Risks Associated with the Use of Favipiravir
The FDA Advisory No. 1038-20 warns hospitals and healthcare providers about the risks associated with Favipiravir, highlighting its teratogenic and embryotoxic effects observed in animal studies. The drug is contraindicated for women who are pregnant or may become pregnant, and physicians must confirm a negative pregnancy test before administration. Male patients are also advised to use effective contraceptive methods while on the medication and for a week after discontinuation, with specific caution against sexual intercourse with pregnant women. Additionally, healthcare providers should monitor patients for potential adverse effects and ensure that the risks are fully communicated to them. Adverse drug reactions should be reported to the FDA through the designated link.
Quick Answers
- What is Risks Associated with the Use of Favipiravir about?
- The FDA Advisory No. 1038-20 warns hospitals and healthcare providers about the risks associated with Favipiravir, highlighting its teratogenic and embryotoxic effects observed in animal studies. The drug is contraindicated for women who are pregnant or may become pregnant, and physicians must confirm a negative pregnancy test before administration. Male patients are also advised to use effective contraceptive methods while on the medication and for a week after discontinuation, with specific caution against sexual intercourse with pregnant women. Additionally, healthcare providers should monitor patients for potential adverse effects and ensure that the risks are fully communicated to them. Adverse drug reactions should be reported to the FDA through the designated link.
- What type of law is FDA Advisory No. 1038-20?
- Risks Associated with the Use of Favipiravir (FDA Advisory No. 1038-20) is a Philippine Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID) Issuances enacted by the Congress of the Philippines.
- When was Risks Associated with the Use of Favipiravir enacted?
- Risks Associated with the Use of Favipiravir (FDA Advisory No. 1038-20) was enacted on Jun 5, 2020.
- What is the citation for Risks Associated with the Use of Favipiravir?
- Risks Associated with the Use of Favipiravir, FDA Advisory No. 1038-20, Jun 5, 2020 (Philippines)
Law Information
- Reference Number
- FDA Advisory No. 1038-20
- Date Enacted
- Subcategory
- Food and Drugs Administration of the Philippines
- Jurisdiction
- Philippines
- Enacting Body
- Congress of the Philippines
Full Law Text
June 5, 2020
FDA ADVISORY NO. 1038-20
| TO | : | All Hospitals and Healthcare Providers |
| SUBJECT | : | Risks Associated with the Use of Favipiravir |
The Food and Drug Administration (FDA) reminds all hospitals and healthcare providers to take extreme caution on the use of Favipiravir. The product has been observed to have teratogenic and embryotoxic effects in animal studies. 1,4 Its use is contraindicated in known or suspected pregnancy.
The FDA advises the licensed physicians to confirm a negative pregnancy test before using Favipiravir in women with child-bearing potential. They should be advised to use or continue using effective contraceptive methods while in use and for another seven (7) days after taking the last dose. If pregnancy is suspected, discontinue its use. 1, 2
Favipiravir is distributed in the sperm. Male patients should be informed of the risk associated on the use of the product. Instruct the patients to use the most effective contraceptive methods while using the product and for another seven (7) days after the last dose. Advise the use of condom and instruct not to have sexual intercourse with pregnant women. 1, 2
Physicians are also advised to carefully monitor patients for other possible adverse effects such as increase in blood uric acid level, diarrhea, decrease in neutrophil count, and elevated liver enzymes — alanine aminotransferase (ALT) & aspartate aminotransferase (AST). 1
The benefit-risk balance should be carefully assessed prior to considering the use of the drug. Risks associated with the drug must be fully explained to patients. 3
All are enjoined to report adverse drug reactions (ADR) to FDA through this link: https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=PH and fill out all the required fields. All hospitals with VigiFlow accounts are encouraged to report in the said platform. For inquiries email us at [email protected]
(SGD.) ROLANDO ENRIQUE D. DOMINGO, MDDirector General
Footnotes
Adverse events were taken from the drug insert.
1. Favipiravir (Haifukang) Tables product information.
2. Favipiravir (Avigan) Tables 200 mg prescribing information. Retrieved 19 May 2020 from https://www.cdc.gov.tw/File/Get/ht8jUiB_MI-aKnlwstwzvw.
3. World Health Organization. (2020). WHO R&D Blueprint. In M. Cavaleri (Chair), COVID-19: Informal consultation on the potential inclusion of Favipiravir in a clinical trial (draft). Geneva, Switzerland.
4. Favipiravir (Avigan) Table 200 mg Review Reports (March 2014), Pharmaceuticals and Medical Devices Agency. Retrieved 26 May 2020 from https://www.pmda.go.jp/files/000210319.pdf.
Cite This Law
Risks Associated with the Use of Favipiravir, FDA Advisory No. 1038-20, Jun 5, 2020 (Philippines)
Risks Associated with the Use of Favipiravir, FDA Advisory No. 1038-20 (Phil. 2020)
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