SON SENELERDE YASAKLANAN,
PİYASADAN ÇEKİLEN VEYA BEKLENEN
ETKİYİ GÖSTERMEYEN İLAÇLARA
ÇRNEKLER
Mixed results with Eli Lilly Alzheimer's drug
solanezumab, but investors pleased
US pharma major Eli Lilly (NYSE: LLY) yesterday reported
detailed results from two Phase III studies for
solanezumab, EXPEDITION1 and ...
FDA Rejects New Cystic Fibrosis Drug
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: April 18, 2011
WASHINGTON -- The FDA has turned down Eli Lilly's new drug
application for liprotamase (Sollpura), a pancreatic enzyme
product for cystic fibrosis and other diseases that cause pancreatic
insufficiency, according to a press release from the company.
FDA Turns Down Merck Birth Control Pill,
Glaucoma Drug
Two products Merck had submitted to the FDA for marketing
approval have been turned away with complete response letters,
the company said.
One was an oral contraceptive combining 2.5 mg of nomegestrol
acetate and 1.5 mg of 17-beta-estradiol, which is currently
marketed in Europe under the name Zoely, Merck explained in a
10Q report filed with the Securities and Exchange Commission.
The other was tafluprost, a prostaglandin analogue intended to
treat glaucoma.
FDA Rejects Another Weight-Loss Drug
WASHINGTON -- The FDA has declined to approve the
investigational weight-loss pill phentermine/topiramate (Qnexa),
marking the second time in a week the agency has rejected a diet
drug.
Pain Patch Rejected for HIV Neuropathy
SILVER SPRING, Md. -- By a vote of 12-0, an FDA advisory panel
said a capsaicin skin patch did not relieve neuropathic pain from
HIV.
FDA Rejects Dapagliflozin for Type 2 Diabetes
WASHINGTON -- The FDA said it would not approve the novel
diabetes drug dapagliflozin until drugmakers Bristol-Myers Squibb
and AstraZeneca supply more data on the drug's benefits and
risks.
FDA Panel Narrowly Rejects Xarelto for ACS
WASHINGTON -- An FDA advisory committee has voted 6-4, with
one abstention, against expanding the marketing indications for
the factor Xa inhibitor rivaroxaban (Xarelto) to include treatment of
acute coronary syndrome (ACS).
FDA Rejects Bone Drug Bid for Metastasis
Prevention
WASHINGTON -- The FDA has turned down an application to
expand indications for denosumab (Xgeva) to include prevention of
bone metastases in men with castration-resistant prostate cancer.
FDA Rejects Merck Sarcoma Drug
WASHINGTON -- The FDA has rejected the approval application
for the sarcoma drug ridaforolimus, according to the drug
developer.
FDA Panel Rejects Lixivaptan for CHF
WASHINGTON -- An FDA advisory panel voted unanimously
Thursday against recommending approval of lixivaptan (Lixar) for
treatment of hyponatremia in congestive heart failure and 3-5
against its use in syndrome of inappropriate antidiuretic hormone
secretion (SIADH).
FDA Panel Nixes Hemispherx CFS Drug
SILVER SPRING, Md. -- An FDA advisory panel voted 8-5 against
recommending approval for the drug rintatolimod (Ampligen) for
use in chronic fatigue syndrome (CFS), citing questionable clinical
trial results that were based on a small number of patients.
FDA Panel Turns Thumbs Down on Vibativ
WASHINGTON -- An FDA panel voted 9-6 on Thursday against
recommending approval of a new indication for hospital-acquired
pneumonia for the skin infection drug telavancin (Vibativ).
FDA Panel Wary on Making Bladder Control Drug
OTC
WASHINGTON -- An FDA advisory panel on Friday voted against
recommending making oxybutynin transdermal patch (Oxytrol)
available over-the-counter (OTC) for overactive bladder (OAB) in
women, citing a bevy of concerns about using the product without
a doctor's oversight.
FDA Staff Flag Renal Risk of Diabetes Drug
The novel type 2 diabetes drug canagliflozin (Invokana) is effective
at lowering blood glucose, but FDA reviewers have raised
concerns about renal and fracture risks.
