January 20, 2011
A pill used for thyroid disease can cause fatal liver failure in children and should no longer be used to treat them, two doctors warn.
Doctors usually first try either propylthiouracil or methimazole to treat children with Graves’ disease, the most common cause of an overactive thyroid. Other treatments are surgery and radioactive iodine.
But over the past 60 years, reports have popped up linking the use of propylthiouracil in children to liver failure, sometimes fatal or requiring a liver transplant.
Propylthiouracil, or PTU, is also a primary treatment for adults with Graves’ disease, but there appear to be fewer liver complications in adults, according to Donald R. Mattison of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Mattison and Dr. Scott A. Rivkees of Yale University School of Medicine noticed the problem in children and decided to do some research and publicize the issue to doctors.
They estimate that five to 10 children die each year from complications of the drug, based on reports to the Food and Drug Administration and others, Mattison said in an interview.
In a letter published in Thursday’s New England Journal of Medicine, the doctors urged colleagues not to give propylthiouracil as an initial treatment to children for an overactive thyroid.
Mattison said there are no guidelines for treating Graves’ disease in children, and most doctors don’t know of this danger. Only about 8,000 youngsters have the disease and pediatricians might see only one or two cases in their career.
Genentech Inc. began pulling its psoriasis treatment Raptiva from the U.S. market because of the drug’s link to a rare, fatal brain disorder that has troubled at least four other medicines.
Genentech, the biotechnology company acquired last month by Swiss drugmaker Roche Holding AG, has told doctors not to write prescriptions for new patients as part of a phased withdrawal of Raptiva to be completed by June 8, the South San Francisco-based company said yesterday in a statement. About 2,000 U.S. patients may be taking Raptiva, Genentech said
The decision to withdraw the drug, which generated $108 million in U.S. sales for Genentech last year, came after three patients were diagnosed since October with the brain infection progressive multifocal leukoencephalopathy, two of whom died, said Tara Cooper, a Genentech spokeswoman. The risk of PML, which causes irreversible brain damage, outweighed Raptiva’s benefits in controlling psoriasis, the company concluded.
“We said, and the Food and Drug Administration agreed, that Raptiva likely causes PML,” said Ivor Caro, Genentech’s senior medical director for dermatology, in a telephone interview. What tipped the balance was that Genentech could neither predict which patients were likely to develop PML, nor come up with a strategy to lessen that risk, he said.
“It was the clinical science perspective, not how much Raptiva was being sold,” Caro said.
$125 Million Charge
The withdrawal will result in a one-time charge of about $125 million, the company said.
The recall last week of 2 million pounds of pistachios because of concerns about salmonella contamination has been expanded, and federal officials say more recalls of foods containing pistachios are on the horizon.
Setton Pistachio of Terra Bella, the California company that is the nation’s second-largest processer of pistachios, originally had recalled all of its pistachios harvested since September.
The recall was expanded this week to cover Setton’s entire 2008 crop, except for raw in-shell pistachios. Most pistachios sold in stores are roasted.
Setton spokeswoman Fabia D’Arienzo said she did not know how many pounds of pistachios were involved in the expanded recall.
“This is going to resemble the peanut recall in that products are going to be added every day as companies discover they used Setton pistachios,” says Caroline Smith DeWaal of the non-profit Center for Science in the Public Interest. “It’s going to take a while for the dust to settle.”
Products are still being recalled that contained peanuts or peanut paste produced by the Peanut Corp. of America, the processor tied to a salmonella outbreak this year that sickened almost 700 people.
No illnesses from pistachio consumption have been reported. The salmonella was detected in testing by an Illinois foodmaker that buys from Setton.
Setton had been processing raw and roasted pistachios on the same production lines without adequate cleaning between uses, says David Acheson, the FDA’s associate commissioner for foods, adding: “Not a good idea.” A Setton official said earlier that roasted pistachios may have picked up salmonella from contact with raw nuts.
Federal and state inspectors have found salmonella in the plant, including on machines used to feed pistachios through the production line.
“There were a number of other factors that demonstrated a lack of microbiological control in the facility,” Acheson says.
