Articles Posted in Product Safety

actemraBig Pharma and medical device makers have opened their wallets for a 2017 lobbying spree, throwing  tens of millions of dollars around the nation’s capital, including to campaign with lawmakers and regulators to defend their soaring prices and to speed the path for their products to get to markets. But credit’s due to officials and organizations like Stat, the online health information site, for building a greater urgency behind a different narrative: It may be as crucial to monitor and regulate drugs and medical devices after they’re publicly available as pre-approval.

A two-part Stat report, aptly titled “Failure to warn,” dismantles existing oversight of prescription medications, especially regulators deeply flawed, big-data driven initiative dubbed Sentinel. The eight-year-old, $207 million program is supposed to mine insurance records to surface side-effects of drugs recently approved by the federal Food and Drug Administration.

But by examining 500,000 reports of side-effects from drugs targeted at the 1.5 million Americans with debilitating rheumatoid arthritis, Stat shows Sentinel’s shortcomings with Roche’s billion-dollar RA product Actemra. The FDA has received 1, 128 reports, complaining about patients who have died while taking it. But the agency, Stat says, “doesn’t have sophisticated tools to determine whether the drug was a culprit or a bystander in those deaths.”

ohio-300x185With more than 4,000 overdose deaths last year alone and a fifth of its residents having received prescriptions for powerful painkillers, the state of Ohio has sued five Big Pharma companies, accusing them of mispresenting opioid drugs’ risks and fueling the medications’ epidemic abuse.

Ohio joins Mississippi in suing makers of increasingly lethal drugs like OxyContin and Percocet, whose addictive nature was hidden and downplayed by Big Pharma, critics say. The abuse of prescription opioids has fueled heroin use, with 33,000 Americans dying last year alone due to overdoses, federal and state health and law enforcement officials have said.

Fatal drug overdoses now exceed gun- or vehicle-deaths and they are matching the terrible tolls exacted at the height of the HIV-AIDS pandemic. Heartland America, and particularly white men, have been hard hit by the opioid drug crisis, with Ohio, Kentucky, New Hampshire and West Virginia recording the nation’s highest numbers of overdose deaths.

kid-belts-300x300Keeping kids safe is a constant challenge. Here are some new cautions from recent news reports:

Seat belts save lives—if used, and correctly

Although seat belts can be big lifesavers and a major way to protect passengers from injury, they don’t work if they’re not used—and correctly—especially with children. More than 4 in 10 youngsters killed in vehicular crashes between 2010 and 2014 were improperly restrained, particularly in vehicles’ front seat, or they weren’t buckled in at all, researchers found after studying National Highway Traffic Safety Administration data.

Polycythemia vera is so rare that just under 3 or so per 100,000 American men, most older than 60, are diagnosed each year with this rare form of blood cancer. Pseudobulbar affect, or PBA, is an uncommon neurological condition afflicting as few as 2 million Americans, causing them to experience uncontrolled, inappropriate bouts of laughter or tears.

What  links these two unusual maladies? Big Pharma hype: Both have taken starring roles in audacious and apparently successful advertising and marketing campaigns that have surprised even experts in the field.

IMG_1029-300x201Although critics—including the agency’s incoming chief—want the federal Food and Drug Administration to speed its approval processes for prescription medications, new research shows there can be significant risks in a go-go-go approach to Big Pharma oversight. Experts at Yale Medical School have found that a third of the drugs that hit the market with FDA approval between 2001 and 2010 suffered major safety issues that were only found after the medications became publicly available.

Of 222 drugs scrutinized by researchers, 71 were withdrawn or required public announcements about their previously undiscovered risks, including some that were slapped with “black box” warnings—one of the FDA’s most stern indicators a medication carries significant side effects.

The authors of the study, published in the Journal of the American Medical Association, said the drug approval process is imperfect, and it can frustrate many because it can be time-consuming, taking years for a medication to go from lab bench to bedside.

vaper-300x112The Trump Administration has sent disturbing signals on whether it will keep Big Tobacco from hooking more Americans on high-tech, nicotine-addictive products—so-called e-cigarettes used, especially by the young, for “vaping,” as well as cigars and hookahs.

The federal Food and Drug Administration, almost exactly a year ago, announced it would crack down, in particular, on e-cigarettes, forcing their makers to submit them for regulatory approval and oversight. Uncle Sam also barred makers from targeting the young with certain kinds of product advertising and giveaways. E-cigarettes still cannot be sold to consumers younger than 18 and free samples are still barred.

But the Washington Post has reported that the administration is delaying key aspects of its rules on vaping, cigars, and hookahs so newly installed federal health officials can get up to speed in their posts.

codeineWhen severe colds, flu, or other infections run down youngsters with bad aches or an unrelenting hack, worried parents and doctors may turn to potent painkillers and cough suppressants. But the federal Food and Drug Administration has issued its strongest warnings about key ingredients in some of these, saying kids should not receive medications containing codeine or tramadol.

Both are powerful opioid painkillers. Prescription cough syrups often contain codeine. Tramadol typically is a drug given only to adults, though the FDA says it is seeing it prescribed more often, off label, to kids. Both tramadol and codeine have been prescribed for post-surgery pain for youngsters who have had their tonsils or adenoids removed.

But children, especially those 12 and younger, can have severe reactions to codeine and tramadol. They can slow or labor their breathing.

1-Britax-B-Agile-stroller-in-travel-system-mode-256x300Despite years of public and regulatory pressure, manufacturers continue to dump risky nursery products into the market, sending tens of thousands of children each year to emergency rooms for treatment. These injuries also increased markedly during the last years of a newly published study.

In a study published in the journal Pediatrics, researchers from the Nationwide Children’s Hospital said they scrutinized records on more than a million injuries of youngsters in emergency care for more than two decades (from 1991 to 2011), finding that 66,000 youngsters each year require treatment—almost an incident every eight minutes—due to issues with baby walkers, bouncers and changing tables.

Baby carriers, cribs and mattresses, and strollers caused the preponderance of injuries requiring ER attention, with 81 percent of the injuries affecting youngsters’ head, face, or neck. Most of the injuries were not major and were caused by toddlers falling from nursery products, which the researchers wrote are all too common:

prescription-bottles-1-300x170Some diligent, grown-up sons and daughters may want to check in on mom, dad, and grandma, grandpa, all the aunties and uncles, too. That’s because there’s yet another warning that too many doctors are whipping out their prescription pads all too readily and writing scripts for retirement-age Americans, who now take on average three psychiatric drugs without any mental health history.

Research published in the JAMA Internal Medicine shows that over-prescribing of powerful psychotropic drugs, including sleeping pills, painkillers, and anti-depressants may be more common than believed. The study was based on an analysis of data from a big number of doctors’ office visits, with researchers finding the number of “polypharmacy” incidents (cases in which seniors received scripts for multiple drugs) increased between 2004 and 2013 from 1.5 million to 3.68 million.

This doubling resulted from seniors’ greater openness in talking with their doctors about mental health issues, and, in instances where visits were related to “anxiety, insomnia, or depression,” the researchers write. But, in disturbing fashion, a high number of women and rural patients were involved in cases where multiple psychotropics were prescribed, and many of the prescriptions were for painkillers.

https://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

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