Žádost o informaci ze dne 24. 2. 2026

Ústav žádosti vyhověl a poskytl žadateli následující informace.

We would like to inform you that SÚKL does not possess any internal documents, reports, correspondence, meeting minutes, or decisions and resolutions of any kind relating to the safety, effectiveness, or regulatory assessment of oral phenylephrine-containing medicines. Therefore, your request cannot be accommodated.

You also requested answers to the following questions; this request can be accommodated.

What actions has SÚKL taken, if any, to reassess the effectiveness of oral phenylephrine in light of the new scientific evidence made public by the FDA?

SÚKL took no action for the following reasons:

Firstly, the document to which you are referring as the FDA’s unanimous vote is, in fact, only an FDA briefing document and even contains a disclaimer on the first page, which reads:

The attached package contains background information prepared by the Food and Drug Administration (FDA) for the panel members of the Advisory Committee. The FDA background package often contains assessments and/or conclusions and recommendations written by individual FDA reviewers. Such conclusions and recommendations do not necessarily represent the final position of the individual reviewers, nor do they necessarily represent the final position of the Review Division or Office.

We are bringing the issue of whether orally administered phenylephrine is efficacious as a nasal decongestant (when administered at dosages consistent with the Cough, Cold, Allergy, Bronchodilator and Antiasthma [CCABA] over-the-counter [OTC] monograph) to this Advisory Committee in order to gain the Committee’s insights and opinions.

The background package may not include all issues relevant to the final regulatory recommendation and instead is intended to focus on issues identified by the Agency for discussion by the Advisory Committee. The FDA will not issue a final determination on the issues at hand until input from the Advisory Committee process has been considered and all reviews have been finalized. The final determination may be affected by issues not discussed at the Advisory Committee meeting.

These documents cannot be considered new scientific evidence in themselves until, as stated in the document, the topic has been fully discussed and concluded. We will present the scientific data that support our conclusions and seek concurrence from the AC on the strength of that evidence. Because this would represent a major change in the Agency’s position, we believe that presenting this information in an open public forum, along with a full discussion and vote from the Advisory Committee (AC), will be extremely helpful. (page 9)

On 7 November 2024, the FDA announced its proposal to remove oral phenylephrine from the OTC monograph for human over-the-counter drugs used to treat colds, coughs, allergies, and asthma, based on this document. This is because the document claims that orally administered phenylephrine is not effective as a nasal decongestant. This document is therefore open for public comment.

According to the FDA’s webpage, the procedure for this proposal is still ongoing in the US. The deadline for comments was 7 May 2025:
https://dps.fda.gov/omuf/ordersearch/order_otc000036

For the time being, companies in the US may continue to sell over-the-counter drugs containing phenylephrine for use as a nasal decongestant. The proposed restriction is based on questions regarding efficacy rather than safety concerns.

If, having considered the comments it has received, the FDA concludes that oral phenylephrine is ineffective as a nasal decongestant, it will issue a final order to remove it from the OTC monograph. This would mean that medicinal products containing phenylephrine as a nasal decongestant could no longer be authorized in the US.

We would like to emphasise that, although the regulatory framework for pharmaceuticals is somewhat harmonised between the EU and the USA, this does not apply to this type of proceeding. Furthermore, neither the FDA nor the EU has any binding authority over the other.

Has the SÚKL been in contact with the FDA or requested any information on this matter?
Regarding the explanation in question 1, SÚKL has not requested any information from the FDA on this matter.

Has the SÚKL been in contact with any pharmaceutical company manufacturing or selling drugs containing oral phenylephrine to assess its reported ineffectiveness?

Regarding the explanation in question 1, SÚKL has not been in contact with any pharmaceutical company manufacturing or selling drugs containing oral phenylephrine.

Does the SÚKL intend to investigate on its own or jointly with the EMA to reassess oral phenylephrine before the single EU assessment in 2028?

Regarding the explanation in question 1, SÚKL does not intend to investigate or reassess on its own or jointly with the EMA oral phenylephrine before the Periodic Safety Update Report (PSUR) single EU assessment (PSUSA) in 2028.

The Czech Republic is the lead Member State for safety signals relating to phenylephrine. This is based on continuous assessment of adverse drug reactions reported to EudraVigilance.

According to the Guideline on Good Pharmacovigilance Practices (Module VI), reports of lack of therapeutic efficacy should normally not be submitted to EudraVigilance if there is no associated suspected adverse reaction. The correct way of handling reports of lack of efficacy only is that each marketing authorisation holder collects them and discusses them in PSURs.

Some reports of phenylephrine inefficacy have been incorrectly reported to EudraVigilance, but they are below the detection limit for signal identification.

Therefore, we believe that if there are reports or other data indicative of phenylephrine inefficacy, they should be assessed in the next PSUSA for oral phenylephrine.

If the FDA decision is made prior to 2028, the marketing authorisation holder (MAH) is obligated to include this information in the PSUR, which will therefore be subject to assessment during the PSUSA.

We consider the timeframe for the assessment in 2028 to be sufficient.