Article: USA Today
WASHINGTON — Federal regulators said Wednesday that that they would ask makers of some of the riskiest medical devices to prove that their products were safe and effective — a step that critics have said was long overdue.
In January, the Government Accountability Office issued a report scolding the Food and Drug Administration for failing for decades to fix its system for reviewing categories of devices that have been on the market since before the enactment of the medical device law in 1976.
Such legacy devices, as they are known, were originally allowed on the market with minimal testing. But in the 1976 law Congress told the F.D.A. to gradually reclassify these older devices and decide which ones needed extensive testing before approval of new versions and which ones did not.
The agency never finished that process, leaving 27 different types of devices unexamined — products that include artificial lung membranes, external defibrillators and various pacemaker components.
For decades, the F.D.A. has approved devices in these categories for sale without demanding rigorous tests showing that they work safely. Investigators for the accountability office stated that “it is imperative that F.D.A. take immediate steps” to fix its system for approving such devices, and the agency agreed.
The agency has already undertaken a review of two of these older device types, and it announced Wednesday that it was requiring makers of the other 25 types of devices to submit information to the agency within 120 days, detailing the products’ safety and effectiveness.
Article: NY Times
A soldier formerly based in Casper had no choice but to sue three Casper doctors in federal court for medical malpractice that nearly killed him, he said Tuesday.
“First, it was for my family,” former U.S. Army Staff Sgt. Edward Poche, 39, said in an interview from his home in Byron, Ga.
“I lost my career over what happened, and [the family] had to come first,” Poche said.
He and his wife, Cynthia, also wanted Wyoming residents to know they have the right to take action in similar cases, he said. “I survived; the next guy might not.”
Poche’s attorney, Steven Shapiro, said he partly framed the case with a public perspective. “We told the jury, ‘Is this the kind of care you want in the state of Wyoming?’”
After a four-week trial ending Friday, the jury in U.S. District Court in Cheyenne awarded the Poches $1.6 million in damages – about half of what they were demanding – after finding Dr. Raoul Joubran 60 percent negligent and Dr. Mary MacGuire 40 percent negligent. The jury did not find Dr. James Anderson negligent.
The jury also awarded the federal government $380,000 in compensation for the Bethesda (Md.) Naval Hospital, which had to repair the damages caused by Joubran and MacGuire.
The doctors declined to mediate the case or take it to the Wyoming Attorney General’s Medical Review Panel, Shapiro said.
In court documents and at trial, the doctors said they operated within the standard of care and their efforts saved Poche’s life.
Anderson’s attorney, Jeff Brinkerhoff, said he was surprised at the overall verdict, but pleased that the jury agreed his client met the standard of care.
The family of a man permanently disabled when an iron storm grate dislodged and crashed through his windshield in 2007 has expanded a lawsuit to include companies that allegedly sold or manufactured equipment that was not intended to be used on state highways.
The amended lawsuit, filed in Suffolk Superior Court, alleges that E.J. Prescott of Middleton sold risers to a state highway contractor, SPS New England, knowing that they were unfit for use on a highway project.
E.J. Prescott then failed to warn SPS that the risers were not meant to be used to elevate catch basin grates to the height of the highway surface in spots where they would be exposed to repeated impact by traffic, the suit contends. The suit also names the manufacturer of the risers, Quality Water Products of South Barre, as a third-party defendant.
The lawsuit charges negligence or breach of warranty against 11 companies that had a hand in installing, manufacturing, or selling the equipment that dislodged from Route 128 in July 2007.
Pawel Swierczynski, a North Easton engineer, was driving north in the middle lane of Route 128 in Westwood when a grate crashed through the windshield of his 2003 Toyota Corolla. He sustained catastrophic and life-altering injuries, according to his lawyer, Robert W. Norton.
“Medically, he remains totally and permanently disabled,” Norton said. The suit also raises problems with the catch basins and frames used at the project, saying that they did not meet state specifications and alleging that the manufacturer, Campbell Foundry Co. of Harrison, N.J., had not actually manufactured them, as represented to the state.
Article: Boston Globe
Pulling a medical device off the market is one thing. Removing it from the bodies of thousands of patients is a lot more complicated and dangerous.
