Zyprexa & FDA Prescription Regulation

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.  Our confidence, credentials and resources have helped our clients get compensation from the manufacturers and suppliers of unsafe drugs and products, including Zyprexa.  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.

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.

Pharmaceutical and biotechnology companies account for 9 of the top 50 largest public companies in the world and continue to thrive based on publicly funded research and low tax rates (marketing and research and development costs are deductible).  Brown & Crouppen’s lawyers, skills, credentials and resources have helped our clients get compensation from the manufacturers and suppliers of unsafe drugs and products.

Please consult your physician before discontinuing any medication.

About Brown & Crouppen: Zyprexa 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.

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 online or call our office today at Toll-Free: 866-991-4700.