Current and resolved drug shortages and discontinuations reported to FDA are found here. Below, please find shortages and other isotope supply news reported by our members and industry partners. If you have specific questions about shortages and would like to connect with other members, please visit SNMMI Connect.
July 5, 2022
Novartis resumes production and delivery of radioligand therapy medicines ahead of schedule
In early June, Novartis restarted radioligand therapy (RLT) production at its sites in Ivrea, Italy, and Millburn, New Jersey, and resumed delivery of doses to patients in a phased approach, ahead of the expected six-week timeframe. Issues that led to the temporary, voluntary suspension of production in May have been remediated. These issues did not affect patient safety, and no risk to patients from the doses previously produced at these sites was identified.
Novartis expects that product supply may be initially limited, and they are working hard to resume full production capacity and meet patient demand as quickly as possible. The company continues to communicate with health authorities, and they are aware that Novartis has restarted production and that the delivery of patient doses has resumed. For more information, please click here.
June 30, 2022
Today, Sun Radiopharma informed us that they have a PYP lot entering the market.
May 12, 2022
Iohexol (Omnipaque) and Iodixanol (Visipaque) Shortage
According to a communication from GE Healthcare, a shortage of iohexol (Omnipaque) is occurring as a result of the Chinese government lockdowns related to COVID-19. Secondarily to the iohexol (Omnipaque) shortage, the alternative agent, iodixanol (Visipaque), is in short supply due to an increase in demand. At the recommendation of GE Healthcare, distributors have implemented a 20% allocation on iohexol (Omnipaque) that is expected to continue through the remainder of this shortage. Nearly all of the U.S. supply for this product comes from the Shanghai plant. According to GE Healthcare, the supply impact is not related to quality, raw material supply, or supply chain issues. GE Healthcare will utilize their secondary manufacturing facility in Ireland to supplement U.S. labeled iohexol (Omnipaque) supply.
GE Healthcare has communicated that the impact is temporary, and the Shanghai facility is re-opened and ramping up production as allowed by local COVID-19 mitigation protocols. Total global production of iodine, excluding U.S. production data, was estimated at 32,000 metric tons in 2021 which is equivalent to pre-pandemic levels. GE Healthcare expects to have intermittent supply of iohexol (Omnipaque) until the end of June 2022 and does not have additional information on iodixanol (Visipaque) availability at this time. This mitigation strategy is intended to provide guidance for present and future shortages. Read the full announcement here.
SNMMI is hopeful this supply issue will soon be resolved, but reminds practitioners that radiopharmaceuticals remain available and are an excellent alternative for some diagnostic procedures. For example, V/Q lung scanning should be considered as an alternative to CTA of the pulmonary arteries. Similarly, stress cardiac nuclear studies including PET or SPECT may serve as excellent alternatives in some patients who are scheduled for cardiac CTA.
The American College of Radiology Committee on Drugs and Contrast Media has issued guidance on the contrast agent shortage and has suggested a number of strategies to conserve contrast media including delaying elective procedures.
May 5, 2022
Novartis Announces Temporary Halt in Production of Lutathera® and Pluvicto®
Today, Novartis announced that it will suspend production of Lutathera and Pluvicto at its radioligand therapy production sites in Ivrea, Italy, and Milburn, New Jersey, affecting both commercial and clinical trial supply. The voluntary shutdown is a response to potential quality issues, “out of an abundance of caution,” Novartis said. The company expects that the issues will be resolved within six weeks, at which point production will gradually resume.
One of the drugs, Pluvicto, was approved by the U.S. Food and Drug Administration (FDA) on March 23 to treat metastatic castration-resistant prostate cancer (mCRPC). The therapy, developed after years of extensive research, was shown to reduce the risk of death by 38 percent and reduce the risk of progression by 60 percent in mCRPC patients.
The other drug, Lutathera, was approved by the FDA in early 2018 for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
Novartis hopes to have an update within the next 2-4 weeks.
SNMMI and the patients we serve will need a reliable supply chain for innovative radiopharmaceutical therapies to be used regularly and widely. SNMMI looks forward to further updates and to helping contribute in the radiopharmaceutical therapy space.
Additional information will be posted here as it becomes available. Read the full announcement here.
March 18, 2022
High Flux Reactor back in full operation
NRG restarted the reactor in Petten yesterday, March 17, 2022 as planned. "Within two weeks, the first medical isotopes for nuclear medicine will be delivered to hospitals," said Vinod Ramnandanlal, NRG|PALLAS Commercial Director. "We are pleased that NRG can once again meet the global demand for medical isotopes." Over 1.1 million patient doses will be produced over the next month. Read the full notice here.
March 15, 2022
HFR Reactor Restart on March 17
HFR operations are preparing the start-up of HFR cycle 2022-02 on March 17, 2022 as planned. Nuclear Medicine Europe will provide a further communication only in the event that the restart does not take place on that date. Read the full notice here.
March 8, 2022
HFR Reactor Progresses to March 17 Restart
NRG informed Nuclear Medicine Europe (NMEu) on March 7 that it continues to expect a timely restart of the HFR reactor on March 17, 2022. With commissioning nearly complete and the final inspection of the remaining coolant lines planned for March 9, all other preparations for restart are on track. HFR will provide its next update to NMEu on March 14, 2022. Read the full notice here.
