Recent Drug Safety Alerts – Asrar Qureshi’s Blog Post #1125

Recent Drug Safety Alerts – Asrar Qureshi’s Blog Post #1125

Dear Colleagues! This is Asrar Qureshi’s Blog Post 1125 for Pharma Veterans. Pharma Veterans Blogs are published by Asrar Qureshi on its dedicated site https://pharmaveterans.com. Please email to pharmaveterans2017@gmail.com  for publishing your contributions here.

Covid Vaccine

Scop Transdermal System

Xyzal

Zyrtec

Preamble

Post Marketing Surveillance, Pharmacovigilance, and Adverse Drug Reactions Reporting are tools through which adverse reactions are reported from various parts of the world. The activity is more seriously undertaken in the developed countries. The information thus collected is investigated in detail to see if the adverse reaction was caused by the drug or were other factors involved in the outcome. On the basis of the investigation, the regulatory authorities like USFDA, EMA, TGA etc. issue instructions to add cautions or warnings or black box warnings in the prescribing information or on the pack or both. In extreme cases, the drug may be asked to be withdrawn from the market; cases like Rofecoxib, Terfenadine, Sibutramine, Lomefloxacin, Gatifloxacin etc. were taken off the market. 

Given below are three recent drug safety alerts issued by the USFDA. The same may or may not be shared by the drug companies in Pakistan.

Risk of Severe Itching After Discontinuation of Long-Term Use of Cetirizine or Levocetirizine

May 23, 2025 -- The FDA is warning that patients stopping the oral allergy medicines cetirizine (Zyrtec) or levocetirizine (Xyzal) after long-term use may experience rare but severe itching. These medicines are available in prescription and over the counter (OTC) forms. The itching, also called pruritus, has been reported in patients who used these medicines daily, typically for at least a few months and often for years. Patients did not experience itching before starting the medicines. Reported cases were rare but sometimes serious, with patients experiencing widespread, severe itching that required medical intervention. As a result, we are revising the prescription cetirizine and levocetirizine prescribing information to include a new warning about this risk. We will subsequently request that manufacturers add a warning about pruritus to the Drug Facts Label of the OTC versions.

Cetirizine was approved for oral use by prescription in December 1995 under the trade name Zyrtec (no longer sold as a prescription medicine) and approved for OTC use in November 2007. Levocetirizine was approved for oral use by prescription in May 2007 under the trade name Xyzal and approved for OTC use in January 2017.

Warning About Serious Risk of Heat-Related Complications with Antinausea Patch of Scopolamine Transdermal System

June 18, 2025 -- The U.S. Food and Drug Administration (FDA) is warning that the antinausea patch Transderm Scōp (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death in some cases. Most cases occurred in children 17 years and younger and in adults 60 years and older, who may be sensitive to body temperature control disturbances. As a result, we required that the Transderm Scōp prescribing information be revised to include a warning and other information about this risk.

Most reports of hyperthermia that resulted in serious harm occurred when the Transderm Scōp was used in children 17 years and younger. Transderm Scōp is not FDA-approved for any use in children but is sometimes prescribed “off-label” (which means that it is not an FDA-approved use) to manage excessive drooling in children with cerebral palsy or other neurologic disorders.

Hyperthermia occurred most often within 72 hours after the Transderm Scōp patch was applied to patients’ bodies for the first time. The Transderm Scōp patch can affect the body’s ability to maintain a stable internal temperature, leading to a rise in core body temperature. It can also reduce sweating, which may cause increases in body temperature. Severe cases may lead to heat related complications, such as confusion, loss of consciousness, coma, or death.

Hyperthermia may be exacerbated when patients are in warm environmental temperatures and when they are using external heat sources, such as a heated blanket.

We required the addition of a new warning and other information to the Transderm Scōp prescribing information and patient information leaflet about the risk of hyperthermia resulting in serious harm. These revisions include information to help reduce this risk, particularly in children and older adult patients.

Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination

June 25, 2025 -- FDA has required and approved updates to the Prescribing Information for Comirnaty (COVID-19 Vaccine, mRNA) manufactured by Pfizer Inc. and Spikevax (COVID-19 Vaccine, mRNA) manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines. Specifically, FDA has required each manufacturer to update the warning about the risks of myocarditis and pericarditis to include information about (1) the estimated unadjusted incidence of myocarditis and/or pericarditis following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines and (2) the results of a study that collected information on cardiac magnetic resonance imaging (cardiac MRI) in people who developed myocarditis after receiving an mRNA COVID-19 vaccine. FDA also required each manufacturer to describe the new safety information in the Adverse Reactions section of the Prescribing Information and in the Information for Recipients and Caregivers.

The warning on myocarditis and pericarditis in the Prescribing Information for Comirnaty and Spikevax has been updated to convey that the observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age.

The Fact Sheets for Healthcare Providers and for Recipients and Caregivers for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19, which are authorized for emergency use in individuals 6 months through 11 years of age, have also been updated to include the new safety information in alignment with the Comirnaty and Spikevax Prescribing Information and Information for Recipients and Caregivers.

Sum Up

The above information may be treated in need-to-know category rather than nice-to-know category, and should be brought in discussion.

Concluded.

Disclaimers: Pictures in these blogs are taken from free resources at Pexels, Pixabay, Unsplash, and Google. Credit is given where available. If a copyright claim is lodged, we shall remove the picture with appropriate regrets.

For most blogs, I research from several sources which are open to public. Their links are mentioned under references. There is no intent to infringe upon anyone’s copyrights. If, any claim is lodged, it will be acknowledged and recognized duly.

Reference:

https://www.drugs.com/fda_alerts.html