The danger in the FDA not mentioning the risks when talking about the approval of generic Actos is that the public may not realize that it carries the same risks as the brand-name medication.
Marlton, New Jersey (PRWEB) August 29, 2012
The New Jersey Actos attorneys at Console & Hollawell are warning consumers that despite recent U.S. Food and Drug Administration (FDA) approval the generic versions of the type 2 diabetes drug Actos carries the same risks as its brand-name counterpart. On August 17, 2012 the FDA* announced that they were approving the first ever generic version of Actos (pioglitazone hydrochloride).
In the release, the director of the Office of Generic Drugs in FDA’s Center for Drug Evaluation and Research, Gregory P. Geba, M.D., M.P.H. expressed that this approval is important because it will allow consumers who take the medication to have a more affordable option, according to the FDA announcement. What they failed to mention in the statement are the numerous lawsuits pending against the manufacturers of Actos for its link to bladder cancer, a link that has been admitted by the FDA**.
New Jersey pharmaceutical injury lawyer, Richard Console expressed concern over this misleading statement by the FDA.
“The danger in the FDA not mentioning the risks when talking about the approval of generic Actos is that the public may not realize that it carries the same risks as the brand-name medication,” he said. “This can open up a whole new group of diabetes patients to the harmful effects of this medication.”
A Brief History of Actos
In July of 1999 the FDA approved Actos, manufactured by Takeda Pharmaceuticals and Eli Lilly & Co., for treatment of type 2 diabetes. In 2006 a study conducted by the French Medicines Agency began researching the link between Actos usage and bladder cancer. In August of 2007 the FDA ordered the addition of a boxed warning that Actos may cause or worsen heart failure in patients, according to a report from the Public Watchdog.***
According to the same report, in 2010 a former medical reviewer for Takeda Pharmaceuticals filed a lawsuit against the pharmaceutical company alleging that they failed to report cases of congestive heart failure stemming from Actos to the FDA. Also in 2010, the FDA announced that they would be conducting an ongoing safety review of Actos and its relationship with bladder cancer. Both France and Germany removed the drug from the market on June 9 and 10, 2011 respectively due to the increased risk of bladder cancer.
On June 15, 2011 the FDA announced that the prolonged use of Actos at a high dosage may increase risk of bladder cancer and the warning was added to the label. The FDA also urged doctors not to prescribe Actos to individuals who have bladder cancer.
Consumer Reports Picks Up FDA Slack
Despite the FDA not mentioning that a generic medication will carry the same risks as a brand-name drug, Consumer Reports**** took the initiative to warn their readers that this being a cheaper option does not make it any safer.
They explained that, “we say skip Actos as both a generic and brand-name medication, unless other options have not worked. Pioglitazone can cause serious side effects, such as an increased risk of heart failure, bone fractures, and bladder cancer…Our medical advisers say that people with diabetes should use pioglitazone (generic) or brand-name Actos, only as a last resort.”
Takeda Pharmaceuticals alone could be facing upwards of 10,000 lawsuits from patients that have taken Actos alleging that the drug caused bladder cancer, according to a report from Bloomberg Businessweek.***** That does not even include the potential lawsuits from those who suffered other harmful effects such as congestive heart failure.
Get Help Now
Since 1999, the lawyers at Console & Hollawell have been aggressively defending the rights of victims of Actos. The firm has seen the harmful effects this medication can have on those who take it, and are determined to hold those responsible accountable for this unnecessary harm. If you or someone you love has been the victim of serious injury or death from taking Actos, speak with experienced injury attorneys in New Jersey today to learn your legal rights and options.
Bloomberg Businessweek***** http://www.bloomberg.com/news/2011-12-01/takeda-may-face-10-000-u-s-suits-over-actos-cancer-claims.html