New And Updated Drug Shortages List 11/18/14

The Food and Drug Administration (FDA) has published its new and updated Drug Shortages through 11/18/14. The federal agency publicizes recalls on its website as press releases are not issued for all shortages. View the recalls by New and Updated.

New Drug Shortages

• Baxter, Fresenius Kabi, Hospira, Mylan, and Sagent report shortages of Vancomycin Hydrochloride for Injection, a drug used for serious or severe infections and penicillin-allergic patients. In October 2014, Hospira recalled the medication due to temperature variations during shipping. The companies state that increased demand and shipping delays have caused the shortages. Estimated delivery dates are November, December, and early in 2015.
• Merck has discontinued Imipenem and Cilastatin for Injection (Primaxin I.V. ADD-Vantage), leading to its shortage. The company states that Primaxin 500 mg Vials will continue to be sold but the ADD-Vantage presentation will be discontinued. The agent is a broad spectrum antibacterial agent for intravenous administration, used only to treat or prevent bacterial infections.
• Mylan has discontinued Mesna Injection, stating that the product will be available through mid-2015. Mesna is an intravenous solution administered to cancer patients receiving ifosfamide in order to reduce the risk of hemorrhagic cystitis (inflammation of the bladder).
• Baxter and Hospira, as well as several other companies, have reported shortages of Cefazolin Injection due to an increase in demand. The antibiotic is backordered and may not be available until the end of 2014.
• DORC reports a shortage of Trypan Blue (Membraneblue) due to unavailability of an ingredient. The active ingredient supply disruption is expected to affect the supply for several months. In October 2014, the FDA issued guidance to healthcare providers in using the ophthalmic solution, telling them to prime the syringe by first retracting the plunger or twisting the plunger in a clockwise motion before injecting the fluid.
• GlaxoSmithKline has discontinued Ticarcillin disodium and clavulanate potassium (Timentin) Sterile Powder for Injection & Sterile Injection.

Updated Drug Shortages

The Methylphenidate Hydrochloride (Ritalin, Adderall, Concerta) shortage has been resolved. Actavis, Mallinckrodt, Sandoz, and CorePharm expect no supply issues. The medication for attention deficit hyperactivity disorder (ADHD) has been in short supply for some time. Recently, Mallinckrodt sued the FDA over the drug, stating that the FDA unlawfully reclassified the drug as “not therapeutically equivalent” to Concerta. On November 13, 2014, the FDA changed the classification of the drug, which Mallinckrodt says affects its bottom line.