Drug Safety Labeling Updates July 2024 Part 2: MRI imaging drugs, curious oral contraceptive update, pregnancy-related for gabapentin, Enbrel, HIV drugs
MRI Imaging Drugs: FDA Safety Label Updates
In February 2024, we reported on the boxed warnings that were added to a group of imaging drugs called gadolinium-based contrast agents (GBCA). These drugs are used as part of magnetic resonance imaging (MRI) procedures to provide enhanced image quality for diagnosis of conditions such as multiple sclerosis or cancer.
This month (July 2024), the labels were updated to include the newly identified risk of acute pancreatitis, a gastrointestinal disorder that may occur within 48 hours after the GBCA administration. Check links below for the FDA label updates for each product. If you have taken the drug, please add your review at the rating page link.
“Macrocyclic” (newer type of GBCA) Safety Labeling Changes:
DOTAREM label update (and rating page at Ask a Patient)
ELUCIREM label update (and rating page at Ask a Patient)
“Linear” (older type of GBCA) Safety Labeling Changes:
GADAVIST label update (and rating page at Ask a Patient)
MULTIHANCE and Multihance Multipack (and rating page at Ask a Patient)
OMNISCAN label update (and rating page at Ask a Patient)
PROHANCE and Prohance Multipack label update (and rating page at Ask a Patient)
Curious Oral Contraceptive Safety Label Update: OTC Birth Control Pill in the works?
Cadence Health's oral contraceptive Alesse (ethinyl estradiol; levonorgestrel) had been discontinued when Cadence acquired the rights to it from Pfizer in 2018. Now, the label is being updated to match the labeling of other combination (estrogen and progesterone-containing) oral contraceptives. The updated label now notes the increased risk of cardiovascular events related to cigarette smoking, among other changes.
While the label update is not surprising if the product is going to be reintroduced, it makes us wonder: could this safety label change be a signal that Cadence is using the formulation of Alesse as a development model for its planned over-the-counter birth control pill called Zena?
More on Cadence Health and Zena: https://cadenceotc.com/pages/zena
Drug Safety labeling update for Alesse
As of July 2024, Alesse is still listed in the Drugs@FDA database as "discontinued." See below:
Currently, only one oral contraceptive is available over-the counter in the United States: Perrigo's Opill (norgestrel). It is a progesterone-only pill, sometimes known as a “mini-pill.” Perrigo also purchased rights to a discontinued oral contraceptive (Ovrette) that it "revived" into the OTC product (hence our speculation about Alesse).
Read more about Opill in our newsletter from July 2023:
Read or add reviews for Opill at Ask a Patient:
https://www.askapatient.com/viewrating.asp?drug=17031&name=OPILL
Neurontin, Enbrel, Sunlenca, Viramune XR: pregnancy-related updates
These drugs had their safety label updated to include pregnancy-related and breast feeding risks and/or clinical trial results.
Antiepileptic drug Neurontin (gabapentin)
The label was updated to report that
"studies pertaining to gabapentin use during pregnancy has not indicated an increased risk of major birth defects or miscarriage. There are important methodological limitations hindering interpretation of these studies [see Data]"
Read the whole update here:
Drug Safety Label Update for Neurontin
Rheumatoid arthritis drug Enbrel (etanercept)
The label was updated to report that
"Data from published literature show that etanercept is present in low levels in human milk but is not detected in the plasma of breastfed infants (see Data). There are no data on the effects of etanercept on milk production. There have been no consistent reports of adverse events in breastfed infants over decades of use."
Read the whole update here:
Drug Safety Label Update for Enbrel
HIV Drug Sunlenca (lenacapavir sodium)
The label was updated to report that:
"Patients with HIV infection are advised that breast feeding can lead to transmission of HIV-1 to infants…drug risk of (1) HIV-1 transmission (in HIV-1–negative infants), (2) developing viral resistance (in HIV-1–positive infants), and (3) adverse reactions in a breastfed infant similar to those seen in adults."
Read the whole update here:
Drug Safety Label Update for Sunlenca
HIV Drug Viramune XR (nevirapine)
The label was updated to report that:
"Patients with HIV infection are advised that breast feeding can lead to transmission of HIV-1 to infants. Patients are with HIV-1 infection are advised: that the potential risks of breastfeeding include: (1) HIV-1 transmission to HIV-1–negative infants, (2) developing viral resistance in HIV-1–positive infants, and (3) serious adverse reactions in a breastfed infant similar to those seen in adults."
Read the whole update here:
Drug Safety Label Update for Viramune XR
Thank you for reading Drug Safety Updates. Did you miss July Drug Safety Updates Part 1? Read it here:
Stay tuned for our regular “Drugs & Treatments News” for July 28. This week we’re covering three new drug approvals, cinnamon recalls due to lead, safest spices, research on preventing hearing loss from cancer treatment, drugs allowed or banned at summer Olympics, and more!