting to fulfill his dream, he continued to battle addiction.

He seemed to be back on track after a stay in rehab, but the 30-day program proved to not be enough, according to Walden. She believes TJ wasn’t chasing the high, but rather he was trying to manage the withdrawal. In July 2012, at the age of 21, it proved to be too much: He died of an overdose of Opana ER.

Walden shared TJ’s story with the FDA committee. “He loved his country, and his country failed him. He should not have had access to this very dangerous and highly addictive drug. Too many mothers have gotten a knock on their door saying their child will never come home again. Too many children have had their lives cut short, families destroyed, communities left in ruins.”

America’s crisis

America’s opioid epidemic is a major health crisis. Overdoses of any drug are the leading cause of accidental death in the United States, killing more people than guns or car accidents. Opioids were involved in over 33,000 deaths in 2015, about half of them due to prescription drugs such as Opana ER, the US Centers for Disease Control and Prevention says.
TJ Walden died of an overdose of Opana ER in 2012, at the age of 21.
And prescription drug misuse is frequently a precursor to heroin, the CDC says. In fact, three out of four recent heroin users started with prescription drugs.

FDA Commissioner Dr. Scott Gottlieb has said that the opioid crisis is a priority for him. And that message was emphasized this week, when the agency requested that Endo take Opana ER off the market.

For Walden, it was a moment of hope. “The FDA might start to take some steps that they have needed to take,” she said in an interview. It was also a first for the FDA.

A first for the FDA

The FDA requested that Opana ER be pulled because of its potential for abuse.

Never before has the agency requested that a company pull an opioid drug off the market because of such concerns. In a statement, Gottleib 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.”

He added that this is not going to be an isolated incident. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”

Opana ER was approved in 2006. Its intended use was to manage moderate to severe pain over a long period of time with just one pill. However, it could easily be abused by crushing and snorting the entire pill, giving a user a day’s worth of dosages in just one hit.

Concerned about this abuse potential, Endo reformulated the the pill in 2012 to make it impossible to crush. However, to get around the reformulation, people began melting the drug and injecting it. Sharing needles from Opana use led to an outbreak of HIV in Indiana in 2014 and 2015.
FDA wants opioid painkiller pulled off market

Endo said in a statement that it is reviewing the FDA’s request and evaluating all its options “as we determine the appropriate path forward.”

While acknowledging that the drug has been abused, the company said, “Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products. Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed.” The statement maintains that the drug works well and is safe when used as intended.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said “the abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market. This action will protect the public from further potential for misuse and abuse of this product.”

When asked whether the agency was looking into any other drugs, the FDA said it is assessing the latest available data on abuse patterns from the generic versions of Opana: oxymorphone ER and IR.

Walden, encouraged by the FDA’s announcement, will continue to advocate and educate about the drug crisis, from training people using the opioid overdose antidote naloxone to meeting members of Congress and sharing her story.

She admits there is a lot of work ahead, but she says the announcement is a step in the right direction.

“This has definitely given me some hope. ”

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