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Tom Lamb
Wilmington, NC, USA
Tom Lamb is a lawyer who represents patients and their family in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Drug Injury Lawyers Also See Possible Farxiga And Jardiance Cases For Patients Who Have Ketoacidosis, Kidney Failure, Stroke, Or Heart Attack (Posted by Tom Lamb at DrugInjuryWatch.com) With there being a growing number of Type 2 diabetes patients in the US, it is not a surprise that the pharmaceutical companies are introducing new types of diabetes medications at an increasing rate to capture market share and make profits. One new class of new diabetes medications are Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors, which currently consist of these drugs: Invokana (canagliflozin) -- first available in 2013 Invokamet (canagliflozin and metformin) -- first available in 2014 Farxiga (dapagliflozin) -- first available in 2014 Xigduo XR (dapagliflozin and metformin extended-release) -- first available in 2014 Jardiance (empagliflozin) -- first available in 2014 Glyxambi (empagliflozin and linagliptin) -- first available in 2015 As some of you know, often the serious side effects of new drugs are not recognized until after FDA approval and they are used by a larger patient population than was observed or studied in the earlier clinical trials. And this seems to be the case with Invokana, Farxiga, Jardiance, and these other new diabetes drugs, as there are now numerous adverse event report... Continue reading
Posted 4 days ago at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/07/01/products-levaquin-ruling-idUSL1N0ZH2QA20150701 9th Circuit revives suit linking Levaquin to deadly skin disease By Jessica Dye July 1, 2015 A federal appeals court has reinstated a woman's claim alleging that Levaquin, an antibiotic made by Johnson & Johnson's Janssen Pharmaceuticals unit, caused a life-threatening skin condition that put her in a coma for two weeks. On Tuesday, the 9th U.S. Circuit Court of Appeals said that the district court had been too hasty in concluding that Gail Holmes' strict products liability claim was barred by California's two-year statute of limitations, since she was still in a coma on the day... Continue reading
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 investigating a association between Farxiga, Jardiance, and Invokana with diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. See: "FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood". About a month later, Health Canada took similar action when that drug regulatory agency sent an email alert about its "Information Update - Forxiga, Invokana: Health Canada begins safety review of diabetes drugs known as SGLT2 inhibitors and risk of ketoacidosis". From that June 22, 2015 Health Canada MedEffect email alert we get this: Health Canada initiated a safety review for the prescription diabetes drugs [Forxiga / Farxiga (dapagliflozin)] and [Invokana (canagliflozin)] and the risk of ketoacidosis, a serious condition that leads to high levels of blood acids called ketones. [Forxiga / Farxiga (dapagliflozin)] and [Invokana (canagliflozin)] are known as SGLT2 (sodium-glucose cotransporter-2) inhibitors and are approved in Canada for use in patients with type 2 diabetes to improve blood sugar levels,... Continue reading
Posted Jun 25, 2015 at Drug Injury Watch
Now About Six Years Out From When This Beyaz / Safyral / YAZ / Yasmin / Gianvi / Ocella Drug Injury Litigation Started, Bayer Continues Its Slow-Going Pace (Posted by Tom Lamb at DrugInjuryWatch.com) To put into context the latest YAZ / Yasmin lawsuits and settlement numbers from Bayer, we start by referring back to this earlier article, "YAZ / Yasmin Litigation Update For March 2015: According To Bayer's 2014 Annual Report, 'Additional lawsuits are anticipated.'", where we get this corporate filing information: As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled). As of January 31, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,500 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.9 billion. At present, about 2,000 such claims are under review.... _____________________________________________________ Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi Free Case Evaluation Strictly Confidential, No Obligation. _____________________________________________________ The most recent Bayer information about the YAZ / Yasmin litigation comes from the Bayer Interim Report for First Quarter of 2015 (at pg. 46 of PDF): Yasmin™/yaz™: As of April 20, 2015,... Continue reading
Posted Jun 22, 2015 at Drug Injury Watch
These drug injury lawsuits involve any form of brand name Fosamax -- as well as Actonel, Boniva, and Reclast -- but NOT the generic equivalent of Fosamax, alendronate, nor the generic version of any other bisphosphonates. Of course, any medical questions should be directed to your mother's doctor. Tom Lamb
