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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
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) The FDA has mandated drug label changes for Invokana, Farxiga, and Jardiance, as well as Invokamet, Xigduo, Glyxambi, and Synjardy, as regards some serious side effects and is currently investigating various others. To date, most attention has been directed to the association between these Sodium Glucose Cotransporter 2 (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 "combination" products -- have been linked to serious urinary tract infections (UTIs) that can result in more severe conditions, such as urosepsis and... Continue reading
Posted yesterday 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
Health Canada warns those with type 1 and type 2 diabetes who take SGLT2 inhibitors about the link between DKA and Invokana, Farxiga, Xigduo, and Jardiance. Continue reading
Posted May 19, 2016 at Drug Safety Developments
About 4,400 Cases Still Pending In Federal Court MDL As Well As New Jersey And California State Courts (Posted by Tom Lamb at DrugInjuryWatch.com) In their corporate report Form 10-Q for the first quarter of 2016, Merck & Co., Inc. provided investors and others with their most recent update about what has been going on (or has not been, as it might seem to be the situation) with the thousands of Fosamax - femur fracture cases filed against the drug company. At pages 17-18 of this Merck corporate report for the quarterly period ended March 31, 2016 (a 45-page PDF document), which was released on or about May 5, 2016, we get this information: As previously disclosed, Merck is a defendant in product liability lawsuits in the United States involving Fosamax (Fosamax Litigation).... [P]laintiffs in approximately 4,405 of these actions generally allege that they sustained femur fractures and/or other bone injuries (Femur Fractures) in association with the use of Fosamax.... As of March 31, 2016, approximately 20 cases were pending in the Femur Fracture MDL, excluding the 515 cases dismissed with prejudice on preemption grounds that are pending appeal and the 520 cases dismissed without prejudice that are also pending... Continue reading
Posted May 17, 2016 at Drug Injury Watch
Valerie: Thank you for your Comment and the inquiry. 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. Tom Lamb
1 reply
Four cases of progressive multifocal leukoencephalopathy (PML) among patients who use the multiple sclerosis treatment drug,Tecfidera, have been reported. Continue reading
Posted May 13, 2016 at Drug Safety Developments
Biogen Idec First Added Information About Tecfidera Being Assoicated With PML Brain Infection Back In December 2014, After An FDA Drug Safety Communication Was Issued (Posted by Tom Lamb at DrugInjuryWatch.com) Tecfidera is a drug used to treat relapsing forms of multiple sclerosis (MS). There is a February 29, 2016 FDA letter to Biogen Idec about a revision to the prescribing information for Tecfidera (dimethyl fumarate) having to do with progressive multifocal leukoencephalopathy (PML). But that FDA letter does not inform one further about the new drug safety information for Tecfidera concerning progressive multifocal leukoencephalopathy (PML). To see what is new, one must read Section 5.2 of the current version of the Tecfidera label (Revised: 2/2016), where an added paragraph suggests two developments. The first is that there seems to have been more Tecfidera - PML cases reported in the past year or so. And the second is that lymphonpenia possibly induced by Tecfidera might have a role to play in those additional PML cases. Here is the added paragraph, short but significant, it seems: [Progressive multifocal leukoencephalopathy (PML)] has also occurred in the postmarketing setting in the presence of lymphopenia (<0.8x109/L) persisting for more than 6 months. While the... Continue reading
Posted May 11, 2016 at Drug Injury Watch
PPI-Induced Acute Interstitial Nephritis Is A Kidney-Related Side Effect That Has Been Known About For Many Years, But FDA Only Mandated A Drug Label Change In December 2014 (Posted by Tom Lamb at DrugInjuryWatch.com) The drug companies responsible for the following proton pump inhibitors (PPIs) heartburn drugs added to the Warning and Precautions part of their respective drug labels a new section about acute interstitial nephritis (AIN) in December 2014: Aciphex (rabeprazole sodium) Delayed-Release Tablets Dexilant (dexlansoprazole) delayed-release capsules Nexium (esomeprazole magnesium) delayed-release capsules, for oral use Nexium I.V. (esomeprazole sodium) for injection Prevacid (lansoprazole) delayed release capsules Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets Protonix (pantoprazole sodium) delayed-release tablets Protonix IV (pantoprazole sodium) But there was a medical journal article about the possible increased risk of acute interstitial nephritis among users of Prilosec (omeprazole) -- the first PPI heartburn drug approved by the FDA, in 1989 -- way back in 1992. And over the past ten years, at least, as seen in some articles which are presented below, it became clear that acute interstitial nephritis was a so-called "class effect" for all of these eight proton pump inhibitors. Yet this "new" drug safety warning about PPI-induced acute interstitial nephritis... Continue reading
Posted May 4, 2016 at Drug Injury Watch
A recent article by Obstetrics & Gynecology discusses the slight increased risk of cardiac abnormalities among children exposed to Zofran in utero. Continue reading
Posted May 2, 2016 at Drug Safety Developments
Here Are Some Of The "Findings" From An April 26, 2016 Document Which Seems To Have Disappeared Only Two Days Later (Posted by Tom Lamb at DrugInjuryWatch.com) __________________________________________________ UPDATE: "Ironwood and Allergan Announce Supplemental New Drug Application for 72 mcg Linaclotide in Chronic Idiopathic Constipation Has Been Accepted for FDA Review" (June 9, 2016 Press Release issued by Allergan plc; Ironwood Pharmaceuticals) (6/9/16) __________________________________________________ This morning (4/28/16) my interest was easily piqued by this Google Alert: Uncovered: Safety Issues Linked With Ironwood's Drug, Linzess Seeking Alpha Ironwood's constipation drug, Linzess, is a primary suspect in at least 7 deaths, 85 hospitalizations, 16 disabilities, all in just 3 years since its launch in ... When I clicked through to that article on the Seeking Alpha website, however, I found this notification (accessed 4/28/16, 10:10 am New York time): This article has been removed at the request of the author. Intrigued, I put that article title into a search engine and quickly found online this 65-page PDF document: "Uncovered: fatal safety issues linked with Ironwood’s drug, Linzess" (accessed 4/28/16, 10:15 am New York time). A little while later I decided it might be prudent to "Save" this PDF file given what I... Continue reading
Posted Apr 28, 2016 at Drug Injury Watch
A recent study by the American Diabetes Association found that the diabetes treatment drug, canagliflozin, also causes DKA among those with type 1 diabetes. Continue reading
Posted Apr 28, 2016 at Drug Safety Developments
New FDA research suggests there may not be a link between the DPP-4 inhibitor class of drugs for type 2 diabetes and increased risk of heart failure. Continue reading
Posted Apr 28, 2016 at Drug Safety Developments