As of July 13th, the Food and Drug Administration (FDA) has reported a substantial shortage of Bumetanide Injections, an essential drug utilized in the field of cardiology. Bumetanide holds a critical role in the management of various cardiovascular conditions, contributing to the effective treatment and care of patients.
However, the current scarcity of Bumetanide Injection has raised concerns throughout the healthcare industry. The shortage of Bumetanide Injections has led to several implications affecting patients, physicians, and healthcare facilities.
Treatment plans have been compromised, and healthcare providers are under increased pressure to explore alternative therapies. It is crucial to address this shortage promptly and find effective solutions to minimize the impact on patient care and overall healthcare delivery.
Reasons for the shortage of Bumetanide Injection
Bumetanide holds great importance in the field of medicine due to its therapeutic effects and mechanism of action. As a loop diuretic or “water pill,” bumetanide plays a vital role in the management of fluid retention (edema) and swelling caused by various medical conditions such as congestive heart failure, liver disease, kidney disease, and more.
One of the key reasons Bumetanide is highly valued for its ability to block the active reabsorption of chloride and, possibly, sodium in the ascending loop of Henle. Doing so disrupts the normal electrolyte transfer in the proximal tubule, leading to the excretion of sodium, chloride, and water.
This diuretic effect promotes increased urine production, helping to reduce fluid accumulation in the body. This can provide much-needed relief to individuals suffering from conditions that cause edema, such as heart failure, liver dysfunction, and kidney disorders.
The shortage of Bumetanide Injections can be attributed to several reasons, as reported by the American Society of Health-System Pharmacists (ASHP).
The affected products and the reasons are enlisted in detail below:
| Products Affected | Description | Reason for Shortage provided by the Manufacturer |
| Bumetanide injection, Hikma, 0.25 mg/mL, 10 mL vial, 10 counts | NDC 00641-6007-10 | Hikma did not provide a reason for the shortage |
| Bumetanide injection, Hikma, 0.25 mg/mL, 4 mL vial, 10 counts | NDC 00641-6008-10 | Hikma did not provide a reason for the shortage |
| Bumetanide injection, Pfizer, 0.25 mg/mL, 10 mL vial, 10 counts | NDC 00409-1412-10 – discontinued | Pfizer has discontinued bumetanide injection in August 2022 |
| Bumetanide injection, Pfizer, 0.25 mg/mL, 4 mL vial, 10 counts | NDC 00409-1412-04 – discontinued | Pfizer has discontinued bumetanide injection in August 2022 |
Hikma manufacturing delays
Hikma, a pharmaceutical company, did not provide a specific reason for the shortage of Bumetanide injections. However, according to the information shared by FDA, the shortage can be attributed to an increase in demand for the drug.
The following products are affected:
- 0.25 mg/mL, 4 mL vial: Currently, there is inventory available, but additional lots are scheduled for manufacturing and will be released gradually as they become available to meet the demand.
- 0.25 mg/mL, 10 mL vial: This presentation is temporarily on backorder. However, additional lots were expected to be manufactured and become available between May and June 2023. The product will be made available as it is released.
Pfizer has discontinued production
Pfizer a major pharmaceutical company, has discontinued the production of bumetanide injection as of August 2022. This decision by Pfizer to discontinue the medication has had a significant impact on the overall availability of bumetanide in the market.
Fresenius Kabi has reported increased demand
Fresenius Kabi, another pharmaceutical company, currently has Bumetanide Injections available. However, they have reported an increase in demand for the drug. This surge in demand puts additional strain on the existing supply of bumetanide injection.
Consequences of shortage of Bumetanide injections
The shortage of Bumetanide Injections has led to several consequences, impacting both patients and the healthcare system. Some of the significant consequences include:
Delayed or inadequate symptom relief
Bumetanide injection is known for its effectiveness in relieving symptoms associated with fluid retention, such as swelling and edema. However, the shortage may lead to delayed or inadequate symptom relief for patients. Without access to bumetanide, patients may experience prolonged discomfort and reduced quality of life, as alternative treatments may not be as effective in managing their symptoms.
