Dangerous Drugs & Defective Medical Devices In The News
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Bextra News Stories
FDA Statement on Celebrex, Bextra
Food and Drug Administration cites health risks in asking Pfizer to withdraw
arthritis painkiller.
CNN Money - April 7, 2005
NEW YORK (CNN/Money) - The Food and Drug Administration asked Pfizer and other
manufacturers to revise their labels to include boxed warnings of potential
cardiovascular risks and gastrointestinal bleeding from certain arthritis drugs.
The FDA also asked Pfizer to withdraw Bextra from the market.
Read
more.
Another drug for pain off market
By Rita Rubin, USA TODAY
The Food and Drug Administration announced Thursday that Pfizer (PFE) has agreed
to stop selling Bextra, a popular arthritis drug, because its risks outweigh
its benefits.
The FDA also will now require a "black box" warning — the strongest warning
— on the labels of Pfizer's blockbuster arthritis drug, Celebrex, and other,
older prescription anti-inflammatory pain relievers such as ibuprofen and naproxen.
The warning will highlight the drugs' risks of heart attacks, strokes and bleeding
of the digestive tract.
Read
more.
Bextra Pulled From Market
By E.J. Mundell, HealthDay Reporter
THURSDAY, April 7 (HealthDay News) -- The painkiller Bextra was pulled from
U.S. and European markets Thursday following sweeping new U.S. Food and Drug
Administration actions that mandate black-box warnings on all similar prescription
drugs and labeling changes for similar over-the-counter drugs.
Read
more.
Defibrillator Recall News
Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators
UPDATE: December 29, 2005, FDA MEDWATCH
FDA issued an update to the July and October, 2005, Preliminary Public Health Notification. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.
Read the full report.
Guidant Predicted Heart Device Failures, Report Says
December 25, 2005
(Dec. 25) - Officials at Guidant Corp. projected that as many as 15 of every
10,000 of its Prizm 2 DR implantable heart defibrillator might fail per year,
leading to death in some cases, but did not tell doctors or regulators about
the problems, according to documents filed in a Texas state court.
Read
more.
Guidant Recalls 170,000 Pacemakers
By Peggy Peck, Senior Editor, MedPage Today, September 23, 2005
INDIANAPOLIS, Sept. 23-Guidant said it is recalling 170,000 of its Insignia
and Nexus pacemakers. It was Guidant's fifth recall of pacemakers or implantable
cardioverter-defibrillators (ICDs) since June.
In a statement issued Thursday, the company urged patients with Insignia or
Nexus pacemakers to consult with their doctors. The company did not suggest
across-the-board explants of the devices.
Read
more.
Guidant Recalls Thousands of Pacemakers
By ASHLEY M. HEHER, The Associated Press
Thursday, September 22, 2005
INDIANAPOLIS -- Guidant Corp. issued recalls or safety advisories for almost
170,000 of its top-selling pacemakers on Thursday following a two-week federal
inspection of its cardiac unit.
Since June, Indianapolis-based Guidant has recalled or issued warnings about
88,000 heart defibrillators _ including its leading seller, the Contak Renewal
3 _ and almost 200,000 pacemakers because of reported malfunctions. Pacemakers
use mild electrical current to speed a slow heartbeat; defibrillators use a
bigger jolt to correct life-threatening irregular heartbeats. Surgery to remove
and replace the devices is risky.
Read more.
Guidant Warns on Two Pacemaker Lines
September 22, 2005
INDIANAPOLIS - Guidant Corp. said Thursday it recalled some of its Insignia
and Nexus implantable pacemakers because of failures, including nine cases requiring
emergency hospitalization.
Since June, Guidant has June recalled 88,000 heart defibrillators - including
its leading seller, the Contak Renewal 3 - and issued warnings about 28,000
pacemakers because of malfunctions. Analysts said those actions applied to about
20 percent of the company's products.
In its latest warning, the company said the failures had happened at low rates
with the two families of pacemakers, but that the U.S. Food and Drug Administration
had labeled as a recall its notice that some of the devices might permanently
lose pacing output without warning. A pacemaker sends electrical pulses to the
heart to correct a slow heartbeat.
Other reported failures include loss of telemetry and appearance of a reset
warning message.
No deaths have occured because of the malfunctions, Guidant said.
The company said that as of Sept. 6, it had confirmed loss of pacing output
in 36 of 49,500 Insignia and Nexus pacemakers, including seven that were detected
by doctors before being implanted. No such failures had been found in devices
shipped since March 2004, after a supplier made changes in the manufacture of
a timing component, Guidant said.
The Indianapolis-based manufacturer of cardiovascular therapeutic devices reported
telemetry failures in 16 of 341,000 of the pacemakers, as well.
