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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
Julie: Thank you for your Comment. Please understand, however, that because I am not a physician but only an attorney I am not in a position to give any medical opinion as regards your situation. I wish you the best in all aspects going forward. Have a good week. Tom Lamb
1 reply
Why didn't they tell us sooner? A review of the medical literature from the past 22 years warning about the relationship between heartburn drugs & AIN. Continue reading
Posted 2 days ago at Drug Safety Developments
This Class Of (Heavily Advertised) Drugs Includes Farxiga, Invokana, And Jardiance, Which Also Are Linked To Kidney Failure And Heart Attacks Or Myocardial Infarction (Posted by Tom Lamb at DrugInjuryWatch.com) In an earlier article, "Summer 2016 Update On Diabetes Medicines Invokana / Farxiga / Jardiance: Drug Label Changes And Safety Investigations", we pointed out that Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride) had a July 2016 label change for fatal cases of ketoacidosis, but several other diabetes drugs are known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors did not have a similar label change. It turns out that this was only a matter of time, or timing. In August 2016 we saw FDA letters about approving and mandating a label change for ketoacidosis cases go out for the remaining diabetes medicines in this SGLT2 inhibitors class of drugs: Invokana (canagliflozin); Invokamet (canagliflozin and metformin); Farxiga (dapagliflozin); and, Xigduo XR (dapagliflozin and metformin extended-release). For use as an example, here is the relevant part of an August 17, 2016 FDA Supplemental Approval letter to AstraZeneca Pharmaceuticals LP for Farxiga: Please refer to your supplemental New Drug Application (sNDA) dated and received July 28 2016, submitted under section 505(b)... Continue reading
Posted 2 days ago at Drug Injury Watch
Portola, Which Developed AndexXa, Estimates 100,000 Patients Per Year Suffer From Severe Uncontrollable Bleeding Events That Could Require Such An Antidote (Posted by Tom Lamb at DrugInjuryWatch.com) In mid-August 2016 the US FDA rejected Portola Pharmaceutical's application to market AndexXa (andexanet alfa) as an antidote to three direct Factor Xa inhibitors: Eliquis (apixaban) from Pfizer/Bristol-Myers Squibb; Xarelto (rivaroxaban) from Bayer/Johnson & Johnson; and, Savaysa (edoxaban) from Daiichi Sankyo. The reason this FDA rejection of the AndexXa application is remarkable: There is no reversal agent for Factor Xa inhibitors approved in the United States. And these Factor Xa inhibitors, which serve as blood-thinner drugs, are being used by an increasing number of patients for stroke prevention and for treatment of deep vein thrombosis and pulmonary embolism. From this August 18, 2016 article, "Is It "Game Over" After Portola's FDA Rejection?", posted on The Motley Fool website, we get this contextual information: Portola Pharmaceuticals developed AndexXa to reverse the anticoagulant effects of a new and fast-growing class of drugs known as factor Xa inhibitors.... Factor Xa inhibitors' advantages have turned Xarelto and Eliquis into multibillion-dollar-per-year blockbusters already. But the absence of an antidote that can reverse their anticoagulant effects has kept factor... Continue reading
Posted Aug 22, 2016 at Drug Injury Watch
This is the second article in the Nexium, Prilosec, Prevacid series, in which some of the possible side effects of taking these drugs are discussed. Continue reading
Posted Aug 22, 2016 at Drug Safety Developments
Australia's Drug Regulator Issues Warnings And Mandates Label Changes, Following Similar Action In Europe; Will FDA Follow Thess Leads? (Posted by Tom Lamb at DrugInjuryWatch.com) In early August 2016 we learned about some new apparent side effects of Prolia as well as Xgeva, QT interval prolongation and severe symptomatic hypocalcemia. Denosumab is the active ingredient for Prolia and Xgeva, both of which are made by biotech pharmaceutical company Amgen Inc. Prolia is a treatment for osteoporosis and osteopenia. Xgeva is a drug used for the prevention of skeletal-related events in adults with bone metastases from solid tumors. This emerging drug safety issue was recently addressed by Australia’s Therapeutic Goods Administration (TGA), and was initially identified by that drug regulator during an assessment of adverse event reports relating to Prolia and Xgeva. From this August 12, 2016 article, "Australia’s TGA issues warning on denosumab and QT prolongation", published on the ThePharmaLetter (subscription required) website, we get this detailed information: Product information update Hypocalcemia is a known effect of denosumab and was already captured in the Product Information (link is external) (PI). However, there was previously no reference to QT prolongation, which is a potentially life-threatening disorder, or to severe symptomatic hypocalcemia.... Continue reading
