 Metal-on-metal replacement hips remain high-risk, but other devices are to be downgraded. Another medic performed CPR for a few minutes, and then used a medical device that delivered cardiac compressions mechanically for 64 minutes, until Mr. Schneider’s heart started beating normally on its own. “I’m not sure people would have been able to sustain manual CPR for so long,” said Mr. Schneider, 57. “I’m a lucky guy.” |
Showing posts with label Food and Drug Administration. Show all posts
Showing posts with label Food and Drug Administration. Show all posts
Friday, November 22, 2013
New Scrutiny for Medical Devices
Wednesday, November 20, 2013
FDA warns of rare but serious risk of heart attack and death with cardiac nuclear stress test drugs Lexiscan (regadenoson) and Adenoscan (adenosine)
The U.S. Food and Drug Administration (FDA) is warning health care professionals of the rare but serious risk of heart attack and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). We have approved changes to the drug labels to reflect these serious events and updated our recommendations for use of these agents. Health care professionals should avoid using these drugs in patients with signs or symptoms of unstable angina or cardiovascular instability, as these patients may be at greater risk for serious cardiovascular adverse reactions.
Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Lexiscan and Adenoscan help identify coronary artery disease. They do this by dilating the arteries of the heart and increasing blood flow to help identify blocks or obstructions in the heart’s arteries. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked or unobstructed arteries, which can reduce blood flow in the obstructed artery. In some cases, this reduced blood flow can lead to a heart attack, which can be fatal.The Warnings & Precautions section of the Lexiscan and Adenoscan labels previously contained information about the possible risk of heart attack and death with use of these drugs. However, recent reports of serious adverse events in the FDA Adverse Event Reporting... |
Sunday, November 17, 2013
Addiction Specialists Wary of New Painkiller
Addiction experts protested loudly when the Food and Drug Administration approved a powerful new opioid painkiller last month, saying that it would set off a wave of abuse much as OxyContin did when it first appeared.
An F.D.A. panel had earlier voted, 11 to 2, against approval of the drug, Zohydro, in part because unlike current versions of OxyContin, it is not made in a formulation designed to deter abuse.
Now a new issue is being raised about Zohydro. The drug will be manufactured by the same company, Alkermes, that makes a popular medication called Vivitrol, used to treat patients addicted to painkillers or alcohol.
In addition, the company provides financial support to a leading professional group that represents substance abuse experts, the American Society of Addiction Medicine.
For some critics, the company’s multiple roles in the world of painkillers is troubling.
Dr. Gregory L. Jones, an addiction specialist in Louisville, Ky., said he had long been concerned about financial links between the group and the drug industry, adding that the Zohydro situation amplified those potential conflicts.
Dr. Stuart Gitlow, the current president of the American Society of Addiction Medicine, said he had been unaware until now of Alkermes’s involvement with Zohydro. Dr. Gitlow, who is affiliated with Mount Sinai Hospital in New York City, said that the group would seek more information from Alkermes about the situation and then decide what, if anything, to do next.
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Saturday, November 16, 2013
Class I Recall: Medtronic's Worldwide Voluntary Field Action on Guidewires
Medtronic, Inc. (NYSE: MDT) announced today that the U.S. Food and Drug Administration (FDA) has classified the company's recently initiated voluntary field action related to certain guidewires as a Class I recall.
Based on an internal investigation following a limited number of complaints, including one patient injury, Medtronic began notifying hospitals and distributors worldwide the week of Oct. 21 that some models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach. The notification requested that all potentially affected units be quarantined immediately and returned to the company as soon as possible for credit and replacement.
Medtronic has also taken the necessary steps to prevent future shipments of the recalled products and notified regulatory agencies around the world as appropriate.
The FDA defines a Class I recall as a situation in which there is a reasonable probability that use of, or exposure to, a violative product will cause serious adverse health consequences or death.
The guidewires covered by this recall are designed to facilitate percutaneous coronary interventions or the placement of left ventricular leads for cardiac rhythm devices. They include specific lots from the following eight product lines that were manufactured after mid-April 2013:
- Cougar nitinol workhorse guidewire
- Cougar steerable guidewire
- Zinger stainless steel workhorse guidewire
- Zinger steerable guidewire
- Thunder extra-support guidewire
- Thunder steerable guidewire
- ProVia crossing guidewire
- Attain Hybrid guide wire
Additional information about the recall, including the lot numbers of affected product, is accessible through the Medtronic website – specifically, http://www.medtronic.com/for-healthcare-professionals/index.htm.
