FDA Fears Over Possible Mistakes While Administering Long-Term Opioid Painkiller

The staff at the U.S. Food and Drug Administration (FDA) has raised a warning against the risks associated with incorrect dose administration of an experimental long-term opioid painkiller. According to the agency, the drug can be highly addictive and could prove potentially dangerous to health if incorrect dosage is taken.

The FDA authorities expressed their concern over the misuse of the experimental pill called Xtampza. The long-acting opioid painkiller is a product of Collegium Pharmaceuticals Inc. The drug is designed to be consumed after taking a meal, since the opioid absorption is the maximum in the presence of food.

However, the authorities say that in the absence of adequate amount of food, there are chances that people end up taking an overdose of the drug due to inadequate pain control. An overuse of the drug has been associated with the production of euphoric highs and disruption in the working of the part of the brain that controls breathing.

Xtampza is an oral formulation of oxycodone. Considering the latest findings, the Collegium has proposed to add a clear label on the drug, stating that the drug should be taken only after eating. However, the FDA argued that a label just won't be enough in eliminating or reducing the risks associated with the wrong dosage of the drug.

The FDA further said that while the agency figures out whether the prescription opioid drug's benefits outweighs its risks, the drug manufacturer should consider assessing the effectiveness of the packaging of the drug in preventing its incorrect usage. Just before the FDA's concerns over Xtampza, the federal agency also pointed the likely errors associated with administering Purdue Pharma LP's short-acting opioid painkiller that needs be taken empty stomach.

Overuse or abuse of opioid, including prescription and heroin painkillers, has been a matter of concern for quite some time. In 2011, prescription opioid abuse was declared as an epidemic by the U.S. Centers for Disease Control and Prevention. It is estimated that opioid overdose kills about 44 individuals every day in the United States alone.