Consider the Sprint Fidelis, a heart defibrillator cable. In 2007 its maker, Medtronic, stopped selling it after five patients who had the cables died.
But only now is the full scope of the public health problem becoming clear for the Sprint Fidelis, which is still used by 150,000 people in this country.
In the next few years, thousands of those patients may face risky surgical procedures to remove and replace the electrical cable, which connects a defibrillator to a chamber of the heart.
Medtronic estimates that the cable has failed in a little more than 5 percent of patients after 45 months of being implanted. But as a preventive measure, some patients with working cables are having them removed.
Already, four patients have died during extractions. Experts fear that the toll could quickly rise if such procedures are not performed by skilled doctors at medical centers that have performed many of the operations.
“I think we are just seeing the tip of the iceberg,” said Dr. Charles J. Love, a cardiologist at Ohio State University Medical Center in Columbus, who specializes in cable extractions.
Article: NY Times
As the nation’s second-largest processor of pistachios agreed Monday to recall its entire 2008 crop despite no confirmed illnesses, the Obama administration issued a tough warning to all food makers that sloppy manufacturing practices would no longer be tolerated.
With the warning, the administration signaled that it was substantially changing the way the government oversees food safety. Food-handling practices that in the past would have resulted in mild warnings may now lead to wide-ranging and expensive recalls, even before anyone becomes ill from contaminated food.
“The food industry needs to be on notice that F.D.A. is going to be much more proactive and move things far faster,” said Dr. David Acheson, associate commissioner for foods at the Food and Drug Administration. “We’re going to try to stop people from getting sick in the first place, as opposed to waiting until we have illness and death before we take action.”
Last week, the agency told consumers to avoid eating pistachios — the first time it had issued such a blanket warning in the absence of reports that anyone had been sickened. And in recent days, when tests of the processing plant of Setton Pistachio of Terra Bella, based in Terra Bella, Calif., found salmonella contamination and an inspection revealed troubling gaps in sanitary measures, agency officials urged the company to recall its entire 2008 crop, increasing tenfold the recall announced last week. The F.D.A. does not have the power to recall foods itself.
Article: NY Times
An attorney for a Chester woman who died from a twisted intestine after three trips to the emergency room said her family has agreed to settle a lawsuit with six doctors for $3 million.
Lawyer Chad McGowan told The Herald of Rock Hill that the settlement still must be approved by a judge. The money will go to Heather Sloan’s three children.
The lawsuit said Sloan went to the Chester Regional Medical Center emergency room in March 2005 complaining of abdominal pain, but the person reading a CT scan didn’t see a problem and she was sent home.
Article: Post and Courier
The U.S. Supreme Court agreed Monday to decide a long-running dispute over $10.5 million awarded to plaintiffs’ attorneys in a Georgia case alleging foster care violations.
At issue is a $4.5 million enhancement given lawyers by Senior U.S. District Judge Marvin Shoob, who presided over the 2002 suit that reformed foster care in Fulton and DeKalb counties.
The case prompted the state to cut caseloads of overwhelmed workers, beef up investigations into abuse, increase supervision and prevent overcrowding in foster homes.
Russ Willard, a spokesman for state Attorney General Thurbert Baker, expressed satisfaction the high court agreed to take up the fee issue.
The plaintiffs’ lawyers were rewarded handsomely for their work, Willard said. “The enhancement granted by Judge Shoob represented an inappropriate windfall.”
Marcia Lowry, executive director of New York-based Children’s Rights Inc., which represents the plaintiffs, said important civil rights lawsuits like the foster care case are financed largely through awards of attorneys’ fees.
“We do think the law is clear and we do think Judge Shoob got it right,” she said.
After deciding the plaintiffs’ lawyers should be paid $6 million for their fees and expenses, Shoob added the $4.5 million enhancement.
Shoob said the lawyers brought a higher degree of skill, commitment and professionalism than he had seen in his 27 years on the bench. The lawsuit’s success, Shoob added, “was truly exceptional.”
Judge Ed Carnes strongly urged the high court to take up the case.
Article: AJCNewer Posts »