Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device. Propylhexedrine should only be used via inhalation, any other route can cause serious harm. Immediate medical attention is needed in people who experience severe anxiety or agitation, confusion, hallucinations, paranoia, rapid heartbeat or abnormal heart rhythm, chest pain or tightness. Serious complications from abuse/misuse can lead to death. There is no specific reversal agent in cases of acute intoxication, symptomatic and supportive care should be provided. Lamotrigine (Lamictal) Safety Communication: Increased Risk of Arrhythmias 3/31/21 FDA study review finds a potential increased risk of arrhythmias in patients with heart disease while taking lamotrigine. Safety studies are now being required on medications in the same drug class. Reports of abnormal electrocardiographic findings, chest pain, loss of consciousness, and cardiac arrest prompted further investigation into lamotrigine’s effect on the heart. The public will be updated when additional information becomes available. Providers should assess risks and benefits in patients taking lamotrigine who also have clinically important structural and functional heart disorders, including heart failure, valvular heart disease, congenital heart disease, conduction system disease, ventricular arrhythmias, Brugada syndrome or risk factors for coronary artery disease. Major Medication/Drug‐Related Product Recalls Announced Through MedWatch: Spironolactone 25 mg & 50 mg Tablets, Bryant Ranch Prepack: Recall – Mislabeled, Incorrect Strength 3/10/21 Bryant Ranch Prepack recalled 4 lots of spironolactone tablets because the products have been mislabeled, displaying the incorrect strength. Prepackaged bottles labeled spironolactone 50 mg may contain 25 mg tablets and vice versa. The recalled products include spironolactone 25 mg tablets (NDC 63629106401 [lot 148969], NDCs 63629106402 & 63629106403 [lot 148791] and 50 mg tablets (NDC 63629106701 [lot 148992]), all with an expiration date of 7/31/2022. FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 2 Phenylephrine HCl Injection 10 mg/mL, Sagent Pharmaceuticals: Compromised Vial Seal 3/12/21 Three lots of Phenylephrine hydrochloride injection, USP 10 mg/mL vials (NDC 25021‐315‐01) manufactured by Indoco Remedies Ltd. and distributed by Sagent Pharmaceuticals, were recalled due to potentially loose crimped vial over‐seals which could result in non‐sterile product. Lot numbers involved are PHT8IB2, PHT9IB2, and PHT1JB2. Heal the World Hand Sanitizer 9.6 oz, PNHC: Recall – Resemble Water Bottles 3/17/21 PNHC, LLC, doing business as Heal the World, recalled all lots of Heal the World hand sanitizer packaged in 9.6 oz bottles because they resemble water bottles. No other package sizes were recalled. ChloraPrep 3 mL applicators by BD: Recall ‐ Microbial Contamination Risks 3/25/21 The FDA advised health care providers not to use ChloraPrep 3 mL applicators manufactured by BD (Becton, Dickinson and Company) and labeled with “CareFusion, El Paso, TX” following a recall expansion to include the applicators in all U.S. states. The product is prone to microbial contamination due to product lid failure when exposed to high temperature and humidity, including the growth of Aspergillus penicillioides within the packaging. The drug is used to sanitize skin prior to surgery or catheter procedures. Telmisartan Tablets 20 mg, Alembic Pharmaceuticals: Recall ‐ Mislabeling and Incorrect Strength 3/25/21 One lot of telmisartan 20 mg, USP tablets packaged in 30‐count bottles (lot 1905005661) was recalled due to incorrect product strength in the package (40 mg). FDA advises to check tablets for shape and imprint; the 20 mg tablets should be round with an L202 imprint. Acyclovir Sodium Injection 50 mg/mL, Zydus: Recall ‐ Crystallization 3/25/21 Four lots of acyclovir sodium injection 50 mg/mL in 10 mL and 20 mL