Increased healthcare costs
The shortage of Bumetanide Injections can result in increased healthcare costs for patients and healthcare facilities. Alternative medications or therapies may be more expensive, leading to financial burdens for patients. Healthcare facilities may also incur higher costs by having to source and administer alternative treatments, which can strain limited resources.
Disruption of patient care plans
Bumetanide injection is often an integral part of a patient’s care plan, particularly for individuals with chronic heart conditions requiring long-term management. The shortage disrupts the continuity of care, forcing healthcare providers to make adjustments to treatment plans on short notice.
Increased workload for healthcare providers
Healthcare providers, already burdened with numerous responsibilities, may face an increased workload due to the shortage. They may need to invest additional time and effort in finding suitable alternatives, closely monitoring patients, and managing any potential complications arising from the shortage.
Strategies to mitigate the shortage of Bumetanide injections
Several strategies can be considered to mitigate the bumetanide injection shortage. One potential approach involves easing regulatory processes to expedite the release of available lots. Here are a few strategies that can help address the shortage:
Easing regulatory processes for the release of lots
Streamlining regulatory processes can help expedite the release of available bumetanide injection lots, ensuring timely access to the medication.
Regulatory bodies should consider easing the review and approval processes for manufacturing and releasing bumetanide injection lots. By doing so, they can facilitate the swift availability of medication to meet the demand and alleviate the shortage.
Seeking alternative manufacturing initiatives
Since Pfizer, a major manufacturer, has discontinued bumetanide production, it is crucial to identify and encourage other manufacturing plants to take the initiative.
Pharmaceutical companies, in collaboration with regulatory authorities, should explore partnerships with other manufacturers capable of producing bumetanide injection. This would help mitigate the impact of Pfizer’s discontinuation and ensure a sustained supply of the medication.
Increasing manufacturing by companies with high demand
Pharmaceutical companies reporting an increase in demand for bumetanide injection should focus on ramping up their manufacturing capacity.
Companies that have reported an increase in demand should invest in expanding their manufacturing capabilities. This would help meet the growing market needs and address the shortage by ensuring an adequate supply of the medication.
Consideration of alternative diuretic options
In the face of the bumetanide shortage, healthcare providers should consider alternative diuretic options such as furosemide and torsemide.
Furosemide and torsemide are effective diuretic medications that can serve as substitutes when bumetanide is not readily available. Including these alternatives in treatment protocols can help manage fluid retention in patients until bumetanide becomes accessible again.
Selective use of bumetanide for critical patients
To optimize the limited supply of bumetanide injection, it should be reserved for the most critical patients for whom no other suitable alternative exists.
Healthcare providers should exercise caution and prescribe bumetanide only when it is deemed essential and no other viable options are available. This targeted approach ensures that the medication is prioritized for patients who truly require it.
Alternative medication options for Bumetanide injection
Alternative medication options to consider during the bumetanide shortage include furosemide and torsemide. Here is the dosage equivalence information:
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Furosemide
Similar to Bumetanide, Furosemide treats hypertension by decreasing blood pressure. Fluid retention (edoema) and high blood pressure (hypertension) are two of the most common indications for Furosemide.
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Torsemide
Just like Bumetanide, Torsemide is a loop diuretic. Edema due to heart failure, kidney disease, or liver disease are treated with this medication.
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Spironolactone
Potassium-sparing diuretic Spironolactone is frequently combined with other diuretics. Conditions like heart failure, cirrhosis of the liver, and hormonal imbalances benefit from its ability to decrease fluid retention.
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Hydrochlorothiazide
Thiazide diuretics like hydrochlorothiazide are commonly prescribed for the treatment of edema and high blood pressure. It helps reduce blood pressure and stimulates the production of more urine.
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Ethacrynic Acid
Another diuretic medication that can be used instead of Bumetanide is Ethacrynic Acid. Primarily, it is used to treat edema, and it is especially useful for those who may be allergic to other diuretics.
Pipeline Medical in shortage of Bumetanide Injections
Pipeline Medical understands the difficulties you may be facing due to the shortage, and we want to assure you that we are here to assist you. If you are experiencing any issues with the availability of Bumetanide injections, we encourage you to reach out to us. Our dedicated customer support team is ready to provide guidance, support, and assistance in navigating through this shortage.