Another Alzheimer's drug hits the dust as Bristol-Myers
drops avagacestat development
In yet another research disappointment, US drug major
Bristol-Myers Squibb (NYSE: BMY) recently assessed
data on avagacestat from a completed ...
Pfizer's Inlyta misses primary endpoint in Ph III kidney
cancer trial
US drugs behemoth Pfizer (NYSE: PFE) revealed
yesterday that a Phase III study of Inlyta axitinib) did not
meet its ...
Pfizer and Janssen's bapineuzumab fails to meet one Ph
III study endpoints for Alzheimer's
US drugs behemoth Pfizer (NYSE: PFE) revealed
yesterday that the co-primary clinical endpoints, change
in cognitive and functional performance compared ...
J&J and Pfizer drop bapineuzumab development for
Alzheimer's
There was disappointing - though not really unexpected news yesterday for US health care giant Johnson &
Johnson (NYSE: ...
UK's NICE says Roche's Avastin not cost effective for
advanced ovarian cancer
The UK drugs watchdog the National Institute for Health
and Clinical Excellence (NICE) has published draft
guidance (18 December 18) on the ...
Pfizer's Lyrica misses primary endpoint in seizure
frequency trial; positive in fibromyalgia
US pharma behemoth Pfizer (NYSE: PFE) revealed
disappointing top-line results of a double-blind, placebocontrolled, Phase III study evaluating both the 165 ...
Amgen's Aranesp Misses Primary Endpoint in Phase III
Trial
Amgen said yesterday that a Phase III trial of Aranesp did not meet its
primary endpoint of reducing the composite endpoint of time to death
from any cause or first hospital admission for worsening heart failure.
The trial began in 2006, and had enrolled 2,278 patients. There were
not any new safety findings identified in the study.
Neuraltus Pharma eyes PhIII after missing endpoints
in trial for ALS drug
Despite falling short of goals in a Phase II trial, Neuraltus
Pharmaceuticals saw enough evidence of efficacy in Lou Gehrig's
disease patients on its experimental drug to push forward plans for a
late-state study. Its decision to start the Phase III program next year
underscores the critical need for new therapies against the muscledisabling disorder.
Niacin/laropiprant products to be suspended worldwide
London, UK - The European Medicines Agency (EMA) has
recommended that the marketing, supply, and authorizations of three
identical niacin/laropiprant products—Tredaptive, Pelzont, and
Trevaclyn—for the treatment of adults with dyslipidemia be suspended
across the European Union [1]. In addition, the company that markets
the combination, Merck, has begun working with regulatory agencies in
all countries where the medicine is currently available to develop
communications for healthcare providers and to suspend the availability
of the product, with the timing to be based on individual country
regulations and processes.
Merck Warns Doctors to Stop Prescribing Tredaptive
Merck & Co. says it is suspending its sale of the cholesterol drug
Tredaptive and is telling doctors to quit prescribing the medicine.
Tredaptive is available in about 70 countries, including Europe. The
drug is not approved in the United States. Merck last month said initial
results from a late-stage study showed that adding Tredaptive to
traditional statin therapy did not lower the risk of heart attack, stroke and
related problems.
Daiichi, ArQule Cancer Drug Misses Endpoints
Japan’s Daiichi Sankyo Company and Massachusetts-based ArQule
today said Phase II colorectal cancer drug tivantinib (ARQ 197) used in
combination with irinotecan and cetuximab did not meet its primary
endpoint of Progression-Free Survival. The trial also failed the
secondary endpoint of showing improved response to the drug.
Phase II Ovarian Cancer Drug Fails to Meet Endpoint
Eisai subsidiary Morphotek said yesterday its Phase III study of ovarian
cancer drug farletuzumab (MORAb-003) in combination with carboplatin
and a taxane did not meet the study's primary endpoint of progressionfree survival. The company said it is, however, “committed to research
to understand the potential role of farletuzumab in ovarian and other
types of cancer."
