Takeda, who is defending itself in the Actos litigation where type 2 diabetics have higher than anticipated occurrence of bladder cancer, may be on the verge of another blockbuster drug gone awry. Recent reports in the Wall Street Journal indicate that the Takeda/Affymax anemia drug Omontys, which was approved by the FDA in April 2012, and designed for use in dialysis patients, is subject to reports of serious reactions, deaths, and finally a recall.
In February 2013, the FDA indicated it received reports of 19 serious reactions leading to three patient deaths. On February 13, 2013, the dialysis provider Fresenius said it would stop expanding a Omontys pilot program, after seeing “infrequent” allergic reactions in patients after their first dose. A “small number” of those were serious, the company said in a letter filed with the Securities and Exchange Commission. Takeda and Affymax said the reported reactions occurred within 30 minutes of the patient’s first dose.
Click here to read the full article: Affymax, Takeda Pull Omontys After 3 Deaths
As a result, the companies sent an official “Dear Healthcare Provider” letter–to not only stop initiating therapy in new patients, but to stop dosing current patients as well. In March 2013, the FDA initiated a recall of all Omontys lots.
On March 29, 2013, the Wall Street Journal reported Omontys triggered serious allergic reactions long before February’s recall. The question the WSJ report implies is whether Omontys should have been suspended last fall, rather than in February. Affymax was worried enough in October to ask for the labeling change, and that was before Omontys went into broader use at Fresenius and other dialysis centers. The article asks how many adverse-reaction reports should it take to have a drug suspended.
Click here to read the full Wall Street Journal article: Anemia Drug Had Early Side Effects
Takeda’s Actos is the subject of numerous lawsuits in California and nationally through a MDL proceeding. In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer. A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos.
Actos Has Been Linked To Increased Risk of Developing Bladder Cancer
In September 2010, the FDA ordered a safety review of Actos. The FDA is continuously reviewing the results of an ongoing ten-year study of the long-term risk of bladder cancer in approximately 193,000 diabetic patients taking Actos. A significantly increased risk of bladder cancer has been seen among patients from this group who take the highest doses of Actos (more than 28,000 mg) and who take Actos for longer than one year. Compared to patients never having taken Actos, taking Actos for longer than one year was associated with a forty percent higher risk of bladder cancer.
A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.
If you or a loved one has had a problem with Omontys or has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries. The Brandi Law Firm is a leader in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us.