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Reglan is a drug used to treat gastroesophogeal
reflux disease, also known as acid reflux. Reglan is also
known by its generic name, Metoclopramide.
According to the FDA, Reglan has been linked to a
condition called tardive dyskinesia, which may include
involuntary and repetitive movements of the body, even after the
drugs are no longer taken. There are several other similar
conditions also involving involuntary, repetitive movements that
have been associated with use of the drug Reglan, such as dystonia,
akathisia, and pseudoparkinsonism.
In particular, according to the FDA, tardive dyskinesia is
characterized by involuntary, repetitive movements of the
extremities, or lip smacking, grimacing, tongue protrusion, rapid
eye movements or blinking, puckering and pursing of the lips, or
impaired movements of the fingers. These symptoms are rarely
reversible and there is no known treatment.
People who have taken the drug for more than twelve weeks are
most at risk of developing these conditions. The risk of developing
these conditions increases with the length of use of Reglan and the
amount of dosage of Reglan.
The FDA has issued a "Black Box Warning" to warn people of these
serious side effects. Reglan is still on the market, but is
recommended only for short term use. As of February 2009, doctors
have been advised to avoid prescribing Reglan for long term use in
all but rare cases.
FDA Issues Warning (PDF file)
If you have been diagnosed with any of these conditions, or if
you display these symptoms, don't wait. Call our Reglan
Lawyers today to before the statute of limitations runs
and you no longer have a right to compensation.Our attorneys just
published an article in Trial magazine on this dangerous drug.
Help for Victims of Reglan
If you or a loved one has taken Reglan and has exhibited these
symptoms, please don't hesitate to contact Bubalo Goode Sales &
Bliss to see how we can help. You have rights and may be entitled
to compensation for the harmful side effects of
Reglan.
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Birth Control Pills Causing Serious Side
Effects
Women taking Yaz and Yasmin birth control
products may be at an increased risk of
- Blood Clots
- Pulmonary Embolism
- Deep Vein Thrombosis (DVT)
- Stroke
- Heart Attack
- Gallbladder Disease
Lawsuits Filed Against Manufacturers
Many healthy young women across the U.S. have filed a
Yaz, Yasmin or Ocella lawsuit against the
manufacturers of these drugs (Bayer Healthcare, Berlex
Laboratories, and Tea Pharmaceuticals). The growing number of cases
cites allegations that:
- Potential risks and side effects were not disclosed to the
medical community or users of Yaz, Yasmin & Ocella
- These side effects and the risks involved have not been given
enough research
- Yaz, Yasmin & Ocella side effects are more dangerous than
other contraceptives already on the market
- Those who take Yaz, Yasmin or Ocella are required to be more
closely monitored by their physician
- A recall of Yaz, Yasmin or Ocella is advisable and should have
been issued once these drugs were deemed dangerous for their
harmful side effects
- The manufacturers were attempting to maximize profits by
encouraged misuse or overuse of their products, while not
disclosing or greatly minimizing the harmful side effects of Yaz,
Yasmin, or Ocella
- The manufacturers were negligent in their manners of designing,
testing, marketing, and producing their birth control products
Yaz & Yasmin Information
Yaz, Yasmin & Ocella use a combination of
the hormones ethinyl estradiol and drospirenone. The progestin
drospirenone can increase potassium levels in the blood stream,
which can lead to cardiovascular and gallbladder
problems.
Yaz, Yasmin & Ocella are generally taken every day, with a
prescription from your doctor. While there are other uses for
Yasmin, such as rare cases of acne treatment, the pills work by
preventing ovulation. Another way the medication works is by
causing a change in the woman's cervical and uterine lining, making
it harder for sperm to reach the uterus and making it more
difficult for a fertilized egg to attach to the uterus.
What is Ocella?