February 23, 2022
Update on HFR Reactor Outage
Recently, HFR reactor operator NRG informed Nuclear Medicine Europe of continued progress in efforts to return HFR to service on 17 March. They have submitted a repair plan to the Dutch regulatory authorities, ANVS. NRG expects that ANVS license review will allow HFR restart on March 17th subject to final ANVS approval.
In addition, there was a brief (40-h) outage at the BR2 reactor in Belgium last week, but that is not expected to have a significant impact on the supply of Mo-99 or Lu-177. Overall, the supplies of Mo-99 and Lu-177 have largely returned to normal. Read the full notice here.
February 15, 2022
HFR Reactor Outage – Medical Isotope Supply Returning to Normal
The Nuclear Medicine Europe (NMEu) Emergency Response Team held a call on February 14 on the unplanned HFR outage that resulted in cancellation of the planned HFR first operating cycle of 2022. NMEu was told that the HFR reactor operator, NRG, has a plan to restart the reactor that is being reviewed by their Reactor Safety Committee before submission to the Dutch nuclear safety authority, ANVS, later this week. NRG is aiming to restart the HFR reactor on March 17 for its second cycle of 2022, noting that the licensing and execution of restoring the cooling function must still be performed.
Fortunately, the MARIA research reactor (Poland) has added additional operating days, which has helped to reduce the loss of HFR production capacity. The BR2 reactor also resumed operations February 12—three days earlier than originally planned. Curium has harvested Mo-99 targets from short irradiations at BR2 and is now processing Mo-99 for customers. IRE will resume production on its high-enriched uranium production line later this week. Read the full notice here.
February 10, 2022
A communication from the NMEu Emergency Response Team (ERT) announced the resumption of IRE HEU Mo-99 and 1-131 operations. All IRE technical operations have been completed. The release of the first batch of HEU-based Mo-99 is planned for February 17 and HEU-based 1-131 for February 28. Read the full notice here.
February 08, 2022
Radiopharmaceutical Tc99m Kit Supply Update
Sun Radiopharma is experiencing a supply interruption for several radiopharmaceutical products. In order to successfully re-enter the market, their current strategy is to continuously manufacture one product at a time until sufficient inventory is obtained. The most critical product, Sulfur Colloid, re-entered the market on January 11, 2022. The next anticipated lot release date is noted below. Lots will continue to be released over the next few months. Read the full notice here.
Product Release Schedule
1. Sulfur Colloid: February 18, 2022
2. Mebrofenin: April 15, 2022
3. Mertiatide: April 21, 2022
4. Pyrophosphate: May 9, 2022
5. Sestamibi: June 14, 2022
6. Medronate: June 30, 2022
February 7, 2022
Further Update on Outage of the HFR Reactor
The Nuclear Medicine Europe Emergency Response Team (ERT) held another call on February 7, 2022, on the Petten HFR outage. Although the root cause of the water leak has been identified, the target date for HFR restart cannot yet be provided due to uncertainties with equipment lead time, project execution and nuclear regulatory agency review. The Nuclear Research and Consultancy Group (NRG) will provide the next update on Monday, February 14, 2022.
Of further importance, as the BR2 reactor resumes operations on Saturday, February 12, several days earlier than planned, the supply situation for Tc-99m for nuclear medicine imaging as well as Lu-177 and I-131 for therapy is expected to return to normal by the end of next week. Medical institutions should contact their radioisotope suppliers to determine the specific impact on their orders. Read the full notice here.
February 3, 2022
HFR Reactor Has Not Resumed Operations As Planned
The Petten High Flux Reactor (HFR) reactor did not resume operations as planned on January 20, 2022 due to the detection of a water leak in a cooling system. The planned first 2022 HFR cycle scheduled from 20 January until 20 February 2022 was subsequently cancelled. At this time, a target date for HFR restart cannot be yet be provided as it is dependent upon selection of the preferred technical option and further elaboration of planning. The Nuclear Research and Consultancy Group (NRG), who manages the reactor, will provide the next update on Monday, February 7, 2022.
The Nuclear Medicine Europe Emergency Response Team (ERT) was also given updates from research reactors and Mo-99 producers in regard to actions underway to limit impacts on Mo-99/Tc-99m supply. However, some shortages of Mo-99/Tc-99m will be inevitable until approximately a week after the BR2 resumes operations on February 12th. Reports also indicated some impact on both Lu-177 and I-131 availability. Medical institutions should contact their radioisotope suppliers to determine the specific impact on their orders. NMEu will communicate again with stakeholders on February 7, 2022. Read the full notice here.
January 26, 2022
Alert: HFR Outage Will Impact Isotope Supply
On January 24, the Emergency Response Team (ERT) of Nuclear Medicine Europe (NMEu) communicated that there will be a delay in the restart of the HFR Reactor that will impact the supply of Mo-99 and Lu-177 in coming weeks.
