Are you familiar
with the Prescription Drug User Fee Act (PDUFA)?
The PDUFA was passed in 1992 in response to pressure from drug makers,
doctors and patients to accelerate the drug approval process. This law
requires a drug manufacturer to pay a fee each time they submit an
application to the Food and Drug Administration (FDA) for a new drug’s
approval. The FDA benefits from the drug companies’ mandated contributions
that make up nearly half of the FDA's budget for new drug studies. And the
American public? We are losing our health and our lives because of unsafe
drugs and misleading claims. Since 1997, we have seen more than a dozen FDA
approved drugs removed from the market because of serious side effects
including injury and death.
According to the Public Citizen Health Research Group, the
PDUFA “…has
brought the FDA too close to the industry it regulates for public comfort or
safety and has raised questions about outside pressure to approve new drugs
and the agency’s independence to operate in the public interest…” Brown & Crouppen shares the concern of consumer safety
advocates and we fight to make prescription drug companies accountable for
the harm they cause to those who trust them. We believe that physicians and patients have the right to
expect that properly prescribed and labeled medications which are used as
directed will help a patient – not harm or kill them.
For millions of
people, prescription drugs are necessary to health and even survival. Yet,
the very drugs designed to help people may cause adverse reactions that
range from illness to disability to death. As recently as April 11, 2005
the FDA issued an alert advising health care providers, patients, and
patient caregivers to safety issues regarding Zyprexa and other Atypical
Antipsychotic Drugs. Zyprexa is the brand name for Olanzapine and it
belongs to the family of “atypical” antipsychotic medications that were
approved by the FDA to treat two specific disorders: Schizophrenia and
Bipolar Mania. Yet Zyprexa, Abilify (aripiprazole), Risperdal (risperidone)
and Seroquel (quetiapine) are being prescribed for “off-label” treatment of
elderly demented patients with behavioral disorders. Off-label use refers
to the practice of marketing or prescribing a drug in a different dose, for
a longer period of time, or for a different medical condition than approved
by the FDA. In the April 2005 announcement, the FDA asked manufacturers of
Atypical Antipsychotic Drugs to include a Boxed Warning in their product’s
label that describes the risks and note that these drugs are not approved
for “off-label” indications.
Evidence dating back to the 1950’s tied the use of Zyprexa and similar drugs
to increased risk of diabetes, pancreatitis, hyperglycemia and other
pancreas-related illnesses. Zyprexa’s maker, Eli Lilly, continued to
aggressively market the drug despite its known risks. Zyprexa represents
about one-third of Eli Lilly’s 4.3 billion in sales last year. While Eli
Lilly continues to enjoy the profits from Zyprexa sales, patients continue
to suffer from the known and newly discovered health risks associated with
the drug. Brown & Crouppen believes that the dangers of Zyprexa will
increase as the drug remains in use at nursing homes and hospitals to treat
the outbursts of the mentally ill and elderly.
Brown & Crouppen:
Prescription Drug Injury Lawyers Brown & Crouppen
has been building a reputation for success with
personal injury clients for over 25 years. Today, we are one of
mid-America’s largest personal injury law firms with over 70 legal
professionals and five offices throughout Missouri and Illinois. A large
area of our concentration is dangerous drug litigation involving
manufacturers and suppliers of unsafe drugs and products. If you have
been injured by a dangerous drug, the manufacturer may have failed in its
duty to design, make, inspect and label the product appropriately.
We believe that drug companies who
place profit above people must be held accountable for their negligence and
the damage they cause to innocent victim’s lives.
You can count on the lawyers of Brown & Crouppen for top-notch legal skills
and our commitment to making the justice system work for our clients. If you
have legal concerns and would like to benefit from the support of a strong
team of legal professionals, please contact us onlineor call our office today at 1-800-536-HELP.
Copyright 2005 - Zyprexa Lawyers
.com :
Missouri Injury Lawyers, Brown & Crouppen
Fighting for the legal rights of patients, including lawsuits regarding
prescription medication side effects,
dangerous drugs,
pharmaceutical negligence claims in Missouri and Illinois.
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