Ocella is the generic form of the same drug
(drospirenone) found in Yaz and Yasmin. Ocella is
manufactured by Teva Pharmaceuticals and was introduced to the
market in 2008. Ocella, like Yaz and Yasmin, acts as a diuretic,
which can increase potassium levels in the blood. These high
potassium levels can cause abnormal heart rhythms, slowing the flow
of blood and can lead to blood clots.
What is a Pulmonary Embolism?
Pulmonary embolism is an obstruction of a blood vessel in the
lungs, usually due to a blood clot, which blocks a coronary
artery.
Deep Vein Thrombosis (DVT)
Deep vein thrombosis (DVT) is a blood clot in a major vein,
usually in the legs and/or pelvis. Deep vein thrombosis is an
illness that is difficult to detect and can be fatal if not treated
effectively.
Gallbladder Disease Linked to Yaz, Yasmin &
Ocella
Drospirenone acts as a diuretic, causing patients to lose water,
and leading to a buildup of sludge or bile. The gallbladder's main
purpose is to process this bile, but it cannot function properly
without water. Problems can present themselves in the form of
gallstones, infections, inflammation, or obstructions. Symptoms of
gallbladder disease can include:
- Abdominal Pain
- Chills or Fever
- Heartburn
- Nausea or Vomiting
FDA Criticizes Yaz & Yasmin ads
After the FDA harshly criticized Bayer's portrayal of the birth
control drug Yaz, the manufacturer (Bayer) was forced to revise
their previous advertisements. The ads made very little mention of
the drug's risks and could give the impression that Yaz is safer
than has been noted. Bayer requested that both the commercials be
pulled from the air immediately after receiving the warning letter
from the FDA.
Bayer claimed Yasmin could help premenstrual syndrome (PMS) and
acne. The ads featured women with clear complexions while the
voiceover made the clear skin claims that got the FDA's
attention.
The FDA pointed out that, while Yaz can help reduce acne in
clinical trials, it did not completely clear the patients'
complexions. Bayer has changed its commercials to be more clear
about the benefits and harmful side effects of Yaz and Yasmin since
then.
Yaz & Yasmin Linked to Cardiovascular
Problems
Some of the most serious side effects of Yaz, Yasmin,
and Ocella include blood clots, heart attacks, strokes,
and embolisms. These conditions were more common in women using Yaz
or Yasmin with a previous history of cardiovascular problems.
History of other conditions that have been found to be dangerous
include:
- Heart Disease
- High Blood Pressure
- Being Overweight
- Diabetes
- High Cholesterol
- Liver Cancer
- Gallbladder Problems
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Hormone Replacement Therapy (HRT)
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Teamed Up Seeking Justice Against the
Pharmaceutical Industry
Following is a
compilation of background materials that are the basis for suits against the
manufacturers of a variety of hormone replacement therapy
drugs. We encourage you to review this information carefully if
you feel that you have been injured by taking HRT.
Injuries Caused By Hormone Therapy:
- Breast Cancer
- DES Daughters
- Heart Attacks
- Strokes
- Venous Blood Clots
- Auto-Immune Disease
- Ovarian Cancer
- Gallbladder Cancer
You should know that Bubalo Goode Sales & Bliss and other
law firms have joined forces to seek justice for women who have
been injured by taking oral hormone replacement therapy drugs, such
as Prempro, Premphase, Premarin, Provera, and other estrogens and
progestins. Together, these law firms combine dozens of lawyers who
are devoted solely to protecting your rights. Bubalo Goode Sales
& Bliss is a member of the Plaintiffs' Personal Injury
Discovery Committee (PPIDC), a committee appointed by the federal
district court in Arkansas to prosecute these actions against the
responsible drug companies that manufactured and marketed these
drugs. We are devoted to representing one woman at a
time, and addressing her individual
injuries.
Bubalo Goode Sales & Bliss and its other team members have
filed a major lawsuit in St. Louis against the pharmaceutical
companies who are the market leaders in producing these dangerous
products.