Observations and consequences of the coating issue related to these guidewires should be reported to Medtronic in the United States by calling +1-877-526-7890 on weekdays from 8am to 5pm U.S. Central Time.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA:
- Online at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form
available to fax or mail), or - Call FDA at +1-800-FDA-1088
ABOUT MEDTRONIC
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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Jon L. Gelman of Wayne NJ is the author NJ Workers’ Compensation Law (West-Thompson) and co-author of the national treatise, Modern Workers’ Compensation Law (West-Thompson). For over 4 decades the Law Offices of Jon L Gelman 1.973.696.7900 jon@gelmans.com have been representing injured workers and their families who have suffered occupational accidents and illnesses.
Friday, November 15, 2013
Expediting Drug Development — The FDA's New “Breakthrough Therapy” Designation
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Wednesday, November 13, 2013
FDA Proposes Letting Generic-Drug Makers Change Labels
The Food and Drug Administration proposed allowing generic drug companies to change drug labels after getting reports of bad reactions in patients, a step that could open the generic industry up to greater potential legal liability.
In 2011 and again this year, the Supreme Court issued rulings that shielded generic drug makers from consumer personal-injury lawsuits, even though the justices have allowed similar product-liability claims against makers of branded drugs. The step Friday by the FDA means that generic companies—which sell about 84% of the prescription drugs by volume in the U.S.—would have the same ability to change their labels as brand companies. The FDA would review any proposed changes, as it already does with changes to branded-drug labels. "Our effort is to keep all the labels the same, and to level the playing field," said Janet Woodcock, director of the FDA's center for drug evaluation and research. The proposal, she said, "would change current procedures, where only the brand companies can unilaterally put certain safety information in the label." The Generic Pharmaceutical Association reacted cautiously, saying it is concerned that multiple labels on the same drug "could drive up costs…and should be approached very carefully." Some of the leading makers of generic drugs include Hospira Inc., HSP +0.55%Hospira Inc.U.S.: NYSE$38.74 +0.21+0.55% Nov. 12, 2013 4:00 pm Volume (Delayed 15m) : 2.36MAFTER HOURS$38.58 -0.16-0.43% Nov. 12, 2013... |
Friday, November 8, 2013
Lawyer recalls first meeting with woman who started Risperdal litigation
Brian McCormick remembers meeting Victoria Starr back in 2007 when he first started working for Sheller P.C.
The Oregon woman had approached the Philadelphia law firm about three years prior about filing a qui tam lawsuit on behalf of the U.S. government against the makers of the antipsychotic drug Risperdal.”
McCormick’s law firm filed Starr’s qui tam suit in April 2004, three months after the woman quit her job. She had begun working for Janssen in about 2001. On Monday, Johnson & Johnson announced that it would be paying more than $2.2 billion to resolve civil and criminal claims relating to allegations that the company marketed Risperdal, a drug primarily designed to treat bi-polar disorder and schizophrenia, for uses other than those approved by the Food and Drug Administration. The pharmaceutical manufacturer will pay $1.673 billion to resolve the allegations of off-label marketing for Risperdal and sister drug Invega, the resolution marking the largest involving a single drug in U.S. history, and the third-largest healthcare fraud settlement involving one company, according to the U.S. Attorney’s Office for the Eastern District of Pennsylvania. The massive settlement that resulted from a... |
Tuesday, November 5, 2013
Johnson & Johnson to Pay More Than $2.2 Billion to Resolve Criminal and Civil Investigatio
Today's post is shared from justice.gov
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists\Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
Allegations Include Off-label Marketing and Kickbacks to Doctors and Pharmacists\Global health care giant Johnson & Johnson (J&J) and its subsidiaries will pay more than $2.2 billion to resolve criminal and civil liability arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the nation’s largest long-term care pharmacy provider. The global resolution is one of the largest health care fraud settlements in U.S. history, including criminal fines and forfeiture totaling $485 million and civil settlements with the federal government and states totaling $1.72 billion.
