2011 adverse reactions

Adverse reactions

“Drug Falls Short In Cancer Study”
WSJ. 30 December 2011.

“Epidurals Linked to Paralysis Seen With $300 Billion Pain Market.”
Bloomberg. 28 December 2011.

“The growing downside of cholesterol drugs. 'The harms are really starting to catch up,' says researcher of widely prescribed statins.”
Vancouver Sun. 28 December 2011.

“Bristol-Myers Says Liver Cancer Drug Didn’t Meet Goals in Trial.”
Bloomberg Business Week. 23 December 2011.

“Bristol-Myers: Experimental liver cancer drug failed in late-stage study, other tests continue.”
Washington Post. 22 December 2011.

“FDA to probe Gilenya patient death”
Inpharm. 21 December 2011.

“Targeted drug side effects add to cancer costs.”
Reuters. 21 December 2011.

“Sanofi, Novartis, Astrazeneca get poor results from trial tests on key drugs.”
Washington Post. 20 December 2011.

“Genzyme phase 3 study fails to show superiority for MS drug.”
Pro Active Investor. 20 December 2011.

“Heart drug doubles risk for heart failure.”
All Voices. 20 December 2011.

“Targacept plunges on second drug study failure.”
CNBC. 20 December 2011.

“Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After The First Dose.”
FDA Medwatch. 20 December 2011.

“Three European companies douse hopes for new drugs.”
Reuters. 20 December 2011.

“Nausea drug may be linked with sudden cardiac death.”
Irish Times. 19 December 2011.

“Child Cancer Drugs May Cause Problems Later, Study.”
Medical Daily. 19 December 2011.

“Multaq, Heart Rhythm Drug, Linked With Heart Attack And Stroke Risks; FDA Adds Safety Warnings.”
Huffington Post. 19 December 2011.

“Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events.”
FDA Medwatch. 19 December 2011.

“Pediatric anticancer drugs, other drugs linked to heart disease.”
Food Consumer. 17 December 2011.

“Pfizer Settled About Half of Prempro Cases, Adds to Reserve.”
Bloomberg. 15 December 2011.

“BioSante's "female viagra" fails late-stage trials.”
Reuters. 14 December 2011.

“This includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.”
MedWatch November 2011 Safety Labeling Changes posting. FDA Medwatch. 13 December 2011.

“Actelion pulls out of Trophos buy after ALS drug failure.”
Pharma Times. 14 December 2011.

“Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication- Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn."
FDA Medwatch. 14 December 2011.

“Rare birth defects tied to mom's painkiller use.”
Chicago Tribune. 13 December 2011.

“Some depressed people do worse on drugs: study.”
Reuters. 12 December 2011.

“Scandal Over Mediator, a French Weight-Loss Drug, Prompts Calls for Wide Changes.”
New York Times. 11 December 2011.

“Glaxo's Tykerb Misses Goal In Breast Cancer Trial.”
WSJ. 9 December 2011.

“FDA advisers: revise popular birth control labels.”
Reuters. 8 November 2011.

“More Detail on Risk Urged for a Contraceptive Label.”
New York Times. 8 December 2011.

“FDA staff worried about lung risk with Alexza drug.”
Reuters. 8 December 2011.

“EUROECHO: Cancer Drug Has Early Cardiac Effects.”
MedPageToday. 8 December 2011.

“Alexza’s Inhaled Antipsychotic May Pose Lung Risks, FDA Says.”
Bloomberg Business Week. 8 December 2011.

“Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events.”
FDA Medwatch. 7 December 2011.

 

 

 

“FDA says Yaz and related birth control pills should carry more info about risk of blood clots.”
Washington Times. 7 December 2011.

Pfizer’s Kidney Cancer Drug May Not Be Effective, FDA Staff Report Says.”
Bloomberg. 5 December 2011.

“After heart attacks, two types of drugs are commonly prescribed: antiplatelet treatment and selective serotonin reuptake inhibitors (SSRI) for depression. A retrospective analysis of patients discharged after acute myocardial infarction over 10 years found that compared with aspirin alone, the combined use of an SSRI and antiplatelet therapy resulted in a higher risk of bleeding.”
BMJ 2011; 343 doi: 10.1136/bmj.d7681 (Published 30 November 2011)

“Merck to pay $950 million to settle U.S. Vioxx charge.”
Reuters. 23 November 2011.