Hormone Therapy Industry
For decades, the pharmaceutical industry has marketed and sold
estrogens (both opposed and/or unopposed by progesterone or
progestin), under the brand names Prempro, PremPhase, Premarin,
Provera and others. These have been sold to women and their doctors
to replace the female hormones lost during menopause. During this
time, the drug companies convinced the medical community and the
general public that menopause was a disease that needed to be
treated with hormone replacement therapy drugs. The drug companies
claimed that their hormone replacement therapy drugs could not only
cure typical menopausal symptoms such as hot flashes, night sweats
and irritable mood swings - they claimed that the drugs also could
prevent heart disease and other long term illnesses.
The drug companies made these claims despite the
absence of clinical trials to test the safety and efficacy
of these drugs on a long term basis. All that changed on July 9,
2002 after the National Heart Lung and Blood Institute (NHLBI), a
division of the National Institute of Health, announced that it had
stopped a major clinical trial of the risks and benefits of
combined hormone replacement therapy.
The NHLBI study was a 15-year clinical study conducted by the
Women's Health Initiative (WHI), which was to have continued until
2005. However, the NHLBI terminated the WHI study after data
revealed that, instead of preventing heart disease, there was a
marked increase in heart disease, stroke, blood
clots, and hip fractures in women taking combination hormone
replacement therapy after an average follow up of 5.2 years,
compared with women who took a placebo. Most alarming was the
conclusion of the WHI study that taking combination hormone
replacement therapy increased a woman's risk of breast cancer by
26%.
The WHI study revealed the following alarming risks (which clearly
outweigh the listed benefits) for women who took long-term
combination therapy:
- Breast cancer - up 26%
- Strokes - up 41%
- Blood Clots in the veins - up 107%
- Blood clots in the lungs - up 113%
- Heart disease - up 29%
- Hip fractures - down 34%
- Spinal fractures - down 34%
- Colorectal Cancer - down 37%
The WHI Study also found that the combination hormone regimen
should not be initiated or continued for primary prevention of
coronary heart disease.
Studies subsequent to the WHI study show that the long term
effects of combination hormone replacement therapy are even more
severe than the WHI study revealed. The studies and findings
stemming from the WHI have shown, literally, an epidemic of breast
cancer likely caused by the use of combination hormone therapy.
Scientific proof has shown that hormone replacement therapy is now
recognized as a catalyst to increase the risk of hormone positive
breast cancer, heart attacks, strokes, deep vein thrombosis,
pulmonary emboli, ovarian cancer, and lupus, to list a few.
On January 6, 2003, Wyeth, the manufacturer of Premarin and
Prempro, abandoned its long-standing marketing strategy of
promoting the long-term use of Premarin and Prempro, and announced
that it was adopting new labeling for its hormone therapy drugs in
light of the WHI findings. The warnings now emphasize that Prempro
and other forms of combination hormone therapy are not approved for
the prevention of heart disease.
Primary Drug Companies and Drugs Involved
The primary drugs responsible for the damaging effects of hormone
replacement therapy and the drug companies that manufacture them
are:
- Premarin (Wyeth), alone or when used in combination with
Provera (Pharmacia/Upjohn/Pfizer), Cycrin (Wyeth), or MPA (Barr
Laboratories or Greenstone Limited, a subsidiary of
Pharmacia/Upjohn/Pfizer)
- Prempro (Wyeth)
- Premphase (Wyeth)
Hormones and a History of Harm: DES and Uterine
Cancer
The history of hormone therapy in women contains numerous red
flags that should have cautioned drug companies against the
widespread use of these therapies without adequate testing.
Unnecessary injury associated with the use of these therapies is
the rule, not the exception. Two examples are the use of DES and
uterine cancer.
