Blog Posts - Drug Safety Alerts



FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors

This Follows October 2015 Safety Alert By Health Canada Concerning Increased Risks Of Kidney Problems (Posted by Tom Lamb at DrugInjuryWatch.com) In December 2015 the FDA issued a Drug Safety Communication concerning the risk of ketoacidosis, a serio...
by Drug Injury Watch on Dec 8, 2015

Hepatitis C Drugs Viekira Pak And Technivie Require Warnings Label Changes Due To Liver Injury Reports

FDA Says The Timing Of Liver Injury Suggests That These Are Side Effects, Especially In Patients With Advanced Cirrhosis (Posted by Tom Lamb at DrugInjuryWatch.com) Viekira Pak and Technivie are relatively new drugs used to treat chronic hepatitis C.
by Drug Injury Watch on Oct 26, 2015

Xarelto, Savaysa, Pradaxa, And Eliquis: Safety Secondary To Ease Of Use Is "A Major Wrong Turn" Says Drug Watchdog Group

This New Generation Of Oral Anticoagulants Has Bleeding-Related Adverse Reactions Including Gastrointestinal And Intracranial Bleeds (Posted by Tom Lamb at DrugInjuryWatch.com) The ISMP QuarterWatch published on September 23, 2015 includes an examina...
by Drug Injury Watch on Oct 9, 2015

New FDA Warning That Januvia, Onglyza, Tradjenta, And Nesina Are Associated With "joint pain that can be severe and disabling"

Label Changes About Side Effects For These Type 2 Diabetes Medicines In The Drug Class Called Dipeptidyl Peptidase-4 (DPP-4) Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2015 the FDA announced that it has found indications of a ne...
by Drug Injury Watch on Aug 28, 2015

August 2015 Gilenya Label Change About PML Brain Infection Follows FDA Drug Safety Alert About This Serious Side Effect

These Two PML Cases Did Not Involve The Patients Previously Using The MS Drug Tysabri, As Did The One Which FDA Reported In August 2013 (Posted by Tom Lamb at DrugInjuryWatch.com) On August 4, 2015 the FDA posted on its web site this Safety Alert, &q...
by Drug Injury Watch on Aug 6, 2015

Will There Be Another Drug Label Change For YAZ And Other Drospirenone (DRSP) Birth Control Pills, As FDA Required For Ortho Evra Years Ago

Since Bayer Revised YAZ Label In April 2012 There Has Been More Medical Evidence That DRSP Pills Increase Risks Of Blood Clot Side Effects Like DVT And PE (Posted by Tom Lamb at DrugInjuryWatch.com) The drug labels for Yasmin, YAZ, Safyral, and Beyaz...
by Drug Injury Watch on Jul 29, 2015

Farxiga / Jardiance / Invokana Safety As Regards Diabetic Ketoacidosis Now Being Studied By Health Canada In Addition To Current FDA Investigation

Institute For Safe Medication Practices Signal For Invokana Kidney Failure Risks Seems To Apply To Farxiga, Jardiance, And Other SGLT2 Diabetes Drugs Also (Posted by Tom Lamb at DrugInjuryWatch.com) On May 15, 2015 the FDA announced it is investigati...
by Drug Injury Watch on Jun 25, 2015

Invokana / Farxiga / Jardiance: New Medical Study Finds A History Of Diabetic Ketoacidosis Events Is Associated With Increased Risk of Death

This Ketoacidosis Side Effect For These New Diabetes Medicines Was The Subject Of A May 2015 FDA Drug Safety Warning Which Was, Perhaps, Not Strong Enough About Dangers (Posted by Tom Lamb at DrugInjuryWatch.com) We reported about the recent "FD...
by Drug Injury Watch on Jun 10, 2015

Multiple Myeloma Drug Pomalyst Associated With Side Effects Risks Of Cardiac Failure, Interstitial Lung Disease, And Hepatotoxicity

In May 2015 The Medicines and Healthcare Products Regulatory Agency In UK Issued A Drug Safety Update; Will There Be Similar FDA Action? (Posted by Tom Lamb at DrugInjuryWatch.com) Pomalidomide (brand name: Pomalyst in the US; Imnovid in Europe) is a...
by Drug Injury Watch on Jun 3, 2015

Beyaz / Safyral / YAZ / Yasmin: These Drospirenone Containing Birth Control Pills Have A Higher Risk Of Blood Clot Side Effects Than Older Options

New Medical Journal Article Presents "Compelling Evidence" That These Newer Oral Contraceptives Are Associated With More Venous Thromboembolism Events (Posted by Tom Lamb at DrugInjuryWatch.com) Beyaz, Safyral, YAZ, and Yasmin are birth con...
by Drug Injury Watch on May 27, 2015