The delay is due to discovery of a water leak in the reactor beam tube cooling system. The NRG, which operates the HFR reactor, has not yet been able to discover the root cause of the leak and has put a project team in place to determine a plan of action; additional inspections are expected this week. After the root cause is discovered and repaired, regulatory review and approval must take place before the reactor can resume service.
HFR was scheduled to produce both Mo-99 and Lu-117 this week, so the delay will impact supply in coming weeks. “Medical institutions should contact their radioisotope suppliers to determine the specific impact on their orders,” per the communication from the ERT. Read the full letter here.
Last week, the Department of Energy (DOE) and Department of Health and Human Services (HHS), in accordance with the American Medical Isotopes Production Act of 2012 (AMIPA), issued a joint Secretarial certification that there is a sufficient global supply of Mo-99 produced without the use of HEU available to meet the needs of patients in the United States and that it is not necessary to export United States-origin HEU for the purposes of medical isotope production in order to meet United States patient needs. This certification triggers a congressionally mandated ban on exports of HEU for foreign medical isotope production effective January 2, 2022. The Federal Register notice may be viewed here.
On January 2, 2020, DOE published a Federal Register notice (85 FR 3362) certifying that, at the time, there was an insufficient global supply of Mo-99 produced without the use of HEU and that the export of U.S.-origin HEU for the purposes of medical isotope production was the most effective temporary means to increase the supply of Mo-99 to the domestic U.S. market. This certification was effective for no more than two years from the effective date of January 2, 2020. The Federal Register notice stated that DOE would conduct periodic reviews of the domestic U.S. and global Mo-99 market and would work toward a certification to Congress, regarding the sufficiency of supply as soon as the statutory conditions are satisfied.
In October 2021, DOE sought public input as part of its certification development process and analysis to determine the sufficiency of Mo-99 supply to meet U.S. patient needs. SNMMI's comments may be found here.
Yesterday, Jubilant Pharma of Greater New York announced that its supplier is experiencing shortages of Sulfur Colloid that may extend until December. Therefore, the following ordering restrictions will be implemented for all Sulfur Colloid doses:
To request an accommodation, please contact your pharmacist.
As of today, Choletec commercial availability from one manufacturer is anticipated for August 30th. That manufacturer is working on a routine production plan. Customer orders will be filled based on order date and available inventory. Until the manufacturer achieves a routine production schedule, product allocation will be in place due to the limited inventory.
While a global shortage of Choletec (technetium (99mTc) mebrofenin) persists due to a vial shortage, we have reached out to various suppliers. More supply is on the way and should be released beginning mid-July.
Today, one of our members reported an isotope shortage of Choletec (technetium (99mTc) mebrofenin). After conducting further research as to the cause of the shortage, the Society learned that the culprit is a shortage of vials. This shortage is not unprecedented. Some time ago, there was a DTPA shortage because of a shortage of caps for the vials.
SNMMI President Dr. Vasken Dilsizian released the following statement addressing how the COVID-19 pandemic may affect the supply of Mo-99.
Dear Fellow SNMMI Members,
Much like you, the SNMMI leadership has been closely following the rapidly evolving COVID-19 situation—monitoring the latest recommendations provided by the U.S. Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) to help address its inevitable impact on the nuclear medicine and molecular imaging community. In line with the SNMMI’s mission to improve human health by advancing nuclear medicine, molecular imaging, and radionuclide therapy; SNMMI’s primary focus is on how this issue may affect our ability to care for patients; more specifically, how the COVID-19 pandemic may affect the Mo-99 supply situation.
The SNMMI is particularly paying close attention to how the COVID-19 pandemic might affect different parts of the Mo-99 supply chain including production, target processing, and transportation. As you may imagine, many factors can affect this supply chain, including quarantines and closures of schools that result in the absence of key staff, as well as disruptions in the international transportation network. In order to keep our members as informed as possible, SNMMI is currently taking the following steps:
At this time, no Mo-99 shortages have been reported. Moving forward, SNMMI will remain in close contact with government agencies, trade organizations, and other stakeholders in the nuclear medicine and molecular imaging community to help to ensure an adequate supply of Mo-99.
Vasken Dilsizian, MD
A significant shortage of Mo-99 is expected for the first half of November. The NTP facility in South Africa, which has experienced problems since late last year, has not yet been able to return to service, and a technical issue has developed with the High-Flux Reactor (HFR) in the Netherlands, which is now on unplanned shutdown.
The unexpected HFR shutdown coincides with a planned 11-day shutdown of the OPAL reactor in Australia that began October 29, so significant shortages of Mo-99 are anticipated starting in early November. With significant shortages anticipated, it is essential that users contact their generator/nuclear pharmacy providers for advice about their local situation. The Association of Imaging Producers & Equipment Suppliers (AIPES) Emergency Response Team is closely following the situation. The group issued an update on October 30, and SNMMI will post updates as they become available.
NTP Radioisotopes in South Africa reports that they expect to meet with regulators this week regarding their request to resume Mo-99 production operations. With OPAL having a scheduled shutdown from July 16 – 20 will make things more challenging. The AIPES Emergency Response Team is scheduled to meet again on July 23, 2018.