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Federal Court Fosamax MDL Reassigned From Judge Pisano To Judge Wolfson While We Wait For Appellate Court To Rule On Appeals From Glynn And Gaynor Case Rulings (Posted by Tom Lamb at DrugInjuryWatch.com) ********** UPDATE: "Remaining Fosamax Cases Dismissed But Not Dead" (New Jersey Law Journal, 6/23/15) U.S. District Judge Freda Wolfson of the District of New Jersey has dismissed the last remaining 570 cases in the Fosamax - femur fracture federal court MDL, but the cases could be reinstated if plaintiffs win an appeal currently pending before the U.S. Court of Appeals for the Third Circuit. (6/24/15) ********** Since we last reported on the Fosamax - femur fracture litigation there has been a trial verdict in a California state court case and in early April 2015 the jury sided with the defendant drug company Merck, i.e., defense verdict. This lawsuit was Galper v. Merck, and the trial stated in February 2015. Unless things have changed recently, the next California state court Fosamax lawsuit trial is scheduled to start in July 2015, with one to follow in October 2015. Of course, the results of those California femur fracture trials are much anticipated. Meanwhile, in the federal court Fosamax MDL pending... Continue reading
Posted Jun 17, 2015 at Drug Injury Watch
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 "FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood", issued on May 15, 2012, in this article: "May 2015 Diabetes Drugs - Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible". Diabetic ketoacidosis (DKA) is a relatively rare medical condition with blood glucose of 250 mg/dL or higher with ketonuria, ketonemia, and metabolic acidosis (pH < 7.3 or blood bicarbonate levels < 15 mEq/L). While DKA generally occurs in patients with type-1 diabetes it may occur, also, in patients with type-2 diabetes under stress conditions such as trauma, certain medical events, infection, or prescription drugs -- such as Invokana, Farxiga, and Jardiance, according to the FDA. At the June 2015 American Diabetes Association 2015 Scientific Sessions in Boston the findings of a new medical study about the significance of repeat incidents of diabetic ketoacidosis (DKA) as regards mortality rate were presented... Continue reading
Posted Jun 10, 2015 at Drug Injury Watch
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 multiple myeloma drug. In more detail, from the Celgene Corporation Prescribing information for Pomalyst (accessed 6/3/15): POMALYST, in combination with dexamethasone, is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. ________________________________ Pomalyst Case Evaluation Strictly Confidential, No Obligation. ________________________________ On May 20, 2015 Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom issued this Drug Safety Update, "Pomalidomide: risks of cardiac failure, interstitial lung disease and hepatotoxicity", which stated: A review by the MHRA and other EU medicines regulators concluded that [Pomalyst (pomalidomide)] can cause interstitial lung disease (ILD), cardiac failure and hepatotoxicity. This conclusion was based on data from clinical trials, reports from clinical practice and published case reports. This May 2015 MHRA Drug Safety Update included this detailed information about each of these Pomalyst side effects: Cardiac... Continue reading
Posted Jun 3, 2015 at Drug Injury Watch
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 control pills which contain ethinyl estradiol (EE) and the progestin drospirenone (DRSP). These DRSP oral contraceptives have been associated with several different adverse side effects such as: Blood Clots Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Stroke or Cerebrovascular Accidents (CVA) Heart Attack or Myocardial Infarction From an Editorial piece published May 26, 2015 by the medical journal BMJ, "Fresh evidence confirms links between newer contraceptive pills and higher risk of venous thromboembolism", we get this commentary from Susan S. Jick (a professor of epidemiology at Boston Collaborative Drug Surveillance Program, Boston University School of Public Health): Notably, Vinogradova and colleagues also looked at the newer oral contraceptives, such as those containing desogestrel, gestodene, and cyproterone, as well as the newest pill containing drospirenone, where data have been limited and the magnitude of effects on the risks of venous thromboembolism remains controversial. They found that the newer contraceptives increased risks by around 3.6- to 4.3-fold compared with non-use, and by around twofold compared with oral contraceptives containing levonorgestrel,... Continue reading
Posted May 27, 2015 at Drug Injury Watch
Case Reports Of These Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Causing Diabetic Ketoacidosis (DKA) Presented At Recent Medical Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA is investigating a connection between a certain class of diabetes medicines and diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. From "FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood", issued on May 15, 2015: The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines [Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin)] may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization. We are continuing to investigate this safety issue and will determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness.... A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA),... Continue reading