Drugmakers’Returns on Research Fall as Pipeline Projects Fail."
Business Week. 21 November 2011.

“US FDA revokes Roche's Avastin for breast cancer.”
Reuters. 18 November 2011.

“MedWatch October 2011 Safety Labeling Changes posting. This includes 48 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.”
FDA Medwatch. 18 November 2010.

“GSK diabetes drug fails first of seven phase 3 clinical trials”
WRALtech. 16 November 2011.

“Depression drug disappoints”
Nature, 15 November 2011

“Experimental Drug for Irregular Heart Rhythm Raises Death Risk: Study Dronedarone trial cut short after excess of deaths in patients with permanent form of atrial fibrillation.”
US News. 14 November 2011

“Sanofi’s Multaq Doubled Deaths From Heart Disease in Study.”
Bloomberg. 14 November 2011.

“Apixaban Fails To Meet Goal Vs Enoxaparin At Preventing Clots-Study.”
WSJ. 14 November 2011.

“Three Rockville biotechs report trial results that fail to meet goals.”
Gazette.net. 11 November 2011.

“FDA issues "safety communication" on fenofibrate.”
HeartWire. 9 November 2011.

“AstraZeneca Dealt Setback on Antidepressant”
Wall Street Journal. 9 November 2011.

“Trilipix (fenofibric acid): Drug Safety Communication - Label Change.”
FDA Medwatch. 9 November 2011.

“Depressing Results From Targacept's Phase III Study.”
SeekingAlpha. 9 November 2011.

“Drug blamed for a broader range of harmful effects.”
Nature,09 November 2011

“AstraZeneca, Targacept drug fails depression test.”
Reuters. 8 November 2011.

“Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults.  Healthcare professionals should remain vigilant for cases of malignancy in patients”
FDA Medwatch. 4 November 2011

“NHLBI halts triple therapy arm of IPF study due to safety concerns.”
Modern Medicine. 4 November 2011.

“Lilly Hid Zyprexa’s Diabetes Risks, Student Died, Lawyer Argues.”
Bloomberg. 3 November 2011.

“Boehringer Confirms Pradaxa-Related Deaths, Die Zeit Reports.”
Bloomberg. 2 November 2011.

“Pradaxa Bleeding Deaths Raise Concern.”
MedpageToday. 2 November 2011.

“Drug Fails To Benefit Patients With Kidney Disease”
Ivanhoe.com. 31 October 2011.

“NPS Pharmaceuticals Shares Plunge 33% on Bowel Drug Deaths.”
Bloomberg. 31 October 2011.

“Anthrax vaccine for children: A real fright in time for Halloween.”
Washington Post. 31 October 2011.

“IVF 'could double cancer risk'.”
The Independent. 27 October 2011

“Flu vaccine doses recalled in scare over side-effects”
Aberdeen Press & Journal 26th OCtober 2011

“Naproxen and ibuprofen rank highly for cardiovascular safety”
British Medical Journal BMJ2011;343:d6311

“What if the drugs don't work? Research repeatedly shows that antidepressants give little benefit – but serious side effects.”
The Independent. 25 October 2011.

“Lilly withdraws sepsis drug Xigris from market”
Reuters. 25 October 2011.

“Side effects. What? Doctors say not taking the medicine can be worse. You cure the itchy toes, but you might get liver failure, depressive symptoms, severe neutropenia and toxic epidermal necrolysis. Those are just some of the possible side effects of a pill for athlete's foot.”
Times Union. 21 October 2011.

“Amid Continued Clinical Trial Failures, No Novel Acute Ischemic Stroke Drug Therapies Are Forecasted to Launch Through 2020.”
Marketwatch. 20 October 2011.

“J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues.”
Bloomberg. 12 October 2011.

“Bristol’s Sprycel May Increase Hypertension Risk, FDA Says.”
Bloomberg. 11 October 2011.

“Teva, Baxter, Mckesson to Pay $162 Million Punitive Damages Over Propofol.”
Bloomberg. 11 October 2011.

“Weight loss pills investigated as cause of liver failure.”
SpireHealthCare. 26 September 2011.

“Tolerx cuts staff, auctioning assets after PhIII failure.”
Fiercebiotech. 7 October 2011.

“New Warning Added to Avastin Label. FDA: Cancer Drug Raises Risk of Ovarian Failure.”
Webmd. 7 October 2011.

