Smiths Medical is recalling certain CADD Administration Sets and Medication Cassette Reservoirs

Smiths Medical Recalls Certain CADD System Administration Sets and Cassette Reservoirs for Issues Causing Delay, Interruption, or Under-Delivery of Therapy

Smiths Medical is recalling certain CADD Administration Sets and Medication Cassette Reservoirs, used with the CADD ambulatory infusion system, for two issues: a risk of tubing occlusion and a risk of false “No Disposable Attached (NDA)” alarms. Either of these issues can cause delay of therapy, interruption 12 Drug News – Volume 10, Issue 2
of therapy, or under-delivery of medication, which all have the potential to cause serious patient harm or death.

The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.

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Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant

Global Pharma Healthcare Issues Voluntary Nationwide Recall of Artificial Tears Lubricant Eye Drops Due to Possible Contamination

Global Pharma Healthcare is voluntarily recalling all lots within expiry of their Artificial Tears Lubricant Eye Drops, distributed by /EzriCare, LLC- and Delsam Pharma, to the consumer level, due to possible
contamination. The Centers for Disease Control and Prevention (CDC) alerted FDA to an investigation of a multi-state cluster of Verona Integron-mediated Metallo-β-lactamase (VIM)- and Guiana-Extended
Spectrum-β-Lactamase (GES)- producing carbapenem-resistant Pseudomonas aeruginosa (VIM-GESCRPA) infections possibly associated with the use of the artificial tears manufactured by Global Pharma Healthcare. To date, there are 55 reports of adverse events including eye infections, permanent loss of vision, and a death with a bloodstream infection. Risk Statement: Use of contaminated artificial tears can result in the risk of eye infections that could result in blindness.

Artificial Tears (carboxymethylcellulose sodium) Lubricant Eye Drops, 10 mg in 1 mL, ½ fl oz (15 ml) bottle are used as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Consumers with questions regarding this recall can contact the distributors: Aru Pharma/Ezricare, LLC – by phone: 1-518-738-7602 or by e-mail: arupharmainc@yahoo.com from Monday to Friday, 11am to 4pm
EST; or DELSAM Pharma LLC by phone: 1-866-826-1309 or by e-mail: delsampharma@yahoo.com from Monday to Friday from 11am to 4pm EST. Consumers should contact their physician or healthcare
provider if they have experienced any problems that may be related to using these over-the-counter drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA0178

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Trodelvy

FDA Approves Trodelvy (sacituzumab govitecan-hziy)for patients with
specific metastatic hormone recepter breast cancers having received
endocrine-based therapy and at least two additional therapies.

The Food and Drug Administration has approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for patients with unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Trodelvy (sacituzumab govitecan-hziy) is a targeted-chemotherapy drug used to treat certain types of breast and urothelial cancers (a type of bladder cancer). Trodelvy is an antibody-drug conjugate containing an antibody called sacituzumab linked to govitecan (SN-38), a chemotherapy drug.

Sacituzumab targets and attaches to a protein called Trop-2, which is overexpressed on the surface of certain cancer cells. The antibody-drug conjugate is then internalized into the cancer cell where the linker between the antibody and drug is broken by a process called hydrolysis, releasing the chemotherapeutic govitecan into the cancer cells.

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Jesduvroq

FDA Approves Jesduvroq (daprodustat) for Anemia Caused by Chronic
Kidney Disease for Adults on Dialysis

The U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis. Other FDA-approved treatments for this condition are injected into the blood or under the skin. The FDA granted the approval to GlaxoSmithKline LLC.

Jesduvroq is not approved for patients with anemia due to chronic kidney disease who are not on dialysis because its safety has not been established in that population.

The most common side effects of Jesduvroq include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.

Patients should not use Jesduvroq if they also take certain drugs that cause increased levels of Jesduvroq or if they have uncontrolled high blood pressure.

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