On April 1, 2020, the US FDA approved Sevenfact(R) (coagulation factor VIIa-jncw) IV injection indicated to treat and control bleeding episodes in adults and adolescents 12 years of age or older with hemophilia A or B with inhibitors. Sevenfact, which contains an active ingredient expressed in genetically engineered rabbits, demonstrated a significantly high proportion of successfully treated mild or severe bleeding episodes in clinical trials. It carries a boxed warning regarding the risk of thrombosis.
Prescribing information can be found at: https://www.fda.gov/media/136610/download.
The monograph for coagulation factor VIIa -jncw can be found at: http://www.micromedexsolutions.com/micromedex2/librarian/deeplinkaccess?source=deepLink&SearchTerm=coagulation+factor+VIIa-jncw.Last modified: 04/07/2020 12:08:39 Full Article
FDA: COVID-19 and NSAIDs
On March 19, 2020, the US FDA addressed reports which raise concerns about the use of NSAIDs, particularly ibuprofen, in patients with Coronavirus 2019 (COVID-19). The FDA is currently not aware of scientific evidence establishing an association between ibuprofen and worsening COVID-19 symptoms. All prescription NSAID labels warn that "the pharmacological activity of NSAIDs in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections." Patients who use over-the-counter (OTC) or prescription drugs should take these medications in accordance with instructions on the label and as directed by their health care professional. The FDA is investigating this issue further and will communicate publicly when more information is available. For the full FDA statement, visit the following link: https://www.fda.gov/drugs/drug-safety-and-availability/fda-advises-patients-use-non-steroidal-anti-inflammatory-drugs-nsaids-covid-19.
HFSA/ACC/AHA: COVID-19 and Antihypertensives
On March 17, 2020, the HFSA/ACC/AHA issued a statement addressing the use of antihypertensives (ie, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or other renin angiotensin aldosterone system (RAAS) antagonists) in COVID-19 patients. Presently, there are no clinical data showing any benefits or risks with the use of antihypertensives in Coronavirus 2019 (COVID-19) patients with a history of cardiovascular (CV) disease. Therefore, healthcare clinicians should not initiate or discontinue any antihypertensive therapy in patients presenting with COVID-19 and underlying CV disease and should make individualized treatment decisions based on best practice standards. As further research data are available, the HFSA/ACC/AHA will update these recommendations as needed. For the full HFSA/ACC/AHA statement, visit the following link: https://www.acc.org/latest-in-cardiology/articles/2020/03/17/08/59/hfsa-acc-aha-statement-addresses-concerns-re-using-raas-antagonists-in-covid-19
The US FDA is working with US Government partners, including Centers for Disease Control and Prevention (CDC), and international partners to address the coronavirus disease 2019 (COVID-19) outbreak. The FDA plays a critical role in protecting the US from threats including emerging infectious diseases. For continual updates and press releases, visit the following FDA website: https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/coronavirus-disease-2019-covid-19.Last modified: 04/03/2020 22:09:18
IBM Micromedex(R) has the following resources to provide assistance during the COVID-19 crisis:
IBM Micromedex(R) and DynaMed(R) COVID-19 Resource Catalog
Investigational Drug Monographs
The following are investigational drugs that are being researched for the treatment of COVID-19:
COVID-19 EUA Drug Monographs
The US FDA has granted Emergency Use Authorization (EUA) for the following drugs to be used to treat suspected or laboratory-confirmed Coronavirus (COVID-19) infection in hospitalized patients:
On April 1, 2020, the US FDA requested the immediate removal of all prescription and over-the-counter (OTC) ranitidine products (Zantac(R) and generics) from the market. This is the most recent step in an ongoing investigation of the risk of N-nitrosodimethylamine (NDMA), a probable human carcinogen, being found in ranitidine products. The FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of NDMA.
Therefore, the FDA is sending letters to all ranitidine manufacturers requesting withdrawal of ranitidine products from the market. The FDA is also advising consumers to stop taking any OTC ranitidine products, dispose of them properly, not buy more, and use other approved OTC products. Patients taking prescription ranitidine should speak with their healthcare professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA.Last modified: 04/01/2020 12:40:13 Full Article
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