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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
Teva and Pfizer just released generic forms of the ED drug, Viagra. The generic version will have the same active ingredient and side effects as Viagra. Continue reading
Posted yesterday at Drug Safety Developments
Reports Of Drug-Induced Liver Injury And Hypersensitivity Pneumonitis Are At Center Of This Unusual Drug Safety Controversy (Posted by Tom Lamb at DrugInjuryWatch.com) According to the "What is Limbrel?" page of the Limbrel.com website (accessed 12/8/17) which is presented by Primus Pharmaceuticals, Inc.: Limbrel contains flavocoxid, a proprietary blend of natural ingredients from phytochemical food source materials. Flavocoxid is comprised primarily of the flavonoids such as baicalin and catechin. From the "FDA Limbrel Alert" page of the Limbrel.com website (accessed 12/8/17): Limbrel has not been recalled though the FDA has asked Primus to make a voluntary recall. Primus is waiting to obtain the documents on which FDA has based its safety alert and recall request prior to making a final decision, although the opinions of independent experts and the medical literature conflict with FDA’s safety alert and request for recall. We first reported about the November 21, 2017 FDA warning about Limbrel last month in this post, "Osteoarthritis 'Medical Food' Limbrel Tied to Life-Threatening Events". Since then there was this December 4, 2017 FDA statement: The U.S. Food and Drug Administration recommended that Primus Pharmaceuticals, Scottsdale, Arizona, voluntarily recall Limbrel, a capsule marketed to manage the metabolic processes associated with... Continue reading
Posted 5 days ago at Drug Injury Watch
To start, I understand that osteonecrosis of the jaw (ONJ) can be a severe medical condition, as we handled some of those cases several years back. We are not currently handling Fosamax - ONJ cases, and I am not aware of any lawyer who is taking ONJ cases at this time. But that is not to say there might not be some lawyers who are still involved with the earlier litigation against Merck. I wish your mother the best in all aspects going forward. Tom Lamb
1 reply
Jardiance Seemingly Not Associated With Amputations Per Reexamination Of Drug Company Funded EMPA-REG OUTCOME® Trial Data (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2016 the European Medicines Agency (EMA) warned that Invokana and Invokamet were linked to an increased risk of amputations, especially of the toes. Ever since then we have been monitoring the medical literature concerning the risk of lower limb amputations and drugs in the sodium glucose cotransporter 2 (SGLT2) inhibitor class, such as canagliflozin (Invokana / Invokamet), empagliflozin (Jardiance / Glyxambi / Synjardy), and dapagliflozin (Farxiga / Xigduo / Qtern). On November 13, 2017 Boehringer Ingelheim published on their website this press release, "Jardiance® reduced risk of cardiovascular death in adults with type 2 diabetes and peripheral artery disease". Therein, we found this excerpt concerning lower limb amputations: These results, from a post-hoc analysis of the landmark EMPA-REG OUTCOME® trial, were shared as an oral presentation on behalf of Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) at the American Heart Association® (AHA) Scientific Sessions 2017 in Anaheim, Calif. and simultaneously published online [as a Research Letter: "Cardiovascular Outcomes and Safety of [Jardiance (Empagliflozin)] in Patients With Type 2 Diabetes Mellitus and Peripheral Artery Disease:... Continue reading
Posted Nov 28, 2017 at Drug Injury Watch
Limbrel is an osteoarthritis "medical food" that has recently been associated with drug-induced liver injury & hypersensitivity pneumonitis. Continue reading
Posted Nov 28, 2017 at Drug Safety Developments
Will Recent ISMP QuarterWatch Report Prompt FDA Regulatory Action, Including Possible Drug Label Change By Novartis? (Posted by Tom Lamb at DrugInjuryWatch.com) The FDA approved Entresto™ (sacubitril and valsartan) tablets in July 2015 to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction. In the original and still current Prescribing Information for Entresto (Revised 8/2015 and accessed 11/21/17), at Part 5 "Warnings and Precautions", already has some text and data about incidents of low blood pressure in some patients using this rather unique heart failure drug: 5.3 Hypotension ENTRESTO lowers blood pressure and may cause symptomatic hypotension. Patients with an activated renin-angiotensin system, such as volume- and/or salt-depleted patients (e.g., those being treated with high doses of diuretics), are at greater risk. In the double-blind period of PARADIGM-HF, 18% of patients treated with ENTRESTO and 12% of patients treated with enalapril reported hypotension as an adverse event [see Adverse Reactions (6.1)], with hypotension reported as a serious adverse event in approximately 1.5% of patients in both treatment arms. Correct volume or salt depletion prior to administration of ENTRESTO or start at a lower dose. If... Continue reading
