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Clinically important safety information on human medical products from FDA. Comments: MedWatchComments @fda .hhs.gov Privacy:

Silver Spring, MD
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Joined October 2010
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@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects
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23
15
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US FDA MedWatch
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8 months
Do Not Use Smartwatches or Smart Rings to Measure Blood Glucose - FDA Safety Communication
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10
23
16
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US FDA MedWatch
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5 years
Chloroquine Phosphate Intended for Fish: FDA Letter to Stakeholders - Do Not Use as Treatment for COVID-19 in Humans
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US FDA MedWatch
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5 months
Do Not Use Cue Health COVID-19 Tests Due to Risk of False Results: FDA Safety Communication
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2
14
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US FDA MedWatch
@FDAMedWatch
8 years
EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device
1
21
15
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
4 years
Hydroxychloroquine or Chloroquine for COVID-19: Drug Safety Communication - FDA Cautions Against Use Outside of the Hospital Setting or a Clinical Trial Due to Risk of Heart Rhythm Problems
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6
10
9
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
VITEK 2 Gram Positive Antimicrobial Susceptibility Testing Cards by BioMerieux: Recall - Due to False Results for Some Strains of Methicillin-Resistant Staphylococcus Aureus
2
24
13
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
11 years
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to... http://t.co/BTTx55qbaA #FDA
2
41
11
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US FDA MedWatch
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6 years
Fluoroquinolone Antibiotics: Safety Communication - Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients
0
23
12
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US FDA MedWatch
@FDAMedWatch
8 years
Nizoral (ketoconazole) Oral Tablets: Avoid prescribing for skin and nail fungal infections, linked to patient death.
1
30
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US FDA MedWatch
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4 years
Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment
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5
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6 years
SGLT2 (sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area
2
19
11
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
5 years
Tetrahydrocannabinol (THC)-containing Vaping Products: Vaping Illnesses
1
11
10
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US FDA MedWatch
@FDAMedWatch
5 years
Ivermectin Intended for Animals: FDA Letter to Stakeholders - Do Not Use as Treatment for COVID-19 in Humans
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7
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5 years
UPDATE: The FDA Warns that Biotin May Interfere with Lab Tests: Safety Communication
0
5
9
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US FDA MedWatch
@FDAMedWatch
8 years
Certain Homeopathic Teething Products: FDA Warning - Confirmed Elevated Levels of Belladonna
0
15
9
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
10 years
Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria http://t.co/xFnTf0bCPP #FDAMedWatch
0
19
9
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
7 years
Follow FDA Commissioner on @SGottliebFDA
3
3
8
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
7 years
Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease
0
14
8
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
9 years
November 2015 Drug Safety Labeling Changes includes 19 products with revisions to Prescribing Information #FDA
0
9
8
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US FDA MedWatch
@FDAMedWatch
10 months
4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection, and Atropine Sulfate Injection by Hospira: Recall - Due to the Potential Presence of Glass Particulate Matter
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2
10
8
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse
1
16
8
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US FDA MedWatch
@FDAMedWatch
9 years
Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure
1
6
7
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US FDA MedWatch
@FDAMedWatch
9 years
SGLT2 Inhibitors: Labels to Include Warnings About Too Much Acid in Blood and Serious Urinary Tract Infections #FDA
0
14
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Fluoroquinolone Drugs: Drug Safety Communication, FDA Advises Restricting Use for Certain Uncomplicated Infections
0
19
7
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US FDA MedWatch
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9 months
Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult Products by Haleon: Recall - Due to Microbial Contamination
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19
8
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US FDA MedWatch
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6 years
Children’s Advil by Pfizer: Recall - Lot# R51129 Due to Dosage Cup Mislabeling
0
8
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
10 years
Testosterone Products: Drug Safety Communication - FDA Cautions About Use for Low Testosterone Due to Aging http://t.co/kVJJy7v8mT #FDA
0
14
6
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US FDA MedWatch
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1 year
UPDATE - Akorn Issues Voluntary Nationwide Recall of Various Human and Animal Drug Products Within Expiry Due to Company Shutdown
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2
11
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9 years
Licorice Coughing Liquid OTC Cough Syrup: CDER Alert - Contains Unidentified Morphine #FDA
0
10
7
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy
0
3
6
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US FDA MedWatch
@FDAMedWatch
4 years
Hand Sanitizers by 4e Brands North America: Recall Due to Potential Presence of Undeclared Methanol (Wood Alcohol)
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0
6
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
5 years
Ranitidine Tablets, 150mg and 300mg, and Ranitidine Syrup (Oral Solution), 15 mg/mL by Amneal Pharmaceuticals: Recall - Due to Possible Presence of N-nitrosodimethylamine Impurity
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5
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@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Clinicians: take a minute to learn about reporting problems to FDA - view the MedWatch Minute video today!
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MedWatch Minute - For Health Professionals

