Drugs

Put Tramadol in High CSA Classification: Public Citizen

Public Citizen is petitioning FDA and the Drug Enforcement Administration to initiate proceedings to reschedule 2-[(dimethylamino)methyl]-I-(3-methoxyphenol)cyclohexanol, its salts, its optical and geometric isomers, and salts of these isomers, including Tramadol, from Schedule 4 to Schedule 2 of the Controlled Substances Act. The petition says the up-classification is needed “because the drug has a high potential for abuse, with use potentially leading to severe psychological or physical dependence, and is considered dangerous.”

According to Public Citizen Tramadol, a synthetic codeine analog, is an opioid agonist indicated in adults for management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. “It was dangerously unscheduled for 20 years in the U.S. before finally being placed in Schedule 4 in 2014,” the petition says. “Since then, new evidence has accumulated showing that tramadol is an increasingly overprescribed, addictive, potentially deadly narcotic that should be rescheduled to Schedule 2.”

Unlike opioids appropriately placed under the Schedule 4 restrictions, a Public Citizen media statement says, controlled substances in Schedule 2 are known to have a high potential of misuse. Other Schedule 2 drugs include fentanyl, hydrocodone, and oxycodone. Under Schedule 2, much tighter restrictions on prescribing drugs are imposed to prevent misuse and abuse.

“The failure to designate Tramadol as a controlled substance when it was initially approved by FDA and the subsequent placement of the drug in a less restrictive category has promoted the false belief that the drug must have a much better safety profile than other opioids,” says Public Citizen Health Research Group director Michael Carome. “The dangerous misperception of Tramadol’s safety has led to reckless overprescribing of the drug during the past several years of the opioid epidemic.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome