News Articles of Interest
The following news articles are gathered and posted by The Nations Law Firm as a public service. We post articles related to our major practice areas, such as pharmaceutical litigation,business litigation and other civil trial matters, such as catastrophic injuries and wrongful death. We include the latest developments in the pharmaceutical and medical device cases, such as settlements, verdicts and court rulings.
We also post articles that we feel are of interest to our clients, such as health news and important safety alerts.
Some of the news articles are preceded by an introductory note, which I have written in an effort to provide some background and additional information or thoughts about the subject.
If you have any comments or suggestions about the news articles, please contact me.
Cindy L. Nations, J.D.
Articles
DRUG COMPANIES FAILED TO DISCLOSE ZETIA RISKS
By Cindy L. Nations
Unpublished research was recently discovered showing that the popular cholesterol drug Zetia may cause liver damage when used long-term with other cholesterol drugs called statins. The studies were conducted by Zetia manufacturers Merck and Shering-Plough, who claim that the results were not scientifically important enough to be published.
This is not the first time that Zetia has been under public scrutiny. The drug companies were recently criticized for failing to promptly release data from the Enhance trial, which was completed in 2006. The Enhance data may possibly show a link between Zetia and elevated liver enzymes. Merck and Shering-Plough say the full Enhance study results should be released in March of 2008.
The current label for Zetia contains only mild warnings about the drug’s potential to cause liver problems. Based on the newly-released research data, the FDA will determine whether or not stronger warnings may be necessary.
Source: Law Offices of Howard L. Nations
www.howardnations.com
Published January 2, 2008
PHARMACEUTICAL INFLUENCE IS PERVASIVE BUT HARD TO QUANTITATE
by Abigail Zuger, M.D.
The methods used by pharmaceutical companies to market their wares have undergone increasing scrutiny in recent years. This year, several research groups attempted to provide quantitative data on these controversial tactics. [pdf format 22.8Kb]
Source: Journal Watch General Medicine
http://general-medicine.jwatch.org
Published December 28, 2007
LILLY MAY FACE MORE ZYPREXA LAWSUITS AFTER FDA LETTER
Eli Lilly & Co. may attract more lawsuits alleging it failed to warn users that a psychiatric drug was linked to diabetes after the pharmaceutical company received a letter from U.S. regulators. ... Howard Nations, an attorney representing about 185 Zyprexa users with pending cases, said he didn't expect a new round of lawsuits because Judge Weinstein ``wants the cases disposed of.'' He said he does think the FDA letter will bolster claims in remaining suits by showing that Lilly didn't properly warn people of the risks of using Zyprexa. [pdf format 47.1Kb]
Source: Bloomberg
June 29, 2007
IN THE STENT ERA, HEART BYPASSES GET A NEW LOOK
By BARNABY J. FEDER
In light of new concerns over stents' risks, surgery may be poised for a comeback for treating plaque-clogged arteries. [pdf format 157.8Kb]
Source: New York Times
www.nytimes.com
Published: February 25, 2007
LATEST FINDINGS ON STENTS
Recent reports comparing drug-eluting stents with bare metal stents have suggested potentially greater risks for stent thrombosis and for death and myocardial infarction with drug-eluting stents. [pdf format 114.8Kb]
Source: Journal Watch
http://general-medicine.jwatch.org
February 15, 2007
F.D.A. WIDENS SAFETY REVIEWS ON NEW DRUGS
By GARDINER HARRIS
The Food and Drug Administration announced changes intended to ensure that marketed drugs are as safe as advertised. [pdf format 144.6Kb]
Published by New York Times
January 31, 2007
Washington
U.S. DEPT. OF HEALTH & HUMAN SERVICES
Agency for Healthcare Research & Quality - FINAL REPORT
January 17, 2007
Efficacy and ComparativeOff-Label Use of Atypical Antipsychotics
PSYCHIATRY TRAINEES PERCEIVE STIGMA IN MEDICATION TREATMENT
Peter Roy-Byrne, MD
If psychiatrists are sensitive to negative views about psychiatric medication, what do their patients think? [Read full article here.]
Published in Journal Watch Psychiatry
December 18, 2006
DOCTORS TREATING WOUNDED AMERICAN SOLDIERS WITH DANGEROUS DRUG
by Robert Little, Sun Reporter
Despite the fact that Recombinant Activated Factor VII has been linked to deadly blood clots in the lungs, hearts and brains of patients, American military doctors in Iraq are routinely using the blood coagulating drug on hundreds of wounded soldiers. At least 43 deaths have been attributed to Factor VII so far. Factor VII is approved for treating rare forms of hemophilia. [BALTIMORE SUN]
Originally published in The Baltimore Sun
November 19, 2006
DANGEROUS DECEPTION - HIDING THE EVIDENCE OF ADVERSE DRUG EFFECTS
by Jerry Avorn, M.D.
http://content.nejm.org/cgi/content/full/355/21/2169?query=TOC
Published in the New England Journal of Medicine
November 23, 2006
COLA 'IS BAD' FOR WOMEN'S BONES
Women who regularly drink cola could be increasing their risk of osteoporosis, US researchers believe. [more from BBC linking Cola and brittle bones...]
Source: BBC News UK
06 October 2006
Note: The business of pharmaceuticals in the United States is highly competetive and is worth billions of dollars. For years, pharmaceutical companies have showered physicians with gifts -- from ballpoint pens to all-expense paid vacations -- all under the guise of educating physicians on their products. In the industry, this is called "detailing".
Several years ago, the Stanford Center for Research in Disease Prevention conducted a study about the cost of pharmaceutical marketing. The study found that in 1998 free samples given to physicians totaled $6.6 billion of retail value, representing 51.9 percent of the drug promotion expenditures. Pitches by drug-industry reps to in-office physicians - a practice known as detailing - totaled $3.5 billion, accounting for 27.8 percent of the total. Ads in medical journals totaled $540 million, representing a modest 4.3 percent of total drug-promotion expenditures.
Current figures show that physician promotion (free samples, conferences, journal ads, detailing) accounts for nearly 85% of the total spending on prescription drug promotion. Pharmaceutical companies spend over $14 billion dollars per year on detailing.
New York Times
May 20, 2006
UNEASE ON INDUSTRY'S ROLE IN HYPERTENSION DEBATE
By STEPHANIE SAUL
Three pharmaceutical companies donated $700,000 to a medical society that used most of the money on a series of dinner lectures last year to brief doctors on the latest news about high blood pressure.
The same three companies - Merck, Novartis and Sankyo - also gave the money that the medical society used to formulate the main talking point of those briefings, an expanded concept of high blood pressure that many doctors say would increase the number of people taking drugs. [more...]
Source:
The New York Times
www.nytimes.com
Posted May 20, 2006Source: F.D.A. website
http://www.fda.gov
SCIENTISTS WILL GATHER TO DISCUSS SAFETY OF ABORTION PILL
By GARDINER HARRIS
May 11, 2006
Worried about a bacterial infection that led to the deaths of at least five women who took the abortion pill RU-486, scientists from the nation's leading public health agencies will gather in Atlanta today for the first meeting in 10 years on the drug's safety.
Scientists from the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health will consider whether the means of administering abortion drugs make pregnant women more susceptible to the bacterium Clostridium sordellii.
They will also discuss whether the deaths may signal the emergence of a new and more virulent strain of the bacterium that poses a threat to pregnant women generally, not just those who use RU-486. [more ...]
Source:
The New York Times
www.nytimes.com
Note:
Another defective medical device is being recalled. Although no injuries or deaths have been reported as of yet, it is a well-known fact that serious adverse events from medical devices and pharmaceuticals are severely underreported. The FDA estimates that it only receives reports of 1 in 10 to 1 in 100 serious adverse events that actually occur.
On May 5, 2006, the FDA issued a notice of the Class I recall. See the Respironics press release below.
This isn't the first time Respironics has had to recall a defective prpoduct from the market. On September 21, 1993, Respironics issued a voluntary recall of their battery adapter cables. There was a risk that the cables would overheat melting the insulation and potentially causing a fire.
And on December 3, 2003, they issued a voluntary recall of ComfortGel masks. Some of the nasal masks were missing an exhalation port, which is required to allow exhaled air to exhaust properly.
The Nations Law Firm will be monitoring the newly issued ventilator recall. Hopefully, there will be no injuries or deaths as a result of this defect. However, if you or someone you know has suffered serious injury from using a Respironics ventilator, please contact our offices for a free consultation with one of our attorneys.
RESPIRONICS ISSUES WORLDWIDE RECALL OF PLV(R) CONTINUUM(TM) VENTILATOR
May 5, 2006
MURRYSVILLE, Pa., PRNewswire-FirstCall/ -- RESPIRONICS, INC.
(Nasdaq/NMS Symbol: RESP) announced today that it has voluntarily recalled 269 ventilators representing all models and serial numbers of the PLV(R) Continuum(TM) Ventilator. This recall is being conducted because the ventilator may suddenly stop providing mechanical ventilation. This could result in serious injury or death. The recalled ventilators should not be used until the problem is corrected.
Source:
http://www.respironics.com
Respironics Press Release
Issued May 5, ,2006
INJURY TO RESEARCH VOLUNTEERS - THE CLINICAL-RESEARCH NIGHTMARE
Alastair J.J. Wood, M.D., and Janet Darbyshire, M.B., Ch.B.
May 4, 2006
At 8 a.m. on Monday, March 13, 2006, eight healthy young men entered a trial of a drug under development by the small German immunotherapeutics company TeGenero. Six of the volunteers were assigned to receive active drug, and two were to receive placebo...
However, after receiving injections of TGN1412, the six volunteers became desperately ill, had multiple-organ failure, and were transferred to an intensive care unit...As of April 5, five of the volunteers had been discharged from the hospital, and the other man appeared to be recovering. This unexpected and devastating outcome is currently under investigation by the relevant authorities under the supervision of the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), which originally approved the trial and its protocol. A preliminary report has now been completed and released. [more ...]
Source:
New England Journal of Medicine
http://content.nejm.org
Volume 354:1869-1871
May 4, 2006 Number 18
Note:
The Heart Rhythm Society is an international professional group representing more than 4,200 cardiac implant specialists in 78 countries. They focus on education and advocacy for cardiac arrythmia professionals and patients. In 2005, hundreds of thousands of defective pacemakers and defibrillators were recalled and numerous deaths occurred as a result of device failures. Manufacturers of the defective devices, such as Guidant Corporation, have been accused of deceiving and misleading doctors and patients. In an effort to avoid disasters such as this in the future and to better protect the patients, the Heart Rhythm Society has issued a proposal for how to better monitor the safety of medical devices once they're on the market and how to effectively deal with the discovery of dangerous defects. The HRS is accepting public comment until May 30, 2006.
To read the draft, click here.
INT'L GROUP WANTS BETTER HEART DEVICE SAFETY TRACKING
Apr 26, 2006
By Lisa Richwine
WASHINGTON (Reuters) - Makers of implanted heart devices should track their performance better and ask independent experts to evaluate their safety, an international doctors' group proposed on Wednesday.
Regulators also should improve surveillance of potential problems with implanted cardioverter defibrillators (ICDs) and pacemakers on the market and use simple language to explain concerns, the Heart Rhythm Society said in draft guidelines.
Source: Reuters UK
http://today.reuters.co.uk/news
FDA IS CRITICIZED OVER DRUGS' SAFETY PROBLEMS
RESPONSE TO APPROVED MEDICATIONS CITED
Monday, April 24, 2006
By Marc Kaufman
Washington Post Staff Writer
The Food and Drug Administration is sometimes too slow in picking up safety problems once drugs are on the market and in responding to emerging danger signals, a federal study concluded in a report to be released today.
The review by the Government Accountability Office found that the FDA does not have clear policies for addressing drug safety issues and that it sometimes excludes its best safety experts from important meetings.
The report also calls on Congress to consider expanding the FDA's authority to require that drug companies conduct studies of already-approved products. The agency's ability to order post-market studies is now limited, and many drug companies have been slow to conduct studies that they had agreed to undertake as a condition of gaining FDA approval.
The GAO inquiry was requested by Congress in 2004 after the sudden withdrawal of the blockbuster painkiller Vioxx, which was found to increase the risk of heart attacks and strokes in long-term users. Several bills that would toughen the FDA's safety oversight were introduced after the Vioxx withdrawal, and the report offers their sponsors new ammunition.
[more ...]
To view the GAO Report, please click here...
Source: The Washington Post
http://www.washingtonpost.com
BAUSCH & LOMB "WITHDRAWS" RENU CONTACT LENS SOLUTION
April 14, 2006
In what it is calling a "voluntary market withdrawal," Bausch & Lomb is asking retailers to stop selling ReNu with MoistureLoc, a contact-lens solution that's suspected of causing a serious eye infection. Many major retailers have already pulled the product and the company has suspended shipments. ...
Earlier this week, CDC and the Food and Drug Administration said they had information on 109 suspected cases of Fusarium keratitis, an infection that can lead to blindness. Of the 109 cases, 30 had been reviewed and 26 of those involved patients who had used ReNu. [more...]
Source: www.consumeraffairs.com
BRITISH RETHINKING RULES AFTER ILL-FATED DRUG TRIAL
April 8, 2006
By Elisabeth Rosenthal
International Herald Tribune
In February, when Rob O. saw the text message from Parexel International pop up on his cellphone in London — "healthy males needed for a drug trial" for £2,000, about $3,500 — it seemed like a harmless opportunity to make some much-needed cash. Parexel, based in Waltham, Mass., contracts with drug makers to test new medicines.
Just weeks later, the previously healthy 31-year-old was in intensive care at London's Northwick Park Hospital — wires running directly into his heart and arteries, on dialysis, his immune system, liver, kidneys and lungs all failing — the victim of a drug trial gone disastrously bad. [more...]
Source: The New York Times
www.nytimes.com
April 8, 2006
F.D.A. PLANS TO INTENSIFY OVERSIGHT OF HEART DEVICES
By Barry Meier
April 7, 2006
The Food and Drug Administration plans to strengthen how it monitors critical heart devices like defibrillators by appointing outside medical experts to help it review the safety of units already on the market, a top agency official says.
The move would be the first time the F.D.A. would have outside experts regularly advising it about the safety of medical devices being sold ...
Both the agency's action and the medical group's report, which will be released in a few weeks, follow a controversy last year over decisions by the Guidant Corporation not to publicize life-threatening defects in some of its defibrillators. The episode also highlighted gaps in the F.D.A.'s oversight of such products, as well as a lack of uniform standards in the industry governing how and when device flaws are disclosed. [more...]
Source: The New York Times
www.nytimes.com
April 7, 2006
FDA APPROVES FIRST ATTENTION DEFICIT PATCH
April 06, 2006
WASHINGTON - The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children.
The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami. ...
The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs.
Source: APA Online
http://www.psycport.com
FDA APPROVES ADHD PATCH
April 6, 2006
The U.S. Food and Drug Administration (FDA) has approved Daytrana (methylphenidate transdermal system), the first and only non-oral medication for the treatment of attention deficit hyperactivity disorder (ADHD).
Daytrana, a once daily transdermal patch formulation of methylphenidate, will be available in 10 mg, 15 mg, 20 mg and 30 mg dosage strengths. Daytrana is licensed globally to Shire by Noven and will be available in pharmacies in the U.S. in mid 2006. [more...]
Source: www.drugs.com
Published April 2006
MERCK SHARES FALL AFTER LOSING VIOXX TRIAL SHARES OF MERCK FALL 4 PERCENT AFTER LOSING NEW JERSEY VIOXX TRIAL
By JOHN CURRAN
The Associated Press
ATLANTIC CITY, N.J. Shares of Merck & Co. fell Thursday after a New Jersey jury found that the drugmaker concealed the dangers of its painkiller Vioxx in a split verdict that gave one of two plaintiffs in the trial $4.5 million in compensatory damages.
Shares of Merck, which is facing many similar lawsuits, fell $1.47, or 4 percent, to $34.52 in early trading on the New York Stock Exchange.
The trial was the first to address long-term use of the drug and some analysts said the Superior Court jury's decision Wednesday could prompt Merck to rethink its policy of battling each lawsuit individually.
Source: ABC News
http://abcnews.go.com/business
April 6, 2006
MERCK FACES PUNITIVE PHASE OF VIOXX TRIAL
April 6, 2006 9:39:40 AM
NEW YORK (Reuters) - The punitive phase of a trial involving the Merck & Co. (MRK.N) painkiller Vioxx was set to start on Thursday after a jury found the drugmaker failed to warn Vioxx users of heart risks and ordered it to pay a 77-year-old plaintiff at least $4.5 million in damages.
Merck shares fell nearly 4 percent to $34.57 in early trade on Thursday, a day after the jury in Atlantic City, New Jersey, found that Vioxx had been a substantial contributing cause of a heart attack suffered by John McDarby. The jury determined the drug was not a significant cause of a heart attack suffered by a second plaintiff, Thomas Cona.
Merck pulled the $2.5 billion-a-year drug off the market in September 2004 after a study showed it doubled the risk of heart attack and stroke among people who used it for at least 18 months.
The drugmaker has been hit with nearly 10,000 Vioxx-related lawsuits.
Source: WallSt.Net
http://www.wallst.net/news
April 6, 2006
ADHD DRUGS AND CARDIOVASCULAR RISK
By Steven E. Nissen, M.D.
April 6, 2006
On February 9, 2006, the Drug Safety and Risk Management Advisory Committee of the Food and Drug Administration (FDA) voted by a narrow margin - eight to seven - to recommend a "black box" warning describing the cardiovascular risks of stimulant drugs used to treat attention deficit-hyperactivity disorder (ADHD). This action was unexpected, largely because the FDA had not requested a review of current labeling [more...]
The New England Journal of Medicine
PerspectiveSource:
U.S.Food & Drug Administration
www.fda.gov
GATIFLOXACIN LINKED TO DANGEROUSLY HIGH AND LOW BLOOD GLUCOSE
Elizabeth Thompson Beckley
April 1, 2006
The risk of developing serious hyperglycemia was almost 17 times greater for elderly patients who took the antibiotic gatifloxacin (Tequin, Bristol-Myers Squibb) than for those who took another antibiotic, according to two Canadian studies published a month ahead of schedule by the New England Journal of Medicine.1
In the same population, those who took gatifloxacin were four times more likely to be hospitalized for hypoglycemia. [more...]
DOC News April 1, 2006
Volume 3 Number 4 p. 8
© 2006 American Diabetes Association
SERIOUS ADVERSE DRUG EFFECTS - SEEING THE TREES THROUGH THE FOREST
By Jerry H. Gurwitz, M.D.
March 30, 2006 edition
The medical community and the public have been buffeted by a steady stream of news linking the use of widely prescribed medications with serious health risks. The latest in this barrage of unsettling reports is an article by Park-Wyllie et al. that appears elsewhere in this issue of the Journal1 regarding the association of the fluoroquinolone gatifloxacin with dysglycemia....
Changes in drug labeling are often direct-mailed or faxed to doctors or other health care providers.5 Unfortunately, several studies have suggested that such mailings do not result in changes in prescribing practice.6 Furthermore, a recent study found that physicians and other health care providers frequently prescribed drugs in violation of warnings of important risks, including those contained in black boxes.7 Although technologic innovations, such as electronic-health-record–based alerts, hold promise for reducing the risk of unsafe prescribing (especially related to drug–drug, drug–laboratory, and drug–disease interactions), such systems are not yet widely available, particularly in the outpatient setting....
Gatifloxacin now takes its place among an ever-growing list of medications that have been associated with very serious adverse effects. The most immediate question is what should be done with gatifloxacin. It seems clear that the drug's place among broad-spectrum antibiotics available for outpatient use is tenuous at best. For every approved indication for gatifloxacin, there are safer, equally effective, and less costly alternatives. In comparison with other recent experiences regarding adverse drug effects, this choice should not be a difficult one for physicians, patients, regulators, and manufacturers.