Posted Nov 21, 2017 at Drug Injury Watch
Current Uloric Drug Label Includes Warnings About Cardiovascular Events Such As Heart Attacks And Strokes Based On Pre-Approval Trials (Posted by Tom Lamb at DrugInjuryWatch.com) Uloric (febuxostat) is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout, which is a type of arthritis. This gout drug works by lowering uric acid levels in the blood. Uloric is manufactured by Takeda Pharmaceuticals, and was initially approved by the FDA in 2009. On November 15, 2017 there was an email sent by the FDA about this MedWatch Safety Alert, "Febuxostat (Brand Name Uloric): Drug Safety Communication - FDA to Evaluate Increased Risk of Heart-related Death", from which we get this excerpt: ISSUE: FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of heart-related death with febuxostat (Uloric) compared to another gout medicine called allopurinol. FDA required the Uloric drug manufacturer, Takeda Pharmaceuticals, to conduct this safety study when the medicine was approved in 2009. Once the final results from the manufacturer are received, FDA will conduct a comprehensive review and will update the public with any new information. __________________________________________________________________ Uloric Free Case Evaluation Strictly Confidential, No Obligation.... Continue reading
Posted Nov 15, 2017 at Drug Injury Watch
A new study on heartburn and acid reflux drugs analyzed 5 previous studies and found a 33% increased risk of kidney disease & kidney failure. Continue reading
Posted Nov 8, 2017 at Drug Safety Developments
New Analysis Finds Significant Increased Risk Of Bladder Cancer For SGLT2 Inhibitors With Empagliflozin (Posted by Tom Lamb at DrugInjuryWatch.com) For years there has been a lingering concern over whether Sodium-Glucose Co-Transporter-2 (SGLT2) inhibitors, a relatively new class of diabetes drugs, are associated with the development of bladder cancer. The most recent medical journal article we have seen regarding this drug safety issue singles out the SGLT2 inhibitors which contain the active ingredient empagliflozin, which are listed below: 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 Synjardy XR (empagliflozin and metformin hydrochloride) — Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company — FDA Approval: 2016 This article, "SGLT2 inhibitors and risk of cancer in type 2 diabetes: a systematic review and meta-analysis of randomised controlled trials", was published in the October 2017 edition of Diabetologia (after first being made available online in July 2017). It presents the findings of medical researchers who conducted a systematic literature review to identify randomized controlled trials that reported cancer events in Type-2... Continue reading
Posted Nov 7, 2017 at Drug Injury Watch
FDA Investigation Of Potential Link Between Melanoma Skin Cancer And ED Drugs As Well BPH And PAH Medicines Continues (Posted by Tom Lamb at DrugInjuryWatch.com) From this FDA 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)", we learned that the US drug regulator is looking at the possible link between various drugs in the phosphodiesterase 5 (PDE-5) inhibitors class and melanoma as a side effect. The so-called "active ingredients" in the PDE5 class of drugs are sildenafil, tadalafil, vardenafil, and avanafil. The five brand name erectile dysfunction (ED) drugs in the PDE-5 inhibitors class are Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenafil), Staxyn (vardenafil), and Stendra (avanafil). Cialis is also prescribed sometimes when doctors see the signs and symptoms of benign prostatic hyperplasia (BPH). Two other PDE-5 inhibitors, Revatio (sildenafil) and Adcirca (tadalafil), are prescribed for the treatment of pulmonary arterial hypertension (PAH). To date, there has not been any status update from the FDA on their investigation about this possible malignant melanoma side effect of the PDE-5 drugs. But during 2017 thus far, there have been a few medical journal... Continue reading
