Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications
How to Read This Report
This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.
Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.
Ayvakit (active ingredient: avapritinib) tablets
Initial FDA Approval: 2020
Side Effect Update Date: November 8, 2024
Medication Description: Ayvakit treats metastatic stomach cancer, aggressive systemic mastocytosis (ASM), and mast cell leukemia (MCL).
Updated Side Effects/Safety Information: A new warning about drug interactions with ethinyl estradiol-containing contraceptives, which may lead to ethinyl estradiol-associated adverse reactions. If an estrogen-containing contraceptive must be used, a formulation containing 20 mcg or less is recommended.
Because of the risk of fetal harm, males and females of reproductive age are advised to use effective contraception during treatment with Ayvakit and for six weeks after the final dose.
FDA Safety Announcement: Ayvakit FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Brilinta (active ingredient: ticagrelor) tablets
Initial FDA Approval: 2011
Side Effect Update Date: November 4, 2024
Medication Description: Antiplatelet medication used with low-dose aspirin by patients after heart attack, stent placement, or by those with acute coronary syndrome to lower the risk of stroke or heart attack.
Updated Side Effects/Safety Information: Warns of interactions with the cholesterol drug rosuvastatin (brand name Crestor). Because Brilinta increases the concentration of rosuvastatin in the blood, patients taking it should be monitored for statin-related adverse effects.
FDA Safety Announcement: Brilinta FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Caduet (active ingredients: amlodipine and atorvastatin) tablets
Initial FDA Approval: 2004
Side Effect Update Date: November 4, 2024
Medication Description: Combination of amlodipine besylate (a calcium channel blocker used to treat high blood pressure) and atorvastatin calcium (used for treating high cholesterol, brand name Lipitor)
Updated Side Effects/Safety Information: Warns of rare risk of new-onset or exacerbation of myasthenia gravis, including ocular myasthenia, and reports of recurrence when the same or a different statin was administered. Myasthenia gravis is a disease that causes general muscle weakness, weakness in muscles used for breathing, and sometimes eye muscle weakness (ocular myasthenia).
Patients are advised that Caduet and certain other medicines can increase the risk of muscle problems or other side effects. Patients are also now advised to tell healthcare providers if taking medicines for immune system meds, including cyclosporine.
Essential Extras: Lipitor and other atorvastatin-containing drugs had similar label updates warning about myasthenia gravis earlier this year.
FDA Safety Announcement: Caduet FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Delstrigo (active ingredients: doravirine, lamivudine, tenofovir disoproxil fumarate) and Pifeltro (active ingredient: doravirine)
Initial FDA Approval: 2018 (Delstrigo and Pifeltro)
Side Effect Update Date: November 7, 2024
Medication Description: Delstrigo: Used as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg with no previous antiretroviral treatment history (or certain other conditions).
Pfieltro: Used in conjunction with other antiretroviral treatments for the treatment of HIV-1 infection.
Updated Side Effects/Safety Information: New section on the risk of severe skin reactions, including Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN). Patients are advised to discontinue medication and tell their healthcare provider if any rash or severe skin reactions develop, including those on mucosal surfaces such as in the eyes or in the mouth.
FDA Safety Announcement: Delstrigo FDA Safety Label Change and Revised Drug Label
Pifeltro FDA Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Herzuma(active ingredient: trastuzumab-pkrb) and Ogivri (active ingredient: trastuzumab-dkst)
Initial FDA Approval: 2018 (Herzuma) and 2017 (Ogivri)
Side Effect Update Date: November 13, 2024
Medication Description: Breast cancer and stomach cancer (HER-2 positive) treatment
Updated Side Effects/Safety Information: Boxed warning sections have been revised regarding testing that should be done prior to and during treatment in order to evaluate cardiac function.
Providers are advised to evaluate left ventricular ejection fraction (LVEF) prior to initiation of treatment and at regular intervals during treatment.
Providers are advised to verify pregnancy status of females of reproductive age prior to the initiation of treatment.
Post-marketing reports in published literature revealed that use of trastuzumab during pregnancy resulted in cases of oligohydramnios (low level of amniotic fluid), which in most reported cases resolved when trastuzumab was stopped. Read the revised drug label for all of the changes.
Essential Extras: Herzuma and Ogivri are injectable biosimilars (biological generic) for brand name HERCEPTIN (trastuzumab).
FDA Safety Announcement: Herzuma FDA Safety Label Change and Revised Label
Ogivri FDA Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
ILARIS (active ingredient: canakinumab) subcutaneous injection
Initial FDA Approval: 2009
Side Effect Update Date: November 1, 2024
Medication Description: Autoinflammatory disease treatment
Updated Side Effects/Safety Information: A new section was added on serious hypersensitivity reactions of skin and subcutaneous tissues, including post-marketing reports of “Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).” Also called drug hypersensitivity syndrome, DRESS mainly affects adults.
Patients are advised to stop taking ILARIS, contact their healthcare provider and get emergency help if experiencing symptoms of a serious allergic reaction, such as difficulty breathing or swallowing, nausea, dizziness, skin rash, itching, hives, palpitations, or low blood pressure.
FDA Safety Announcement: Caduet FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Linezolid in sodium chloride 0.9% in plastic container (active ingredient: linezolid)
Initial FDA Approval: 2000
Side Effect Update Date: November 7, 2024
Medication Description: Intravenous antibacterial approved for adults and children.Treats infections caused by gram-positive bacteria such as hospital-acquired pneumonia, community-acquired pneumonia, and complicated skin infections such as diabetic foot infections.