This short graphic video gives medical professionals an overview of the MedWatch program with information about how to sign up for it and how to use it.

www.youtube.com
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@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
7 years
Codeine & Tramadol Medicines: Restricting Use in Children, Recommending Against Use in Breastfeeding Women
0
9
7
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1 year
Certain Over-the-Counter Drug Products by Family Dollar: Recall - Because the Products Have Been Stored Outside of Labeled Temperature Requirements
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2
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@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Patients, consumers: take a minute to learn about reporting problems to FDA, view the MedWatch Minute video today!
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MedWatch Minute - For Consumers

The Food & Drug Administration regulates a wide range of products, including drugs for people and animals, biologics, medical devices, dietary supplements, i...

www.youtube.com
0
11
7
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections
0
8
7
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
Ceftriaxone for Injection by Lupin Pharmaceuticals: Recall – Due to Visual Grey Particulate Matter in Reconstituted Vials
0
4
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
7 years
Keytruda (pembrolizumab) in Patients with Multiple Myeloma: FDA Statement - Two Clinical Trials on Hold
0
15
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
5 years
FDA Warns Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication
0
4
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
Xeljanz, Xeljanz XR (tofacitinib): Safety Communication - Safety Trial Finds Increased Risk of Blood Clots in the Lungs and Death with Higher Dose in Rheumatoid Arthritis Patients
0
5
4
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
E-cigarette: Safety Communication - Related to Seizures Reported Following E-cigarette Use, Particularly in Youth and Young Adults
0
10
6
@FDAMedWatch
US FDA MedWatch
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1 year
Do Not Use Certain SD Biosensor Pilot COVID-19 At-Home Tests - FDA Safety Communication
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0
6
4
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US FDA MedWatch
@FDAMedWatch
6 years
Breast Implants: Letter to Health Care Providers - Due to Associated-Anaplastic Large Cell Lymphoma
1
2
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
Losartan Potassium Tablets by Legacy Pharmaceutical Packaging: Recall - Due to The Detection of Trace Amounts Of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) Impurity Found in The Active Pharmaceutical Ingredient (API) and
1
1
6
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US FDA MedWatch
@FDAMedWatch
4 years
Metformin Hydrochloride for Extended-Release Oral Suspension by Sun Pharmaceutical Industries: Recall - Due to N-Nitrosodimethylamine Content Above the Acceptable Daily Intake Limit
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5
6
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US FDA MedWatch
@FDAMedWatch
10 months
Select Batches of Nutramigen Hypoallergenic Infant Formula Powder by Reckitt/Mead Johnson: Recall - Due to Possible Health Risk
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0
16
5
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US FDA MedWatch
@FDAMedWatch
8 years
Well Balance Xanthium & Siler Combo (Bi Yan Pian) by Kingsway Trading: Recall - Contains Banned Ephedra Alkaloids
0
2
4
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
6 years
Losartan Potassium Tablets, USP by Torrent Pharmaceuticals Limited: Expands Recall - Due to an Unexpected Impurity Found in an Active Pharmaceutical Ingredient (API)
1
4
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery
0
5
6
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US FDA MedWatch
@FDAMedWatch
8 years
Fluconazole (Diflucan): Drug Safety Comm, FDA Evaluating Study Examining Use of Oral Fluconazole in Pregnancy
0
14
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
9 years
Metformin-containing Drugs: Drug Safety Communication, Revised Warnings for Patients w/ Reduced Kidney Function
0
13
6
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US FDA MedWatch
@FDAMedWatch
7 years
Fluoroquinolone Antibacterial Drugs UPDATE: Findings from published studies do not support reports of retinal detachment, aortic aneurysm
0
11
6
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US FDA MedWatch
@FDAMedWatch
3 years
Stop Using LuSys Laboratories COVID-19 Tests - FDA Safety Communication
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11
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5
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5 years
Ranitidine by Novitium Pharma: Recall - Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)
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Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and...

Voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of...

www.fda.gov
0
6
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
2 months
Update:Tandem Diabetes Care, Inc. Recalls Version 2.7 of the Apple iOS t:connect Mobile App Used in Conjunction with t:slim X2 Insulin Pump with Control-IQ Technology Prompted by a Software Problem Leading to Pump Battery Depletion
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4
11
6
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
9 years
Codeine Cough & Cold Medicines in Children: Drug Safety Communication, FDA Evaluating Risk of Serious Side Effects http://t.co/Mz4jqDQwba
0
7
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
7 years
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Recommends Separating Dosing
0
6
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
2 years
Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue - FDA Safety Communication
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0
14
5
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US FDA MedWatch
@FDAMedWatch
6 months
ForeverMen by FAonline: Recall - Due Presence of Sildenafil and Tadalafil
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0
6
4
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
3 years
Potential for False Positive Results with Abbott Molecular Inc. Alinity m SARS-CoV-2 AMP and Alinity m Resp-4-Plex AMP Kits
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0
9
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
10 years
Prescription/Over-the-Counter Pain Medicines: Drug Safety Communication Risks of Pain Medicine Use During Pregnancy http://t.co/rAGozgPsZZ
1
6
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
4 years
EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System by Boston Scientific: Class I Recall - Due to Risk of Short-Circuit
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1
2
3
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Fluoroquinolone Drugs for Systemic Use: Drug Safety Communication, Warnings Updated Due to Disabling Side Effects
0
17
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
9 years
Zerbaxa - FDA Cautions About Dose Confusion and Medication Errors http://t.co/tRgq29sUGx #FDA
0
13
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
11 years
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - Risk for possibly permanent nerve damage. http://t.co/EZLpjIzbmr
7
18
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
4 years
Hand Sanitizers: FDA Updates on Recalls Due to Dangerous, Potential Presence of Methanol (Wood Alcohol)
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0
7
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
3 years
Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit by Abbott Molecular: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results
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0
7
3
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
11 years
CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter http://t.co/UtvQBkNJKK #MedWatch
0
4
5
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US FDA MedWatch
@FDAMedWatch
6 years
Impella RP System by Abiomed: Letter to Health Care Providers - Increased Rate of Mortality
0
1
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
10 years
Zyprexa Relprevv (olanzapine pamoate): Safety Communication - FDA Review of Study Sheds Light on Two Deaths http://t.co/QMuhXwmEgf
0
9
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
10 years
February 2015 Safety Labeling Changes posting includes 45 products with changes to Prescribing Information http://t.co/plxuOqYIOo #FDA
0
5
5
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US FDA MedWatch
@FDAMedWatch
3 years
Select Monoject Flush Prefilled Saline Syringes By Cardinal Health: Recall - Products have been found to reintroduce air into the syringe after the air has been expelled
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2
5
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4 years
Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers
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2
5
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4 years
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later
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5
5
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7 years
General Anesthetic & Sedation Drugs: Drug Safety Commun - FDA Approves Label Changes for Use in Young Children
0
4
5
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4 years
Genetic Variants of SARS-CoV-2 May Lead to False Negative Results with Molecular Tests for Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers
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2
4
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Go to FDA MedWatch for clinically important safety information & reporting serious problems w human medical products
1
8
5
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US FDA MedWatch
@FDAMedWatch
4 years
Metformin Hydrochloride Extended-Release Tablets USP, 500 mg by Marksans: Recall - Due to the Detection of N-Nitrosodimethylamine
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5
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8 years
Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)
0
8
5
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US FDA MedWatch
@FDAMedWatch
5 years
Lung Injury Update: FDA Warns Public to Stop Using Tetrahydrocannabinol (THC)-Containing Vaping Products and Any Vaping Products Obtained Off the Street
0
5
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
8 years
Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk #FDA
0
20
5
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US FDA MedWatch
@FDAMedWatch
6 years
Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant
0
7
5
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5 years
All Ranitidine Products (Zantac): Press Release - FDA Requests Removal
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0
5
5
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5 years
Singulair (montelukast) and All Montelukast Generics: Strengthened Boxed Warning - Due to Advice on Restricting Use for Allergic Rhinitis
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4
5
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4 years
Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
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0
7
4
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10 years
Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement- Consumer Warning About Potential Health Risks http://t.co/TqxMW2yDlT
0
17
5
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@FDAMedWatch
5 years
Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
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0
5
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9 years
Gadolinium-based Contrast Agents for MRI: Drug Safety Comm, FDA Evaluating Risk of Brain Deposits With Repeated Use http://t.co/jl823LwVJq
0
11
5
@FDAMedWatch
US FDA MedWatch
@FDAMedWatch
2 years
Certain Lots of Top of the Rockies Alfalfa Cubes by Manzanola Feeds: Recall - Due to Possible Clostridium botulinum Health Risk
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8
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7 years
Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
0
7
4
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@FDAMedWatch
6 years
TB Temporary Bipolar Pacing Leads by Oscor: Recall - Due to Connector Separation Causing Potential for Loss of Pacing
0
0
4
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US FDA MedWatch
@FDAMedWatch
2 years
Epinephrine (L-Adrenaline) USP Bulk Active Pharmaceutical Ingredient by Spectrum Laboratory Products: Recall - Due to Discoloration of Product
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4
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