Source: The New England Journal of MedicineSource:
U.S. Food & Drug Administration
http://www.fdaadvisorycommittee.com
PANEL ADVISES DISCLOSURE OF DRUGS' PSYCHOTIC EFFECTS
By GARDINER HARRIS
March 23, 2006
GAITHERSBURG, Md., March 22 — Stimulants like Ritalin lead a small number of children to suffer hallucinations that usually feature insects, snakes or worms, according to federal drug officials, and a panel of experts said on Wednesday that physicians and parents needed to be warned of the risk.
The panel members said they hoped the warning would prevent physicians from prescribing a second drug to treat the hallucinations caused by the stimulants, which one expert estimated affect 2 to 5 of every 100 children taking them. Instead, they said, the right thing to do in such cases was to stop prescribing the stimulants. [more...]
Posted on The New York Times website
View article here.
HIGH COURT BLOCKS SUIT CLAIMING INVESTMENT FRAUD
March 21, 2006
WASHINGTON (AP) -- The Supreme Court made it harder Tuesday for investors to join forces to file high-stakes fraud lawsuits against companies.
The 8-0 decision blocks state class-action lawsuits by stockholders who contend they were tricked into holding onto declining shares.
Justice John Paul Stevens, writing for the court, said that to rule otherwise would allow ''wasteful, duplicative litigation.''
The decision does not shut the door to lawsuits filed by individual stockholders, but rather to suits brought on behalf of large groups.
''There had been some upswing in these after the Enron and WorldCom scandals,'' said Columbia Law School professor John Coffee, who believes it will be too expensive for individual stock owners to pursue such suits.
It was a major victory for Merrill Lynch & Co., which faced a spate of lawsuits prompted in part by New York Attorney General Eliot Spitzer's 2002 probe into the investment banking firm's practices.
Source: The Associated Press
Posted on The New York Times website
Revisiting Schizophrenia: Are Drugs Always Needed?
March 21, 2006
By BENEDICT CAREY
The only responsible way to manage schizophrenia, most psychiatrists have long insisted, is to treat its symptoms when they first surface with antipsychotic drugs, which help dissolve hallucinations and quiet imaginary voices.
Delaying treatment, some researchers say, may damage the brain.
But a report appearing next month in one of the field's premier journals suggests that when some people first develop psychosis they can function without medication — or with far less than is typically prescribed — as well as they can with the drugs. And the long-term advantage of treating first psychotic episodes with antipsychotics, the report found, was not clear. [more...]
Reviewers Cite Flaws at Guidant
March 21, 2006
By BARRY MEIER
An expert panel commissioned last summer by the Guidant Corporation to review its handling of heart device flaws said yesterday that the company had systematically failed to fully assess patient safety in deciding whether to publicize product failures.
The group found that decisions made by Guidant about how to address or disclose product problems were driven by statistical projections from engineers rather than assessments from doctors about the medical consequences of those failures. The group urged Guidant to create an outside panel of physicians and others who would regularly monitor the safety of its devices and advise the company about when and how to notify doctors and patients about problems. [more...]
New York Times
Read article locally
JAGGED LITTLE PILLS
March 19, 2006
By LAUREN SLATER
Op-Ed Contributor
Somerville, Mass.
Our psychotropics seem to go through fairly predictable 20-year cycles, so eerily consistent that at this point we should be able to pinpoint in precisely what year our newest superstar will fumble. What's odd is that we don't. Rather, each time the negative side effects come into view, we act slapped, surprised, as though this were the strangest thing in the world. [more...]
AFTER 2 MORE DEATHS, PLANNED PARENTHOOD ALTERS METHOD FOR ABORTION PILL
March 17, 2006
By Gardiner Harris
WASHINGTON, March 17 — After receiving reports that two more women died after taking abortion pills, Planned Parenthood, the nation's largest provider of abortion and contraceptive services, announced that it would immediately change the way it gives the medicines.
The change partly resolves a long-running dispute between Planned Parenthood and the Food and Drug Administration over the safest way to provide pill-based abortions.
The F.D.A. has now received reports that six women in the United States died after taking RU-486, or Mifeprex. A seventh died in Canada. The two most recent deaths and two of the previous four underwent their procedures at Planned Parenthood clinics, a spokeswoman said.