Posted Aug 15, 2016 at Drug Injury Watch
A discussion of common Proton Pump Inhibitor drugs such as Nexium / Prilosec / Prevacid, reasons for their prescription, and their link to kidney injuries. Continue reading
Posted Aug 11, 2016 at Drug Safety Developments
To the best of my knowledge, as of today (8/9/16) only Pradaxa has an FDA-approved reversal agent, or antidote; it is called Praxbind. Tom Lamb
1 reply
Current Product Liability Litigation Cases Involving Popular Drugs With Serious Side Effects That Are Starting To Gain More Attention (Posted by Tom Lamb at DrugInjuryWatch.com) This article will feature three types of drug injury cases that are starting to gain some momentum in terms of the number of lawsuits filed against the responsible pharmaceutical companies in courts across the country. (1) Diabetes Medicines in the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Class of Drugs Invokana (canagliflozin) — Janssen Pharmaceuticals Invokamet (canagliflozin and metformin) — Janssen Pharmaceuticals Farxiga (dapagliflozin) — AstraZeneca Pharmaceuticals Xigduo XR (dapagliflozin and metformin extended-release) — AstraZeneca Pharmaceuticals Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company These drug injury lawsuits primarily involve the following side effects: Diabetic Ketoacidosis (DKA) Ketoacidosis Ketosis Acute Kidney Injury Kidney Failure / Renal Failure Kidney Damage Pyelonephritis (kidney infection) Urosepsis (blood infection) Urinary Tract Infection (UTI) (2) Erectile Dysfunction (ED) Pills, Benign Prostatic Hyperplasia (BPH) Medicines, and Pulmonary Arterial Hypertension (PAH) Medications in the Phosphodiesterase 5 (PDE-5) Inhibitors Class of Drugs Adcirca (tadalafil) -- Eli Lilly and Company Cialis (tadalafil) -- Eli Lilly and Company... Continue reading
Posted Aug 5, 2016 at Drug Injury Watch
New studies are comparing Eliquis, Savaysa, Xarelto, Pradaxa, and Coumadin for effectiveness in blood clot treatment and risk for major bleeding events. Continue reading
Posted Jul 29, 2016 at Drug Safety Developments
To Date, More Attention Paid To The Association Between These Sodium-Glucose Cotransporter-2 Inhibitors And Diabetic Ketoacidosis Or Acute Kidney Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Over the past year the FDA has mandated several drug label changes for Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, and Synjardy, to increase the warnings about some serious side effects linked to these relatively new diabetes medicines. And the FDA is currently investigating additional adverse reactions that may be associated with these sodium-glucose cotransporter-2 (SGLT2) inhibitors drugs. To date, most attention has been directed to the association between the SGLT2 inhibitors and diabetic ketoacidosis. For example, see this December 2015 article, "FDA Adds Ketoacidosis Warnings To Diabetes Drugs Invokana, Farxiga, And Jardiance As Well As Other SGLT2 Inhibitors". More recently, there was an FDA announcement concerning a label change about the acute kidney injury side effect, as covered in this June 2016 article, "Invokana, Invokamet, Farxiga, Xigduo: Warnings About Acute Kidney Injury Risk Are Increased On Revised Drug Labels For These Diabetes Medicines". What has received less attention, it seems, is the fact that these still relatively new diabetes drugs -- Invokana, Farxiga, and Jardiance, as well as their several... Continue reading
Posted Jul 27, 2016 at Drug Injury Watch
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Though the main legal focus has concerned the risk of melanoma as a side effect of Viagra, research shows that Cialis and Levitra can also cause melanoma. Continue reading
Posted Jul 19, 2016 at Drug Safety Developments
According To Drug Regulators, New Possible Side Effects Include: Fatal Cases Of Ketoacidosis; Leg, Foot, And Toe Amputations; And, Lactic Acidosis (Posted by Tom Lamb at DrugInjuryWatch.com) On June 14, 2016 the FDA announced it has strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet as well as Farxiga and Xigduo XR. These relatively new diabetes drugs are known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors. Notably missing from this June 2016 drug safety warning were Jardiance (empagliflozin), Glyxambi (empagliflozin and linagliptin), and Synjardy (empagliflozin and metformin hydrochloride), which are also part of the SGLT2 Inhibitors class of drugs. About a month later, however, only those three diabetes drugs from Boehringer Ingelheim Pharmaceuticals, Inc. received a Supplemental Approval letter from the FDA concerning a label change about ketoacidosis, an apparent serious side effect. Using the July 8, 2016 FDA letter for Jardiance as a representative document showing this most recent revision to the safety information for these drugs: Please refer to your Supplemental New Drug Application (sNDA) dated and received February 12, 2016.... This Prior Approval supplemental new drug application proposes to amend the Jardiance Prescribing Information and Patient Information with new text informing that fatal... Continue reading
