Tris Pharma has expanded its voluntary recall of infant ibuprofen because it may contain overly high concentrations of the drug.
The company, based in Monmouth Junction, New Jersey, announced the move this week.
It says the concentration can be as high as 10 percent above the specified limit. The affected brands include CVS health and Equate and are sold at Walmart, CVS, and Family Dollar stores.
Infants already susceptible to the adverse effects of ibuprofen could be at a slightly higher risk if given medication from a recalled bottle. There’s a remote possibility an elevated level of ibuprofen could lead to permanent kidney damage in babies.
Other potential adverse health effects include nausea, vomiting, stomach pain and diarrhea.
Tris Pharma says it hasn’t received any reports of related health problems.
Study Links Opioid Epidemic to Painkiller Marketing
Researchers are reporting a link between doctor-targeted marketing of opioid products and the increase in U.S. deaths from overdoses.
In a county-by-county analysis, they found that when drug companies increased their opioid marketing budgets by just $5.29 per 1,000 population, the number of opioid prescriptions written by doctors went up by 82 percent and the opioid death rate was 9 percent higher a year later.“It really doesn’t take much marketing to increase the number of deaths,” lead author Dr. Scott Hadland, a pediatrician and researcher at Boston Medical Center’s Grayken Center for Addiction, told Reuters Health by phone.
It’s not the amount of money paid to individual doctors that’s key, he found. It’s the number of small interactions—such as repeatedly bringing lunch to the office staff or treating the physician to dinner—that seems most influential.
“We’ve had our eyes on these drug companies making large dollar payments—often tens or hundreds of thousands of dollars—to these doctors, yet the public health problem appears to be driven by the subtle acts and the very widespread meals affecting a very large number of doctors,” Hadland said.
In an editorial in JAMA Open Network, where the study appears, Jordan Trecki of the U.S. Drug Enforcement Administration warns that the new analysis only addresses part of the problem.
“As the opioid epidemic grows, it is evolving beyond prescription medications and heroin to involve illicitly produced fentanyl, fentanyl-related substances, and other opioids, either alone or in combination,” Trecki said. “It is clear that a variety of approaches will be necessary to control this epidemic.”
Hadland agreed. Prescription drugs account for 40 percent of opioid overdoses, 17,000 of which are fatal each year.
Nonetheless, he and his colleagues write, the United States “continues to vastly exceed the rest of the developed world in opioid prescribing, and many individuals with opioid use disorder are first introduced to opioids through a prescription. Our findings suggest that direct-to-physician opioid marketing may counter (the) current national efforts to reduce the number of opioids prescribed and that policymakers might consider limits on these activities as part of a robust, evidence-based response to the opioid overdose epidemic in the United States.”
Nearly a year ago, Purdue Pharma, the company that makes OxyContin and a key player in the crisis, announced it would no longer market its painkillers to doctors.
Hadland characterized that as “an appropriate response to this crisis,” noting that many medical schools have banned drug company marketing and New Jersey has tried to limit the amount of money a doctor can receive from a drug company.
“But our data are suggesting that it’s much less important to place a cap on the dollar amount and better to place a cap on the number of interactions with a single doctor,” he said.
Hadland’s team looked at county-by-county data from 2013 to 2015 that included overdoses, what the companies spent on marketing to doctors, the number of marking interactions, prescribing rates, and socio-demographic data.
Information on marketing costs, such as meals, travel costs, education costs and consulting fees paid, came from the new Open Payments database mandated by the Physician Payments Sunshine Act, which is part of the Affordable Care Act known as Obamacare.
It showed that more than 67,000 U.S. doctors got 434,754 payments totaling nearly $40 million, or almost $600 per physician. About 1 in 5 family physicians received opioid-related marketing during the study period.
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