“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.
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.”
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.
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.
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.
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. ”