PPA LAWSUIT NEWS
PPA News
Breaking
News!
April 15, 2003
- Companies may have known about PPA stroke link
Internal memos show that two large drug makers knew about the link
between PPA and strokes. In 2000, PPA was taken off the market because
of the serious and concerning PPA side effects linked to the popular
ingredient. Used in many cold remedies and diet pills, PPA was linked
to hemorrhagic strokes that affected mainly young women, causing
a high number of PPA lawsuits.
The companies named in the 300 individual PPA lawsuits were New
Jersey companies Novartis Pharmaceuticals and Wyeth and the companies
have maintained there was a lack of concrete scientific evidence
leading them to ascertain the strokes were the result of PPA. Now
it appears that the companies may have been sitting on PPA side
effects evidence. Just last month, evidence began to surface that
showed the companies may have known PPA side effect risks for years
despite adamant denials.
First made in the early 1900s, PPA had been available in a wide
range of over-the-counter medications for decades. Six billion doses
of PPA were sold in the U.S. alone every year. Not until 1991 when
reports of strokes led to Congressional hearings was the widely
used ingredient ever addressed. In 1996, the FDA proposed that additional
PPA warning labeling be added to all PPA containing products. A
Yale University PPA study was finally completed in 2000 showing
evidence that there was an increased risk of stroke with PPA use
that led to the FDA withdrawal.
Memos used in recent PPA lawsuits have shown that as early as 1989
executives may have known about possible PPA side effects. A January
19, 1989 Sandoz Pharmaceutical (now Novartis) memo was written acknowledging
that PPA side effects occurred in small doses, not just in instances
of abuse or overdose. In 1996, a three-page Wyeth-Ayerst Pharmaceutical
memo made note that strokes and other side effects were reported
in patients following excessive and recommended doses of products
with PPA.
February 8, 2001
A report from the General Accounting Office has found eight of ten
prescription drugs that were withdrawn from the U.S. market since
January 1, 1997 may have posed a greater health risk to women than
to men. Although in about half the cases risk were greater to women
because more women were using the prescription drugs containing
PPA, there were certain drugs that when prescribed more evenly to
men and women physiological differences between the sexes may account
for a higher incremental risk to the women than the men. The particular
PPA containing drugs that demonstrated a higher risk of side effects
to women included withdrawn hypertension drug Poscior, antihistamines
Seldane and Hismanal, and heartburn drug Propulsid. At the end of
last year, the FDA started taking steps to remove PPA from over
the counter medicines found in cold remedies and weight loss products
because of the evidence showing PPA increased the risk of hemorrhagic
stroke in women but not men.
August 22, 2001
A study in the Journal of the American Medical Association showed
weight loss products containing PPA, including Dexatrim and Acutrim
that has come under FDA scrutiny, can interact with other medications.
The FDA has requested all drug companies that have products containing
PPA discontinue marketing because PPA is shown to increase the risk
of hemorrhagic stroke, which is bleeding into the brain or into
tissue surrounding the brain.
November 28, 2000
PPA, which is found in dozens of over the counter cold remedies
and diet drugs, will be banned soon. Depending on when and how much
drug companies knew, PPA lawsuits may be soon to follow.
November 11, 2000
The FDA issued a warning for Americans not to use over the counter
cold remedies and diet pills that contain PPA because it causes
hemorrhagic strokes, especially in young women. Cold remedies containing
PPA includes Alka-Seltzer Plus, Comtrex, Contac 12, Coricidin D,
Dimetapp, Robitussin, Tavist-D, Traiminic, and appetite suppressants
containing PPA include Acutrim and Dexatrim. These PPA containing
medicines are brand names so it is important to check if the generic
and/or store brands also contain PPA. Currently, the only appetite
suppressants that are non-prescription contain PPA so other alternatives
should be sought.
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November 8, 2000
The FDA asked drug companies to stop marketing popular cold remedies
and appetite suppressants that contain PPA due to the link to hemorrhagic
stroke in women. The FDA says they are taking steps to remove PPA
from the over the counter and prescription medications. This announcement
came on November 6th after the New England Journal of Medicine released
a 5-year study linking PPA to hemorrhagic stroke in women.
The FDA's advisory committee cited this study when saying that
PPA is unsafe. Researchers at the Yale University School of Medicine,
who performed the study, found that women ages 18-49 who took appetite
suppressants containing PPA were 16 times more likely to have a
hemorrhagic stroke than other women and women using cold or cough
remedies containing PPA for the first time had a threefold increased
risk of hemorrhagic stroke.
