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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
A recent article by Obstetrics & Gynecology discusses the slight increased risk of cardiac abnormalities among children exposed to Zofran in utero. Continue reading
Posted yesterday 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) 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 had read on the Seeking Alpha site earlier. And I am sure glad I did so -- because when I started to write this article at about 4:00 pm and tried to access the online PDF version... Continue reading
Posted 5 days ago 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 5 days ago 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 5 days ago at Drug Safety Developments
The EMA recently released guidelines for healthcare providers on how to reduce the risk of diabetic ketoacidosis among those taking SGLT2 inhibitors. Continue reading
Posted 7 days ago at Drug Safety Developments
These Relatively Recent Direct-Acting Antivirals Are Increasingly Popular For Treating Chronic Hepatitis C, But There Could Be Serious Side Effects In Addition To The High Costs (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2016 Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) discussed its ongoing safety review of the direct-acting antivirals class of drugs used for treating long-term, or chronic, hepatitis C. From this April 15 EMA News item, "Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2016" we get an overview of this still emerging drug safety issue: At its previous meeting in March, the Committee had initiated a review following cases of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C. In April 2016, data from a study became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with these medicines. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended... Continue reading
Posted Apr 22, 2016 at Drug Injury Watch
The EMA reviews data from recent clinical studies to investigate possible link between canagliflozin and an increased number of toe amputations. Continue reading
Posted Apr 20, 2016 at Drug Safety Developments
The FDA recently released a label revision for Reclast, including the side effect "osteonecrosis of other bones." Continue reading
Posted Apr 18, 2016 at Drug Safety Developments
Recent Medical Journal Articles Report That Proton Pump Inhibitors May Be Linked To Chronic Kidney Disease And Acute Renal Injury (Posted by Tom Lamb at DrugInjuryWatch.com) Prilosec, Prevacid, and Nexium are in the proton pump inhibitors (PPIs) class of drugs and are used regularly by many people to treat heartburn and acid reflux. These medications are available by prescription and over-the-counter (OTC) from various pharmaceutical companies. Such medications include: PRILOSEC (omeprazole magnesium) | prescription drug | AstraZeneca LP PRILOSEC OTC (omeprazole magnesium) | over-the-counter | Procter & Gamble Manufacturing Co. PREVACID (lansoprazole) | prescription drug | Takeda Pharmaceuticals America, Inc. PREVACID 24 HR (lansoprazole) | over-the-counter | Novartis Consumer Health, Inc. NEXIUM (esomeprazole magnesium) | prescription drug | AstraZeneca LP NEXIUM 24HR (esomeprazole magnesium) | over-the-counter | Pfizer Consumer Healthcare For many, if not most, people using any of those widely advertised drugs, the following drug safety information will probably come as quite a surprise, given that it has not received much attention, yet. There is mounting medical evidence that the use of these proton pump inhibitors (PPIs) results in an increased risk of developing chronic kidney disease (CKD) as well as CKD disease progression and end-stage renal disease (ESRD).... Continue reading
Posted Apr 15, 2016 at Drug Injury Watch
Ann: I have reviewed the information which you submitted to us. My law firm cannot help you with this matter. I suggest you contact another law firm at this time. Please understand that my law firm has not been retained to represent you or anyone else in connection with this matter, and in no way is my law firm providing you with legal representation in this matter or any other matter at the present time. Out of an abundance of caution, I bring to your attention that a lawsuit must be filed within a certain number of years from the date of death, diagnosis, or incident giving rise to your damages or injuries. The deadline is usually known as the statute of limitations. We wish you the best in all aspects going forward. Tom Lamb
1 reply
Set Of Newer Diabetes Medications Containing Saxagliptin And Alogliptin Also Being Investigated By FDA For Increased Risk Of Renal Failure (Posted by Tom Lamb at DrugInjuryWatch.com) On April 5, 2016 the FDA took regulatory action by mandating that the pharmaceutical companies AstraZeneca and Takeda make label changes for some of their still relatively new diabetes drugs. This move was announced by means of "FDA Drug Safety Communication: FDA adds warnings about heart failure risk to labels of type 2 diabetes medicines containing saxagliptin and alogliptin". The diabetes drugs covered by this FDA action are: AstraZeneca’s Onglyza (saxagliptin) AstraZeneca’s Kombiglyze XR (saxagliptin and metformin extended release) Takeda’s Nesina (alogliptin) Takeda’s Kazano (alogliptin and metformin) Takeda’s Oseni (alogliptin and pioglitazone) Apparently, the FDA's decision to order the label changes for this class of diabetes drugs was based on the evaluation of two large clinical trials conducted in patients with heart disease that were discussed at FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting in April 2015. And, some of you may recall this previous MedWatch alert, "Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk", from back in February 2014. The recent April 2016... Continue reading
