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Bristol-Myers Squibb Recalls Mislabeled Anticoagulant Drug

June 19, 2017

Pharmaceutical company Bristol-Myers Squibb has recalled one lot of 5 mg Eliquis (apixaban) tablets after the batch was identified as being mislabeled.

Featured In: Drug Safety News

THE LATEST
Merck Halts Enrollment in Keytruda Clinical Trials Following Patient Deaths

June 15, 2017 - Merck has announced that they will not be enrolling any new patients into two Phase III clinical trials involving Keytruda (pembrolizumab) following reports of patient deaths.

Featured In: Clinical Trials News, Drug Safety News


FDA and Endo Pull Opioid Pain Drug from the Market

June 12, 2017 - The FDA has asked Endo Pharmaceuticals to pull its opioid pain medication, Opana ER (oxymorphone hydrochloride), from the market amid concerns that the drug’s benefits do not outweigh the potential risk of abuse.

Featured In: Drug Safety News



1 in 6 Patients with Atrial Fibrillation May Be Getting Wrong Dose of Blood

June 7, 2017 - New research conducted at the Mayo Clinic has found that one in six Americans on blood thinners to treat irregular heart rate – known as atrial fibrillation – could be taking too much or too little of the medication.

Featured In: Drug Safety News


Nanofluidic Device Could Improve Quality of Biologic Drugs

May 24, 2017 - MIT engineers have developed a nanofluidic device capable of assessing the quality of biologic drugs as they’re being manufactured.

Featured In: Biotech News, Drug Safety News


Opioid Prescriptions for Minor Injuries Contribute to Growing Epidemic

May 18, 2017 - While many assume that patients prescribed large quantities of opioid drugs – such as oxycodone – for chronic pain are at the highest risk of abuse and dependence, new research suggests that small prescriptions for these narcotic painkillers could be just as dangerous.

Featured In: Drug Safety News

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Medicinal Chemistry Excellence: Efficient and Innovative Solutions for Superior Pre-clinical Candidates

Tumor-Size-Based Measurements as Endpoints in Cancer Clinical Trials


32 Percent of FDA-Approved Drugs Associated with Postmarket Safety Events

May 12, 2017 - This trend was identified by researchers in the Department of Medicine at Brigham and Women's Hospital, who published their findings in JAMA.

Featured In: Drug Safety News


FDA Sends Warning Letters to Manufacturers of Fake Cancer Drugs

April 27, 2017 - The FDA is cracking down on the sale of illegal cancer drugs by sending warning letters to 14 US companies selling the unapproved products.

Featured In: Drug Safety News, Pharmaceutical Marketing News


Women with Unexplained Clots May Now be Advised to Stop Taking Blood Thinners

April 5, 2017 - Researchers at the University of Ottawa have developed and validated a rule which may help physicians decide whether some women can stop taking blood thinners after a venous thrombosis.

Featured In: Drug Safety News


IBS Patients Taking Viberzi May Be at Increased Risk of Pancreatitis

March 22, 2017 - According to a recent drug safety communication issued by the US Food and Drug Administration (FDA), patients with irritable bowel syndrome (IBS) with diarrhea should not be treated using Viberzi (eluxadoline), if they do not have a gallbladder.

Featured In: Drug Safety News


FDA Advisory Committees Find Benefits of Endo’s Opioid Drug Don’t Outweigh Risks

March 16, 2017 - Advisory committees to the US Food and Drug Administration (FDA) have voted that the risk of abuse associated with Endo International’s opioid drug, Opana ER (oxymorphone hydrochloride extended release), outweighs its benefits.

Featured In: Drug Safety News, Pharmaceutical News


Some Online Pharmacies in UK Dispensing Antibiotics Without Prescription

February 22, 2017 - A new study suggests that online pharmacies in the UK could be contributing to the global health issue of antibiotic resistance by allowing patients to obtain antibiotics without a prescription.