“Breast cancer drug tied to diabetes in older women.”
Reuters. 6 October 2011.

“Risky Pregnancy Drug Raised Daughters' Cancer Odds”
New York Times. 5 October 2011.

“Doctors Grow Wary of Avastin for Eye Treatment”
New York Times, October 4th 2011

“Sangamo Halts Diabetes Drug Development After Failing Trial.”
Bloomberg. 3 October 2011.

“Regular aspirin users at higher risk of sight problems, research suggests.”
Daily Telegraph. 3 October 2011.

“Painkiller linked to heart attack risk.”
The Independent. 29 September 2011.

“Antipsychotics get mixed review for unapproved use.”
Chicago Tribune. 28 September 2011.

'Cost of failure pushes up drug prices'.
Times of India. 28 September 2011.

“HRT could significantly increase chances of asthma attack. Scientists say it could trigger asthma in healthy - and make symptoms worse. Calls to stop prescribing if patients complain of breathing problems.”
Daily Mail. 28 September 2011.

“Reapproval of anti-bleeding drug stirs controversy.”
Globe and Mail. 25 September 2011.

“Zofran (ondansetron): Drug Safety Communication -Risk of Abnormal Heart Rhythms.”
FDA Medwatch. 15 September 2011.

 “‘Safe’low-dose aspirin still causes serious stomach bleeding”
Clinical Gastroenterology and Hepatology, 2011, 15 September 2011

“Anti-nausea drug may pose risk to heart rhythm: FDA.”
Reuters. 15 September 2011.

“Commonly Used Pain Pills Increase Kidney Cancer Risk in Study.”
Bloomberg. 12 September 2011.

“FDA MedWatch- August 2011 Safety Labeling Changes: 44 Medical Product Labels with Changes.”
FDA MedWatch. 12 September 2011.

“UPDATE 2-US FDA advisers wary of time limit on bone drugs.”
Reuters. 9 September 2011.

“TNF Treatment for Rheumatoid Arthritis Boosts Skin Cancer Risk. But review also finds the drugs don't heighten risks for other cancers.”
Healthday. 7 September 2011.

“Tumor Necrosis Factor-alpha (TNFa) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab).”
FDA Medwatch. 7 September 2011.

“Ibuprofen taken in pregnancy 'doubles risk' of miscarriage.”
The Independent. 7 September 2011.

“F.D.A. to Review Safety of Popular Bone Drugs.”
New York Times. 5 September 2011.

“Five More Reports of Avastin Injections Causing Blindness.”
New York Times. 2 September 2011.

“FDA Chides Pfizer For Omitting Drug Risks On Lipitor Website.”
Shots. 2 September 2011.

“Bone Drug Increases Kidney Failure Risk.”
Renal Business. 2 September 2011.

“Four LA Avastin patients lost vision in injected eye”
Reuters. 1 September 2011.

“Osteoporosis-Is Treatment More Dangerous Than the Disease?”
West Palm Beach. 1 September 2011.

“Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions.”
FDA Medwatch. 1 September 2011.

“MedWatch safety alert: Reclast (zoledronic acid).”
FDA Medwatch. 1 September 2011.

“Compensation system urged for research victims.”
Washington Post. 31 August 2011.

“Avastin Injections Are Reported to Cause Blindness.”
New York Times. 31 August 2011.

“United Therapeutics (UTHR) UTHR Hits 52-Week Low On Lung Drug Failure.”
Market Intelligence Center. 24 August 2011.

“The Darker Side of Breast Cancer Drugs Revealed.”
IBT. 23 August 2011.

“Heart Failure Drug Not as Effective on US Patients. Study finds beta blockers work much better elsewhere.”
Art Chimes, St. Louis, Missouri VoA. 22 August 2011.


"Anti-Clotting Drug May Cause Severe Bleeding With No Benefit. Eliquis does not reduce heart attacks, stroke or death in high-risk patients, researchers find."
HealthDay. 24 July 2011.

"Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events."
FDA Medwatch. 22 July 2011.

"FDA Reviewing Osteoporosis Drugs for Esophageal Cancer Risk."
Bloomberg. 21 July 2011.

"EU recommends restricted use of GSK's flu shot."
Reuters. 21 July 2011.

"UPDATE 1-U.S. FDA probes Sanofi's heart drug Multaq."
Reuters. 21 July 2011.