Updated Side Effects/Safety Information: The label was updated to warn of the risk of rhabdomyolysis. Rhabdomyolysis is the breakdown of muscle tissue that leads to the release of muscle fiber contents into the blood. Once in the blood, the substance, called myoglobin, may cause kidney damage. A telltale sign of this condition is very dark urine.
Essential Extras: A similar update was made for the antibiotic Zyvox (linezolid tablets, injection, and oral suspension) in June 2024.
FDA Safety Announcement: Linezolid in Sodium Chloride FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Oxaliplatin injection, for intravenous use (active ingredient: oxaliplatin)
Initial FDA Approval: 2002
Side Effect Update Date: October 31, 2024
Medication Description: Platinum-based chemotherapy drug used in combination with fluorouracil and leucovorin to treat advanced colorectal cancer.
Updated Side Effects/Safety Information: The Boxed warning was revised around hypersensitivity reactions. Serious and fatal hypersensitivity adverse reactions can occur within minutes of administration. This drug is contraindicated in patients with hypersensitivity reactions to oxaliplatin and other platinum-based drugs. Clinical trials results were updated. Please see the complete label for all the changes.
FDA Safety Announcement: Oxaliplatin FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Spravato (active ingredient: esketamine) nasal spray
Initial FDA Approval: Ketamine was initially approved as an anesthetic in 1970. Spravato was approved for treatment-resistant depression in 2020.
Side Effect Update Date: November 4, 2024
Medication Description: Spravato nasal spray treatment is used along with an oral antidepressant to treat adults with treatment-resistant depression or those with major depression experiencing suicidal thoughts.
Updated Side Effects/Safety Information: The “Cognitive Impairment” subsection under Warnings and Precautions was updated to report that in a three-year long-term, open-label clinical trials in adults, the effect of Spravato on cognitive functioning remained stable over time. The label also says “Long-term cognitive and memory impairment have been reported with repeated ketamine misuse or abuse.”
The Adverse Reactions section was updated to include post-marketing reports of hypotension, or low blood pressure.
Essential Extras: Considered a psychedelic medicine, Spravato is administered under the supervision of a healthcare provider at a certified treatment center.
FDA Safety Announcement: Spravato FDA Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Sunlenca tablets and subcutaneous injection (active ingredient: lenacapavir sodium)
Initial FDA Approval: 2022
Side Effect Update Date: November 25, 2024
Medication Description: Treats HIV-1 infection in adults with multidrug resistant HIV-1 infection.
Updated Side Effects/Safety Information: The Patient Information section was updated with guidance on safe product storage. Patients are advised that the bottle contains a desiccant packet to help keep the medicine dry. The desiccant packet should not be eaten and should remain in the bottle during storage. Also, tablets should be stored in their original bottle or blister pack and the bottle should be kept tightly closed.
There is a new warning that improper administration of injection has been associated with serious reactions including ulcer at injection site. Provides guidance on missed doses of the every-six-months injection. Patients advised to tell their health care providers if they miss or plan to miss an injection. Oral Sunlenca therapy may be prescribed for up to six months in case of missed dose.
Essential Extras: Initial treatment regimen includes oral tablets. This is followed by once every 6 months maintenance injection dosing.
FDA Safety Announcement: Sunlenca FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Scemblix (active ingredient: asciminib hydrochloride)
Initial FDA Approval: 2021
Side Effect Update Date: October 29, 2024
Medication Description: Treats chronic myelogenous leukemia, also known as CML, a type of cancer of the white blood cells.
Updated Side Effects/Safety Information: This safety label update was made to support its expanded approval for treating adults with newly diagnosed cases of Philadelphia chromosome-positive chronic myelogenous leukemia (CML).
Extensive clinical trial data were added to the warnings and precautions section under myelosuppression, pancreatic toxicity, hypertension, and more. No differences in safety or efficacy of Scemblix were observed between patients 65 years of age and older compared to younger patients. Check the label for all of the clinical trial additions.
Essential Extras: The new approval was granted under “accelerated” status, and may be contingent upon additional clinical trial results. CML occurs when a cell in the bone marrow undergoes a breakage of two chromosomes (chromosomes nine and 22), which then fuse to form a characteristic abnormal chromosome, called the Philadelphia chromosome (named for the city in which it was first identified).
FDA Safety Announcement: Scemblix FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Vonjo (active ingredient: pacritinib citrate) capsules
Initial FDA Approval: 2022
Side Effect Update Date: November 12, 2024
Medication Description: Treats primary or secondary myelofibrosis (a bone marrow blood cancer).
Updated Side Effects/Safety Information: The warnings and precautions and the patient information section were updated to inform of drug interactions. Strong and moderate CYP3A4 inhibitors taken concurrently will reduce the effectiveness of Vonjo.
Warnings are also added about interactions with other types of drugs, including hormonal contraceptives.
The side effect of low platelet counts was added to the “most common side effects” section of the patient information guide. It advises that your healthcare provider will do blood tests and an electrocardiogram (ECG) before you start treatment and as needed during treatment to check for side effects.
FDA Safety Announcement: Vonjo FDA Safety Label Change and Revised Drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Voxzogo (active ingredient: vosoritide) injection
Initial FDA Approval: 2021
Side Effect Update Date: November 4, 2024
Medication Description: Approved as a daily treatment to increase the height and growth of pediatric patients with achondroplasia with open epiphyses (growth plates that have not yet closed).
Updated Side Effects/Safety Information: The label was updated to warn of post-approval reports of hypertrichosis, which is abnormal, excessive hair growth.
Essential Extras: Continued approval may be contingent upon results of ongoing clinical trials.
Read more about achondroplasia at Medline Plus.
FDA Safety Announcement: Voxzogo FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