“The conduct at issue in this case jeopardized the health and safety of patients and damaged the public trust,” said Attorney General Eric Holder. “This multibillion-dollar resolution demonstrates the Justice Department’s firm commitment to preventing and combating all forms of health care fraud. And it proves our determination to hold accountable any corporation that breaks the law and enriches its bottom line at the expense of the American people.”
The resolution includes criminal fines and forfeiture for violations of the law and civil settlements based on the False Claims Act arising out of multiple investigations of the company and its subsidiaries.
Friday, November 1, 2013
As Robot-Assisted Surgery Expands, Are Patients And Providers Getting Enough Information?
Today's post is shared from kaiserhealthnews.org.
The use of robotic surgical systems is expanding rapidly, but hospitals, patients and regulators may not be getting enough information to determine whether the high tech approach is worth its cost. Problems resulting from surgery using robotic equipment—including deaths—have been reported late, inaccurately or not at all to the Food and Drug Administration, according to one study.  The FDA assesses and approves products based on reported device-related complications. If a medical device malfunctions, hospitals are required to report the incident to the manufacturer, which then reports it to the agency. The FDA, in turn, creates a report for its Manufacturer and User Facility Device Experience database. The use of surgical robots has grown rapidly since it was first approved for laparoscopic surgery (a type of surgery that uses smaller incisions than in traditional surgery) by the FDA in 2000. Between 2007 and 2011 the number of da Vinci systems installed increased by 75 percent in the United... |
Thursday, October 31, 2013
Aviation Safety: F.A.A. Allows Use of Electronic Devices Throughout Flights
Finally, the US F.A.A. has taken a step forward in making the airplane flight experience a better one. For decades, passengers and crew have been battling flight attendants over turning off and stowing personal electronic devices (PED). With so many passengers and crew virtually attached to the Internet for data, news and other media electronically, it was inevitable that PED use would be allowed on flights. Now the airlines will adjust its electronics to create a profit center for the sale of Internet and network access. The burden has also shifted to US airlines to commit to a testing program, and establish protocols for stowing devices. Today's post is shared from nytimes.com .
The change will most likely take effect before the end of the year, the F.A.A. said. Rules for cellphone use are set by the Federal Communications Commission, and unlikely to change soon, because of the nature of the cellphone system. The administrator of the F.A.A., Michael P. Huerta, said he expected that, with rare exceptions, airlines would allow the use of tablets, MP3 players and smartphones in “airplane mode,” with their cell network connections turned off. The airlines will have to conduct tests on their equipment and submit the results to the F.A.A. for approval, he said. Soon after Mr. Huerta spoke, Delta and JetBlue announced that they would submit a plan for passengers to use electronics in flight. The change would not be universal, Mr. Huerta said.... |
Wednesday, October 30, 2013
Leading Coal Industry Law Firm Withheld Evidence of Black Lung Disease
| A miner’s struggle for benefits due to black lung disease spotlights aggressive tactics by a mining company law firm. Jackson Kelly recently was named by U.S. News & World Report as the nation’s top firm in mining law. But its actions are sometimes unethical, according to current and former judges, lawyers and state disciplinary officials. As a result, sick and dying miners have been denied benefits and affordable medical care. The firm, documents show, over the years has withheld unfavorable evidence and shaped the opinions of doctors reviewing miners’ medical claims by providing the physicians only what the lawyers wanted them to see. In a pending case involving a West Virginia miner named Gary Fox, Jackson Kelly was found to have withheld pathology reports from two doctors who concluded that Fox likely had black lung. The Center for Public Integrity - See more at: http://www.fairwarning.org/2013/10/68752/#sthash.lbQd8rOJ.dpuf |
F.D.A. Shift on Painkillers Was Years in the Making
Narcotic pain killers have been the subject of concern and regulation by employers' and their insurance carriers nationally. The evolution of the FDA proposed action to regulate is revealed in today's post is shared from the NYTimes.com
When Heather Dougherty heard the news last week that the Food and Drug Administration had recommended tightening how doctors prescribed the most commonly used narcotic painkillers, she was overjoyed. Fourteen years earlier, her father, Dr. Ronald J. Dougherty, had filed a formal petition urging federal officials to crack down on the drugs.  Since then, narcotic painkillers, or opioids, have become the most frequently prescribed drugs in the United States and have set off a wave of misuse, abuse and addiction. Experts estimate that more than 100,000 people have died in the last decade from overdoses involving the drugs. For his part, Dr. Dougherty, who foresaw the problem, retired in 2007 and is now 81 and living in a nursing home. “Too many lives have been ruined,” his daughter said. The story behind the F.D.A.’s turnaround on the pain pills, last Thursday, involved a rare victory by lawmakers from states hard hit by prescription drug abuse over well-financed lobbyists for business and... |
Thursday, October 24, 2013
FDA Proposes Changes in Pain Medication Prescriptions
The US FDA has announced proposed changes will be forthcoming in labeling for pain relief medication:
Consumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.