Posted May 20, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/05/15/fda-diabetes-idUSL1N0Y615520150515 UPDATE 2-U.S. FDA warns on newer class of type 2 diabetes drugs By Bill Berkrot May 15, 2015 May 15 (Reuters) - The U.S. Food and Drug Administration on Friday warned that a widely used newer class of type 2 diabetes drugs sold by AstraZeneca, Johnson & Johnson and Eli Lilly in partnership with Boehringer Ingleheim may cause dangerously high levels of blood acids that could require hospitalization. The oral drugs belong to a class known as SGLT2 inhibitors that work by causing blood sugar to be secreted in the urine. They include AstraZeneca's Farxiga (dapagliflozin), J&J's... Continue reading
New Medical Research Suggests The Safety Of A Testosterone Drug Might Depend On Its Form: Injections / Shots; Creams / Gels; Skin Patches (Posted by Tom Lamb at DrugInjuryWatch.com) On March 3, 2015 an FDA Drug Safety Communication about testosterone products was issued requiring drug companies to make a “labeling change to inform of possible increased risk of heart attack and stroke with use”. Now, according to a large retrospective cohort medical study published online by the JAMA Internal Medicine journal in May 2015, we learn that short-acting testosterone injections or shots -- such as the Depo-Testosterone (testosterone cypionate) injection from Pharmacia and Upjohn Company (a division of Pfizer) -- are associated with a higher risk of cardiovascular events, hospitalizations, and deaths when compared with gels or patches. From the Abstract for "Comparative Safety of Testosterone Dosage Forms" (an Online First article), we get this overview of the new medical research: Importance Increases in testosterone use and mixed reports of adverse events have raised concerns about the cardiovascular safety of testosterone. Testosterone is available in several delivery mechanisms with varying pharmacokinetics; injections cause spikes in testosterone levels, and transdermal patches and gels cause more subtle but sustained increases. The comparative... Continue reading
Posted May 13, 2015 at Drug Injury Watch
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) are important antiplatelet blood-thinning medicines used to prevent heart attacks, strokes, and other clot-related diseases. The Dual Antiplatelet Therapy (DAPT) trial was published by the New England Journal of Medicine (NEJM) on November 16, 2014 in this article, "Twelve or 30 Months of Dual Antiplatelet Therapy after Drug-Eluting Stents". That same day came this related item, "FDA Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death", from which we get this information: FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents.... FDA has not... Continue reading
Posted May 6, 2015 at Drug Injury Watch
Quoted from http://www.forbes.com/sites/larryhusten/2015/05/05/200-year-old-heart-drug-linked-to-increased-risk-of-death/ 200-Year-Old Heart Drug Linked To Increased Risk Of Death Larry Husten Forbes May 5, 2015 For more than 200 years physicians have been trying to figure out how and when to use the heart drug digoxin. Although it has a narrow therapeutic window and potentially dangerous interactions with other drugs, it is endorsed by current guidelines and widely given to patients with heart failure (HF) and atrial fibrillation (AF). However, there have been no randomized trials in AF and only one trial, the famous DIG trial, in HF. In that trial digoxin had no impact on mortality... Continue reading
New FDA Rule Requires Drug Company To Replace Current Simple Pregnancy Category Designation With A Summary Of The Risks Of Using Zofran During Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) ____________________________ UPDATE: Novartis and GlaxoSmithKline (GSK) have reportedly completed the final stages of GSK’s oncology portfolio buyout. As such, Novartis is now the responsible drug company for Zofran and would be making any Zofran label changes going forward. (5/19/15) _____________________________ Starting earlier this year drug injury products liability lawsuits alleging birth defects caused by the use of Zofran (ondansetron) during pregnancy for so-called "morning sickness" have been filed against the pharmaceutical company GlaxoSmithKline (also known as GSK or Glaxo). One standard contention found in the Zofran lawsuit Complaints filed to date is as follows: GSK falsely and negligently represented to the medical community and expectant mothers, including Plaintiff and her providers, that: a. Zofran was safe and effective for treating pregnancy-related nausea; b. Zofran had been adequately tested and studied in pregnant women; c. Zofran use during pregnancy did not increase the risk of bearing children with birth defects; and, d. Zofran’s “Pregnancy Category B” designation established the safety and efficacy of Zofran for treating pregnancy-related nausea. In December 2014... Continue reading
Posted Apr 29, 2015 at Drug Injury Watch
Muscle-Wasting Side Effect "Rhabdo" Seems To Apply To Entire ADHD Class Of Drugs Given That April 2015 FDA Letter Was Sent To All Manufacturers (Posted by Tom Lamb at DrugInjuryWatch.com) We start in the US where an April 15 FDA letter to drug companies like Janssen Pharmaceuticals (regarding Concerta) stated that new safety information pertaining to the association between the use of stimulants used to treat Attention Deficit Hyperactivity Disorder (ADHD) and rhabdomyolysis, or "rhabdo" for short, should be added to the drug labels for ADHD medications such as these: Adderall Concerta Focalin Ritalin Strattera Vyvanse According to the PubMed Health page for rhabdomyolysis, from the US National Library of Medicine: Rhabdomyolysis is a condition in which damaged skeletal muscle tissue breaks down rapidly. Breakdown products of damaged muscle cells are released into the bloodstream. Some of these, such as the protein myoglobin, are harmful to the kidneys and may lead to kidney failure. Next we turn to an April 2015 Health Canada safety alert about methylphenidate products such as Concerta and Ritalin being associated with prolonged and painful erections -- a medical condition called priapism -- in male patients, including children. From that Health Canada alert about Concerta and... Continue reading