Posted Apr 8, 2016 at Drug Injury Watch
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. Tom Lamb
1 reply
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. Tom Lamb
1 reply
Two "Potential Signals of Serious Risks/New Safety Information Identified By FAERS" Reports From 2015 Were Not Made Public By FDA Until February - March 2016 (Posted by Tom Lamb at DrugInjuryWatch.com) We only recently learned that the FDA has been evaluating the need for additional drug safety regulatory action as regards the controversial class of relatively new diabetes drugs known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors. The following SGLT-2 inhibitors are currently approved by the FDA: Farxiga (dapagliflozin) tablet Glyxambi (empagliflozin/linagliptin) tablet Jardiance (empagliflozin) tablet Invokamet (canagliflozin/metformin HCl) tablet Invokana (canagliflozin) tablet Synjardy (empagliflozin/metformin HCl) tablets Xigduo XR (dapagliflozin/metformin HCl) extended release tablet These seven diabetes medicines are currently being investigated by the FDA for the following possible "new" side effects: Strokes Thromboembolic Events Deep Vein Thrombosis (DVT) Pulmonary Embolism (PE) Acute Renal Injury Kidney Damage Kidney Failure What led us to this recent discovery was a March 29, 2016 news report, "Possible Drug Risks Buried in Delayed FDA 'Watch Lists'", published online by Medscape (registration required). We start with this excerpt from that Medscape investigative report: The potential-signals list for the second quarter of 2015, the one that flagged SGLT-2 inhibitors for stroke and thromboembolic events, should have been posted... Continue reading
Posted Mar 31, 2016 at Drug Injury Watch
In May 2015 FDA Issued A Warning That Invokana, Farxiga, And Jardiance Are Assoicated With This Serious Side Effect And Other Adverse Reactions (Posted by Tom Lamb at DrugInjuryWatch.com) Invokana, Farxiga, and Jardiance are sodium-glucose cotransporter-2 (SGLT2) inhibitors, a class of prescription medicines that are FDA-approved for use with diet and exercise to lower blood sugar in patients with Type 2 diabetes. From this March 17, 2016 MedPage Today report, "Canagliflozin in T1D Has Ketoacidosis Problem", we get a good overview of a recent medical study which found that an established Invokana side effect needs to be closely watched for when Invokana is prescribed "off-label": Type 1 diabetes patients taking canagliflozin (Invokana) off-label were at a higher risk of of ketoacidosis than were those on placebo in a randomized trial. The drug, an SGLT-2 inhibitor for patients with type 2 diabetes, was associated with a serious case of diabetic ketoacidosis (DKA) in five of 117 patients on 100 mg/day of the drug and in seven of 117 on 300 mg/day in an 18-week trial funded by Janssen, which markets the drug. None of the 117 patients in the placebo group had DKA, reported Anne Peters, MD, at the University of... Continue reading
Posted Mar 24, 2016 at Drug Injury Watch
While Focus Of Study Was Sildenafil, The Active Ingredient Of Viagra, Melanoma Risk Likely Increased By Vardenafil (Levitra) And Tadalafil (Cialis) Also (Posted by Tom Lamb at DrugInjuryWatch.com) The latest medical research results about the link between melanoma skin cancer and Viagra (sildenafil) was published March 10, 2016 in the medical journal Cell Reports. One of the most significant take-away points from this new medical article about the increased risk of melanoma associated with Viagra is that this skin cancer side effect most likely applies to Cialis (tadalafil) and Levitra (vardenafil), also. This March 2016 Cell Reports article is titled "Sildenafil Potentiates a cGMP-Dependent Pathway to Promote Melanoma Growth". From the Summary view for the online version of this medical journal report we get these Highlights: • Melanoma cells express a cGMP signaling pathway involving PDE5 • The cGMP pathway promotes MAPK signaling and melanoma cell growth and migration • PDE5 degrades cGMP and thus acts as a brake on the growth-promoting cGMP pathway • The PDE5 blocker [Viagra (sildenafil)] releases the PDE5 brake, leading to increased tumor growth For the in-depth findings we take you to the Full Text view of this article on the Cell Reports website. To... Continue reading
Posted Mar 18, 2016 at Drug Injury Watch
