Benadryl Challenge: FDA warns about serious problems with high doses of the allergy medicine diphenhydramine

Diphenhydramine is an antihistamine used to temporarily relieve symptoms due to hay fever, upper respiratory allergies, or the common cold, such as runny nose and sneezing.  It works by blocking histamine in the body, which is a substance that causes allergic symptoms.  When used as recommended, it is a safe and effective medicine.  Diphenhydramine is marketed under the brand-name Benadryl, store brands, and generics.  It is also available in combination with pain relievers, fever reducers, and decongestants.  

On September 24, 2020 FDA warned that taking higher than recommended doses of the common over the counter (OTC) allergy medicine diphenhydramine (brand name Benadryl) can lead to serious heart problems, seizures, coma, or even death.

FDA further added that teenagers ending up in emergency rooms or dying after participating in the “Benadryl Challenge” encouraged in videos posted on the social media application TikTok.

FDA investigating these reports and conducting a review to determine if additional cases have been reported.

FDA also contacted TikTok and strongly urged them to remove the videos from their platform and to be vigilant to remove additional videos that may be posted.  

Instruction for consumers, parents, and caregivers

Consumers, parents, and caregivers should store diphenhydramine and all other OTC and prescription medicines up and away and out of children’s reach and sight. 

FDA recommended to lock up medicines to prevent accidental poisonings by children and misuse by teens, especially when they are home more often due to the COVID-19 pandemic and may be more likely to experiment.  

Always read the Drug Facts label included on all OTC medicines to find out if they contain diphenhydramine, how much and how often you should take them, and important safety information. 

Do not take more than the dose listed on the label, as doing so can cause serious problems.  If someone takes too much diphenhydramine and is hallucinating, can’t be awakened, has a seizure, has trouble breathing, or has collapsed, immediately get medical attention or contact poison control at 1-800-222-1222 or online. 

Instruction for Health care professionals

Health care professionals should be aware that the “Benadryl Challenge” is occurring among teens and alert their caregivers about it.  Encourage teens and caregivers to read and follow the Drug Facts label.  In the event of an overdose, health care professionals should attempt to determine whether a patient with a suspected overdose took diphenhydramine.

FDA urges health care professionals and consumers to report side effects involving diphenhydramine and other medicines to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

Source: FDA Drug Safety Communications 

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Updated MHRA Guidance on the PSMF for products authorized in UK

                                                                  MHRA

From 1 January 2021, for medicines authorized in Great Britain, Marketing Authorization Holder (MAH) holders must maintain PSMF that described the pharmacovigilance system for UK authorized products.

• The PSMF must describe the global pharmacovigilance system and reflect the global availability of safety information for UK authorized products.
• MAH need to make sure that every pharmacovigilance system covering UK authorized products has been assigned a unique PSMF number by the MHRA.
• A UK PSMF number can be requested via the MHRA Submissions Portal from 1 January 2021.
• A UK PSMF number can be requested via the MHRASubmissions Portal from 1 January 2021.
• Single request for UK PSMF number should be submitted to MHRA, where the pharmacovigilance system is shared by several MAHs.

• For MAs that are specific to Great Britain: PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.

For MAs that are specific to Great Britain, legal requirements concerning the format and content of the PSMF are outlined in Part 1 of Schedule 12A of HMR, which mirrors Chapter I of CIR. 

• For MAs that cover the whole of the UK or are specific to Northern Ireland: the PSMF must be located either at the site in the European Union, where the main pharmacovigilance activities are performed or at the site where the QPPV operates, in accordance with Article 7(1) of the CIR. The PSMF must be accessible electronically at the same point in the UK from which the reports of suspected adverse reactions referred to in regulation 187 of the HMRs are accessible.

For MAs that cover the whole of the UK or are specific to Northern Ireland, the legal requirements concerning the format and content of the PSMF that are outlined in Chapter I of CIR will remain unchanged.

As the legal requirements concerning PSMF format and content are identical for MAs that cover the whole of the UK and Northern Ireland, and those that are specific to Great Britain, a single PSMF can be used for all UK authorized products.

Source💬: MHRA- www.gov.uk 

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MHRA Submission: The Role of Initial Company Administrator

The UK has left the EU, and the transition period after Brexit comes to an end this year. From 1 January 2021, for medicines authorized in Great Britain, Marketing Authorization Holder (MAH), will be required to submit pharmacovigilance data to the MHRA, according to GB requirements.

MHRA will require following submissions via the new MHRA Gateway or/ICSR Submissions portal.

• All pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
• All medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications and Developmental Safety Update Reports (DSURs)) to the Agency
• E-cigarette producers
• Brokers of medicinal products·

The first person in an organization who completes the registration process will become the initial company administrator.

Factors to be considered for initial company administrator-

1. 👉Smaller Organizations- a company administrator may also be responsible for making submissions or managing a team who will make submissions. It is recommended that each organization has more than one company administrator.

2. 👉Larger Organizations – may have different teams or departments who will be doing submission via MHRA Submission Portal like regulatory affairs, pharmacovigilance units, clinical trials teams etc. MAH need to carefully consider who is best in organizations for initial company administrator. This person will be responsible for adding further company administrators.

 A difference between Company Administrator and User

 👮A company Administrator: -

• A company administrator has the ability to add, edit and disable other users.
• A company administrator will also be able to see records of submissions made by users.
• A company administrator also has the ability to register multiple companies under their account.
• The initial company administrator will have the same permissions as any subsequent company administrators. However, they will be responsible for completing the user access steps for the organization and setting up the first set of additional company administrators and users.
• There are no limits to the number of company administrators

 👷A User:

• A user cannot add other users and can only make submissions for the organization they are registered to.
• A user will not see records of submissions made by other users.
• They can be added to multiple legal entities if required.

Note: if adding more than 5 users at a time, the changes will be made but you will be redirected to the homepage rather than the “user maintenance” page. To confirm that your new users have been added, simply navigate back to the “user maintenance” page.

Source: MHRA- www. gov. uk

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How to gain access for performing submissions to the MHRA from 1 January 2021

 

The following groups will need to take access to MHRA Submissions in order to start submissions from 1 January 2021:

• All pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities
• All medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications and Developmental Safety Update Reports (DSURs)) to the Agency
• E-cigarette producers
• Brokers of medicinal products

Gaining access to MHRA submission can be divided into three parts –

• User registration – the end to end process for adding an initial company administrator
• Add a new user – add an internal colleague as a user or company administrator
• Add a new external user – add a third-party consultant/consultancy as a user or company administrator

Prerequisite points💬 –

• The first Person In any organization who completes the registration process will become the first responsible administrator. Hence it is advisable that right person with appropriate consensus/permission becomes company administrator (registering as company administrator without permission could cause unnecessary confusion and delay to the company’s operational activities.
• Access of 5-digit company number(s) if any organization has previously submitted to the MHRA. (If you have not submitted to the MHRA, please email reference.data@mhra.gov.uk as you will need to register as a new company prior to beginning this process).
• All third-party consultants/consultancies have their own 5-digit company number and have registered for MHRA Submissions using that number.         

New Users

New users can straightway reach to MHRA account request page via the following link-

https://mhrabpm.appiancloud.com/suite/plugins/servlet/registration

Source: MHRA- www.gov.uk

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