Long-Term Combined Plavix - Effient Use May Be Associated With An Increased Overall Risk Of Non-Cardiovascular Death Compared To Shorter Therapy Period

FDA Drug Safety Communication Issued In November 2014 About The Dual Antiplatelet Therapy (DAPT) Trial Which Was Published In The New England Journal of Medicine (Posted by Tom Lamb at DrugInjuryWatch.com) Plavix (clopidogrel) and Effient (prasugrel)...
by Drug Injury Watch on May 6, 2015

In Canada, ADHD Drugs Like Adderall, Concerta, And Ritalin Are Getting New Warnings About Suicide-Related Adverse Events

Increased Warning About The Risk Of Suicidal Thoughts And Behaviors Being Added To Attention Deficit Hyperactivity Disorder (ADHD) Drug Labels (Posted by Tom Lamb at DrugInjuryWatch.com) On March 30, 2015 Health Canada issued an Information Update do...
by Drug Injury Watch on Mar 30, 2015

A New Case Of Progressive Multifocal Leukoencephalopathy (PML) In A Patient Using Gilenya Is Reported By Novartis In Canada

Company Is Investigating This Gilenya - PML Case To See Whether Brain Disease Might Be A Side Effect Of Its MS Drug (Posted by Tom Lamb at DrugInjuryWatch.com) Gilenya (fingolimod) capsules were approved by the FDA in 2010 and by Health Canada in 201...
by Drug Injury Watch on Feb 23, 2015

Zofran Associated With Birth Defects When Used During Pregnancy As An "Off-Label" Morning Sickness Treatment

Medical Researchers Find Increased Risk Of Heart Defects And Cleft Palates In Babies Born To Women Using Zofran (Posted by Tom Lamb at DrugInjuryWatch.com) Women with severe morning sickness who were prescribed Zofran (ondansetron) -- a GlaxoSmithKli...
by Drug Injury Watch on Feb 9, 2015

UK Drug Safety Regulator Issues New Warnings About The Use Of Depakote / Depacon / Depakene By Women During Pregnancy

Updates Information About Extent Of Serious Developmental Disorders Such As Autism Spectrum Disorders (ASD) As Well As Congenital Malformations And Birth Defects Like Spina Bifida (Posted by Tom Lamb at DrugInjuryWatch.com) Depakote, Depakote CP, and...
by Drug Injury Watch on Jan 26, 2015

Topamax Taken During Pregnancy Associated With A Significant Increased Risk Of Cleft Lip For Infants Born To Those Mothers

Recently Revised Topamax Label Includes Data Of 2014 Annual Report From The North American Antiepileptic Drug (NAAED) Pregnancy Registry (Posted by Tom Lamb at DrugInjuryWatch.com) By means of an October 21, 2014 FDA letter to Janssen Pharmaceuticals...
by Drug Injury Watch on Nov 24, 2014

Xarelto: Drug-Induced Liver Injury Warning Should Be Added To Drug Label Prescribing Information For Xarelto Say Medical Researchers

Medical Journal Article Reports On Two Patients Who Experienced Severe Liver Damage Onset During Xarelto Treatment (Posted by Tom Lamb at DrugInjuryWatch.com) Most adverse drug reaction case reports associated with the still relatively new anticoagul...
by Drug Injury Watch on Nov 10, 2014

Some Patients Who Stopped Taking Cymbalta Have Suffered From Extended And Severe Withdrawal Reactions Without Warning

Cymbalta Discontinuation Syndrome / Symptoms Include "Brain Zaps", Extreme Mood Swings (anger, irritability), And Neurological Or Physical Problems (Posted by Tom Lamb at DrugInjuryWatch.com) While generally thought of as an antidepressant...
by Drug Injury Watch on Oct 27, 2014

Mirapex / Requip / Neupro: Significant Increased Risk Of Compulsive Behaviors -- Gambling, Shopping, And Sex -- For These Parkinsons And Restless Leg Drugs

These Impulse Side Effects, As Seen In Adverse Drug Events Reports, Are Much Higher Than Previously Thought According To New Medical Journal Article (Posted by Tom Lamb at DrugInjuryWatch.com) Thomas Moore, A.B., a senior scientist at the Institute o...
by Drug Injury Watch on Oct 21, 2014

European Medicines Agency (EMA) Committee Recommends Further Restrictions On Use Of Depakote / Depakene / Depacon By Women Of Childbearing Age

Cites Higher Risks Of Neural Tube Defects Like Spina Bifida, Hypospadias, And Other Birth Defects As Well As Increased Risk Of Autism Spectrum Disorder (Posted by Tom Lamb at DrugInjuryWatch.com) More restrictions of the use of valproate drugs -- suc...
by Drug Injury Watch on Oct 14, 2014


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