Research shows that anticancer drug gefitinib—sold under the brand name Iressa—causes deadly side effects, such as interstitial pneumonitis, anorexia, and corneal erosion. The Rottenstein Law Group, an Iressa law firm, compassionately advocates for those who have suffered Iressa side effects. If you’ve taken Iressa and believe it harmed you, contact RLG for a free, confidential legal consultation immediately. We will evaluate your case and remain on the lookout for Iressa recalls and Iressa class action lawsuits.
What Is Iressa and What Is It Prescribed For?
Iressa is the brand name for the drug gefitinib. Made and sold by British pharmaceutical company AstraZeneca plc, this prescription medication is used to treat non-small cell lung cancer (NSCLC). The U.S. Food and Drug Administration (FDA) first approved the drug in May 2003 in the form of 250 mg oral tablets. In June 2005, the FDA substantially revised Iressa’s indication to allow prescriptions only for patients whose treating physicians had or were currently benefiting from Iressa. AstraZeneca proposed to limit distribution of the drug under the Iressa Access Program. The FDA took these measures because the drug proved ineffective at prolonging cancer patients’ life expectancies. The FDA chose not to require an Iressa recall.
According to the Iressa FDA label, scientists do not fully understand the drug’s mechanism of action. They believe Iressa acts on a cell structure called “epidermal growth factor receptor (EGFR).” In some forms of lung and breast cancer, the tumor cells contain too many EGFRs, which leads to their replication. Iressa supposedly selectively inhibits EFGR. The FDA label adds, “No clinical studies have been performed that demonstrate a correlation between EGFR receptor expression and response to gefitinib.”
The FDA made its dramatic change to Iressa’s label after learning of the results of two studies. Because the agency first approved the drug for NSCLC by an accelerated approval process that resulted in a tumor response rate of 10 percent, the drug’s actual efficacy was not known. In one of the two studies, 1,692 took either Iressa or the placebo, and the researchers found no benefit to Iressa. In the second study, patients with stage III NSCLC who had already undergone radiation and chemotherapy took Iressa, and there too, researchers did not determine any benefit.
The Japanese Ministry of Health, Labor and Welfare still allows Iressa to be sold for NSCLC treatment. There, doctors and patients found that the drugs side effects often proved fatal. By 2005, British newspaper the Times reported that 1,473 patients had suffered Iressa side effects, including 588 deaths. There, relatives of family members filed Iressa lawsuits against AstraZeneca’s Osaka subsidiary and the government for approving the drug. In February 2011, the Japan Times reported that the Osaka District Court ordered AstraZeneca to pay 60.5 million yen (about $780,000) to nine out of 11 plaintiffs. The court did not find the government liable. In September 2011, a Niigata plaintiff whose mother died from Iressa side effects lost his Iressa lawsuit.
Iressa Might Cause Death
Based on what Japanese users claimed, Iressa side effects include:
- Stomatitis (inflammation of the mouth’s mucous membranes);
- Skin reactions;
- Paronychia (fungal infection of the fingernail);
- Blepharitis (eyelid inflammation);
- Corneal erosion; and
- Interstitial pneumonitis (pneumonia).
These side effects, particularly interstitial pneumonitis, can be fatal to Iressa users.
RLG’s Iressa Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Iressa lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file an Iressa lawsuit on your behalf if necessary. RLG will also keep you up to date on any Iressa class action lawsuits, FDA Iressa warnings, and Iressa FDA recall announcements. If you have taken Iressa and believe it harmed you, contact RLG today.