Posted Apr 22, 2015 at Drug Injury Watch
As Analysis Did Not Reveal Causes Of The Increase In Death Incidents, FDA Asks Its Advisory Committee To Discuss This Safety Issue At April 2015 Meeting (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "AstraZeneca, Takeda Diabetes Drugs Should Warn of Risk" (4/15/15, Bloomberg) (4/15/15) ______________________________________________________________________________ The AstraZeneca diabetes drugs Onglyza (saxagliptin) and Kombiglyze (saxagliptin plus metformin) will come under scrutiny at an April 14, 2015 FDA meeting according to early news reports about that upcoming event. We previewed in this April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in this article we wrote last month, "Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting". Last Friday, April 10, FDA posted online their Briefing Material document for this Kombiglyze / Onglyza safety meeting (PDF file, 105 pages). _____________________________________________________________________ Free Onglyza / Kombiglyze Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ As regards what that FDA staff document contained and its significance, from an April 10, 2015 Bloomberg news report, "AstraZeneca’s Diabetes Drug May Raise Death Risk, FDA Says": AstraZeneca Plc’s type 2 diabetes drug Onglyza showed an increased risk of death in an analysis by U.S. regulators of... Continue reading
Posted Apr 13, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/04/10/astrazeneca-onglyza-fda-idUSL2N0X70PU20150410 AstraZeneca's diabetes drug Onglyza may increase death rate - FDA By Toni Clarke April 10 (Reuters) - AstraZeneca Plc's diabetes drug Onglyza may be associated with an increased rate of death, according to a preliminary review of data by the U.S. Food and Drug Administration. The FDA's report, posted on the agency's website on Friday, comes ahead of an April 14 meeting of an FDA advisory panel to discuss the safety of Onglyza and a similar drug from Takeda Pharmaceutical Co called Nesina. Onglyza won U.S. approval in 2009 and Nesina in 2013. A trial of more... Continue reading
However, It Seems No Further Research About This Congenital Birth Defect Being Caused By Zofran Use During Pregnancy Has Been Done By GlaxoSmithKline (Posted by Tom Lamb at DrugInjuryWatch.com) So-called "morning sickness", or nausea and vomiting (NVP), is the most common medical condition of pregnancy, affecting more the 75% of all pregnancies to some degree. In fact, severe NVP, or hyperemesis gravidarum, can be debilitating and require hospitalization. For many years now, some women with morning sickness have been prescribed Zofran (ondansetron) and had babies born with birth defects and other congenital malformations. Remarkably, Zofran is not even approved by the FDA as a treatment to reduce morning sickness when women are pregnant. Rather, this GlaxoSmithKline drug has been approved by FDA for the prevention of nausea or vomiting associated with chemotherapy and radiotherapy as well as in some instances following surgery. As far back as 2004 some medical researchers have noted that while Zofran is being used for morning sickness, or NVP, there have been no sufficient medical studies examining its safety in pregnancy. From "The safety of ondansetron for nausea and vomiting of pregnancy: a prospective comparative study", published by the medical journal BJOG: an International Journal of... Continue reading
Posted Apr 6, 2015 at Drug Injury Watch
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 document with new safety information about Adderall, Concerta, Ritalin, and similar medications titled "ADHD drugs may increase risk of suicidal thoughts and behaviors in some people; benefits still outweigh risks". From that item we get this description about the emerging ADHD drugs safety issue: The new warnings advise that there have been reports of suicide-related events in patients treated with ADHD drugs. The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide. These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment.... New information has emerged since to suggest that the risk of suicidal thoughts and behaviours may apply to all other ADHD drugs. There is little evidence to establish that these drugs cause suicidal thoughts and behaviours, but it is possible that they may contribute to the risk.... [emphasis added] The following is a list of some brand name ADHD... Continue reading
Posted Mar 30, 2015 at Drug Injury Watch
