Actos: FDA Warnings and Updates

Background Information

Actos, also known as pioglitazone, is a medication prescribed to help control blood sugar levels in individuals with Type 2 diabetes.​ It belongs to a class of drugs called thiazolidinediones.​ In 2011, the FDA raised concerns about Actos and its potential link to an increased risk of bladder cancer.​ This led to the inclusion of warning labels on Actos and other drugs containing pioglitazone.​ While the drug was pulled from the market in some countries due to safety concerns, it remains available to consumers in the U.​S.​ The FDA continues to monitor the safety of Actos and has required updates to the medication’s label to reflect the potential risks associated with its use.

FDA Warning on Bladder Cancer Risk

The U.​S.​ Food and Drug Administration (FDA) issued a warning on June 15, 2011, regarding the potential increased risk of bladder cancer associated with the use of pioglitazone, a drug used to treat Type 2 diabetes. This warning came after studies indicated a higher risk of bladder cancer when using pioglitazone for longer than one year.​ As a result, the FDA mandated that drug manufacturers include warning labels on medications containing pioglitazone, such as Actos, to inform patients about this risk.​ Despite safety concerns leading to the withdrawal of Actos in some countries, the FDA has required updates to the drug’s label to reflect the bladder cancer risk.​

International Response

After the FDA’s warning regarding the potential increased risk of bladder cancer associated with pioglitazone, international responses varied.​ While the FDA required warning labels on drugs containing pioglitazone in the U.​S.​, some countries took more stringent actions.​ For example, the drug was withdrawn from the market in European countries like France, Germany, and India due to safety concerns.​ Health regulators in these countries ordered the removal of Actos from the market following studies showing an elevated risk of bladder cancer and heart problems.​ Despite these international responses, Actos remains available to American consumers with updated label warnings reflecting the potential risks.​

Ongoing Safety Review

As part of its continuous assessment of Actos (pioglitazone), the FDA has incorporated information regarding the increased risk of bladder cancer into the drug’s warning and precaution section on the label.​ Keeping in view the elevated risk associated with long-term use, the FDA required updates to the labeling information for Actos and other medications containing pioglitazone.​ Takeda Pharmaceuticals, the manufacturer of Actos, is collaborating with the FDA to adjust the prescribing information accordingly.​ Moreover, Takeda is supporting a decade-long epidemiological study examining the potential link between Actos and bladder cancer, conducted by the University of Pennsylvania and Kaiser Permanente Diabetes Registry of Northern California, with results expected by the end of 2012.​

Updated Label Warnings

After the FDA’s alert on the potential risk of bladder cancer associated with long-term use of pioglitazone-containing medications like Actos, the FDA required updates to the warning labels of these drugs. Takeda Pharmaceuticals, the manufacturer of Actos, collaborated with the FDA to incorporate this crucial information onto the drug’s label.​ The updated label now includes specific details about the increased risk of bladder cancer, ensuring that consumers are well-informed about the potential risks when using Actos to manage Type 2 diabetes.​

Advisory on Smartwatch Devices

The U.​S.​ Food and Drug Administration (FDA) has issued a warning cautioning consumers to avoid using specific smartwatches or smart rings that claim to measure blood sugar levels without breaking the skin. The FDA alert emphasizes that these devices have not been authorized or approved for this purpose, highlighting potential risks associated with relying on unapproved technology for health monitoring.​ It is essential for individuals to be cautious and seek guidance from healthcare providers regarding appropriate and approved methods for monitoring their health conditions.​

Generic Availability

Actos, also known as pioglitazone, is available in generic form, offering an alternative to the brand-name medication.​ Generic drugs like pioglitazone contain the same active ingredients as their brand-name counterparts and are often more affordable.​ As a generic version of Actos, pioglitazone provides individuals with Type 2 diabetes the option for cost-effective treatment while still effectively helping to control blood sugar levels when used in conjunction with proper diet and exercise.​

In conclusion, the FDA’s warnings and updates regarding Actos (pioglitazone) have brought attention to the potential risks associated with the medication, particularly the increased risk of bladder cancer.​ While the drug remains available in the U.​S.​ with updated label warnings, other countries have taken more stringent actions, such as pulling Actos from the market. Ongoing safety reviews and collaborations between the FDA and Takeda Pharmaceuticals continue to monitor and address the concerns, emphasizing the importance of informing consumers about the potential risks and ensuring their safety when using Actos to manage Type 2 diabetes.​