Massive Recall of Antidepressant Capsules Over Cancer Risk
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In a notable public health move, over 233,000 bottles of an antidepressant medication have been recalled by health officials due to teh presence of a chemical linked to cancer risks.
The U.S.Food and Drug Administration (FDA) announced on December 5 that capsules of duloxetine, marketed by New Jersey-based Rising Pharmaceuticals, have been classified as a Class II recall. This classification is the FDA’s second most severe level,indicating that the product may cause temporary or medically reversible adverse health effects.
The recall was initiated due to the presence of nitrosamine impurities, specifically N-nitroso-duloxetine, which exceeds the recommended interim limits set by the FDA. Nitrosamine impurities have been linked to an increased risk of cancer when exposure occurs over extended periods.
“Nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time.”
FDA Statement
Rising Pharmaceuticals voluntarily issued the recall on November 19, but the company has not yet responded to inquiries from USA TODAY. The FDA has emphasized that while the risk of cancer is a concern, the presence of nitrosamines in this case does not immediately pose a severe threat.
This recall comes as part of ongoing efforts by the FDA to monitor and address potential impurities in medications. The agency has been particularly vigilant in recent years, following similar recalls involving blood pressure medications and other drugs.
What You Need to know
- The recalled product is duloxetine capsules, sold by Rising Pharmaceuticals.
- the recall was issued due to the presence of N-nitroso-duloxetine, a nitrosamine impurity.
- The FDA has classified this as a Class II recall, indicating potential for reversible health effects.
- Consumers are advised to consult their healthcare providers for alternative treatment options.
For those currently taking duloxetine, it is crucial to consult with a healthcare professional before discontinuing use. The FDA encourages consumers to report any adverse reactions or quality problems experienced with the use of this product through the MedWatch Adverse Event Reporting program.
The FDA’s continued focus on medication safety underscores the importance of rigorous quality control in pharmaceutical manufacturing. As this recall unfolds, public health officials will be closely monitoring its impact and providing updates as necessary.
For the latest updates on this recall and other health-related news, stay tuned to World Today News.
FDA Expands Recall of Duloxetine Capsules Due to Nitrosamine Contamination
The U.S. Food and Drug Administration (FDA) has issued an expanded recall for duloxetine capsules, a medication commonly used to treat depression and anxiety, due to potential contamination with nitrosamines. The recall now includes 233,003 bottles of the drug, manufactured by Rising Pharmaceuticals, following an initial recall in October involving 7,107 bottles produced by Towa Pharmaceutical Europe.
Nitrosamines are chemical compounds that can pose health risks if consumed in high quantities over extended periods. According to the FDA, exposure to these substances at or below acceptable daily intake limits for 70 years is not expected to increase the risk of cancer. Though, the agency has classified the recall as a class II event, indicating that while the risk of serious adverse health consequences is remote, ther is still a possibility of temporary or medically reversible effects.
What You need to Know About the Recall
The FDA’s initial recall in October targeted 7,107 bottles of duloxetine capsules, which are marketed under brands such as Cymbalta, Drizalma, and irenka. These medications are primarily used to treat mental health disorders,including anxiety and depression,as well as other conditions like chronic pain and fibromyalgia,according to the cleveland Clinic.
The expanded recall, announced on November 19, now encompasses 233,003 bottles of duloxetine capsules in various sizes, including 30-count, 90-count, and 1000-count bottles. Both the initial and expanded recalls are classified as Class II, reflecting the FDA’s assessment of the potential health risks associated with the contamination.
What Are Nitrosamines, and Why Are They a Concern?
Nitrosamines are a group of chemical compounds that can form in certain conditions, including during the manufacturing process of pharmaceuticals.While low levels of nitrosamines are present in everyday foods and water, prolonged exposure at higher levels can increase the risk of cancer. The FDA has established acceptable daily intake limits to minimize this risk, but any contamination in medications remains a cause for concern.
“Patients should talk to their health care professionals about concerns and other treatment options,” the FDA advises on its website. The agency urges anyone who may have affected medication to stop taking it immediately and consult their healthcare provider for guidance.
Steps to Take if You Have Recalled Medication
If you or a loved one is using duloxetine capsules and suspect they might potentially be part of the recall,it’s crucial to take action. The FDA recommends discontinuing use and reaching out to your healthcare provider to discuss alternative treatment options.While the risk of serious harm is considered low,taking precautionary measures is essential to ensure safety.
For more information on the recall,including specific lot numbers and expiration dates,visit the FDA’s official website or contact Rising Pharmaceuticals directly. Staying informed and proactive can help protect your health and well-being during this recall.
For the latest updates on recalls and safety alerts, visit USA TODAY’s recall database.
FDA Expands Recall of Popular Blood Pressure Medication Due to Cancer-Causing Contaminants
The U.S. Food and Drug Administration (FDA) has announced an expanded recall of a widely used blood pressure medication, citing concerns over the presence of nitrosamines, a group of perhaps cancer-causing contaminants. This latest recall affects over 233,000 bottles of the drug, adding to a growing list of medications pulled from the market due to similar safety issues.
