FDA Approves Prescription Opioids Without Critical Safety Data, Study Says

Opioid pain relievers oxycodone pills.

Opioid pain relievers oxycodone pills.
Photo: Eric Baradt (Getty Images)

According to a new study on Monday, the Food and Drug Administration is lax that prescription opioid treatment was approved to be withdrawn in the late 1990s. The study found that the FDA routinely approved new opioid drugs or new formulations of existing drugs based on limited evidence from clinical trials and often with little information about their potential safety risks — a Concern, given that the role prescription opioids are considered. Drug overdose has played a crisis.

The study, published in Annals of Internal Medicine, looked at 48 new drug applications (NDAs) for opioid products, meaning they were successfully submitted to the FDA between 1997 and 2018. NDA is the formal paperwork that pharmaceutical companies have to file. For an experimental product to receive FDA approval, and they typically include data from clinical trials involving human volunteers. During that time, one of all these NDAs was for an existing opioid, with the company either asking for approval for a new methodology to take it, a new approved dose, or a newly approved combination of existing drugs.

Caleb Alexander, an epidemiologist, doctor and drug safety researcher lead author at Johns Hopkins University, said in an email, “We examined an important aspect of opioid regulation — how long the FDA has set to bring new products to market . “

The vast majority of NDAs, a total of 39, belong to a product for the treatment of chronic pain. But while only 21 of the NDA for chronic pain provided data from Phase III clinical trials, the phase of clinical research considered the gold standard for evidence of the drug’s effectiveness or safety. And even these tests were relatively short and concise, with a mean study size of about 300 participants who were followed for an average length of 84 days (a similar size and test length opioid for acute pain in NDAs Was seen for treatment).

In addition, these tests were often designed to exclude patients who were not expected to respond well to the drug or who were at high risk of bad side effects, which is a common practice in the industry and one Trial of random withdrawal (EERW) known as rich enrollment. Originally, volunteers who do not respond well to a drug in early trials are left out of the next phase of research, which is randomized and placebo-controlled. Although advocates have claimed that the EERW test allows doctors to have better study drugs that only work for a minority of patients – opioids are a well-known example – critics have Argued These tests can be manipulated by drug companies so that the drug is more effective or safer in a real-world setting.

Another common problem, Alexander said, is that pharmaceutical companies often did not collect or present data to the FDA about how often their drugs are being diverted or used for non-medical reasons.

The FDA allows companies to submit new products for approval that are based on existing drugs with the necessary evidence for a completely new drug. But the shortcuts taken in the test data from these NDAs make it difficult for doctors to know how safe or effective these drugs are for a single patient. And this is particularly of concern for opioid drugs intended to be taken by chronic pain patients in a month or for years.

Last year, an estimated 71,000 Americans died From a drug overdose, most often an opioid is involved. Prescription opioids are no longer the leading cause of deaths from opioid overdose, as more potent synthetic opioids such as fentanyl have emerged. Many people who use opioids for pain relief do not develop opioid use disorder, but many people who develop opioid use disorder Often report first Using prescription opioids. The first wave of opioid crisis during the 1990s and 2000s was filled with the glare of prescription opioids that then became readily available in the market – a trend that the FDA played Part in the cause And Haven’t done enough in order to stop.

In particular, the FDA was criticized in 1996 for approving opioid oxicope based on evidence of its low drug exposure that was later found to be misleading. And critic Keep accusing This agency is lagging behind approving new opioid products, without much clear evidence That these products are meeting an unmet need.

Alexander’s study does not mean that the FDA’s handling of new opioid approvals during the past 20 years has affected the overdose crisis. But he noted that “both physicians and patients rely on the FDA to ensure the drugs are safe and effective when they are approved, and the FDA missed significant opportunities to expand the underlying evidence base of these products . ” While their study points to some encouraging trends, with recent approvals based on larger sample sizes, there are other indications that the FDA is still declining. For example, data from the EURR tests have actually been used in recent years in the presented NDAs.

Going forward, Alexander said, the FDA could improve opioid regulation so that manufacturers need to produce more, and more relevant, information about the systemic safety and efficacy of opioids, as well as these companies to follow. Develop better guidelines.

“FDA should also make chronic opioids relatable so that the labeling for these important products better reflects the conditions under which they have been studied for regulatory approval,” he said.

Gizmodo The FDA reached out to comment on the new study, and we will update this article when we hear back.


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