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Ashcraft & Gerel
LLP
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CLAIMS FOR STROKE RESULTING FROM PHENYLPROPANOLAMINE OR PPA
IN
OVER THE COUNTER DIET DRUGS AND
COLD MEDICATIONS
[Introduction: Although our offices are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug and pharmaceutical practice is national in scope, and our lawyers are handling many drug cases around the country. Therefore, regardless of what state you're in, please complete our inquiry form on this web site or email us so that we can have an attorney from our drug litigation department contact you.]
1. What is PPA?
Phenylpropanolamine ("fen-el-pro-pa-nol-a-mine" or "PPA") is
an ingredient used in many over-the-counter and prescription
cough and cold medications as a decongestant to relieve stuffy
nose or sinus congestion and in over-the-counter weight loss
products.
PPA has been available for at least 53 years, if not longer.
Americans take 6 billion doses of the ingredient each year in
a wide range of prescription and over-the-counter products,
including the popular brand names Alka-Seltzer Cold, Bayer
Cold, Dexatrim, Dimetapp, Robitussin-CF, Dristan, Tavis-D,
Allerest, Triaminic, Allergy Relief, Contac, and Sucrets Cold.
By some calculations there are as many as 400 over-the-counter
products containing PPA.
2. Adverse Events
A recent industry funded
study conducted by Yale University
found that PPA increases the risk for hemorrhagic stroke
(bleeding into the brain or into tissue surrounding the
brain). The study included a long history of published serious
adverse events, including hemorrhagic stroke, attributed to
PPA going back to 1979. These cases were attributable to PPA
because they typically occurred close in time to ingestion of
PPA in otherwise healthy younger people. There was a lack of
other plausible explanation for the occurrence of these events
in these younger individuals. In addition, PPA is known to
cause cerebral vasculitis, a severe inflammation of the blood
vessels in the brain, which in combination with the blood
pressure raising effects of PPA, can result in cerebral or
subarachnoid brain hemorrhage and stroke. Since the dangers of
PPA were not previously known to the public, it is highly
likely that many such individuals who suffered hemorrhagic
stroke never associated this terrible event with their use of
products containing this drug. Further, even doctors and other
medical personnel may well have failed to make the connection
between the stroke and PPA, because they were unfamiliar with
the dangers of the drug.
Symptoms include headache, nausea and stimulation. Other than
stroke, acute psychosis, convulsions, acute renal failure,
heart damage and hypertension have also been reported.
Though the Food and Drug Administration (FDA) has only 51
confirmed reports of hemorrhagic stroke, analysts relying upon
the Yale Study now estimate that 200-500 strokes occurred per
year in women age 18-49 due to PPA. It is well known that only
a very small percentage of adverse drug reactions are ever
reported to the FDA. With estimates that the percent of cases
of over-the-counter adverse drug reactions that are sent to
the FDA are between 5% and 10% of those that actually occur,
this total of 51 reported cases of hemorrhagic stroke can mean
as many as 510 to 1020 cases have actually occurred in persons
using PPA containing products.
3. Regulatory Action
On October 19, 2000
Public Citizen formally petitioned the FDA for an immediate ban on the use
of PPA in all over the counter products,
and on the same day the FDA convened a meeting of its Nonprescription Drugs
Advisory Committee to discuss the safety issues of PPA in over-the-counter
drug products.
The Committee
determined that there is an association between PPA and
hemorrhagic stroke.
A
letter
was sent to the manufacturers of
drug products containing PPA by the FDA on November 3, 2000.
This letter asked manufacturers to voluntarily discontinue
marketing products with PPA in the interests of public health.
Manufacturers were further requested to reformulate such
products with other ingredients.
On November 6, 2000, in response to the Yale study, the FDA
ordered that all over-the-counter manufacturers remove PPA
from their products. The FDA determined that the conditions
for which PPA is used did not justify the risk of serious harm
posed by the drug. The FDA concluded that PPA "cannot be
considered to be safe for continued use".
(FDA Talk Paper,
11/6/00)
.
4. Population at Risk
The Yale study of patients at 43 hospitals found that women
aged 18 to 49 who had taken appetite suppressants with PPA
were 16 times more likely to suffer a hemorrhagic stroke.
There was no reason to believe that men face a lower risk.
Further, among men and women taking a cough or cold remedy
containing PPA for the first time, the risk of a stroke was
three times higher than normal.
5. Precautions
There are other available products on the market not
containing PPA that can fulfill the same role as the withdrawn
products. Consumers should ask their pharmacist or health care
provider what other products are available for their needs.
Over-the-counter drug products containing this ingredient may
be identified by looking for "phenylpropanolamine" in the list
of active ingredients on the label. If a prescription nasal
decongestant or cough/cold product is being used, consumers
should talk to their pharmacist or health care provider to
determine if PPA is present.
If you think you or a loved one may have suffered an injury or damages as a result of using a product containing PPA, you owe it to yourself to speak to an experienced drug or pharmaceutical lawyer. Ashcraft & Gerel's lawyers are now accepting claims for injuries caused by Phenylpropanolamine or PPA. Our lawyers have been leaders in mass tort and product liability cases and settlements, including asbestos, breast implants and tainted blood. Our lawyers have been at the forefront of the Fen-Phen diet drug claims for over two years, and our attorneys are well situated to see the Phenylpropanolamine or PPA cases to a successful damage recovery for our clients. Although our offices are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug litigation is national in scope, and, in association with attorneys in other states, we are involved in many cases around the country. We have a toll free number for you to call to have an attorney answer your questions with regard to your specific case. That number is 1-800-725-6470. If you would prefer, please feel free to e-mail us or complete the help inquiry form on this web site to inquire about your claim. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question so that a lawyer can provide you with the specific claim information you seek.
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