Articles Posted in Product Safety

fish-300x232If you’re an expectant mom trying to diversify your diet and to eat healthier this summer, two federal agencies are offering evidence-based advice about seafood dining: Use a little caution with servings of certain fish like king mackerel, marlin, shark, swordfish, and bigeye tuna that tend to carry higher levels of problematic mercury.

The federal Food and Drug Administration and Environmental Protection Agency have teamed up to revise their safe fish guidelines and to offer these in a handy guide to not only pregnant women but to all parents really.

The agencies say that fish can be a tasty, protein- and nutrient-rich part of Americans’ diets with grown-ups and kids encouraged to eat two to three servings or roughly 8- to 12-ounces-per-week. But fish also carry mercury traces, which “can be harmful to the brain and nervous system if a person is exposed to too much of it over time.”

eclipse-300x235Weather permitting, Washingtonians soon will get a good view of a full eclipse of the sun — not the whole thing but a good chunk. Here’s hoping that all viewers of this much-anticipated astronomical event take due precautions so they don’t damage their eyesight.

Residents around the nation’s capital can expect to see an 81 percent blockage of the sun at the peak of the Aug. 21 eclipse, not the full solar cover or “totality” that millions of Americans are planning and traveling to view in peak spots that fall in a 70-mile wide swath across the country from Oregon to South Carolina.

Be warned: Don’t think just because the sun overhead is mostly blocked that it is safe even then to stare upwards with unprotected eyes. That might leave a careless viewer in the district with crescent-shaped burns on the back of the eyes, says a vision expert and longtime aficionado who says he has seen 19 eclipses.

cig-300x225The nation’s long war on one of its leading preventable killers has taken a surprising tactical turn, as the head of the federal Food and Drug Administration has declared that tobacco companies will face new regulations aimed at slashing nicotine in cigarettes.

FDA Commissioner Scott Gottlieb argues that cutting the noxious and addictive nicotine will help Americans unhook themselves from tobacco use, prompting less cigarette smoking, and, potentially increasing the use of possibly less harmful health vices, like nonburning “e-cigarettes” for vaping.

Gottlieb, at the same time, put further off a planned FDA crackdown on e-cigarette makers, delaying for several years requirements that they disclose ingredients in their colorful, flavored vaping liquids and demonstrate that they and other e-cigarette products do not cause health harms.

ExpiredDrug-300x225Americans each year needlessly toss hundreds of millions of dollars in costly, valuable, and still potent drugs, a wasteful practice driven by a “myth,” the mistaken belief in and scrupulous adherence to already debunked product expiration dates.

Drug discards, including of medications that may be in short supply nationwide, occur all along the distribution chain, from corner druggists up to giant health system pharmacies.

The practice flies in the face of known evidence, much of it developed, verified, and shared by the same force that presses for expired meds to get tossed: Uncle Sam.

fda-300x125Pro-business and anti-consumer  lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed and some even killed already by defective and dangerous medical devices.

The dispute focuses on a provision to triple the time that companies would get to report product issues to the federal Food and Drug, giving medical device makers three months to do so, rather than 30 days as now required. They still must report to the agency immediately any incident in which a patient is harmed.

Although consumer safety advocates are decrying the oversight changes that GOP members of Congress are pressing, medical device makers are downplaying the regulatory shifts, saying they will eliminate needless bureaucracy. They say that if lawmakers don’t approve the rule changes it may sink the broader and crucial legislation they’re embedded in. The House has just approved and sent to the U.S. Senate the bigger FDA bill, which also provides 60 percent of the fee-based funds for agency drug and medical device reviews.

Pinocchio_Smoking-300x169Tougher ratings for movies targeting teen-agers and higher cigarette taxes may be two good ways to crack down on Big Tobacco’s persistent and harmful peddling of its poisonous wares, health experts say, based on information flowing from the sprawling Golden State.

The federal Centers for Disease Control and Prevention has just assessed Hollywood’s progress in reducing depictions of tobacco in the movies, finding that, under pressure from anti-smoking campaigns,  Tinsel Town had slashed its showing of the use or implied use of cigarettes, cigars, pipes, hookah, smokeless tobacco products and electronic cigarettes from 2005 to 2010. But that progress has reversed since then, and now, based on top 10 grossing movies in any calendar week, cinematic depictions of tobacco use has soared by 80 percent.

Although pictures rated G or PG, those films most accessible to the broadest movie-going audiences, saw reductions in their showing of smoking and other tobacco use, depictions of these negative health practices rose sharply in movies aimed more at teenagers and older youths  in those works with ratings of PG-13 (by 43 percent) and R (by 90 percent).

kidguns-300x168We love our kids dearly, and most of us would do most anything for them. So why can’t folks with sway get it together to make some straight-forward, common sense changes that would significantly benefit young people? Here are three suggestions, based on recent reports:

  1. Congress should make clear that it not only supports but it will fund public health research into gun violence, which is killing kids at unacceptable rates.
  2. Hospitals and surgeons should make public and transparent their surgical volume and outcome data on procedures performed on youngsters.

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.

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