Last year was a turbulent year for drug-maker Takeda Pharmaceuticals - maker of the popular diabetes medication Actos - and 2012 doesn't look like it will be any calmer. The drug maker faces allegations that Actos, which is the world's best-selling diabetes treatment, can lead to an increased risk of bladder cancer and eye disorders.
Actos in 2011
Last year after a government sponsored study revealed bladder concerns, the French Medicines Agency began telling French doctors to stop prescribing the drug - which was followed by Takeda issuing a recall of Actos in France. After reviewing France's report, German officials also suspended Actos use in Germany.
The U.S. Food and Drug Administration (FDA) also conveyed their Actos concerns in 2011. Last summer, the FDA issued a safety announcement stating that the use of pioglitazone (Actos) "for more than one year may be associated with an increased risk of bladder cancer." This led to an update of Actos drug labels that now recommend health professionals to:
- Not use pioglitazone in patients with active bladder cancer
- Use pioglitazone with caution in patients with a history of bladder cancer
Moreover, the new Actos labels recommend patients to contact their doctor if they experience any blood or red color in their urine, or any other symptoms such as pain while urinating - all of which can be indicative of bladder cancer.
Unfortunately for Actos users, bladder cancer is not the only health concern associated with Actos use. A study presented at last year's San Diego meeting of the American Diabetes Association found a 3 to 6 times increased risk of developing an eye disorder called diabetic macular edema, which can eventually lead to blindness.
Actos in 2012
Takeda already faces hundreds of lawsuits stemming from Actos use - with some commentators estimating as many as 10,000 will eventually be filed. Since Actos is used throughout the country, lawsuits are similarly filed in courts peppered throughout the nation. However, a recent federal Judicial Panel on Multidistrict Litigation order has decided to consolidate all the Actos cases in the Western District of Louisiana.
Consolidation of similar cases before a single judge is often done in federal courts for the sake of judicial economy as it avoids duplicative document exchanges and the same issues being decided in different ways. The parties involved in current Actos litigation argued for a variety of venues for consolidation, but in the end the court decided on the Western District of Louisiana, stating, "We are persuaded that the Western District of Louisiana is an appropriate transferee district for this litigation. The allegations in this nationwide litigation do not have a strong connection to any particular district, and related actions are pending in numerous districts across the country."
Even though this decision technically only dealt with 11 Actos suits, it did state that over 100 other Actos cases may be treated as "tag-along" cases, and thus may be eventually tried in Louisiana. If some estimates are correct, this decision may also impact thousands of other potential Actos lawsuits.