Posted Jul 13, 2016 at Drug Injury Watch
The EMA will now investigate all SGLT2 inhibitor diabetes drugs for a possible link to increased lower-extremity amputations. Continue reading
Posted Jul 11, 2016 at Drug Safety Developments
Melanoma Skin Cancer: FDA Is Evaluating The Need For Regulatory Action; More Lawsuits Filed; Another Research Study (Posted by Tom Lamb at DrugInjuryWatch.com) In late June 2016 the Food and Drug Administration (FDA) said it will study a potential link between melanoma skin cancer and erectile dysfunction (ED) drugs such as Viagra, Cialis, and Levitra. This announcement appeared in the agency's latest watch list of drugs with possible safety issues, "January - March 2016: Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)". In relevant part, the document listed these drugs which have been associated with melanoma as a serious side effect. PDE-5 inhibitors: Adcirca (tadalafil; Eli Lilly and Company): tablets Cialis (tadalafil; Eli Lilly and Company): tablets Levitra (vardenafil hydrochloride; GlaxoSmithKline): orally disintegrating tablets Revatio (sildenafil citrate; Pfizer): tablets, oral suspension, and injection Staxyn (vardenafil hydrochloride; GlaxoSmithKline): orally disintegrating tablets Stendra (avanafil; Vivus and Auxilium Pharmaceuticals): tablets Viagra (sildenafil citrate; Pfizer): tablets From this July 1, 2016 Medscape article, "New FDA Watch List: Possible ED Drug–Melanoma Link and More", we get some background information about that June 2016 FDA investigation announcement: The agency will be on the heels of other researchers when... Continue reading
Posted Jul 6, 2016 at Drug Injury Watch
Some Xarelto And Eliquis Lawsuits Accuse Drug Makers Of Failing To Warn That In Event Of Uncontrollable Bleeding There Is No Antidote, Just Like With Savaysa (Posted by Tom Lamb at DrugInjuryWatch.com) The headline of a recent medical news report about Savaysa (edoxaban), from Daiichi Sankyo, made it seem that there are no serious problems with the use of this still relatively new non-vitamin K antagonist oral anticoagulant. Published June 20, 2016 by Healio - HemOnc Today, "Edoxaban safe, effective for extended prevention of recurrent VTE" starts out with this apparent ringing endorsement: Extended treatment with the oral anticoagulant [Savaysa (edoxaban)] prevented recurrent venous thromboembolism and led to fewer major bleeding events than warfarin among patients with venous thromboembolism, according to a post-hoc analysis of a randomized trial. For what it is worth, I want to point out that Daiichi Sankyo funded this study. But more interesting, I think, is how this Healio - HemOnc Today news reports ends, focusing on the continuing lack of any FDA-approve antidote for Savaysa, as well as Eliquis and Xarelto. The growing availability of agents for the reversal of bleeding caused by direct oral anticoagulants suggests that they can be used regularly and safely,... Continue reading
Posted Jun 30, 2016 at Drug Injury Watch
I appreciate you sharing this most unfortunate story with us. We wish you the best in all aspects going forward. Tom Lamb
1 reply
Meanwhile Jardiance, Glyxambi, And Synjardy, Also In The SGLT2 Inhibitors Class Of Diabetes Drugs, May Help Slow Progression Of Kidney Disease In Patients At High Cardiovascular Risk (Posted by Tom Lamb at DrugInjuryWatch.com) In May 2016 this drug safety labeling change for Invokana (canagliflozin) was approved By FDA Center for Drug Evaluation and Research (CDER): WARNINGS AND PRECAUTIONS Acute Kidney Injury and Impairment in Renal Function INVOKANA causes intravascular volume contraction and can cause renal impairment. There have been postmarketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients receiving INVOKANA; some reports involved patients younger than 65 years of age. Then on June 14, 2016 the FDA announced it has strengthened the existing warning about the risk of acute kidney injury for Invokana and Invokamet as well as Farxiga and Xigduo XR. Based on recent reports, the side effects warnings in the drug labels have been revised to include more exact information about acute kidney injury. More precisely, from the Data Summary part of this document, "FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)", we get this detailed information: A search of the FDA Adverse... Continue reading
Posted Jun 22, 2016 at Drug Injury Watch
The FDA issues a new warning concerning the relationship between Abilify use and compulsive gambling, eating, shopping, or sexual activity. Continue reading
Posted Jun 21, 2016 at Drug Safety Developments