Guidant Corporation Knowingly Endangered Patients' Lives
Deaths resulting from Guidant's delayed recalls are yet another reason we need
the civil justice system as the last line of defense when corporate CEOs put
profits ahead of safety.
Malfunctioning heart devices mean the difference between life and death for
patients, yet Guidant executives only acknowledged defects with multiple heart
devices when the New York Times was to publicly reveal the defects in an article
the next day, according to the New England Journal of Medicine.
Read
more.
FDA: Defibrillator defects on the rise
Friday, September 16, 2005
WASHINGTON (AP) -- Malfunctions in implanted heart defibrillators were on the
rise even before this summer's massive recall by Guidant Corp., government and
Harvard University scientists reported Friday.
About 20 of every 1,000 defibrillators implanted are malfunctioning, and defects
led to 31 deaths between 1990 and 2002, concluded research sponsored by the
Food and Drug Administration. The deaths represent only a fraction of the more
than 400,000 defibrillators implanted during those years, but a troubling number
nonetheless as regulators grapple with how to better ensure the safety of hard-to-replace
devices.
Read
more.
F.D.A. Had Report of Short Circuit in Heart Devices
By BARRY MEIER, NY Times September 12, 2005
Months before the Food and Drug Administration issued a safety alert in June
about problems with Guidant Corporation heart devices, the agency received a
report from the company showing that some of those units were short-circuiting,
agency records obtained by The New York Times show.
But the agency did not make that data public at the time because it treats
the information it receives in such reports as confidential. While the agency
has a policy of reviewing the reports within 90 days, it is unclear when regulators
did so within that time frame or how they first interpreted the information.
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more.
Joshua Oukrop Died While Guidant Executives Dragged Their Feet
Joshua Oukrop, of Minnesota, was an active college student, studying to be
a teacher. He loved to be active outdoors: hiking, snowboarding and bicycling.
In 2001, at age 17 Joshua had been diagnosed with a severe case of the genetic
heart disease, hypertrophic cardiomyopathy, which can lead to abrupt cardiac
arrest. He had been falling down or fainting at sports practice and during marching
band, so his father took him to a heart specialist because Joshua's older brother
had been previously diagnosed with the heart disease. The doctors implanted
an internal defibrillator, the Ventak Prizm 2 DR made by Guidant Corporation,
that was designed to shock his heart if he went into cardiac arrest.
Read
more.
FDA Says Defibrillator Defects on the Rise
By LAURAN NEERGAARD, The Associated Press
WASHINGTON Sep 16, 2005 — Malfunctions in implanted
heart defibrillators were on the rise even before this summer's massive recall
by Guidant Corp., government and Harvard University scientists reported Friday.
About 20 of every 1,000 defibrillators implanted are malfunctioning, and defects
led to 31 deaths between 1990 and 2002, concluded research sponsored by the
Food and Drug Administration. The deaths represent only a fraction of the more
than 400,000 defibrillators implanted during those years, but a troubling number
nonetheless as regulators grapple with how to better ensure the safety of hard-to-replace
devices.
Read
more.
Guidant Implantable Defibrillator Recall
Due to in ability to deliver an electrical shock during episodes of arrhythmia
FDA and Guidant Corporation notified health care providers and patients of
the recall of certain implantable defibrillators and cardiac resynchronization
therapy defibrillators. These devices, surgically implanted in persons who have
a type of heart disease that creates the risk of a life-threatening heart arrhythmia
(abnormal rhythm), can develop an internal short circuit without warning, resulting
in the devices' inability to deliver an electrical shock during episodes of
arrhythmia -- which could lead to a serious, life-threatening event. There have
been two deaths reported to FDA suspected to be associated with this malfunction.
The devices affected by this notification are:
- PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
- CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
- CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
Read
the complete MedWatch 2005 Safety summary, including the link to the FDA Press
Statement.
FDA Updates Consumers on Guidant Corporation's Implantable Defibrillators
FDA News - July 1, 2005
As the Food and Drug Administration (FDA) continues to evaluate the safety
and performance of certain implantable defibrillators manufactured by Guidant
Corporation, the Agency has now classified the recalled devices. This additional
information on the relative health risks of the devices will help patients and
doctors take appropriate action, if necessary.
Classifications can fall into three categories, with Class I being the most
serious. These numerical classifications are based on the probability that the
device failure could lead to adverse health effects.
"Malfunctions in these devices can lead to serious consequences and it's
important for patients to call their doctor for additional information and personalized
advice," said Daniel Schultz, MD, Director of FDA's Center for Devices
and Radiological Health. "However, it's also important to understand that
in most cases these defibrillators work well and save lives."
Read
the complete story.