Donna: The Pliva, Inc., et al. v. Mensing case was decided by the Supreme Court of the United States (SCOTUS) on June 23, 2011. Justice Clarence Thomas delivered the opinion of the Court, concluding that federal drug regulations applicable to generic drug manufacturers directly conflict with, and thus pre-empt, state law claims. The bottom line is that the US Supreme Court ruled in favor of the generic drug company and against the injured patient such that at the present time any "failure to warn" lawsuit involving a generic drug would be dismissed based on this Mensing case ruling. Justice Sonia Sotomayor, in her dissent opinion, did well in pointing out the apparent absurdity of this new Supreme Court ruling about generic drug company lawsuits: "As a result of today’s decision, whether a consumer harmed by inadequate warnings can obtain relief turns solely on the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug. The Court gets one thing right: this outcome 'makes little sense'." Certainly not fair to people like you, I agree; but it is the current legal situation in the US as regards genric drugs. Tom Lamb
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FDA Letters To AstraZeneca And Novo Nordisk Approve Addition Of Information About Increased Risk For Medullary Thyroid Carcinoma (MTC) (Posted by Tom Lamb at DrugInjuryWatch.com) The diabetes drugs Bydureon (exenatide extended-release) for injectable suspension and Victoza (liraglutide [rDNA origin]) injection) were the subject of March 2015 FDA letters concerning the supplemental approval about labeling revisions. Each of these FDA letters, to AstraZeneca and to Novo Nordisk respectively, contain this paragraph: We also refer to our letter dated October 7, 2014, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for long-acting GLP-1 receptor agonist products. This information pertains to the risk of medullary thyroid carcinoma. ___________________________________________________________________ Bydureon / Byetta / Januvia / Victoza Free Case Evaluation Strictly Confidential, No Obligation. ___________________________________________________________________________ In both AstraZeneca's Bydureon Prescribing Information and Novo Nordisk's Victoza Prescribing Information, the March 2015 label revisions concerning medullary thyroid carcinoma (MTC) can be seen in the so-called "Black Box" warning at the beginning of that document as well as at part 5.1 Risk of Thyroid C-cell Tumors in the Warnings and Precautions section. As you may know, these diabetes drugs, Bydureon and Victoza, are alleged to... Continue reading
Posted Mar 23, 2015 at Drug Injury Watch
Bayer Claims It Settled About 300 Of These Cases While Another 1300 Lawsuits Were Filed From Mid-October 2014 To The End Of January 2015 (Posted by Tom Lamb at DrugInjuryWatch.com) For establishing a baseline as regards the current progress (or lack thereof) being made by Bayer to resolve the YAZ / Yasmin litigation which began back in 2009, from this article, "December 2014 YAZ / Yasmin Litigation Update: Still Over 2000 DVT And/Or PE Cases Not Settled According To Bayer's Most Recent Financial Report", we get these numbers: As of October 13, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,000 (excluding claims already settled). As of October 13, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 9,200 claimants in the U.S. for a total amount of about US$1.8 billion. ___________________________________________________ Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi Free Case Evaluation Strictly Confidential, No Obligation. ____________________________________________________ Next, we go to the PRODUCT-RELATED LITIGATION part of Bayer's Annual Report 2014 (at pg. 311 of the PDF document): Yasmin™ / yaz™: As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about... Continue reading
Posted Mar 16, 2015 at Drug Injury Watch
Quoted from http://www.reuters.com/article/2015/03/09/us-pfizer-chantix-warning-idUSKBN0M527T20150309 U.S. FDA warns of seizure, alcohol risk with Pfizer's Chantix Mon Mar 9, 2015 (Reuters) - The U.S. Food and Drug Administration warned on Monday that Pfizer Inc's quit-smoking drug, Chantix, has been associated with seizures and that some patients who drink while taking the drug may become aggressive or black out. The agency said it approved an update to the drug's label in September but issued the public notice to ensure patients are aware of the changes "and can consider this new information when making prescribing decisions." Typically such warnings are made at the time of... Continue reading
These Two New AstraZeneca Diabetes Medications With Saxagliptin Are Part Of The Incretin Mimetic Class Of Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) At an April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for for AstraZeneca's relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) will be discussed. For some background, one might want to read this article, "Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014", which we posted about a year ago. From a March 2015 statement issued by AstraZeneca in connection with this upcoming Kombiglyze XR / Onglyza FDA Advisory Committee Meeting: The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin) was a randomised, double-blind, controlled trial evaluating the effect of saxagliptin on the incidence of major adverse cardiovascular events in patients with type 2 diabetes mellitus and at an elevated risk for CV events. The SAVOR study was conducted as part of the Postmarketing Requirement for the US New... Continue reading
Posted Mar 9, 2015 at Drug Injury Watch