New England Journal of Medicine report notes an increase in heroin use among patients with opioid dependence following the introduction of reformulated OxyContin; Purdue post-marketing study also finds an increase in heroin-related calls to poison control centers.
Purdue Pharma LP’s abuse deterrent formulation of OxyContin (oxycodone HCl controlled-release) has helped reduce abuse of the opioid since its introduction in August 2010 but led addicts to turn to other drugs, particularly heroin, according to a study reported in the New England Journal of Medicine.
In a letter to the editor in the July 12 issue of NEJM, Theodore Cicero, of Washington University in St....
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The Senate “SMART OTC” Act would require the FDA to identify product categories that could be eligible for an Rx-to-OTC switch and create a framework to work with sponsors.
Drug companies are being urged to review their internal processes to ensure compliance with new requirements in the EU’s variations guidelines, which take effect in January 2026.
A new guideline finalized by the International Council of Harmonisation is expected to reshape how non-interventional drug safety studies use real-world data, bringing clarity, consistency, and global alignment.
Intercept will voluntarily take Ocaliva off the market at the request of the US FDA, which put the clinical trials of the primary biliary cholangitis drug on a clinical hold.
Drug companies are being urged to review their internal processes to ensure compliance with new requirements in the EU’s variations guidelines, which take effect in January 2026.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The risks, as well as the benefits, of vaccination could be long-term, Advisory Committee on Immunization Practices member Retsef Levi said. The FDA’s Tracy Beth Høeg also said long-term safety data are needed to inform the benefit-risk analysis of the hepatitis B birth dose.