Federal officials do not yet know the cause of the latest two deaths. The previous four resulted from systemic infections with a virulent bacteria, Clostridium sordellii. Planned Parenthood announced in a statement that one of the two recent deaths occurred within days of the victim's undergoing a pill-based abortion, while the other woman died within five weeks. [more...]
TWO WOMEN DIE AFTER USING ABORTION PILL
Posted March 17, 2006
By Andrew Bridges
Associated Press. WASHINGTON - Two more women have died after using the abortion pill RU-486, regulators said Friday in a warning that brought renewed calls for pulling the controversial drug from the market.
The organization that provided the pill to the two women said it would immediately stop disregarding the approved instructions for the pill's use.
The Food and Drug Administration warned doctors to watch for a rare but deadly infection previously implicated in four deaths of women who had taken the drug. The drug, also called Mifeprex or mifepristone, has not been proved to be the cause in any of those cases.
Nor has the FDA confirmed the cause of the latest two deaths. However, in one of them, the woman's symptoms appeared to resemble those in the cluster of four cases in California where the women died from an infection of the bloodstream, or sepsis.
The Mercury News
www.mercurynews.com
SURGICAL DEVICE POSES A RARE BUT SERIOUS PERIL
Published: March 17, 2006
By BARNABY J. FEDER
Kristina A. Fox entered a Portland, Ore., hospital in the fall of 1998 hoping a routine, minimally invasive form of surgery called laparoscopy would relieve a painful gynecological condition.
She went home the same day destined to become part of a simmering debate over whether medical device makers and health care providers have been overlooking - some would say ignoring - an easily preventable, but potentially devastating, laparoscopy hazard. [more...]
Source: The New York Times
Read article locally H-E-B PRESS RELEASE
Source:
http://www.fda.gov/oc/po/firmrecalls/heb03_06.html
6 FALL SERIOUSLY ILL DURING DRUG TEST IN LONDON
By THE ASSOCIATED PRESS
March 15, 2006
LONDON, March 15 (AP) - Six men taking part in trials of a new drug to treat autoimmune diseases and leukemia became seriously ill, a hospital official said Wednesday. British regulators immediately suspended the tests.
Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, said two of the men were in critical condition and four were in serious condition but showing signs of improvement. All six fell ill on Tuesday night.
A research organization based in Waltham, Mass., the Parexel International Corporation, which supervised the trial, identified the drug as TGN1412, a monoclonal antibody developed by TeGenero AG., of Würzburg, Germany.
"The drug, which is untested and therefore unused by doctors, has caused an inflammatory response, which affects some organs of the body," Dr. Suntharalingam said.
The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six were the only people given the drug in a small trial. Two other patients received placebos.
"Our immediate priority has been to ensure that no further patients are harmed," said Kent Woods, the agency's chief executive. "We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken."
The names of the six men were not released. But one woman said her boyfriend, a 28 year old London bar manager, was among them.
"They just keep saying, 'He's very, very sick and we are doing all we can,' " Myfanwy Marshall told the BBC. "They are saying he could be lying there in six months. He needs a miracle - those were their words."
Ms. Marshall said her boyfriend had decided to take part in the trial for the cash, about $3,500, to pay bills.
Dr. Herman Scholtz, chief of Parexel International Clinical Pharmacology, said such adverse drug reactions were extremely rare.
TeGenero's chief executive, Dr. Benedikte Hatz, said, "These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies, which enabled us to progress investigations into human volunteers."
Dr. Thomas Hanke, Parexel's chief scientific officer, said the company had "adhered to standard clinical research guidelines." He said TGN1412 had not caused any problems in previous tests and called for a speedy investigation.
CONGRESS, CONTROLLED SUBSTANCES, AND PHYSICIAN-ASSISTED SUICIDE - ELEPHANTS IN MOUSEHOLES
March 9, 2006
by George J. Annas, J.D., M.P.H.
The U.S. Supreme Court's decision in Gonzales v. Oregon to reject the U.S. attorney general's authority to prohibit physicians in Oregon from prescribing Schedule II drugs for their terminally ill patients to commit suicide can seem paradoxical and confusing.1 How is it that California cannot permit the patients of physicians who recommend marijuana, a Schedule I drug, to possess legally and use marijuana that they may need to survive, but Oregon can legally permit physicians to prescribe Schedule II drugs and patients to possess and use such drugs to end their lives? [more...]
