5 Essential Drugs Currently Facing Shortages

Earlier this year, the number of active US drug shortages hit an all-time high of 323.¹ As of September 2024, this number decreased to 277, yet 50% of these shortages have persisted for 2 or more years, impacting lifesaving products.

Drug shortages occur when commercial supply fails to meet demand.² Generally, these shortages fall within 3 key categories: product-specific issues, marketwide supply constraints, and reimbursement and market access limitations. Contributing factors within these categories include natural disasters, market economics, product discontinuation, sourcing or manufacturing limitations, and shifts in prescribing or patient demand patterns.

Although the total number of shortages has declined from its peak, many continue to persist. Here are 5 drugs currently experiencing shortages in the US:

1. ADHD Medications

Various medications used to treat attention-deficit/hyperactivity disorder (ADHD) have been listed in the FDA Drug Shortage Database since 2022.³ This includes amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate tablets; the shortage was first reported on October 12, 2022. This treatment contains central nervous system stimulants that contribute to hyperactivity and impulse control.⁴

It is available in all doses through Elite Laboratories, Epic Pharma, Lannett Company, Sunrise Pharmaceutical, and USPharma Windlas.³ Conversely, Alvogen, Aurobindo, Granules Pharmaceuticals, and SpecGx reported a shortage of all or some doses due to a shortage of an active ingredient. Also, Teva reported a shortage in select doses due to increased demand for the drug, and Sandoz had most doses on intermittent backorders through October 2024.

Another ADHD medication currently in shortage is lisdexamfetamine deimsylate, which increases attention and decreases restlessness in adults and children who are overreactive, cannot concentrate for long periods, or are easily distracted and impulsive.⁵ This treatment was added to the Drug Shortage Database on July 14, 2023.³

All or select doses of this treatment, respectively, are available through Takeda Pharmaceuticals and Rhodes Pharmaceuticals. Conversely, other manufacturers, including Alvogen, Apotex, Hikma, Lannett Company, Viatris, Solco Healthcare, and Sun Pharma, have limited availability due to a shortage of an active ingredient; similarly, SpecGx has it on backorder due to this shortage.

2. Pain Treatments

Several treatments used to manage pain are currently in shortage, including injectable opioids like morphine sulfate and fentanyl citrate. Morphine sulfate injection was first added to the Drug Shortage Database 7 years ago on October 31, 2017. It is currently available in select dosing through Amphastar, Fresenius Kabi, Hikma, Pfizer, and Piramal Critical Care. Conversely, Fresenius Kabi, Hikma, and Pfizer continue to face high demand, impacting their stock.

Additionally, fentanyl citrate injection was first added to the Drug Shortage Database on January 1, 2012. It is available in most doses through Fresenius Kabi, Pfizer, and Hikma. However, certain doses from Pfizer and Hikma have limited supply or rely on scheduled production to meet demand, respectively.

3. Chemotherapy Drugs

Although the shortage of cisplatin, a widely used chemotherapy drug, was resolved this past summer, the shortage of other chemotherapy drugs, like methotrexate sodium injection and carboplatin, persists.⁶

Methotrexate sodium injection, a chemotherapy treatment that kills cancer cells by preventing them from making DNA, was first added to the Drug Shortage Database on March 13, 2023.³ It is currently available through Fresenius Kabi and Hikma Pharmaceuticals.

Conversely, methotrexate sodium injection is unavailable through Accord, Pfizer, and Teva. Accord noted that it will be unavailable for 30 to 45 days due to the shortage of an active ingredient, while Pfizer and Teva only have limited availability due to increased demand for the drug.

Similarly, carboplatin injection was first added to the Drug Shortage Database on April 28, 2023. It is available through various manufacturers (Eugia, Fresenius Kabi, Gland Pharma Limited, Ingenus, and Teyro Labs). However, Pfizer and Teva have carboplatin in shortage due to increased demand, while Accord is dealing with manufacturing delays.

4. Insulin

Because of various shortages this past year, many patients with diabetes have had trouble obtaining insulin.⁷ Eli Lilly reported shortages of 10 mL vials of insulin lipro (Humalog) as new regulations led to a brief manufacturing delay. This also resulted from increased demand as other manufacturers struggled with shortages, causing patients to seek Lilly's insulin. However, Lilly discontinued its 3 mL Humalog vials, which were mainly used by hospitals, to free up capacity for 10 mL vials.

Novo Nordisk reported similar shortages for insulin aspart (Fiasp or NovoLog). It announced that manufacturing delays will cause Fiasp vials to be in short supply through October. Earlier this year, Novo Nordisk also reported shortages of NovoLog.