I am sorry to hear about your loss. Unfortunately, we know that there have been other tragic events like this one, as our law firm is handling some Xarelto, Eliquis, and Savaysa bleeding cases as drug injury lawsuits filed against the responsible pharmaceutical companiers. If we can be of assistance as regards a possible legal case, please do not hesitate to contact me. Tom Lamb
1 reply
Drug Company Announces It Will Recall Zecuity Skin Patches From Pharmacies As Well As Temporarily Suspend Sales, Marketing, And Distribution Of Product (Posted by Tom Lamb at DrugInjuryWatch.com) On June 10, 2016 Teva Pharmaceuticals sent a so-called "Dear Doctor" letter to health care providers about Zecuity, its migraine drug patch. From this PDF document we get the following: Dear Health Care Provider: The purpose of this letter is to inform you that we are suspending the sale, marketing and distribution of ZECUITY® (sumatriptan iontophoretic transdermal system), indicated for the acute treatment of migraine with or without aura in adults. Teva has received postmarketing reports of application site reactions described as “burn” and/or “scar” in patients treated with ZECUITY. Descriptions of these reactions have included severe redness, cracked skin, blistering or welts, and burns or scars where the patch was worn. Patients described severe pain, itching, or burning. Although many cases resolved within hours to weeks, there are reports of cases with unresolved skin reactions, typically skin discoloration, after several months. On a different front, at Teva's Zecuity.com web page, we get this information: Teva Pharmaceuticals has voluntarily suspended sales, marketing and distribution of ZECUITY (sumatriptan iontophoretic transdermal system). Teva has... Continue reading
Posted Jun 13, 2016 at Drug Injury Watch
Researchers Suggest Pharmaceutical Companies And FDA Should Reconsider OTC Availability Due To Inappropriate Use Of Nexium As Well As Prilosec and Prevacid (Posted by Tom Lamb at DrugInjuryWatch.com) A team of medical researchers recently examined the so-called "mechanism of injury" for the long-term use of Nexium -- and perhaps other heartburn or reflux medications in the proton pump inhibitor (PPI) class of drugs -- apparently causing an increased risk of kidney problems as well as heart attacks and dementia. As background, there is a growing body of medical evidence which indicates that some popular heartburn drugs and acid reflux medicines like Prevacid, Prilosec, and Nexium can cause some serious kidney-related side effects. In more detail, the use of these proton pump inhibitors (PPIs) for even just a couple of weeks can result in an increased risk of developing: Acute Interstitial Nephritis (AIN) Chronic Kidney Disease (CKD) End-Stage Renal Disease (ESRD) Severe Renal Impairment Kidney / Renal Failure Acute Kidney Injury Further, there is at least one medical study which shows the correlation between a longer time period of Prevacid, Prilosec, and Nexium use, and an increased risk of developing these serious kidney or renal conditions. As for this recent medical... Continue reading
Posted Jun 6, 2016 at Drug Injury Watch
Thank you for your Comment. We are only representing US citizens is Fosamax lawsuits filed in this country. Moreover, we are not accepting any new bisphosphonate - femur fracture cases here, for various reasons. I wish you the best going forward. Tom Lamb
1 reply
The children of women who took Lyrica during the first trimester of pregnancy may be at an increased risk for birth defects. Continue reading
Posted May 25, 2016 at Drug Safety Developments
Animal Studies Have Lyrica Possibly Linked To Skeletal Malformations, Neural Tube Defects, And Other Abnormalities, But Safety Data On Lyrica Use During Human Pregnancy Are Scarce (Posted by Tom Lamb at DrugInjuryWatch.com) Women who took Lyrica (pregabalin) while pregnant were about three times more likely to have babies with major birth defects compared with women who did not take Lyrica, according to study done by a team of medical researchers in Europe that was recently reported in the journal Neurology. From the Abstract for this report, "Pregnancy outcome following maternal exposure to pregabalin may call for concern", from the Neurology.org website ("Published online before print May 18, 2016") we get an overview of the new Lyrica research: Objective: To investigate pregnancy outcomes following maternal use of [Lyrica (pregabalin)]. Methods: This multicenter, observational prospective cohort study compared pregnancy outcomes in women exposed to [Lyrica (pregabalin)] with those of matched controls (not exposed to any medications known to be teratogenic or to any antiepileptic drugs).... Conclusions: This study demonstrated a signal for increased risk of major birth defects after first trimester exposure to [Lyrica (pregabalin)]. However, several limitations such as the small sample size, differences across groups in maternal conditions, and concomitant... Continue reading
Posted May 23, 2016 at Drug Injury Watch