The New England Journal of Medicine
Volume 354:1079-1084, Number 10Source:
http://www.fda.gov/cder/drug/infopage/gatifloxacin/default.htm
GUIDANT MDL JUDGE SETS COURSE FOR 2007 BELLWETHER CASE TRIALS
March 6, 2006
In re Guidant Corp. Implantable Defibrillators Prods. Liab. Litig.
The judge overseeing the multidistrict litigation over allegedly defective Guidant Corp. defibrillators says he wants to hold trials in representative or "bellwether" cases beginning in March 2007 and has asked opposing counsel to help select cases best suited for advanced consideration.
The announcement of target trial dates for leading suits over certain Guidant implantable defibrillators came in one of two new pretrial orders by U.S. District Judge Donovan W. Frank of Minneapolis. In the other, he revealed the creation of a "common benefit" fund to reimburse plaintiffs' counsel for their individual efforts in the interests of plaintiffs in each of the MDL member cases.
Last June Guidant issued a global recall of certain Ventak defibrillator models, citing reports of four dozen malfunctions that may have been linked to two deaths.
The judge said that, based on case recommendations from plaintiffs' attorneys and counsel for Guidant, he would select a case or a group of cases that may be ripe for consolidation. He said about five prospective cases will be chosen based on their ability to "illustrate and inform the parties and the court of important issues in the litigation."
Judge Frank noted that once he makes the selections, the defendant should file dispositive motions by Dec. 1, with the plaintiffs' counsel responding by Jan. 1, 2007. The defense will have until Jan. 15, 2007, to reply, in advance of a March 15, 2007, trial date.
The judge pledged that both parties would have equal chance to suggest steps that will result in a fair selection of representative trials.
"Whether the best interests of individual plaintiffs and the defendants and this litigation in general will be found in locating a test case that will consolidate a number of individual cases to be tried together, or whether the court tries three to five cases that are of value to this litigation, is a decision that can be made consistent with the schedule set forth in this order," Judge Frank wrote.
He said the common benefit fund would be under the stewardship of plaintiffs' liaison counsel Charles S. Zimmerman and created through the levy of a 4 percent assessment on the "gross monetary recovery" from suits over any Guidant pacemaker or defibrillator now part of, or later transferred to, the MDL.
The judge specified that half each assessment would be taken from the attorneys' fee portion of any settlement and the other half from the "client portion of individual fee contracts." He said attorneys performing work inuring to the benefit of all Guidant MDL plaintiffs would be free to submit requests for recovery of time and other expenditures, provided that they were not incurred on any "client-specific" endeavor.
Andrews Medical Devices Litigation Reporter
FOR IMMEDIATE RELEASE -- St. Marys, OH -- March 6, 2006 -- Classic Delight, Inc. of St. Marys, Ohio is recalling "Egg Salad on Vienna Bread, Pilot good to go" sandwiches because the product has the potential to be contaminated with Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headaches, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women. No illnesses resulting from the consumption of this product have been reported to date. [more...]The Food and Drug Administration today approved Emsam (selegiline), the first skin (transdermal) patch for use in treating major depression. The once a day patch works by delivering selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. [more...]
PUBLIC CITIZEN PETITIONS FDA TO BAN DARVON PRODUCTS
PRESCRIPTION PAINKILLER CAUSES MANY FATALITIES; PETITION FILED TODAY WITH FDA
February 28, 2006
WASHINGTON, D.C. – Public Citizen today petitioned the U.S. Food and Drug Administration (FDA) to immediately begin to phase out the widely prescribed pain reliever propoxyphene (Darvon, Darvocet and generic versions) from the market because the drug has been associated with more than 2,000 accidental deaths, is physically addictive and is no more effective than safer alternatives. [more...]
Public CitizenThe U.S. Food and Drug Administration (FDA) today unveiled a major revision to the format of prescription drug information, commonly called the package insert, to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources. [more...]Posted on FDA Advisory Committee website
http://www.fdaadvisorycommittee.com
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