"Lilly's failed Alzheimer's drug raises troubling questions for drug class."
Fiercebiotech. 21 July 2011.

"Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer."
FDA Medwatch. 21 July 2011.

"Young people should not take flu vaccine, watchdog says."
Daily Telegraph. 21 July 2011.

"Doctors writing fewer prescriptions for Abbott cholesterol drug."
Chicago Tribune. 20 July 2011.

"AstraZeneca to Face 2012 Trial in Arkansas Over Sales of Anti-Psychotic."
Bloomberg. 19 July 2011.

"'No benefit' from depression drugs."
Yahoo News. 19 July 2011.

"Nabi smoking vaccine fails in study; shares skid."
CNBC. 18 July 2011.

"Brain swelling may be common with Alzheimer's drugs."
Reuters. 18 July 2011.

"Heart Warning Added to Label on Popular Antipsychotic Drug."
New York Times. 18 July 2011.

"ICAD: Alzheimer's Patients Not Helped by Antidepressants."
Medpage Today. 18 July 2011.

"Oncology Therapies Most Likely to Fail at Development Stage."
IStockAnalysis. 14 July 2011.

"Research and Markets: Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure."
14 July 2011.

"Biotech Sector Grapples With High Failure Rates."
Market Watch. 14 July 2011.

"Certain Painkillers May Raise Odds of Stroke, Heart Attack: Study."
Healthday News. 14 July 2011.

"MedWatch June 2011 Safety Labeling Changes."
FDA Medwatch. 14 July 2011.

"Study: Stop-Smoking Aid Ups Cardiovascular Risks. Warning might be added to Chantix box."
VOA News. 11 July 2011.

"Top R&D Drug Failures - Toxicity and Serious Adverse Events in Late Stage Drug Development are the Major Causes of Drug Failure."
PR Newswire. 11 July 2011.

"Sanofi MS drug Lemtrada misses a goal in study."
Forbes. 11 July 2011.

"Atrial fibrillation trial halted; Multaq linked to other heart problems."
LA Times. 7 July 2011.

"Idera says Merck KGaA dropping cancer drug."
Forbes. 7 July 2011.

"UPDATE 1-Sanofi halts clinical trial of heart drug Multaq. Trial halted after heart problems.
"
Reuters. 7 July 2011.

"Drug Flops for Acute Heart Failure."
Medpage Today. 7 July 2011.

"Study Finds Heart Failure Drug Ineffective. Billions wasted on Natrecor in decade it took to find out it doesn't work, expert says."
US News. 6 July 2011.

"Antidepressant use in pregnancy may raise autism risk."
CNN. 6 July 2011.

"Pfizer Drug Tied to Heart Risks."
WSJ. 5 July 2011.

"Anti-HIV drug Kaletra can cause adrenal problems in newborns."
LA Times. 5 July 2011.

"Senators question Medtronic about unreported side effects of spinal protein."
BMJ 5 July 2011; 343:d4284 doi: 10.1136/bmj.d4284

"Pfizer Drug Tied to Heart Risks."
WSJ. 5 July 2011.

"Painkillers 'Raise Irregular Heartbeat Risk'."
Sky News. 5 July 2011.

"Ibuprofen and aspirin linked to irregular heart rhythm."
Daily Telegraph. 4 July 2011.

"Down's warning to older IVF mothers: Fertility drugs may lead to embryo problems."
Daily Mail. 4 July 2011.

"Pfizer's quit smoking drug raises heart risks: study."
Reuters. 4 July 2011.

"25 die every week from side effects."
Sunday Express. 3 July 2011.

"Valproate Products: Drug Safety Communicaton - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy)"
FDA Medwatch. 30 June 2011.

"New medicine approvals slumped to record low in 2010."
InPharm. 29 June 2011.

"European drug agency extends review of safety of pioglitazone"
BMJ Published 29 June 2011

"Intensive vaccine programme linked to higher death rate in infants"
29 June 2011 Human and Experimental Toxicology

"Anticholinergic effects of common drugs are associated with increased mortality in over 65s"
BMJ 2011 28 June 2011

"As Ph3 failures spike Big Pharma hits the brakes on R&D spending."
Fiercepharma. 27 June 2011.

"AIDS drugs can cause premature ageing: study"
Reuters. 26 June 2011.

"Bristol diabetes pill tied to certain cancers."
Reuters. 25 June 2011.