Another contributor to the insulin shortage was manufacturers discontinuing their products. For example, Novo Nordisk announced last November that it would be transitioning insulin detemir injection (Levemir FlexPens and vials) out of the US market by the end of 2024.⁸ Therefore, there is insufficient supply for usual ordering as Novo Nordisk's stock is expected to be depleted by early December 2024.

5. Diabetes/Weight Loss Medications

On Thursday, after years of ongoing shortages due to increasing demand, all doses of Ozempic and Wegovy (semaglutide; Novo Nordisk) are now listed as “available” on the drug shortage list.⁹ Despite this, the FDA still considers it in shortage since patients may experience variability at a particular pharmacy location regardless of whether a drug is in shortage.

Once the Ozempic and Wegovy shortage is completely over, the FDA will list them as “resolved” and remove them from the shortage list. This was done earlier this month for Mounjaro and Zepbound (Eli Lilly) as the supply now exceeds demand.

Ozempic and Wegovy both contain semaglutide, while Mounjaro and Zepbound contain tirzepatide. Ozempic and Mounjaro are both FDA-approved to treat patients with type 2 diabetes, and Wegovy and Zepbound are approved for weight loss.

Honorable Mention: IV Fluids

Earlier this month, the FDA added Dextrose 70% intravenous (IV) solution, Peritoneal Dialysis Solution, and Lactated Ringers IV Solution to the Drug Shortage Database.¹⁰ This is because of Hurricane Helene’s impact on a Baxter manufacturing plant, which produces over 60% of large-volume IV fluids in the US.¹¹ As a result, Baxter products are not available in adequate supply to meet the current demand.

Given the shortage, the FDA released guidance that allows temporary flexibility for compounding these drugs without patient-specific prescriptions.¹⁰ It urges careful patient tracking for compounded drug-related issues and encourages reporting adverse events.

If supplies dwindle, additional drugs could be added to the shortage list. The FDA also acknowledged concerns about expired IV fluids, clarifying that extending expiration dates requires manufacturer stability data; as of October 18, no such data has been received to support an extension.

References

1. National drug shortages: January 2001 to September 2024. ASHP. Accessed October 31, 2024. https://www.ashp.org/drug-shortages/shortage-resources/drug-shortages-statistics
2. Pourmahram T. Collaborative solutions are needed to address and mitigate America’s drug shortages. AJMC. June 17, 2024. Accessed October 31, 2024. https://www.ajmc.com/view/collaborative-solutions-are-needed-to-address-and-mitigate-america-s-drug-shortages
3. FDA Drug Shortages. FDA. Accessed October 31, 2024. https://dps.fda.gov/drugshortages
4. Durbin K. Adderall. Drugs.com. Updated August 23, 2023. Accessed October 31, 2024. https://www.drugs.com/adderall.html
5. Lisdexamfetamine dimesylate (oral route). Mayo Clinic. Updated February 1, 2024. Accessed October 31, 2024. https://www.mayoclinic.org/drugs-supplements/lisdexamfetamine-dimesylate-oral-route/description/drg-20070888
6. Keenan J. FDA commissioner heralds end to US shortfall of chemo drug cisplatin. Fierce Pharma. July 1, 2024. Accessed October 31, 2024. https://www.fiercepharma.com/manufacturing/fda-heralds-end-us-shortfall-chemo-drug-cisplatin
7. Alltucker K. As insulin shortages persist, what diabetes patients can do. USA Today. October 24, 2024. Accessed October 31, 2024. https://www.usatoday.com/story/news/health/2024/10/24/insulin-shortage-2024-ozempic-diabetes/75821654007/
8. Insulin detemir injection. ASHP. Updated September 22, 2024. Accessed October 31, 2024. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=1006
9. Kindelan K. Ozempic, Wegovy move closer to no longer being in shortage, FDA says. ABC News. October 30, 2024. Accessed October 31, 2024. https://abcnews.go.com/GMA/Wellness/ozempic-wegovy-move-closer-longer-shortage-fda/story?id=115321505
10. Gallagher A. FDA adds intravenous fluids to list of drug shortages. Pharmacy Times. October 18, 2024. Accessed October 31, 2024. https://www.pharmacytimes.com/view/fda-adds-intravenous-fluids-to-list-of-drug-shortages
11. Navigating IV fluid shortages post-Hurricane Helene: insights from USP on compounding and conservation strategies. Pharmacy Times. October 24, 2024. Accessed October 31, 2024. https://www.pharmacytimes.com/view/navigating-iv-fluid-shortages-post-hurricane-helene-insights-from-usp-on-compounding-and-conservation-strategies