Recent Article Sets Forth A Review Of Various Medical Studies Done Over Time, Which Shows Some Conflicting Evidence For Zofran-Associated Birth Defects (Posted by Tom Lamb at DrugInjuryWatch.com) It seems safe to say, now, that the use of Zofran (ondansetron) should be avoided in the first trimester of pregnancy due to the apparent increased risks of certain major birth defects. But as set forth in this December 2015 Medscape Pharmacists article, "[Zofran] Ondansetron in Pregnancy", there is mixed evidence in the medical literature about what birth defects specifically and the extent of that danger. To start, for an overview of the situation, we get these three basic facts (footnotes omitted) from this very informative Medscape Pharmacists article: Nausea and vomiting in pregnancy occurs in up to 80% of women, with about 15% requiring antiemetic medication. Unfortunately, nausea and vomiting peak during the first trimester of pregnancy, coinciding with greatest fetal susceptibility to teratogenic effects of medications. [Zofran (ondansetron)] is not recommended by current guidelines as a first-line option for nausea and vomiting in pregnancy. The author of this article, Darren J. Hein, PharmD, then goes on to summarize the findings of several medical studies concerning Zofran-associated birth defects, as we... Continue reading
Posted Mar 11, 2016 at Drug Injury Watch
These Popular Fluoroquinolones Antibiotics Have Been Suspected Of Causing Serious Vision Problems And Visual Side Effects During Past Several Years (Posted by Tom Lamb at DrugInjuryWatch.com) In January 2016, Health Canada issued the latest drug safety alert concerning Avelox, Levaquin, and Cipro, this one having to do with a serious side effect concerning the eyes. From this document "Summary Safety Review - Oral FLUOROQUINOLONES - Assessing the Potential Risk of Retinal Detachment", we get these summary points about the current situation: Health Canada's follow-up safety review concluded that a link between the use of fluoroquinolones and the occurrence of retinal detachment cannot be ruled out at the present time. Given that retinal detachment is a medical emergency, the recommendations of the review were that the current labeling for oral fluoroquinolones be revised to highlight the urgency to see a health care professional if patients experienced vision problems during or following oral fluoroquinolone administration. We will wait to see what label changes are made in Canada by the drug companies responsible for Avelox, Levaquin, and Cipro concerning this apparent retinal detachment side effect. And we will watch for any similar revisions to the Prescribing Information for these popular antibiotics here in... Continue reading
Posted Mar 4, 2016 at Drug Injury Watch
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 husband's situation. I wish your husband and you the best in all aspects going forward. Tom Lamb
1 reply
Farxiga, Jardiance, And Other New SLGT2 Diabetes Drugs Also Cause Metabolic Acidosis As Well As Other Serious Side Effects (Posted by Tom Lamb at DrugInjuryWatch.com) A new class of drugs for Type 2 diabetes that blocks the protein sodium glucose cotransporter 2 (SGLT2), in effect, lowers blood sugar by causing the kidneys to excrete some circulating glucose rather than return it to circulation. These SGLT2 diabetes drugs are currently approved for use by patients in the US: Invokana (canagliflozin) — Janssen Pharmaceuticals — FDA Approval: 2013 Invokamet (canagliflozin and metformin) — Janssen Pharmaceuticals — FDA Approval: 2014 Farxiga (dapagliflozin) — AstraZeneca Pharmaceuticals — FDA Approval: 2014 Xigduo XR (dapagliflozin and metformin extended-release) — AstraZeneca Pharmaceuticals — FDA Approval: 2014 Jardiance (empagliflozin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2014 Glyxambi (empagliflozin and linagliptin) — Boehringer Ingelheim Pharmaceuticals — FDA Approval: 2015 Synjardy (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2015 According to data from IMS Health, Invokana, the first to win U.S. approval, reached 1.1 million dispensed outpatient prescriptions in the second quarter of 2015, followed by Farxiga with 411,000, and Jardiance with 136,000. And from the ISMP QuarterWatch published January... Continue reading
Posted Feb 26, 2016 at Drug Injury Watch
Viagra Has Been Associated With A Higher Incidence Of Invasive Melanoma, A Side Effect Which May Also Be Linked To Cialis, Levitra, And Similar ED / BPH / PAH Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) Viagra (sildenafil), the most common drug prescribed for male erectile dysfunction (ED), appears to increase the risk for invasive melanoma but not cutaneous squamous cell carcinomas nor basal cell carcinomas. Essentially, Viagra acts by inhibiting phosphodiesterase 5 (PDE5). Experimental in vitro studies show that PDE5 inhibition augments tumor cell invasiveness, supporting this new Viagra side effect finding. Some patients who developed melanoma after using Viagra have filed a drug injury lawsuits against the pharmaceutical company Pfizer seeking legal compensation. In late 2015 a motion to transfer was filed on behalf of those Plaintiffs to have those lawsuits pending in the federal court system consolidated in was is called a "multidistrict litigation" (MDL) case. In more detail, on December 11, 2015 a legal document captioned In re: VIAGRA® PRODUCTS LIABILITY LITIGATION, MDL No. 2691 was filed with the Judicial Panel on Multidistrict Litigation (JPMDL) seeking consolidation of all Viagra - melanoma lawsuits pending in various federal courts around the country. Soon thereafter, on December 22,... Continue reading