"In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.
"The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications.
They also are meant to reduce problems associated with their use," says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," Throckmorton adds.
They also are meant to reduce problems associated with their use," says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA's Center for Drug Evaluation and Research. "Altogether, the actions we're now announcing are part of FDA's efforts to make opioids as safe as possible for those who need them," Throckmorton adds.
"He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.
Medical Device Litigation: Medtronic, Inc. v. Stengel
Issue: Whether the Medical Device Amendments to the federal Food,Drug, and Cosmetic Act preempt a state-law claim alleging that a medical device manufacturer violated a duty under federal law to report adverse-event information to the Food and Drug Administration.
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Sunday, October 20, 2013
Naloxone Expansion In California Will Enable Family, Friends To Save Lives At Home
Family and friends of more drug users in California will soon be able to reverse overdoses at home with a lifesaving injectable drug.
On Thursday, Gov. Jerry Brown signed into law Assembly Bill 635, authored by Assemblymember Tom Ammiano, which will expand the use of the drug naloxone. Naloxone, also known by its brand name Narcan, can be administered to a person suffering from an opiate overdose to restore breathing. Naloxone is non-addictive, non-toxic, fairly cheap and is easy to administer through the nose or intravenously. It was approved by the Food and Drug Administration in 1971 and is stocked in thousands of emergency rooms, ambulances and post-surgery recovery rooms across the country. But frequently, opiate users don't make it to the hospital in time. For that reason, in 2008, California implemented a pilot program in seven counties that allowed drug users, their family and friends, health care professionals and addiction counselors to administer naloxone in an emergency -- and be protected from civil or criminal liability if anything goes wrong. The bill that Brown signed into law extends the program across all of California. Starting Jan. 1, drug users and their family and friends will be able to request a naloxone prescription from a doctor or addiction treatment program. For example, "if a teen is known to be picking up OxyContin, their family might -- in the treatment process -- want a naloxone prescription, just in case," Ammiano's communications director Carlos... |
Tuesday, September 24, 2013
Use Only as Directed
During the last decade, more than 1,500 Americans dieda fter accidentally taking too much of a drug renowned for its safety:acetaminophen, one of the nation’s most popular pain relievers.
Acetaminophen – the active ingredient in Tylenol– is considered safe when taken at recommended doses. Tens of millions of people use it weekly with no ill effect. But in larger amounts, especially in combination with alcohol, the drug can damage or even destroy the liver. Davy Baumle, a slender 12-year-oldwho loved to ride his dirt bike through the woods of southern Illinois, died from acetaminophen poisoning. So did tiny five-month-old Brianna Hutto. So did Marcus Trunk, a strapping 23-year-old construction worker from Philadelphia. The toll does not have to be so high. The U.S. Food and Drug Administration has long been aware of studies showing the risks of acetaminophen – in particular, that the margin between the amount that helps and the amount that can cause serious harmis smaller than for other pain relievers. So, too, has McNeil Consumer Healthcare, the unit of Johnson & Johnson that has built Tylenol into a billion-dollar brand and the leader in acetaminophen sales. Yet federal regulators have delayed or failed to adopt measures designed to reduce deaths and injuries from acetaminophen overdose,which the agency calls a “persistent, important public health problem.” The FDA has repeatedly deferred decisions on consumer protection seven when they were... |
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