FOR A FREE CASE EVALUATION, CALL 1-800-632-1404

If you took Actos® (pioglitazone) for a year or longer and have been diagnosed with bladder cancer, call the Actos bladder cancer lawyers with our firm at 1-800-632-1404. Our firm is currently reviewing cases involving persons who took Actos® for control of blood sugar.

ACTOS AND PRODUCT LIABILITY

Actos® is a pioglitazone drug used to treat type 2 diabetes. Pioglitazone is an insulin sensitizer that works by making the tissues more sensitive to the effects of insulin. Bladder Cancer and Congestive Heart Failure are two potential side effects of Actos®.

Prescription drugs may not be sold in the United States unless they are first approved by the FDA.  A manufacturer seeking approval to market a new drug – often called the “referenced listed drug” or “RLD” – must submit a New Drug Application (“NDA”) to the FDA, with proof that the drug is safe and effective and the proposed label is accurate and adequate.  See, e.g., 21 U.S.C. § 355 (b)(1), (d). 

A manufacturer of a generic drug, which is designed to be a copy of a previously-approved RLD, can gain expedited FDA approval by submitting an Abbreviated New Drug Application (“ANDA”) demonstrating that its generic drug is “bioequivalent” to the RLD and its proposed safety and efficacy labeling is “the same as the labeling approved for the [brand-name] drug.”  See Pliva v. Mensing, 131 S. Ct. 2567, 2574 (2011) (quoting 21 U.S.C. § 355(j)(2)(A)(v)).  As addressed below, because the products are bioequivalent, doctors and pharmacists frequently rely on representations made by the RLD-holder in prescribing and dispensing generic versions of a drug.

Because knowledge about a drug’s benefits and risks grows over time, especially after a drug has begun to be marketed, the FDA has procedures by which a manufacturer can change an approved application or labeling.  In fact, FDA regulations require that the labeling “be revised to include a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.”  21 C.F.R. § 201.80(e). 
Most changes to a drug’s labeling are requested through a “Prior Approval Supplement,” which, as the name implies, requires FDA approval before the change may be implemented.  See 21 C.F.R. § 314.70(b).  If the change is to “add or strengthen a contraindication, warning, precaution, or adverse reaction,” however, it may be done through a “Changes Being Effected” (“CBE”) supplement, which allows the change to be implemented before the FDA has acted on the application.  See 21 C.F.R. § 314.70(c).  While brand and generic manufacturers may use both types of supplements, see 21 C.F.R. § 314.97, generic manufacturers are more limited in what they can do, because they are always subject to the requirement that their labels be the same as that of the RLD.  Mensing, 131 S. Ct. at 2575.

Drug companies may also communicate information about their drugs to doctors and pharmacies through other means.  For example, manufacturers of brand-name drugs typically pay to publish their drugs’ labeling information in the Physician’s Desk Reference (“PDR”), which is provided for free to doctors and pharmacists across the nation, and is the primary way in which they receive information about the efficacy of, and risks associated with, prescription drugs.  See Conte v. Wyeth, Inc., 168 Cal. App. 4th 89, 98 n.4 (Cal. Ct. App. 2008); See Allen Rostron, Prescription for Fairness:  A New Approach to Tort Liability of Brand-Name and Generic Drug Manufacturers, 60 Duke L.J. 1123, 1133 (2011).  Drug products are listed by both their brand and generic names, id., just as the brand-name product label refers to the generic name of the drug throughout.  See 21 C.F.R. § 201.57(a)(2).  Brand manufacturers also sometimes communicate information through the use of “Dear Health Care Professional” (“DHCP”) letters.

There are no regulations prohibiting generic drug companies from communicating in these ways, but they rarely if ever choose to do so, and instead rely on the brand manufacturers to communicate information about the drugs.  Even if generic manufacturers would choose to use those methods of communications, the FDA considers them to constitute “labeling,” so they also “must be consistent with and not contrary to [the RLD’s] approved . . . labeling.”  See 21 C.F.R. § 201.100(d)(1).

BACKGROUND

Since 1999, Actos® has been prescribed as part of an overall treatment regimen for controlling blood sugar in diabetic patients. In recent years it has also been prescribed as a diabetes preventative in those who show the early signs of the disease. In September 2010, the U.S. Food and Drug Administration (FDA) began a safety review of Actos® when new data was discovered that suggested a link to increased risk of bladder cancer.

The risk of bladder cancer is MUCH HIGHER for those that take the drug at higher cumulative doses and for longer periods of time. This increased risk is also greater in men than in women. The FDA has issued a warning of the elevated risk to patients who have been taking Actos®, but added that patients should not stop taking Actos® unless instructed to do so by their physicians. The active ingredient in Actos® is also contained in other drugs, namely Actoplus Met®, Actoplus Met XR®, and Duetact®.

Although Actos® continues to remain on the shelves of drug stores in the United States, the drug is under a long-term observational study by the FDA. France suspended the drug and Germany recommended not to start new patients on the drug due to mounting concerns for their citizens.

RISK OF BLADDER CANCER

In June of this year the U.S. Food & Drug Administration (FDA) issued a warning about the popular diabetes drug Actos(pioglitazone). The FDA had found that the use of pioglitazone for more than a year may be linked to an increased risk of bladder cancer.

SYMPTOMS OF BLADDER CANCER

Common symptoms of Actos®-related bladder cancer may include:

• ■Blood in urine, sometimes creating a change in urine color
• ■Frequent urination
• ■Painful urination
• ■Urinary tract infection

If you or a loved one developed bladder cancer during or after taking Actos®, Actoplus Met®, Actoplus Met XR®, or Duetact®, call us now at 1-800-632-1404 or SUBMIT A SHORT CASE FORM HERE for a free, no obligation, evaluation of your case.

HERE TO HELP.

If you are interested in claims for Actos, an Actos lawsuit, information on an Actos class action, or want to speak with anActos attorney, please call us today at 1-800-632-1404.

Members of our firm are attorneys currently representing clients who have taken several prescription drugs and claim injuries associated with those drugs, including Topamax®, Wellbutrin®, Fosamax®, and Actos®. Members of the firm also represent clients across the globe pertaining to medical device failures, including the Advanced Bionics HiRes90k® cochlear implant , the TVM / TVT transvaginal mesh – sling and the DePuy hip implant. For a free case evaluation, please contact:

CALL US TOLL FREE: (800) 632-1404

EMAIL: click here

FILL OUT THIS FORM:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.