Posted Feb 19, 2016 at Drug Injury Watch
New Drug Safety Announcement By European Medicines Agency (EMA) Intended To Help Minimize Risk Of DKA Side Effect With This Class Of New Diabetes Drugs (Posted by Tom Lamb at DrugInjuryWatch.com) The Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors diabetes drugs currently available in the US are: Invokana — FDA Approval: 2013 Invokamet — FDA Approval: 2014 Farxiga — FDA Approval: 2014 Xigduo XR — FDA Approval: 2014 Jardiance — FDA Approval: 2014 Glyxambi — FDA Approval: 2015 Synjardy — FDA Approval: 2015 These new SGLT-2 inhibitors diabetes medications are distinctive from other diabetes drugs insofar that they make the kidneys extract a significant amount of sugar from the blood to be excreted in urine. On February 12, 2016 the European Medicines Agency (EMA) issued a drug safety alert about the possibility of atypical cases of diabetic ketoacidosis (DKA) associated with this relatively new class of medications used to treat type 2 diabetes. This EMA announcement, "SGLT2 inhibitors: PRAC makes recommendations to minimise risk of diabetic ketoacidosis", followed a review conducted by the agency's Pharmacovigilance Risk Assessment Committee (PRAC). From this February 2015 EMA drug safety alert concerning Invokana, Farxiga, Jardiance, and similar diabetes drugs we get these facts about this DKA side... Continue reading
Posted Feb 15, 2016 at Drug Injury Watch
Medical Journal Article Says FDA Might Make This Change For Patients Using Eliquis, Pradaxa, Savaysa, Or Xarelto (Posted by Tom Lamb at DrugInjuryWatch.com) UPDATE: Xarelto trial results reaffirmed despite faulty device (Reuters, 2/5/16) Europe's drug regulator said on Friday the defective blood clotting test device used in a key trial for the approval of Bayer's top-selling anti-clotting drug Xarelto did not distort the study's main findings. "Xarelto can continue to be used as before, in line with the current prescribing information," the European Medicines Agency (EMA) said on its website. (2/8/16) ___________________________________________________ According to this BMJ medical journal article, "Rivaroxaban: can we trust the evidence?", published on February 3, 2016, a faulty medical device used in the clinical trial leading to the FDA's approval of Xarelto (rivaroxaban) has called those results into question. But in this letter to the New England Journal of Medicine (NEJM), "Point-of-Care Warfarin Monitoring in the ROCKET AF Trial", also published on February 3, 2016, the medical researchers who conducted that Xarelto clinical trial conclude that the use of this device "did not have any significant clinical effect on the primary efficacy and safety outcomes in the trial." However, going back to the BMJ article, we... Continue reading
Posted Feb 5, 2016 at Drug Injury Watch
JAMA Pediatrics Article Reports Increased Risk Is Greatest When These Depression Medicines Are Used By Mothers During The Second And/Or Third Trimester (Posted by Tom Lamb at DrugInjuryWatch.com) Some popular medications prescribed to treat depression are in the Selective Serotonin Reuptake Inhibitors, or SSRIs, class of drugs, including the following: Wellbutrin (bupropion); Celexa (citalopram); Cipralex (escitalopram); Prozac (fluoxetine); Luvox (fluvoxamine); Remeron (mirtazapine); Paxil (paroxetine); Effexor (venlafaxine); and, Zoloft (sertraline). A recent medical journal article discussed the extent to which these drugs, when used by women during pregnancy, are associated with an increased autism risk in children. The bottom line is that using selective serotonin reuptake inhibitors (SSRIs) during the second or third trimester of pregnancy is associated with a heightened risk for autism spectrum disorder (ASD) in children. This is according to a JAMA Pediatrics study which is the subject of this article, "Antidepressant Use During Pregnancy and the Risk of Autism Spectrum Disorder in Children", first published online in December 2015. For that study the medical researchers used data from a population-based cohort study of women from Quebec who delivered 145,000 full-term singleton infants. Children were followed until a mean age of 6.2 years. From the Abstract for the... Continue reading
Posted Jan 29, 2016 at Drug Injury Watch
Max Mitchell, The Legal Intelligencer January 27, 2016 In its bid to toss a $3 million verdict, Janssen Pharmaceuticals has asked the state Superior Court to find that federal law pre-empts a plaintiff's negligent failure-to-warn claims over the name-brand anti-seizure medication Topamax. During oral arguments Wednesday in Anderson v. Janssen Pharmaceuticals, which resulted in a $3 million award to a mother who claimed Topamax caused birth defects in her child, counsel for the drugmaker attempted to distinguish the suit from two other cases in which the Superior Court previously rejected similar ­pre-emption arguments. In asking the court to find that... Continue reading
Posted Jan 28, 2016 at Drug Safety Developments