Learn More About Iressa Claims

Iressa (generic name: gefitinib) was approved by the Food and Drug Administration (FDA) in May, 2003, to treat non-small cell lung cancer in patients who do not respond to chemotherapy.

Lung cancer killed an estimated 160,390 American men and women in 2007. Non-small cell lung cancer accounts for approximately 85 percent of all lung cancer cases.

The drug, which is marketed by Astra Zeneca, was green-lighted under an accelerated FDA approval program after it was shown to reduce tumor sizes dramatically – between 50 percent to 90 percent. However, clinical trials later determined that: 1/ patients taking Iressa did not live any longer than patients taking a placebo and 2/ while Iressa had the ability to shrink tumors, it worked only in about one in every 10 patients who took it. Call a pharmaceutical lawyer, drug effects attorney, pharmaceutical attorney, or medical malpractice attorney for information on pursuing a lawsuit.

In April, 2004, two research studies tried to answer why Iressa worked well for some and not others. Researchers found that people who responded well to Iressa had common mutations in their tumors while people without these mutations did not respond to the drug. In other words, the answer lay in a person’s genes.

Iressa and drugs such as Gleevac and Tarceva are part of a relatively new class of cancer drugs which specifically target a gene in tumors called the epidermal growth factor receptor (EGFR). The receptor allows the tumor to grow and spread, while these cancer drugs block the receptor.
Despite this finding, in 2005, the consumer group Public Citizen petitioned the FDA to ban Iressa. In doing so, it cited findings that linked Iressa to numerous deaths.

Iressa is alleged to be responsible for 588 deaths in Japan since its 2002 launch. The FDA‘s own database recorded 144 reports of acute interstitial pneumonia (a rare but serious type of pneumonia) for U.S. patients taking Iressa between May 2003 and September 2004 -- including 87 deaths, according to Public Citizen. I

Rather than pull Iressa from the market, however, the FDA decided to allow those cancer patients who appeared to benefit from its treatment to continue using it. But it added a more restrictive warning to its drug label, advising patients to consider taking one of two other drugs that – unlike Iressa – had proven effective in prolonging survival.

In the three years since Public Citizen called for Iressa’s ban, the drug has continued to be used by cancer patients -- and has even undergone somewhat of a rebirth. In May 2008, the American Society of Clinical Oncology released abstracts from new clinical trials which showed Iressa being successfully used to treat breast and lung cancers.

In a 1,400 patient study, in which some patients were given Iressa while others were given a form of chemotherapy, the patients treated with Iressa lived 7.6 months and those with chemotherapy lived 8 months. The one year survivals were 32 and 34 percent respectively.

Despite the slightly longer survival rates for those receiving chemo, Iressa patients reported a better quality of life. That is because Iressa – which is administered once a day in pill form – was easier to take and did not have the side effects that accompanied the chemo. Also, Iressa was not associated with the nausea, blood disorders, personality changes or hair loss that patients who received chemo reported. Iressa’s main side effects were acne, a rash or a mild diarrhea.

Researchers estimate that Iressa could help about 17,000 patients a year.

If you or a loved one developed acute interstitial pneumonia or other health complications after taking Iressa, contact a qualified drugs effects attorney, medical malpractice lawyer, pharmaceutical attorney, or personal injury lawyer to determine if you are entitled to receive damages.

In February, 2005, Astra Zeneca’s Japanese subsidiary faced a class action lawsuit over the fatal side-effects of Iressa. Documents presented to the Tokyo District Court alleged that the manufacturer took part in a cover-up over the dangers of Iressa and treated its Japanese patients as “laboratory animals”.

Other medical malpractice and drug compensation suits are expected to be filed. Contact a medical malpractice attorney, personal injury attorney, or pharmaceutical lawyer for legal advice.

Concerns over whether you or a loved one should be using Iressa – or questions about switching to another cancer medicine -- should be addressed to your physician.

Lung cancer is the leading cause of cancer death in the United States, according to the American Cancer Society. In 2008, approximately 215,000 Americans were diagnosed with lung cancer. Lung cancer is the leading cancer killer in both men and women in this country; it is responsible for more deaths than the next three most common cancers combined (colon, breast and prostate). 

Japanese lawyers claim that more than a third of lung cancer patients treated with Iressa suffered side-effects and died as a result of the treatment, rather than the cancer. Japan makes up more than 40 per cent of Iressa’s global sales.

The Iressa Victims’ Association pushed for a ban on Iressa, which they say exploited their desperation by promising them the “drug of their dreams”. A pharmaceutical attorney or drug effects lawyer should be contacted if you believe you have a lawsuit against the manufacturer.

Since its 2002 launch, more than 200,000 patients have taken Iressa worldwide. While its results have proven positive for some, only ten percent of the people who took the drug improved.  Some even got worse.

In a report published in the British medical journal, The Lancet, (Nov. 22, 2008) Iressa was shown to work as well as traditional chemotherapy, given by vein every three weeks, as a second-line treatment for lung cancer. Although neither therapy prolonged survival beyond eight months, Iressa caused fewer serious side effects and was viewed as a better choice for patients who did not do well on their first round of chemotherapy.

AstraZeneca withdrew its European marketing application for Iressa -- but pushed for its launch in Japan -- when research showed that it had greater benefit for Asian cancer patients than for Caucasian cancer patients.

Sales of Iressa were $238-million in 2007. Sales were up 12% in the first quarter of 2008, but that was believed to be due to the falling dollar. Astra Zeneca had previously forecast Iressa’s global sales would grow to $916-million by 2010.

Today, Iressa is overshadowed by rival drugs Tarceva and Erbitux that also treat non-small cell lung cancer.

There are no court settlements to report at this date.

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AstraZeneca: withdrawal of Iressa application adds to woe

Iressa as Good as Chemotherapy for Lung Cancer: Daily pill easier to take, has fewer side effects than chemotherapy, experts say