Birth
Defects
A stampede of pharmaceutical companies sought to market
Synthetic Estrogen or "DES". In their haste for profits, none of
the pharmaceutical giants paused to question the safety or benefit
of this drug. By 1947, the FDA approved DES for the treatment of
miscarriages even though no testing had been performed. This form
of synthetic estrogen stayed on the market for this purpose until
1971 and was given to millions of pregnant women. Tragically,
mothers who took DES had a 40% to 50% increased chance of breast
cancer. It also caused multiple birth defects and other injuries,
as explained below:
- DES sons may have lowered sperm counts; sterility; increased
risk of testicular cancer; missing, small, or undescended
testicles; cysts; and abnormally small penises, as well as a higher
than average risk of depression.
- DES daughters are the best-known victims of the drug. Among
them, their mothers' DES use has been linked to immune system
disorders, bone loss, and breast cancer. In addition, DES daughters
have been shown to have suffered from cervical dysplasia, a
potentially pre-cancerous condition; adenosis, a "pre-cancerous
cell change"; a cancer known as clear cell adenocarcinoma (found in
approximately one of every one thousand DES daughters); a T-shaped
uterus; a small, hooded, or incompetent cervix; and an increased
risk of miscarriages and ectopic pregnancies. These reproductive
system malformations often result in difficulties conceiving and
carrying children to term and contribute to the injuries in their
children...1
Uterine Cancer
Unfortunately, the reckless attitude of the drug industry toward
hormones did not end with DES. The use of "unopposed" estrogen
(Wyeth's best seller being Premarin®) also resulted in an epidemic
of endometrial cancer.
The following Figure 12 shows the annual number of
estrogen prescriptions to women ages 50-74 in a sample area when
compared to the number of new cases of endometrial cancer. As the
prescription rate for estrogen fell, so did the incidence of
cancer.
Figure One
By the 1980's, the increased risk of endometrial cancer from
"exogenous estrogen," (like Wyeth's best seller, Premarin®) had
become obvious. Studies consistently found that the long term use
of estrogen increased the chances of cancer at least three times or
perhaps more.3
1 See generally "DES Third-Generation
Liability: A Proximate Cause," 18 Cardozo L. Rev. 1217, 1220-21
(1996)1221. (Authority and footnotes deleted.)
2 Donald F. Austin, M.D., MPH and Kathleen M. Roe, MPH,
The Decreasing Incidence of Endometrial Cancer: Public Health
Implications, 72 American Journal of Public Health, No. 1
(January, 1982).
3 See, e.g., Hulka, B.S., et al., Estrogen
and Endometrial Cancer: Cases and Two Control Groups from North
Carolina, 137 Am. J. Obstet. Gyneocol. 92 (May, 1980)
(relative risks were as high as 4.1 for estrogen taken more than 3
½ years); See also Jelovek, F.R., et al, Risk of Exogeenous
Estrogen Therapy and Endometrial Cancer, 137 Am. J. Obstet.
Gynecol. 85 (May, 1980).
Combined Therapy Causes Disease
The solution of the drug industry to endometrial cancer of the
uterus was "combined therapy." Combined therapy involved coupling
estrogen with progesterone. Before the 1980's, women were
prescribed primarily estrogen only. This caused a lack of hormonal
balance because estrogen alone over stimulated the lining of the
uterus causing uncontrolled growth. This hyper stimulation, in
turn, resulted in a condition known as "hyperplasia." To avoid this
risk, progestins were given, to induce menses. Bleeding allowed the
endometrial lining of the uterus to shed and brought the otherwise
uncontrolled growth somewhat under control, due to a balance of the
progestins "opposing" the estrogen.
Progestin was added to protect against UTERINE CANCER. However,
the role of progestin and estrogen concerning BREAST CANCER were
untested and unclear. As early as 1980, independent studies
suggested a causal connection between HRT and breast
cancer.4 Unfortunately for the women taking these drugs,
the warning signs went largely unheeded by the drug
companies.