Cholesterol Drug Pulled From Market
Drug maker Bayer pulled its popular cholesterol-lowering
medication off the market today amid reports of a deadly side
effect.
According to the Food and Drug Administration., Bayer
Pharmaceuticals voluntarily withdrew Baycol, known
generically as cerivastatin, as a result of the 31 patients deaths
associated with the drug over the last four years.
Sepsis Drug Xigris Pulled From
Worldwide Market
October 25, 2011 — Eli Lilly is withdrawing activated drotrecogin
alfa (Xigris), a drug intended to treat severe sepsis in high-risk
patients, from all markets including the United States in the wake
of a new study showing that the agent did no better than a placebo
in reducing mortality.
F.D.A. Orders Prescription Cold Drugs
Pulled From Market
The Food and Drug Administration on Wednesday ordered that
about 500 prescription drugs used to treat colds, coughs and
allergies be removed from the market, saying that the medicines
had never gone through a federal review of their safety and
effectiveness.
Novartis agrees to pull Valturna® from
market and adds warning labels on drugs
containing aliskiren
DALLAS – April 20, 2012 ― Novartis has announced it will pull its
combination product Valturna® (which contains aliskiren and valsartan) from
U.S. markets. Aliskiren (Tekturna®), one of the components of Valturna, will
remain on the market for appropriate high blood pressure patients after the
conclusion of a Federal Drug Administration (FDA) assessment of the drug.
Only 3.8% of Big Pharma Research
Targets Diseases Affecting Poor
Aspirin Use Linked to Macular
Degeneration
Published: January 21, 2013
Reviewed by Zalman S. Agus, MD; Emeritus Professor, Perelman School of
Medicine at the University of Pennsylvania and Dorothy Caputo,
•
In this study, regular aspirin use was associated with increased
risk of incident neovascular age-related macular degeneration,
independent of a history of cardiovascular disease and smoking.
•
Note that the nonrandomized design of the study does not allow
for determination of causality due to the potential for residual
confounding.
10 Prescription Drugs Pulled From the
Shelves and Why
Prescription drugs have done wonders for the field of medicine. They’ve
healed suffering patients and relieved chronic pain, in addition to causing
serious health risks and side effects that inevitably caused them to be pulled
from the market. Many of the so-called “miracle drugs” of our lifetime proved
to be more dangerous than the original condition itself. Here are 10
prescription drugs pulled from the shelves and why:
• Vioxx
In 1999, Vioxx was the most heavily marketed pharmaceutical in the
world. A potent arthritis pain killer, Vioxx, promised to improve the lives
of millions of aging baby boomers suffering from the terrible pain of
arthritis and an aggressive marketing campaign made Vioxx an
overnight sensation. However, this success soon turned into a
nightmare for manufacturer Merck when reports of increased risk of
heart attack and stroke began to pour in. The drug was retired in 2004,
and has since been linked to over 27,000 deaths.
• Thalidomide
Thalidomide was a popular morning sickness medication
prescribed worldwide under several different brand names throughout
the 1960s and 1950s. The FDA, however, refused to approve the drug
due to possible safety concerns. The drug was soon linked to
catastrophic birth defects around the world. This regulatory success by
the FDA was instrumental in shaping the drug approval process in the
United States. The rest of the world, including 13 highly developed
nations, was not so lucky.
• Rezulin
From its inception, Rezulin, intended to treat diabetes, was
clouded by controversy. A leading FDA physician, Dr. John Gueriguian,
cautioned that Rezulin could be dangerous and urged the FDA not to
approve the drug. The FDA responded to his warnings by firing him
and discarding his report. Soon after its approval, Rezulin was linked to
sudden liver failure and over 390 deaths.
• Duract
The FDA had a plan for Duract, a pain killer that had already been
shown to have potentially fatal side effects if taken longer than
prescribed. The plan was simple: add a warning label that urged
patients to take Duract only as prescribed. The problem was that
patients did not follow this warning. After 68 deaths were linked to
Duract it was pulled from the shelves.