"Little Progress Seen in Treating Chronic Pain"
MedPage Today. 23 June 2011.

"Merck withdraws cladribine tablets from approval process."
Manufacturing Chemist. 22 June 2011.

"FDA Panel Votes Against Gout Drug."
WSJ. 22 June 2011.

"High Doses of Cholesterol Drugs Raise Risk of Diabetes, Researchers Find."
Bloomberg. 22 June 2011.

"Rotavirus vaccine linked to rare cases of intussusception, again"
BMJ 2011 Published 22 June 2011

"High-dose statins 'increase Type 2 diabetes risk'"
Daily Telegraph. 22 June 2011.

"Rotavirus vaccine linked to rare cases of intussusception, again."
BMJ 22 June 2011; 342:d3826 doi: 10.1136/bmj.d3826.

"US FDA panel rejects Novartis drug for gout"
Reuters. 21 June 2011.

"Pfizer stop-smoking pill raises heart risk: FDA."
Reuters. 16 June 2011.

"Bayer Loses U.S. High Court Case on Baycol Class-Action Suit."
Bloomberg. 16 June 2011.

"Pfizer stop-smoking pill raises heart risk-FDA."
Reuters. 16 June 2011.

"Takeda’s Diabetes Drug Actos May Raise Risk of Bladder Cancer, FDA Says."
Bloomberg. 16 June 2011.

"FDA Warns of Drug's Potential Heart Risk."
WSJ. 16 June 2011.

"Atypical antipsychotics linked to OSA in depressed patients."
Medwire Today. 15 June 2011.

"Seizure drugs tied to pregnancy risks."
Reuters. 15 June 2011.

"Boehringer, Pfizer’s Spiriva Mist Inhaler May Up Death Risk."
Bloomberg. 15 June 2011.

"FDA Warns of Risks With Liraglutide."
Medpage Today. 14 June 2011.

"Yellow Fever Vaccine Risky for MS Patients."
MedPage Today. 14 June 2011.

"France, Germany Suspend Takeda's Actos On Bladder Cancer Risk."
WSJ. 10 June 2011.

"Takeda’s Actos Drug Suspended in France on Cancer Risk Study."
Bloomberg. 9 June 2011.

"Drugs for benign prostate tumors increase the risk of aggressive cancers, FDA says."
LA Times. 9 June 2011.

"Merck, Glaxo Drugs Add Warnings About Prostate Cancer Risk."
Bloomberg. 9 June 2011.

"Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations."
FDA Medwatch. 8 June 2011.

"Takeda's Actos Drug Suspended in France on Cancer Risk Study."
SF Gate. 8 June 2011.

"FDA issues warning on cholesterol drug."
Washington Post. 8 June 2011.

"Exelixis reports deaths in cancer drug study."
Bloomberg Business Week. 6 June 2011.

"New drug failure rates rising in Phase II and III clinical trials."
MedCityNews. 2 June 2011.

"Johnson & Johnson Hid Antibiotic Levaquin Risk, Lawyer Says."
Bloomberg. 1 June 2001.

"FDA Limits Diabetes Drug Even More."
National Journal. 18 May 2011.

"This posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE."
MedWatch April 2011 Safety Labeling Changes.
FDA Medwatch. 17 May 2011.

"Failure Rates for Phase II Trials."
PharmTechTalk. 12 May 2011.

"Erythropoietin for heart attacks falls at the first hurdle."
BMJ 11 May 2011

“Experiments in animals led researchers to evaluate erythropoietin as a treatment for myocardial infarction, with the hope that it might reduce infarct size if given soon after an early and successful percutaneous coronary intervention. Results from the first phase II trial were disappointing, however, and at least one commentator thinks they spell the end for this particular line of inquiry (p 1908).”
JAMA2011;305:1863-72

"Anemia Drug May Worsen Heart Attacks. Study finds Procrit offers no cardiac protection, may increase risk after acute attack."
USNews. 10 May 2011.

"Drug regulators accused of risking patient safety."
The Guardian. 10 May 2011.

"Bisphosphonates linked to atypical fractures of the femoral shaft"
N Engl J Med. 2011 May 5

"Glaxo May Settle 1,000 More Lawsuits Over Avandia, Patients’ Lawyer Says."
Bloomberg. 4 May 2011.

"FDA warning for teething drug."

