FDA Public Hearing Set For Fentanyl Patch Safety

Introduction

The U.S FDA scheduled a joint meeting on August 3 of its Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees to discuss the outcome of the recent evaluations of risk evaluation and mitigation strategies (REMS) concerning the use of fentanyl patches.

Fentanyl patch, manufactured by a subsidiary of Johnson & Johnson, was introduced as a Duragesic pain patch to relieve persistent chronic pain for those who need constant pain treatment and are under other opioid medications. However, if the fentanyl gel comes in direct contact with the skin, it can cause severe complications. In September 2013, the FDA issued a public warning stating that the disposal procedure must be done with care as the patch can be dangerous even after it is discarded.

Earlier, an Ohio jury recently postponed the first bellwether trial date for the Opioid litigation to six months from the earlier date. U.S. District Judge Dan Aaron Polster announced all three cases filed by the local governments against opioid manufacturers, distributors, and pharmacies providing opioid drugs, would go for trial on September 3, 2019.

The move would delay the resolution of the opioid epidemic, the major concern among people across the U.S. battling to prove that prescription drugs are unsafe for prolonged use and can cause severe complications. Opioid overdose has been reported to cause abnormal breathing, unconsciousness, vomiting, and even death. Pregnant women taking opioid as a painkiller blame the drug for the alleged birth defects in their babies. As per 2016 statistics on drug overdose deaths in the U.S., 66% of events correspond to opioids addiction.

More than 400 opioid-related lawsuits are centralized as a part of multidistrict litigation, MDL No. 2804 (In Re: National Prescription Opiate Litigation) in the Northern District of Ohio before U.S. District Judge Dan A. Polster.

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