FDA recalls blood pressure medicine over cancerous chemical – USA Today

Report on the Recall of Prazosin Hydrochloride and its Implications for Sustainable Development Goals

1.0 Executive Summary

This report details the voluntary recall of over 580,000 bottles of Prazosin Hydrochloride capsules, a medication for high blood pressure, initiated by Teva Pharmaceuticals USA. The recall is due to the presence of a carcinogenic chemical impurity. This action directly aligns with the United Nations Sustainable Development Goals (SDGs), particularly SDG 3 (Good Health and Well-being), by safeguarding public health from hazardous chemicals and ensuring the safety of medical products.

2.0 Recall Details

Teva Pharmaceuticals USA issued a voluntary recall on October 7 for specific lots of Prazosin Hydrochloride capsules. The U.S. Food and Drug Administration (FDA) subsequently classified this as a Class II recall on October 24.

• Product: Prazosin Hydrochloride Capsules
• Indication: Treatment of high blood pressure (hypertension) and off-label management of Post-Traumatic Stress Disorder (PTSD) symptoms.
• Total Quantity Recalled: Over 580,000 bottles

3.0 Affected Products

The recall encompasses three dosage strengths of the medication:

• 1 mg capsules: 181,659 bottles
• 2 mg capsules: 291,512 bottles
• 5 mg capsules: 107,673 bottles

Specific lot numbers and code information are available on the FDA’s official Enforcement Report.

4.0 Health Risk Assessment and SDG Alignment

The recall was initiated due to the presence of a nitrosamine impurity, N-nitroso Prazosin impurity C, which is a potential human carcinogen. The FDA has designated this a Class II risk, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health consequences.

4.1 Contribution to SDG 3: Good Health and Well-being

This regulatory action is a critical measure in advancing several targets within SDG 3:

• Target 3.4: By removing a medication contaminated with a carcinogen, this recall helps reduce premature mortality from non-communicable diseases (NCDs) such as cancer, ensuring that treatments for conditions like hypertension do not introduce new health risks.
• Target 3.9: The recall directly supports the goal to substantially reduce the number of deaths and illnesses from hazardous chemicals and contamination. Identifying and removing contaminated pharmaceuticals from the supply chain is a fundamental component of achieving this target.
• Target 3.8: Ensuring access to safe, effective, quality, and affordable essential medicines is a cornerstone of achieving universal health coverage. Regulatory oversight and corrective actions like this recall are essential to maintaining the integrity and safety of the pharmaceutical supply chain.

4.2 Contribution to SDG 12: Responsible Consumption and Production

The recall also highlights the importance of ensuring sustainable production patterns, specifically Target 12.4, which calls for the environmentally sound management of chemicals and wastes throughout their life cycle. Proactive quality control and recall mechanisms are essential components of responsible pharmaceutical production.

5.0 Recommendations for Consumers

While official guidance from the manufacturer was not specified, standard procedure for a drug recall advises affected individuals to take the following steps:

1. Verify if their medication is part of the recall by checking the lot number.
2. Contact their pharmacist and prescribing healthcare provider for guidance and to arrange for an alternative medication.
3. Follow instructions from their pharmacist or local health authority for proper disposal of the recalled medication.

Analysis of SDGs, Targets, and Indicators

1. Which SDGs are addressed or connected to the issues highlighted in the article?

The article on the recall of blood pressure medication due to a cancer-causing chemical impurity connects to several Sustainable Development Goals (SDGs). The primary connections are with goals related to health, responsible production, and institutional effectiveness.

• SDG 3: Good Health and Well-being: This is the most directly relevant SDG, as the article discusses a public health risk associated with a widely used medication for non-communicable diseases like high blood pressure and mental health conditions like PTSD. The recall aims to prevent adverse health consequences, including cancer.
• SDG 12: Responsible Consumption and Production: This goal is relevant because the issue stems from a production problem—the contamination of a pharmaceutical product with a hazardous chemical. The recall itself is an act of corporate responsibility aimed at managing the lifecycle and impact of a product that has become unsafe for consumption.
• SDG 16: Peace, Justice and Strong Institutions: The article highlights the role of a key public institution, the U.S. Food and Drug Administration (FDA). The FDA’s actions in classifying the risk, overseeing the recall, and providing public information demonstrate the function of an effective and transparent institution dedicated to protecting public safety.

2. What specific targets under those SDGs can be identified based on the article’s content?

Based on the article’s focus, the following specific targets can be identified:

1. SDG 3: Good Health and Well-being

   • Target 3.4: “By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.” The recalled drug, prazosin hydrochloride, is used to treat high blood pressure (a non-communicable disease) and is also prescribed for PTSD symptoms. The recall, prompted by a “cancer-causing chemical,” is a preventative measure to avoid increasing mortality from another non-communicable disease (cancer).
   • Target 3.9: “By 2030, substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water and soil pollution and contamination.” The recall is a direct response to the presence of a hazardous chemical, “N-nitroso Prazosin impurity C,” in a pharmaceutical product. The article states that “Exposure to the product can lead to severe health risks,” directly linking the chemical contamination to potential illness and death.

2. SDG 12: Responsible Consumption and Production

   • Target 12.4: “By 2020, achieve the environmentally sound management of chemicals and all wastes throughout their life cycle…and significantly reduce their release to air, water and soil in order to minimize their adverse impacts on human health…” The recall of over half a million bottles of medication by Teva Pharmaceuticals is an example of managing the adverse human health impacts of a chemical impurity introduced during the product’s life cycle. It represents a corrective action in the management of chemical safety in consumer products.

3. SDG 16: Peace, Justice and Strong Institutions

   • Target 16.6: “Develop effective, accountable and transparent institutions at all levels.” The article showcases the role of the FDA as an effective and transparent institution. The FDA’s classification of the recall as a “Class II risk,” its public reporting on the specific impurity, and the provision of a public-facing “Enforcement Report” are all actions that demonstrate institutional accountability and transparency in protecting public health.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

The article provides specific information that can serve as or imply indicators for measuring progress towards the identified targets:

1. Indicators for SDG 3 Targets

   • For Target 3.9 (Reduce illnesses from hazardous chemicals): The article provides a direct, quantifiable indicator: the number of product units recalled due to chemical contamination. The text specifies, “The recall involves more than 580,000 prazosin hydrochloride capsules,” broken down by dosage: “1 mg capsules: 181,659 bottles,” “2 mg capsules: 291,512 bottles,” and “5 mg capsules: 107,673 bottles.” Tracking the frequency and volume of such recalls serves as a measure of how well hazardous chemicals are being managed in consumer products.

2. Indicators for SDG 12 Targets

   • For Target 12.4 (Sound management of chemicals): An implied indicator is the implementation of corporate and regulatory policies for product safety and recalls. The article describes a “voluntary recall” issued by Teva Pharmaceuticals, which points to a corporate policy for managing product safety issues. This action, coupled with the FDA’s oversight, indicates a system for the sound management of chemical risks.

3. Indicators for SDG 16 Targets

   • For Target 16.6 (Effective and transparent institutions): An indicator is the public availability of information from government institutions. The article explicitly mentions and links to the FDA’s public database, stating, “For more information about the Code Information and the recall lot number, visit the FDA’s Enforcement Report here.” The existence and accessibility of such a report is a clear indicator of institutional transparency and accountability.

4. Table of SDGs, Targets, and Indicators

Source: ca.news.yahoo.com