Nitrosamines are chemicals commonly found in water, cured and grilled meats, dairy products, and vegetables, according to the FDA. While trace amounts of these contaminants are present in everyday life, prolonged exposure to higher levels has been linked to an increased risk of cancer. The agency has been vigilant in monitoring and addressing the presence of nitrosamines in pharmaceuticals to protect public health.
Recalls Across Multiple Medications
This isn’t the first time nitrosamines have prompted widespread recalls. Since 2018, more than 12 million bottles of blood pressure-lowering drugs, including valsartan and losartan, have been removed from shelves due to the presence of these harmful substances. The same contaminants have also triggered recalls of other medications,such as the heartburn drug Zantac,the diabetes medication metformin,and the smoking cessation treatment Chantix.
The FDA’s ongoing efforts to identify and address nitrosamine contamination highlight the agency’s commitment to ensuring the safety of prescription drugs. However, these repeated recalls raise questions about the manufacturing processes and quality control measures in the pharmaceutical industry.
What Consumers Should Know
Patients currently taking the recalled medication are advised not to stop taking their prescribed drugs without consulting their healthcare provider. The FDA emphasizes that the risk of harm from untreated high blood pressure or other conditions may outweigh the potential risks associated with the contaminated medication. Healthcare professionals will work with patients to transition them to alternative treatments as needed.
The FDA’s expanded recall serves as a reminder of the importance of vigilance in drug safety and the need for robust regulatory oversight. As the agency continues to investigate and address these issues, consumers can stay informed by visiting the FDA’s website for the latest updates on recalls and safety alerts.
Contributing: Ken Alltucker
This article originally appeared on USA TODAY: Duloxetine recall: FDA expands recall to more than 233,000 bottles
And Drug Management (FDA) has announced an expanded recall of popular blood pressure medications due to the presence of cancer-causing contaminants known as nitrosamines. This recall affects several widely used medications, including those containing valsartan, losartan, and irbesartan, which are commonly prescribed to manage high blood pressure and other cardiovascular conditions.
Nitrosamines are chemical compounds that can form during the manufacturing process of pharmaceuticals and certain foods. While low levels of nitrosamines are naturally present in the environment, prolonged exposure to higher levels can increase the risk of cancer. The FDA has established acceptable daily intake limits to minimize this risk, but any contamination in medications remains a significant concern for public health.
### What You Need to Know About the Recall
– **Affected Medications**: The recall includes medications such as valsartan, losartan, and irbesartan, which are used to treat high blood pressure, heart failure, and other cardiovascular conditions.
– **Contaminants**: The recalled medications contain nitrosamine impurities, including N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA), and others.
– **Class II Recall**: The FDA has classified this recall as a Class II event, indicating that the use of the contaminated products may cause temporary or medically reversible adverse health effects, but the risk of serious health consequences is remote.
– **Next Steps**: Patients currently taking these medications should consult their healthcare providers immediately to discuss choice treatment options. Discontinuing use without consulting a healthcare professional is not recommended.
### Why Are Nitrosamines a Concern?
Nitrosamines are a group of chemical compounds that can form in certain conditions, including during the manufacturing process of pharmaceuticals. While low levels of nitrosamines are present in everyday foods and water, prolonged exposure at higher levels can increase the risk of cancer. The FDA has established acceptable daily intake limits to minimize this risk, but any contamination in medications remains a cause for concern.
“Patients should talk to their healthcare professionals about concerns and other treatment options,” the FDA advises on its website. The agency urges anyone who may have affected medication to stop taking it immediately and consult their healthcare provider for guidance.
### Steps to Take if You Have Recalled Medication
If you or a loved one is using blood pressure medications and suspect they might be part of the recall, it’s crucial to take action. The FDA recommends discontinuing use and reaching out to your healthcare provider to discuss alternative treatment options. While the risk of serious harm is considered low, taking precautionary measures is essential to ensure safety.
For more information on the recall, including specific lot numbers and expiration dates, visit the FDA’s official website or contact the manufacturers directly. Staying informed and proactive can help protect your health and well-being during this recall.
### The FDA’s Continued Vigilance
The FDA’s expanded recall underscores the agency’s ongoing commitment to ensuring the safety and quality of medications available to the public. The agency has been particularly vigilant in recent years, following a series of recalls involving nitrosamine contamination in various drugs, including blood pressure medications, heartburn drugs, and antidepressants.
“The FDA remains dedicated to protecting public health by identifying and addressing potential risks associated with pharmaceutical products,” said Dr.janet Woodcock, Acting Commissioner of the FDA. “We will continue to work with manufacturers to ensure that all medications meet our rigorous safety standards.”
For the latest updates on recalls and safety alerts, visit [USA TODAY’s recall database](https://www.usatoday.com/recalls/) or the [FDA’s official website](https://www.fda.gov). Stay informed and take action to protect your health and the health of your loved ones.