Featured In: Drug Safety News


Statins and Diabetes: Despite Potential Link, Doctors Still Agree On Cholesterol-Lowering Effectiveness

January 19, 2017 - A commentary published in The American Journal of Medicine, has attempted to address the possible link between statins – a class of cholesterol-lowing drugs – and diabetes.

Featured In: Drug Safety News


FDA Advisory Committees Find Benefits of Endo’s Opioid Drug Don’t Outweigh Risks

March 16, 2017 - Advisory committees to the US Food and Drug Administration (FDA) have voted that the risk of abuse associated with Endo International’s opioid drug, Opana ER (oxymorphone hydrochloride extended release), outweighs its benefits.

Featured In: Drug Safety News, Pharmaceutical News


Anticholinergic Medication Use May Increase Hospital Visits

January 3, 2017 - A study conducted at Indiana University Center for Aging Research, Indiana University (IU) Center for Health Innovation and Implementation Science, and Regenstrief Institute, has found that older adults taking anticholinergic medications may visit the hospital more often.

Featured In: Drug Safety News


FDA Allows Pfizer’s Chantix to Drop Black Box Warning

December 22, 2016 - Based on the results of an 8,144 patient post-marketing study of the drug, the regulator has approved the removal of a black box warning from the product’s packaging.

Featured In: Drug Safety News


Some Immuno-Oncology Drugs Carry Risk of Rare Heart Damage

November 7, 2016 - Two weeks after beginning treatment with Bristol-Myers Squibb’s Opdivo and Yervoy immuno-oncology drug combo, two melanoma patients died as a result of myocarditis.

Featured In: Drug Safety News


Celgene and IBM to Launch Drug Safety Program

November 7, 2016 - The initiative – called IBM Watson for Patient Safety – will automatically collect, organize and analyze large amounts of data generated during, and after, drug development.

Featured In: Drug Safety News


Preventing Postoperative Opioid Addiction through Better Pain Management

October 31, 2016 - A team at the University of Michigan are addressing the US opioid epidemic by looking for ways to reduce the number of opioid prescriptions, both before and after surgery.

Featured In: Drug Safety News


Regeneron and Teva Face FDA Hold On Chronic Pain Clinical Trial

October 18, 2016 - Yesterday, Israel-based Teva Pharmaceuticals and their partner Regeneron, announced that the US Food and Drug Administration (FDA) has put their Phase IIb clinical trial for a chronic pain medication on hold.

Featured In: Drug Safety News, Clinical Trials News


Study Suggests Some NSAIDs Associated With Increased Risk Of Heart Failure

October 3, 2016 - According to researchers at the University of Milano-Bicocca in Italy, the use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) has been linked to an increased risk of heart failure and hospitalization.

Featured In: Drug Safety News


Is Codeine Still The Best Choice For Pediatric Pain Management?

September 21, 2016 - The physician’s group is advising healthcare providers to stop prescribing codeine-based medication to children, and is looking to increase awareness of the risks of the drug in those under the age of 18.

Featured In: Drug Safety News, Life Science News


Antibiotic Use Linked to Type 1 Diabetes Risk in Animal Models

September 2, 2016 - As the gut microbiome begins to form, some studies suggest it could have a dampening effect on the immune system, preventing it from becoming overly sensitive.

Featured In: Drug Safety News


NIH Permanently Closes Drug Production Facility For Clinical Trials

August 15, 2016 - A facility used to manufacture drugs for early-stage clinical trials has been shut down by the National Institutes of Health (NIH), after an inspection found problems with the plant’s aseptic production practices.

Featured In: Drug Safety News


Update: FDA Panel Supports Approval Of Valeant’s Psoriasis Drug With Risk Management

July 21, 2016 - While the FDA has not officially approved the drug, the agency usually follows the advice of the advisory panel.

Featured In: Drug Safety News, Pharmaceutical Marketing News


FDA Concerned As Experimental Psoriasis Drug Linked To Suicide Risk

July 19, 2016 - During clinical trials of the treatment, six participants committed suicide but the FDA said a lack of data made it difficult to determine the events’ effect on drug safety.