The form of progestin used in most combined therapies, starting in
the 1980's after the disaster of endometrial cancer, was
Medroxyprogesterone acetate (MPA). MPA is contained in many of the
drugs sold by the drug companies as the "opposition" to estrogen
supposedly needed to avoid uterine cancer. Provera® (manufactured
by Pharmacia / Upjohn / Pfizer), Cycrin® (Wyeth), and Prempro®
(Wyeth) contain MPA.
Other drug companies made a generic form of MPA in order to
capture a share of the HRT market. Although MPA was combined with
estrogen to supposedly protect against uterine cancer, it has
been used for years to induce breast cancer in laboratory animals
for the purpose of studying breast cancer and its treatments.
Moreover, progesterone had just been recognized by the World Health
Organization ("WHO"), International Agency for Research on Cancer
("IARC"), as a known human carcinogen. The IARC's recognition was
made on the basis of laboratory animals studies that have been
known for decades.5
Importantly, the marketing of this HRT combination of known
carcinogens, after sales of "monotherapy" or "unopposed" estrogen
alone were destroyed by the risk of uterine cancer, began without
any safety studies or "clinical trials." The definition of
"clinical trial" is explained by Reference Manual on Scientific
Evidence, 2nd at 338, as follows:
- To determine whether an agent is related to the risk of
developing a certain disease or an adverse health outcome, we might
ideally want to conduct an experimental study in which the subjects
would be randomly assigned to one of experimental study in which
the subjects would be randomly assigned to one of two groups: one
group exposed to the agent of interest and the other not exposed.
After a period of time, the study participants in both groups would
be evaluated for development of the disease. This type of study,
called a randomized trial, clinical trial, or true experiment, is
considered the gold standard for determining the relationship of an
agent to a disease or health outcome. Such a determining study
design is often used to evaluate new drugs or medical treatments
and is the best way to ensure that any observed difference between
the two groups in outcome is likely to be the result of exposure to
the drug or medical treatment.
(Emphasis Added.)
New drugs in the United States, at least in the recent past,
generally have been proven to be safe and effective through
clinical trials. The FDA can typically refuse a New Drug
Application ("NDA") if that drug is not supported by "adequate and
well controlled investigations." Clinical trials generally are
considered the "gold standard" defined by FDA Regulations as the
proof generally needed for safety and efficacy.
Until July, 2002, combination HRT had never been subjected to
the "gold standard" required of almost all modern medications. In
other words, no one had tested these drugs in clinical trials for
safety and efficacy prior to giving them to millions of women. As
of July, 2002, 38% of American women used HRT.6
Forty-six (46) million prescriptions were written for Premarin® in
the year 2000 with more than $1 Billion in sales to its
manufacturer.7 In addition, "... 22.3 million
prescriptions were written for Prempro® (conjugated estrogens plus
medroxyprogesterone acteate)."8 "Since the mid-1980's,
combined estrogen/progestin use [had] steadily increased."
9
As stated in the accompanying editorial that appeared in the
Journal of the American Medical Association (JAMA) on the
date the initial findings of the WHI were published: "… the whole
purpose of healthy women taking long-term estrogen/progestin
therapy is to preserve health and prevent disease. The results of
this study [WHI] provide strong evidence that the opposite is
happening for important aspects of women's health…"
10
4 Ross, R.R., et al., A Case-Control Study of
Menopausal Estrogen Therapy and Breast Cancer. 243 J.A.M.A.
1635 (April 1980).
5 IARC's Fourth Annual Report on Carcinogens,
emphasizes that there has been no adequate human study of the
effect of progesterone. However: "Progesterone is reasonably
anticipated to be a human carcinogen based on sufficient
evidence of carcinogenicity in experimental animals (IARC
1982)."
Go to: http://ehp.niehs.nih.gov/roc/toc10.html for a
complete copy on line.
6 Fletcher, Suzanne W., et al., Failure of Estrogen
Plus Progestin Therapy for Prevention, 288 J.A.M.A. 366 (July,
2002).
7 Id.
8 Id.
9 Id.
10 Fletcher, Suzanne W., et al., supra. at
367.
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