FDA – The Checkup

08MayMay 8, 2023

Provider Alert! Monovalent Moderna and Pfizer-BioNTech COVID-19 Vaccines Removed From Formulary on April 21, 2023

Date: May 8, 2023 Attention: All Providers Effective Date: April 21, 2023 Call to action: Texas Children Health Plan (TCHP) would like to inform providers that effective April 21, 2023, the U.S. Food and Drug Administration (FDA) amended the emergency use authorizations of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines. This is to simplify the vaccination schedule for most individual vaccines, and monovalent are no longer authorized for use in the United States. This announcement includes authorizing the current bivalent vaccines (original and...

By Texas Children's Health PlanFacilities, OB/GYNs, Office Managers, Primary Care Providers, Provider Alert, SpecialistsCOVID, COVID-19, FDA, Formulary, Removal, vaccines0 CommentsRead more...

11AprApril 11, 2023

Provider Alert! FDA Withdrawal of Makena®

Date: April 10, 2023 Attention: All Providers Effective Date: April 06, 2023 Call to action: Effective April 6, 2023, the U.S. Food and Drug Administration (FDA) announced the final decision to withdraw the approval of Makena and its generics, which was approved to reduce the risk of preterm birth in women pregnant with one baby who have a history of spontaneous preterm birth. Makena and its generics are no longer FDA approved and cannot be lawfully distributed. This is in result due to...

By Texas Children's Health PlanFacilities, OB/GYNs, Office Managers, Primary Care Providers, Provider Alert, SpecialistsFDA, makena, pregnancy, Preterm Birth, Withdrawel0 CommentsRead more...

26OctOctober 26, 2022

Provider Alert! Clinical Criteria Update for Orkambi Effective November 9

Date: October 25, 2022 Attention: Providers Effective Date: October 1, 2022 Providers should monitor the Texas Children’s Health Plan (TCHP) Provider Portal regularly for alerts and updates associated to the COVID-19 event. TCHP reserves the right to update and/or change this information without prior notice due to the evolving nature of the COVID-19 event. Call to action: Texas Children Health Plan (TCHP) will revise clinical prior authorization criteria for Orkambi (lumacaftor/ivacaftor) to comply with the recent Food and Drug Administration-approved age indications. How this impacts...

By Texas Children's Health PlanFacilities, OB/GYNs, Office Managers, Primary Care Providers, Provider Alert, Specialistsclinical criteria, cystic fibrosis, FDA, orkambi, Prior Authorization0 CommentsRead more...

08AprApril 8, 2020

Provider Alert! FDA removing all ranitidine products from the market

Attention: All Providers and Pharmacies Effective Date: April 2, 2020 Call to action: The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in...

By Texas Children's Health PlanOB/GYNs, Office Managers, Primary Care Providers, Provider Alert, SpecialistsFDA, provider alert, provider alerts, Ranitidine0 CommentsRead more...

06JanJanuary 6, 2020

Zantac/ranitidine drug recalls due to NDMA impurity

Multiple drug manufacturers have issued voluntary drug recalls for several Zantac drug products and its generic, ranitidine. Ranitidine is a histamine-2 receptor antagonist used to treat heartburn and related conditions. Potentially impacted customers are being notified with a recommendation to stop taking the medication and to discuss alternative therapies with their provider. The recalls are due to discovery of an impurity (N-nitrosodimethylamine [NDMA]) in the finished product. NDMA is classified as a probable human carcinogen that may be found in certain...

By Texas Children's Health PlanOB/GYNs, Primary Care Providers, SpecialistsDrug Recall, FDA, Recall, Zantac0 CommentsRead more...

12JunJune 12, 2017

Provider Alert! Codeine and Tramadol should NOT be prescribed for children

On April 20, 2017 the US Food and Drug Administration (FDA) issued a statement that CODEINE is CONTRAINDICATED for treatment of pain or cough for children under 12 years. The also WARN against its use in adolescents 12-18 years old, especially those with obesity, obstructive sleep apnea, or severe lung disease. The FDA considers TRAMADOL to be CONTRAINDICATED for children younger than 18 to treat pain from tonsillectomy or adenoidectomy. Note that Tramadol is not FDA approved for use in...

By Texas Children's Health PlanPrimary Care ProvidersAAP, Codeine, FDA, Pain Medication, Pain Medicine, provider alert, Tramadol0 CommentsRead more...

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