Behealthyspringfield. 4 May 2011.

"Pfizer stock hit by drug death link reports."
Pharma Times. 26 April 2011.

"Rheumatoid Arthritis Drug Linked to 1 Death in Clinical Trial."
OnlineJournal. 26 April 2011.

"Drug to Prevent HIV Fails."
MedIndia. 25 April 2011.

"US FDA details timeframe of Biogen MS drug's risks. Infection risk higher after two years of treatment - FDA * FDA updates warning on brain infection with Tysabri"
Reuters. 22 April 2011.

"New studies point to clot risk of Bayer's Yasmin."
Reuters. 22 April 2011.

"FDA details timeframe of MS drug Tysabri's risks."
Reuters. 22 April 2011.

 

"Blood Pressure Drug Could Raise Risk Of Breast Cancer Recurrence."
MedIndia. 21 April 2011.

"Birth-Control Pills With Drospirenone Raise Clot Risk in Study."
Bloomberg. 21 April 2011.

"Killer drug is most prescribed by doctors"
The Use of Medicines in the United States: Review of 2010; the IMS Institute for Healthcare Informatics 20 April 2011

"Some Birth Control Pills Pose Gallstone Risk."
Medpage Today. 20 April 2011.

"Study in Africa testing AIDS drug to prevent infection is halted."
Washington Post. 18 April 2011.

"J&J Asks Risperdal Judge for ‘Small Penalty,’ Not ‘Billions’."
Bloomberg. 18 April 2011


"Alli/Xenical Diet Drugs Liver Injuries Reported."
Allvoices. 16 April 2011.

"Hitting the Target, Missing the Mark: How Targeted Therapies Have Left Patients Wanting."
Xconomy. 14 April 2011.

"
Clues to Why Rheumatoid Arthritis Drug Humira Fails Some Patients. Nearly a third develop an immune reaction to the drug that thwarts its effectiveness, study finds."

US News Health. com. 12 April 2011.

“This posting includes 55 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.”
FDA Medwatch. 12 April 2011.

“Pfizer, Medivation’s Dimebon Fails in Huntington’s Study”
Bloomberg. 11 April 2011..

“Novartis ends Tasigna trial in intestinal cancer. Novartis ends late stage study of Tasigna in gastrointestinal cancer as drug didn't meet goals.”
Yahoo. 11 April 2011.

“Revlimid (lenalidomide): Ongoing Safety Review – increased risk of developing new malignancies.”
FDA Medwatch. 8 April 2011.

“IPF drug fails in new trial.”
E science. 8 April 2011.

“Benzocaine Topical Products: Sprays, Gels and Liquids: Risk of Methemoglobinemia” [a serious, potentially lethal reaction]
FDA Medwatch. 7 April 2011.

“Some diabetes drugs work better than others. Study finds some drugs more effective in preventing stroke, heart attack, death.”
MSNBC. 7 April 2011.

“Avastin debate highlights challenges of a catastrophic drug program.”
The Globe and Mail. 6 April 2011.

“Higher bleeding risk seen in J&J, Bayer clot drug.”
Reuters. 5 April 2011.

“Omeros drops after late-stage drug trial failure.”
Bloomberg Business Week. 1 April 2011.

“SPECIAL REPORT - When the drugs don't work.”
Reuters. 31 March 2011

“Amgen, Takeda drug fails advanced lung-cancer study.”
Reuters. 30 March 2011.

 

 

“Article title: 'Combination ACE inhibitor therapy increases risk of kidney failure and death'.”
Sciencecentric. 25 March 2011

"Targacept reports disappointing results for diversifying reach of drug compound."
Winston-Salem Journal. 25 March 2011

“Heart drug linked to higher breast cancer risk.”
WHTC. 22 March 2011

“XenoPort Announces Failure of Drug Candidate for Heartburn.”
Toronto Star. 21 March 2011.

“Drug used to treat type 2 diabetes linked to heart problems.”
Sify. 18 March 2011.

“Study provides further evidence for diabetes drug risk. Rosiglitazone appears to increase the risk of heart problems.”
Inthenews. 18 March 2011.

“Drug used to treat type 2 diabetes linked to heart problems.”
Sify. 18 March 2011.