• Redux
In the 1980s, Redux, commonly known as “Fen-Phen,” was a
revolutionary diet treatment that helped users drop pounds and keep
them off. The drug would later be linked to over 100 deaths due to
heart valve disease brought on by continued use. The drug was
removed by Wyeth Pharmaceuticals in 1997, but not before extensive
litigation cost the company billions of dollars in settlements and
damages.
• Zelnorm
This treatment for irritable bowel syndrome was perhaps best
known for its strange marketing campaign showing women with
symptoms of irritable bowel syndrome written on their stomachs. The
drug was widely prescribed and eventually approved for men before it
was linked to increased risk of heart attack and stroke and pulled from
the shelves.
• Seldane
In 1985, Seldane was introduced as the first non-drowsy
antihistamine. However, not long after its initial release, Seldane was
shown to be highly cross reactive with other prescription drugs, over
the counter medications and even foods such as grapefruit juice.
Seldane was retired as other less reactive drugs entered the market,
but the problems associated with its cross reactivity led the FDA to
mandate extensive initial testing of chemical interactions before a drug
could win approval.
• Propulsid
Propulsid was a successful heartburn medication used in the
treatment of severe gastric reflux. In 2000, however, it was linked to
severe heart rhythm abnormalities and over 80 deaths. It was pulled
from the market shortly thereafter.
• Posicor
Posicor’s approval as a treatment for cardiovascular disorders
came with a list of three other medications that could cause deadly
drug interactions if taken simultaneously. Needless to say, this list grew
immediately, and Posicor’s benefits were soon outweighed by its list of
over 25 potentially fatal drug interactions. It was replaced by safer
alternatives and voluntarily removed from the market in 1998.
• Reglan
Reglan is widely prescribed acid reflux treatment that only recently
has been linked to a terrible disorder called tardive dyskenisia, which
can lead to uncontrolled movement and permanent disfigurement. The
FDA has applied its “black box” warning to Reglan, and numerous
lawsuits have been filed in connection with Reglan’s devastating side
effects.
Update on Withdrawals of Dangerous Drugs
in the U.S.
Worst Pills, Best Pills Newsletter Article, January 2011
In October 2010, the FDA finally banned the diet drug sibutramine (MERIDIA) because of
safety reasons, including increased heart attacks and strokes.
As a result of this action, we are updating our list of drugs approved after 1992 that were
eventually removed from the market for safety reasons. The FDA has now withdrawn 20
drugs, all of which were approved in 1993 or later. (Three of these drugs were withdrawn
and later allowed back on the market with much more restricted use.)
We chose 1993 as a starting point because Congress first enacted the Prescription Drug
User Fee Act (PDUFA) the previous year and its effects had clearly begun to be seen by
the beginning of 1993. This law changed the drug-regulation landscape in the U.S. by
requiring the FDA to collect fees from pharmaceutical manufacturers to review their new
drug applications. Thus the drug industry, rather than the American public, became an
important customer of the FDA. We have long been concerned that the enactment of this
law — and the drug industry pressure accompanying this funding — has lowered safety
standards for approval and has kept demonstrably dangerous drugs on the market for far
too long.
Table 1 lists 11 of the drugs that we warned Worst Pills, Best Pills News subscribers not
to use before the drugs were banned. Our readers were warned an average of 3.3 years
before the drugs came off the market.
We warned readers of the dangers of the NSAID bromfenac (DURACT) 203 days before it
was banned. This NSAID was on the market for less than a year (342 days).
Table 2 lists the generic and brand names of all 20 of the withdrawn drugs, as well as the
dates the drugs were approved and removed from the market. The last column shows
the number of years each drug was on the market before it was withdrawn — an average
of 4.1 years for the 20 drugs.
Of the 20 drugs, two were antibiotics: grepafloxacin (RAXAR) and gatifloxacin (TEQUIN);
three were nonsteroidal anti-inflammatory drugs (NSAIDS): bromfenac (DURACT),
rofecoxib (VIOXX) and valdecoxib (BEXTRA); two drugs were for weight loss: sibutramine
and dexfenfluramine (REDUX); and one was for type-2 diabetes: troglitazone (REZULIN).
