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Drug Safety Communications

When FDA learns of a new safety risk with a drug, it publishes a Drug Safety Communication and often changes the label. These are FDA's communications since 2020, with the drugs each one names.

The 43 Drug Safety Communications FDA lists from Jan 14, 2020 to Nov 9, 2026, each with the drugs it names linked to their FDA records.

  • Last 12 months: 7
  • Boxed warnings: 8
  • Newest: Nov 9, 2026

Communications per Year

FDA's current list, 2020 to Nov 9, 2026.

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

  • Full year
  • 2026 to date

Every Communication

Newest first. Drugs are matched by ingredient name in the communication's text.
Drugs named
Nov 9, 2026FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Conditioninsulin glargine-aldyorforglipron calciumsemaglutidetirzepatidelixisenatideinsulin degludecliraglutidedulaglutide
Sep 15, 2026FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Usedeoxycholic acid
Sep 1, 2026FDA Adds Boxed Warning to Labeling for Ferric Carboxymaltose Injection (Injectafer) to Describe Risk of Low Phosphate Levels Boxed warningferric citrateferric carboxymaltose
Jun 10, 2026FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injuryorlistat
Mar 31, 2026FDA Identifies Cases of Serious Liver Injury in Patients Taking Tavneos (avacopan) for Severe Active Anti-neutrophil Cytoplasmic Autoantibody (ANCA)-associated Vasculitisavacopan
Mar 20, 2026FDA Is Requiring Warning about Vitamin B6 Deficiency and Associated Seizures for Drug Products Containing Carbidopa/Levodopafoscarbidopa; foslevodopacarbidopa; levodopalevodopaentacapone
Jan 13, 2026FDA Requests Removal of Suicidal Behavior and Ideation Warning from Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) Medicationssemaglutidetirzepatideliraglutide
Aug 28, 2025FDA to recommend additional, earlier MRI monitoring for patients with Alzheimer’s disease taking Leqembi (lecanemab)lecanemab-irmb
Aug 27, 2025FDA removes risk evaluation and mitigation strategy (REMS) program for the antipsychotic drug Clozapineclozapine
Jul 31, 2025FDA is requiring opioid pain medicine manufacturers to update prescribing information regarding long-term usenalmefene hydrochloridenaloxone hydrochloridehydromorphone hydrochloridebuprenorphinefentanyl citratetramadol hydrochlorideoxycodone hydrochloridemorphine sulfate+2 more
Jun 30, 2025FDA requires expanded labeling about weight loss risk in patients younger than 6 years taking extended-release stimulants for ADHDmethylphenidate hydrochlorideamphetamine sulfate
Jun 18, 2025FDA adds warning about serious risk of heat-related complications with antinausea patch Transderm Scōp (scopolamine transdermal system)None matched
May 16, 2025FDA requires warning about rare but severe itching after stopping long-term use of oral allergy medicines cetirizine or levocetirizine (Zyrtec, Xyzal, and other trade names)cetirizine hydrochloridelevocetirizine dihydrochloride
Jan 22, 2025FDA adds Boxed Warning about a rare but serious allergic reaction called anaphylaxis with the multiple sclerosis medicine glatiramer acetate (Copaxone, Glatopa) Boxed warningNone matched
Dec 12, 2024Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic acid) to treat primary biliary cholangitisobeticholic acid
Sep 12, 2024FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause Boxed warningfezolinetant
Jan 19, 2024FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab) Boxed warningdenosumab-adet
Jan 11, 2024Update on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesityinsulin glargine-aldysemaglutidetirzepatidelixisenatideinsulin degludecliraglutidedulaglutide
Nov 28, 2023FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)levetiracetamclobazam
May 11, 2023FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions Boxed warningmethylphenidate hydrochloridedextroamphetamineamphetamine sulfate
Apr 13, 2023FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe usenaloxone hydrochloridehydromorphone hydrochloridebuprenorphinefentanyl citratetramadol hydrochlorideoxycodone hydrochloridemorphine sulfateoxymorphone hydrochloride+1 more
Jun 30, 2022FDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)duvelisibofatumumab
Jun 1, 2022FDA approval of lymphoma medicine Ukoniq (umbralisib) is withdrawn due to safety concernsumbralisib tosylate
Mar 30, 2022FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imagingiopamidoliohexoliopromideioversol
Feb 3, 2022FDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)umbralisib tosylate
Jan 12, 2022FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and painnaloxone hydrochloridebuprenorphine
Nov 2, 2021FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injuryNone matched
Jul 20, 2021FDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statinsamlodipine besylateatorvastatin calciumrosuvastatin calciumpitavastatin sodiumsimvastatinezetimibelovastatinfluvastatin sodium
Jun 16, 2021FDA warns that vapors from alcohol-based hand sanitizers can have side effectsNone matched
May 26, 2021Due to risk of serious liver injury, FDA restricts use of Ocaliva (obeticholic acid) in primary biliary cholangitis (PBC) patients with advanced cirrhosisobeticholic acid
Mar 31, 2021Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseaselamotriginelacosamidezonisamidetopiramatefosphenytoin sodiumcenobamatecarbamazepineeslicarbazepine acetate+2 more
Mar 25, 2021FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harmNone matched
Feb 4, 2021Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)methotrexatetofacitinib citrate
Oct 15, 2020FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluiddiclofenac sodiumcelecoxibacetaminophenaspirinibuprofen sodiumnaproxen sodium
Sep 24, 2020FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)None matched
Sep 23, 2020FDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class Boxed warninglorazepamdiazepamclobazamalprazolam
Aug 26, 2020FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) Boxed warningcanagliflozin
Jul 23, 2020FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disordernaloxone hydrochloridebuprenorphine
Apr 24, 2020FDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problemshydroxychloroquine sulfateazithromycin
Mar 4, 2020FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis Boxed warningbudesonidecetirizine hydrochloridelevocetirizine dihydrochloridefexofenadine hydrochlorideloratadinemontelukast sodium
Feb 13, 2020FDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the marketNone matched
Jan 28, 2020FDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problemsclozapine
Jan 14, 2020Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)None matched

A Drug Safety Communication is how FDA announces a new safety concern or labeling change for a drug or class. FDA's current list starts in 2020; older communications are in FDA's archive. Drugs named are the ingredients with a Drugs@FDA record that appear in the communication's title or text, so a class communication lists each member it names. Refreshed weekly. FDA, Drug Safety Communications

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.