“UPDATE 1-Europe starts safety probe into Takeda's Actos. Evaluation follows possible link to bladder cancer risk.”
Reuters. 18 March 2011

“lmesartan implicated in cardiovascular deaths.”
BMJ 2011; 342:d1622 doi: 10.1136/bmj.d1622. 16 March 2011

“Amylin, Takeda Suspend Clinical Activities in Obesity Trial.”
Bloomberg. 16 March 2011.


“This posting includes 53 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE.” 
February 2011 Safety Labeling Changes. FDA Medwatch. 16 March 2011.

“GSK/Tolerx type 1 diabetes drug fails in Phase III.”
Pharma Times. 14 March 2011.

“Experts call for stricter regulations in clinical trials of new drugs.”
Post Gazette. 14 March 2011

“Otelixizumab Proves to be Unsuccessful for the Treatment of Diabetes.”
Topnews. 12 March 2011.

“Glaxo, Tolerx diabetes drug fails in study.”
Bloomberg Business Week. 11 March 2011.

“Sanofi lung cancer drug fails in late-stage trial.”
Inpharm. 11 March 2011

 

“UPDATE 2-AstraZeneca in $68.5 mln settlement over Seroquel.”
Reuters. 10 March 2011.

“Osteoporosis Drug Reclast Linked to Kidney Failure. Public Citizen wants FDA to warn physicians, consumers.”
Consumer Affairs. 10 March 2011

"Fate of novel painkiller mAbs hangs in balance"
Nature Biotechnology,
Volume 29, Pages 173–174  doi:10.1038/nbt0311-173 Published online 09 March 2011

“Prenatal exposure to some epilepsy drugs may be associated with reduced intellectual abilities”
BMJ 2011; 342:d1432 doi: 10.1136/bmj.d1432 (Published 9 March 2011)

 

“Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies.”
FDA Medwatch. 8 March 2011

“For the desperately ill, trials of new drugs offer one last hope. But as this terrifying story shows, if it all goes wrong, you could be on your own.”
Daily Mail. 8 March 2011

“Japan halts Pfizer, Sanofi vaccines after four die.”
Reuters. 7 March 2011

“Repligen bipolar depression drug fails in study. Repligen says bipolar depression drug did not work better than placebo in mid-stage trial.”
Yahoo. 7 March 2011.

“FDA warns of birth defects with Topamax.”
FindLaw. 4 March 2011.

“FDA: migraine drug ups risk for oral birth defects.”
Reuters. 4 March 2011.

“Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns”
FDA Medwatch. 4 March 2011.

“J&J’s Risperdal Consta Found No Better Than Cheaper Drugs.”
Bloomberg. 3 March 2011.

“Study: Drugs from Emerging Markets Have High Failure Rates.”
Heartland. 1 March 2011

“Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack, including Ziagen, Trizivir, and Epzicom”
FDA Medwatch. 1 March 2011


“DES and birth defects: FDA acknowledges"tragedy" from 40 years ago.”
Boston.com. 24 February 2011


"FDA MedWatch - January 2011 Safety Labeling Changes; 43 products with revisions to Prescribing Information.

The MedWatch January 2011 Safety Labeling Changes posting includes 43 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, PATIENT PACKAGE INSERT, and MEDICATION GUIDE."
FDA Medwatch. 24 February 2011.

"Small Seizure Risk With Flu, Pneumococcal Vaccines. CDC Says Getting the Vaccines Together Raises Risk of Febrile Seizure in Kids."
Webmd.com. 23 February 2011


“Pfizer Reaches Deal To Resolve All Trovan Litigation”
Pharmalot. 22 February 2011

“Revlimid (lenalidomide): Ongoing Safety Review – increased risk of developing new malignancies.”
FDA Medwatch. 8 April 2011

"Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns"
FDA Medwatch. 22 February 2011.
 

"FDA cites Sanofi over drug side effect reporting."
Reuters. 22 February 2011.

"Can Prescription Amphetamine Use Raise Parkinson's Risk? Study found those who said they had used Benzedrine or Dexedrine showed 60 percent greater likelihood."
Healthday. 20 February 2011.

"Diabetes drug to be withdrawn over heart risk fears."
New Zealand Herald. 17 February 2011.

"State sues drug maker"
2theadvocate. 17 February 2011.
 

"Cancer Drugs Have Worst Phase III Track Record"
Internal Medicine News. 16 February 2011.