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November 7, 2000
Drugs stores are now pulling dozens of over the counter cold remedies
and diet pills off the shelves following the government warning
that PPA can cause hemorrhagic strokes, especially amongst young
women. The FDA is getting ready to ban PPA that will take several
months to go through the legal steps. Manufactures were asked by
the FDA to voluntarily stop selling their products that contain
PPA and replace the ingredient with a safer alternative. The FDA
had an unusually strong health warning to consumers saying "We
suggest you stop taking the drug immediately and use an alternative."
Consumers were warned to check their prescriptions to make sure
they aren't taking medications with PPA. Some top selling manufacturers
refused to reveal their plans regarding their PPA containing products,
including maker of Triaminic and Tavist-D, Alka-Seltzer Plus, and
Dexatrim. About 6 billion doses of PPA are sold in the U.S. every
year, with the majority of drugs not requiring a prescription. While
the study found women more at risk for hemorrhagic strokes when
using a PPA containing product, the FDA cautioned that not enough
men were studied to ensure they are safe.
October 20, 2000
One day after a U.S. regulatory panel recommended banning PPA some
drug companies announced they are in the process of replacing the
PPA found in many diet aids and decongestants. The drug companies
are under pressure to act quickly or be accused of knowing the dangers
of PPA that would result in PPA lawsuits. In anticipation of a PPA
recall, many drug companies have begun to market new versions of
their over the counter products without PPA. As with every drug
and legal action, it will depend on when and how much drug companies
knew to see if PPA lawsuits are soon to follow. Other drug manufacturers
are still disputing the Yale study, arguing there is no proof that
PPA causes hemorrhagic strokes.
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Public Citizen Links
Public Citizen is the consumer advocacy group that first expressed
their concern over the safety of PPA as early as 1983. The group
has been very proactive in their desire to remove PPA containing
products from the market and have gone straight to the FDA to do
so. PPA was recalled in November 2000 following a study linking
PPA to hemorrhagic stroke. If you would like to speak with a PPA
attorney regarding the PPA Lawsuit, contact
us.
October 12, 2001
Letter urging the FDA to reject drug industry's request for liability
disclaimer in its withdrawal of products containing PPA.
The FDA had issued a notice of a "Proposal to Withdraw Approval
of New Drug Applications and Abbreviated New Drug Applications"
on August 14, 2001 for products containing PPA because of the safety
concerns showing the link between PPA and hemorrhagic strokes. Letters
from some drug companies to the FDA requested the FDA include in
its final rule withdrawing approval of products containing PPA a
disclaimer regarding industry liability and PPA lawsuits. The disclaimer
would state the withdrawal of PPA containing drugs does not mean
the drugs were marketed negligently, which is the companies' request
in hopes of avoiding product liability PPA lawsuits.
To read the entire letter click
here.
October 19, 2000
Petition to the Food and Drug Administration requesting an immediate
ban of all uses of PPA in over the counter products.
Public Citizen petitioned the FDA for an immediate ban of all uses
of PPA in over the counter products. PPA was found in many weight
loss drugs and cold remedies. The consumer group found that there
was an abundant amount of evidence showing the dangers of PPA, in
addition to the 5-year Yale study finding "PPA increases the
risk for hemorrhagic stroke." There have been reports dating
as far back as 1979 showing the adverse effects that can occur when
using a product containing PPA, including hemorrhagic strokes.
Ten years ago a review of PPA found 142 cases of adverse reactions
that included 24 intracranial hemorrhages, eight seizures, and eight
deaths. Most of the adverse reactions were due to hemorrhagic strokes.
There are also FDA reports showing that there was evidence of PPA
causing hemorrhagic strokes. An FDA memo dated August 6, 1991 shows
an FDA medical officer reported that there had been a total of 44
cases of strokes with 35 of them being hemorrhagic strokes. There
was an updated added to the report on a September 27, 2000 memo
stating an additional 16 cases of hemorrhagic strokes were associated
to PPA.
To read the entire petition click
here.
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October 19, 2000
Testimony before the Food and Drug Administration NonPrescription
Drugs Advisory Committee Meeting on Safety Issues of PPA.
Public Citizen made a testimony before the FDA regarding their petition
asking for an immediate ban of all uses of PPA in over the counter
products found in cold remedies and appetite suppressants. The group
cited the Yale study finding "PPA increases the risk for hemorrhagic
stroke".
To read the entire publication testimony click
here.
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