Featured In: Drug Safety News, Clinical Trials News


hand sanitizer 300 photo hand sanitizer300_zpsriz8xqgx.jpg FDA Asks For Safety And Effectiveness Of Active Ingredients In Hand Sanitizers

July 4, 2016 - Amid increased use of over-the-counter (OTC) antiseptic hand sanitizers, the US Food and Drug Administration (FDA) is requesting more scientific data from manufacturers on the products’ safety and effectiveness.

Featured In: Drug Safety News, Life Science News


Arthritis150 photo Arthritis150_zpstscbpvsw.jpg Cancer Immunotherapy Linked To Increased Risk Of Rheumatologic Disorders

June 28, 2016 - A recent study conducted by Johns Hopkins University researchers has found a connection between cancer immunotherapy treatments and an increased risk of developing rheumatologic disorders, such as arthritis.

Featured In: Drug Safety News, Biotech News


Diabetes Drugs Could Harm Kidneys, Warns FDA

June 16, 2016 - Two drugs used to treat type 2 diabetes – Johnson & Johnson's Invokana and AstaZeneca's Farxiga – have been shown to be associated with acute kidney injury, according to the US Food and Drug Administration (FDA).

Featured In: Drug Safety News


Pain Paradox: Opioid Painkillers Prolong Chronic Pain In Rats

June 1, 2016 - A new study conducted by researchers at the University of Colorado Boulder, has found that opioids, like morphine, paradoxically increase the pain response in rats.

Featured In: Drug Safety News, Pharmaceutical News


Migraine Drugs May Be Underused Due To FDA-Mandated Black Box Warnings

May 11, 2016 - The results of the study suggest that these medications could be safe for a new subset of migraine sufferers, including the 10 million patients that experience migraine-associated changes in vision, touch, speech, thinking or strength, known as an aura.

Featured In: Drug Safety News, Pharmaceutical News


Patient Advocacy Group Calls On Congress To Investigate FDA’s Role In Essure Approval

May 2, 2016 - A women’s advocacy group for patients who experienced adverse reactions associated with Bayer’s contraceptive implant, Essure, have criticized the US Food and Drug Administration (FDA) for its alleged lack of oversight for the medical device.

Featured In: Drug Safety News, Pharmaceutical Marketing News


Epilepsy Drug’s Risk Of Birth Defects May Be Exaggerated

April 8, 2016 - In contrast to the results of an initial study, the epilepsy drug lamotrigine may not increase the risk of birth defects.

Featured In: Drug Safety News


Contaminated Heparin May Still Be On The US Market

April 4, 2016 - While the alleged contamination is different from the earlier case, some members of congress are criticizing the US Food and Drug Administration (FDA) for failing to prevent the current issue.

Featured In: Drug Safety News


Public Health Officials Call For FDA Black Box Warnings On Opioids and Benzodiazepines

February 25, 2016 - Health officials across the US are asking that the US Food and Drug Administration (FDA) add new warning labels to opioid and benzodiazepine drugs.

Featured In: Drug Safety News


Update: Investigation Continues Into Cause of Deadly French Drug Clinical Trial

February 8, 2016 - Investigators in France are still trying to determine why a Phase I clinical trial – conducted last month – left one person dead and five others seriously injured.

Featured In: Drug Safety News, Clinical Trials News


Neurochemical Variants Could Be Safer Alternative To Morphine

February 1, 2016 - According to researchers at Tulane University and Southeast Louisiana Veterans Health Care System, an analog of the neurochemical endomorphin could be just as effective as morphine at treating pain, without the addictive qualities of the drug.

Featured In: Drug Safety News, Life Science News


French Drug Trial Leaves One Participant Brain Dead, Five Others Seriously Ill

January 19, 2016 - During a Phase I clinical trial run by French drug evaluation company, Biotrial, six participants became critically ill – one of which has now been declared brain dead.

Featured In: Drug Safety News, Clinical Trials News


 
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