"Negative experiences can stop painkillers working"
BBC. 16 February 2011

"No drop in U.S. kids' pneumonia rate after vaccine"
Reuters. 16 February 2011
 

"The risks of taking pain medicine. Nausea, stomach bleeding, heart disease and more: The list of potential dangers from taking over-the-counter pain medications is lengthy."
Los Angeles Times. 14 February 2011

"Heart failure warning with dronedarone"
PJ Online. 14 February 2011.


"Success rates for experimental drugs falls: study"
Reuters. 14 February 2011.


"Drug's belated recall a bitter pill. Newport-based Xanodyne has pulled painkillers, but lawsuits remain"
Cincinnati. 13 February 2011

"Blood pressure drug 'could harm stroke patients'"
Daily Telegraph. 11 February 2011

"Pfizer Said to Pay $330 Million to Settle Prempro Lawsuits Claiming Cancer"
Bloomberg. 9 February 2011

"FDA Panel Urges Stricter Standards for Cancer Drugs"
Medpage Today. 8 February 2011

"GSK revised label of diabetes drug Avandia to include restrictions"
Healthy Living. 7 February 2011

"New rosiglitazone label includes restrictions on use"
The Heart. 7 February 2011

"Another failure for AstraZeneca"
Sharecast. 7 February 2011
 

"AstraZeneca abandons work on prostate cancer drug zibotentan"
Yahoo. 7 February 2011

"Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events"
FDA Medwatch. 4 February 2011

"Celgene Falls On Revlimid Fears, Explanation For Trial Halt"
WSJ. 3 February 2011

"Finnish health authorities see link between Pandemrix and narcolepsy"
http://www.fiercevaccines.com February 2, 2011

"FDA rejects another diet pill"
Washingon Post.  2 February 2011.
 

"Avandia Lawsuit Settled by GlaxoSmithKline Day Before Scheduled Trial"
Drugwatch. 1 February 2011.

"Antisoma stock plummets on another drug failure"
Pharma Times. 1 February 2011.

"Bevacizumab implicated in excess fatal adverse events"
BMJ 2011; 2011; 342:d606 doi: 10.1136/bmj.d606. 1 February 2011.

"U.S. rejects Orexigen diet drug over heart risks"
Reuters. 1 February 2011.

"WHO reviews GSK H1N1 flu shot after narcolepsy link"
Reuters. 1 February 2011.

"Pfizer to Pay $142.1 Million Over Neurontin Marketing"
Bloomberg. 28 January 2011.
 

"Eisai's Rollercoaster: Sepsis Drug Failure Overshadows Eventful Few Days"
Seeking Alpha. 28 January 2011.
  

"Child Flu Vaccine Seizures?"
CBS News. 26 January 2011.

"Eisai's Sepsis Drug Eritoran Fails to Save More Lives in Final-Stage Study"
Bloomberg, 25 January 2011

"GSK set aside $3.4bn in last quarter of 2010 to cover legal costs"
BMJ 2011; 2011; 342:d488 doi: 10.1136/bmj.d488 (Published 24 January 2011).

"EU Agency Reviews Sanofi Heart Drug"
WSJ. 21 January 2011
  

"US warns of liver damage with heart drug"
The Independent. 19 January 2011
 

"Glaxo’s Legal Problems Lead to New $3.4 Billion Charge"
New York Times. 16 January 2011

"Painkiller paracetamol's 'link to liver failure'"
Daily Express. 15 January 2011.

"Sanofi to Send Letter on Multaq Liver Failure Cases"
Bloomberg. 14 January 2011
 

"Afib Drug Tied to Reports of Liver Injury"
MedPage Today. 14 January 2011

"UPDATE 2-Sanofi confirms liver damage in 2 Multaq patients"
Reuters. 14 January 2011
 

"Diabetics join fray in French weight pill furor"
Reuters. 13 January 2011.
 

"Popular painkillers can increase heart attack risks, study shows"
The Independent. 12 January 2011

"Analysis shows heart, stroke risk of pain drugs"
Reuters. 11 January 2011

"Statins may raise stroke risk in some: study"
Reuters. 11 January 2011 

"Roche Sued by Patient Claiming Cancer From Pulled Psoriasis Drug Raptiva"
Bloomberg. 8 January 2011

"Popular Breast Cancer Drug Avastin to be Phased Out"
Daily Rosetta. 8 January 2011

"Avastin raises heart failure risk in breast cancer"
Reuters. 5 January 2011