Another diabetes drug, rosiglitazone (AVANDIA) recently has had some restrictions on its
use but unlike in Europe, where it was completely banned, it is still being used in the U.S.
What You Can Do
You should keep reading Worst Pills, Best Pills News or WorstPills.org. They are your
independent second opinion for drug safety.
Also, you should remember the Seven-Year Rule. You should not use a new drug until at
least seven years after it is approved, unless it is one of those exceedingly rare drugs
that offers a documented benefit over existing therapeutic options.
Consumers may report serious adverse events with drugs to the FDA’s MedWatch
Adverse Event Reporting program either online or by regular
Table 1. Time between Worst Pills, Best Pills News Warning and Market
Withdrawal
Generic Name
(BRAND NAME)
Worst Pills, Best
Pills News Readers
Warned
Date
Withdrawn in
U.S.
Years between
Withdrawal and
Worst Pills
Warning
sibutramine
(MERIDIA)
4/1/1998
10/8/2010
12.5 years
tegaserod
(ZELNORM)
6/1/2004
3/30/2007
2.8 years
gatifloxacin
(TEQUIN)
7/1/2002
5/1/2006
3.8 years
valdecoxib
(BEXTRA)
12/1/2002
4/7/2005
2.4 years
rofecoxib (VIOXX)
4/1/2001
9/29/2004
3.5 years
cerivastatin
(BAYCOL)
3/1/1998
8/8/2001
3.4 years
cisapride
(PROPULSID)
8/1/1998
3/24/2000
1.7 years
troglitazone
(REZULIN)
1/1/1998
3/21/2000
2.2 years
grepafloxacin
(RAXAR)
4/1/1998
8/11/1999
1.4 years
bromfenac
(DURACT)
12/1/1997
6/22/1998
0.6 years
dexfenfluramine
(REDUX)
7/1/1996
9/15/1997
1.2 years
Table 2. Twenty Drugs Approved After 1992 and Later Withdrawn From the
Market for Safety Reasons (Starting With the Most Recently Withdrawn:
Sibutramine)
No
Generic Name (BRAND
NAME)
Date of U.S.
approval
Date of U.S.
withdrawal
Time on
the
Market
20
sibutramine (MERIDIA)
11/22/1997
10/8/2010
12.9
years
19
efalizumab (RAPTIVA)
10/28/2003
4/8/2009
5.5 years
18
trasylol (APROTININ)
12/29/1993
11/5/2007
3.9 years
17
tegaserod (ZELNORM)
7/24/2002
3/30/2007
4.7 years
16
gatifloxacin (TEQUIN)
12/17/1999
5/1/2006
6.4 years
15
technetium (99m TC)
fanolesomab (NEUTROSPEC)
7/2/2004
12/19/2005
1.5 years
14
hydromorphone (PALLADONE)
9/24/2004
7/13/2005
0.8 years
13
valdecoxib (BEXTRA)
11/16/2001
4/7/2005
3.4 years
12
natalizumab (TYSABRI)
11/23/2004
2/28/2005
0.3 years
11
rofecoxib (VIOXX)
5/20/1999
9/29/2004
5.4 years
10
levomethadyl (ORLAAM)
7/9/1993
9/2/2003
10.2
years
9
cerivastatin (BAYCOL)
6/26/1997
8/8/2001
7.3 years
8
rapacuronium (RAPLON)
8/18/1999
3/30/2001
1.6 years
7
alosetron (LOTRONEX)
2/9/2000
11/28/2000
0.8 years
6
cisapride (PROPULSID)
7/29/1993
3/24/2000
9.7 years
5
troglitazone (REZULIN)
1/29/1997
3/21/2000
3.1 years
4
grepafloxacin (RAXAR)
11/6/1997
8/11/1999
1.8 years
3
bromfenac (DURACT)
7/15/1997
6/22/1998
0.9 years
2
mibefradil (POSICOR)
6/20/1997
6/8/1998
1.0 years
1
dexfenfluramine (REDUX)
6/1/1996
9/15/1997
1.3 years