vials were recalled after complaints of crystallization in vials. Lots being recalled are L000155, L000156, L000126 and L000127. Durisan Antimicrobial Solutions Hand Sanitizer: Recall – Microbial Contamination 3/25/21 Sanit Technologies LLC, doing business as Durisan, recalled Durisan Antimicrobial Solutions Hand Sanitizer due to microbial contamination with Burkholderia cepacia complex and Ralstonia pickettii. A complete list of the recalled lots can be found on the FDA site and the product has been added to the FDA do‐not‐use list of hand sanitizers. Dietary Supplement Recalls & Public Notifications Notifications were issued regarding undeclared active ingredients or contaminants in the following products. Patients are advised not to purchase or use these products. Product Promoted Use Undeclared Ingredient(s) or Contaminants 2 Own The Knight Sexual enhancement Sildenafil and tadalafil 69MODE Blue 69* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Furious X 1350 Sexual enhancement Sildenafil and tadalafil Imperial Extreme 2000 mg* Sexual enhancement Sildenafil and tadalafil Krazy Night* Sexual enhancement Sildenafil, tadalafil and vardenafil PremierZen Black 5000* Sexual enhancement Sildenafil and tadalafil Rhino SE7EN2 Sexual enhancement Sildenafil and tadalafil Shogun‐X 15000mg* Sexual enhancement Sildenafil, tadalafil and vardenafil Shogun‐X 7000* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Stiff Rox Sexual enhancement Sildenafil and tadalafil Titanium 18K Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Black 25K* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Thumbs Up 7 Blue 69K* Sexual enhancement Sildenafil and tadalafil Thumbs Up 7 Red 70K* Sexual enhancement Sildenafil, tadalafil and vardenafil Thumbs Up 7 White 11K* Sexual enhancement Sildenafil, tadalafil and/or vardenafil Yin‐Yang Essence Men Power Sexual enhancement Sildenafil and tadalafil Zing Plus Sexual enhancement Sildenafil *recalled FDA Activity Newsletter WSU Drug Information Center March 2021 Page | 3 New Product Shortages Date Initially Posted Desmopressin Acetate (Stimate) Nasal Spray 3/12/21 Disopyramide phosphate capsules 3/19/21 Cortisone acetate tablets 3/26/21 Chlordiazepoxide hydrochloride USP capsules 3/30/21 Brand Name or Sole Source Product Discontinuations/Withdrawals Date Posted Neomycin sulfate, polymyxin b sulfate, bacitracin zinc, and hydrocortisone ointment (Cortisporin, Pfizer) 3/9/21 – alternative corticosteroid and antibiotic combinations remain available Neomycin sulfate, polymyxin b sulfate, and hydrocortisone cream (Cortisporin, Pfizer) ‐– alternative 3/9/21 corticosteroid and antibiotic combinations remain available Estradiol patch (Alora, Allergan) – alternative estradiol transdermal products remain available 3/24/21 Norethindrone acetate, ethinyl estradiol tablets (Femhrt, Allergan) – generics remain available 3/24/21 Norethindrone acetate, ethinyl estradiol, ferrous fumarate kit (Tilia Fe, Allergan) – generics remain 3/24/21 available Norethindrone acetate, ethinyl estradiol, ferrous fumarate kit (Estrostep Fe, Allergan) – generics remain 3/24/21 available New Drug Approvals: Description (See Attached Drug Summaries) Date Approved Serdexmethylphenidate and Central nervous system stimulant for the treatment of attention 3/2/21 dexmethylphenidate / Azstarys / deficit hyperactivity disorder in patients 6 years or older Corium, Inc Tivozanib / Fotivda / Aveo Kinase inhibitor for the treatment of relapsed or refractory 3/10/21 Pharmaceuticals, Inc advanced renal cell carcinoma in patients who have received two or more prior systemic therapies Ponesimod / Ponvory / Janssen Sphingosine 1‐phosphate receptor modulator for the treatment 3/18/21 Pharmaceuticals, Inc of relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing‐remitting disease, and active secondary progressive disease in adult patients. Dasiglucagon / Zegalogue / Zealand