Zyprexa in the News
LILLY ZYPREXA WARNING/CONFUSION
Daily Schizophrenia News Blog - February 25, 2005
This week Eli Lilly warned doctors about Zyprexa, Zyrtec confusion. Eli Lilly
and Co. announced this week that it has changed the labeling on its antipsychotic
Zyrexa to avoid confusion with Pfizer Inc.'s allergy medicine Zyrtec after some
patients were given the wrong drug.
Read
the full story.
ZYPREXA MAKER ISSUES WARNING FOR ELDERLY
Reuters - February 20, 2004
Eli Lilly and Co. on Friday said it has warned doctors that its schizophrenia
treatment Zyprexa, its best-selling drug, significantly raises the risk of death
and stroke in elderly patients suffering from dementia.
Read the full story.
RESEARCHERS WARN ANTIPSYCHOTIC DRUG MIGHT BE LINKED TO DIABETES
HealthNewsDigest.com - July 1, 2002
Research from Duke University Medical Center suggests there might be a link
between at least one drug used to treat schizophrenia and the onset of diabetes,
a disease widely recognized as one of the leading causes of death and disability
in the U.S.
The drug, olanzapine (trade name Zyprexa), belongs to a relatively new family
of medications called atypical antipsychotics, which are used to treat schizophrenia,
paranoia and manic-depressive disorders. Other drugs in this class include clozapine,
risperidone, quetiapine and ziprasidone.
The researchers found metabolic abnormalities ranging from mild blood sugar
problems to diabetic ketoacidosis and coma in patients who had been prescribed
olanzapine, most of whom were otherwise not known to be diabetic.
Read
the full story.
DOCTORS ISSUE WARNING ON ANTI-PSYCHOTIC DRUGS
MSNBC News Health - The Associated Press - January 27, 2004
People taking certain drugs for schizophrenia, manic-depression, autism, dementia
or several other psychiatric disorders should be carefully watched for signs
they are developing diabetes, obesity or high cholesterol, four medical societies
say.
Read the full story.
ZYPREXA LAWSUITS
Zyprexa-lawsuits.com
Eli Lilly's antipsychotic drug Zyprexa is one of the most frequently prescribed
drugs for schizophrenia, and represents forty percent of the company's domestic
sales. It may also represent a serious health risk for those prescribed the
drug. As the Wall Street Journal reported in April 2003, an eight0year study
of Zyprexa, part of a class known as "atypical," revealed that as of 2002, 288
Zyprexa patients had developed diabetes. Of those nearly three hundred people,
sevety-five became severly ill, and twenty-three died.
Read
the full story.
LAWSUIT LAUNCHED OVER ANITPSYCHOTIC DRUG
Edmonton Sun - March 8, 2005
Two Albertans who took the antipsychotic drug Zyprexa and then developed diabetes
have launched a lawsuit…
Read
the full story.
DISCOVERY LIMITED IN ZYPREXA CASE
Indianapolis Star - December 7, 2004
A federal judge has told Eli Lilly and Co. to be ready for trial within a year
to defend its star drug Zyprexa against charges in federal court that the drug
causes diabetes and related problems.
Read
the full story.
Able Laboratories in the News
FDA ADVISES CONSUMERS ABOUT RECALLED DRUGS FROM ABLE LABORATORIES
FDA News - May 27, 2005
The Food and Drug Administration (FDA) is taking action to ensure that the
public is fully aware that Able Laboratories of Cranbury, NJ, is conducting
a nationwide recall of all of its manufactured drugs (mostly generic prescription
drugs, including drugs containing acetaminophen) because of serious concerns
that they were not produced according to quality assurance standards. Able Laboratories
has ceased all current production.
Read
the full story.
Paxil in the News
2005 Safety Alerts for Drugs, Biologics, Medical Devices, and Dietary Supplements
Paxil (paroxetine HCL)
Paxil CR Controlled-Release Tablets
The FDA has determined that exposure to paroxetine in the first trimester of
pregnancy may increase the risk for congenital malformations, particularly cardiac
malformations. At the FDA's request, the manufacturer has changed paroxetine's
pregnancy category from C to D and added new data and recommendations to the
WARNINGS section of paroxetine's prescribing information. FDA is awaiting the
final results of the recent studies and accruing additional data related to
the use of paroxetine in pregnancy in order to better characterize the risk
for congenital malformations associated with paroxetine.
Physicians who are caring for women receiving paroxetine should alert them
to the potential risk to the fetus if they plan to become pregnant or are currently
in their first trimester of pregnancy. Discontinuing paroxetine therapy should
be considered for these patients. Women who are pregnant, or planning a pregnancy,
and currently taking paroxetine should consult with their physician about whether
to continue taking it. Women should not stop the drug without discussing the
best way to do that with their physician.
Read
the complete MedWatch 2005 Safety Summary.
If you or a loved one has suffered as the result of a dangerous
drug or medical device, please contact a pharmaceutical litigation lawyer at
Bisnar & Chase to discuss your case.
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