Posted Oct 31, 2017 at Drug Injury Watch
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A recent study found that SGLT2 diabetes drugs such as Invokana, Farxiga, and Jardiance may have an increased risk of acute renal failure. Continue reading
Posted Oct 31, 2017 at Drug Safety Developments
Thank you for your 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. Have a good day. Tom Lamb
1 reply
A new study suggests that HCV clearance lowers the risk of liver cancer occurrence, regardless of whether DAA treatment or interferon treatment is used. Continue reading
Posted Oct 25, 2017 at Drug Safety Developments
Future Clinical Trials And Investigations Need To Clarify Whether This Amputation Drug Injury Could Be A Class Effect Of All SGLT2 Inhibitors (Posted by Tom Lamb at DrugInjuryWatch.com) During this year we have written several times about the still developing drug safety issue of lower limb amputations linked to Invokana use: A "Dear Doctor" Letter For Invokana Amputations Side Effect Was Sent September 2017 By Janssen In Canada Analysis Of FDA Adverse Event Reports Describes Extent And Nature of Invokamet / Invokana - Amputation Side Effect Invokana - Amputation Side Effect Gets "Black-Box Warning" On Revised Drug Label Issued In July 2017 Diabetes Medicine Invokana Gets New Warning About Lower Limb Amputation Added To Drug Package Insert In Canada What still is not clear to drug regulators and medical researchers, however, is the so-called "mechanism of injury" which explains how and why there is an increased risk of lower limb amputations for patients using Invokana. Further, it remains uncertain whether this serious side effect may be associated with Farxiga, Jardiance, and other diabetes drugs known as Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors. These precise concerns were addressed in a recent Commentary piece, "CANVAS: Straight Talk Needed on Amputation Risk", by Harpreet S.... Continue reading
Posted Oct 24, 2017 at Drug Injury Watch
Los Angeles City Attorney Mike Feuer has launched an investigation into the drug manufacturer of Nuedexta, Avanir Pharmaceuticals. Continue reading
Posted Oct 23, 2017 at Drug Safety Developments
A recent article published in JAMA Surgery finds that diagnoses of breast implant-associated lymphoma are increasing as more information becomes available. Continue reading
Posted Oct 19, 2017 at Drug Safety Developments
Severe Cases Of Pancreatitis And Sphincter Of Oddi Spasm Reported Even After Just The First Dose Of Viberzi, With Some Resulting In Patient Deaths (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2017 this document was issued, "FDA Drug Safety Communication: FDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder". The following month, in April 2017, the drug company Allergan released a new Viberzi drug label, the details of which are set forth in this earlier article, "FDA Warns of Serious Pancreatitis Risk in Some Patients Taking Viberzi", on our Drug Safety Developments blog. Viberzi (eluxadoline) is approved for use in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). Viberzi works by activating opioid receptors in the gut to decrease bowel contractions, which leads to less diarrhea. It can also help to ease stomach-area or abdomen pain and improve stool consistency. According to the above-mentioned March 2017 FDA document: Hospitalizations related to pancreatitis, including deaths, have been reported with Viberzi in patients who do not have a gallbladder. Hospitalizations related to pancreatitis have also been reported in patients with a gallbladder. Symptoms of pancreatitis can occur after... Continue reading
Posted Oct 18, 2017 at Drug Injury Watch
Nuedexta has been prescribed to a large number of patients in nursing homes, but there is a lack of research done on its effects in the elderly population. Continue reading
Posted Oct 16, 2017 at Drug Safety Developments
The Aesthetic Surgery Journal recently published an article on the risk of death due to breast implant-associated lymphoma. Continue reading
Posted Oct 12, 2017 at Drug Safety Developments
The FDA recently reported in their Adverse Event Reporting System that Nexium / Prilosec / Prevacid may lead to polyps of the stomach and duodenum. Continue reading
Posted Oct 11, 2017 at Drug Safety Developments
FDA Was Already Investigating The Dipeptidyl Peptidase IV (DPP-IV) Inhibitor Class Of Diabetes Drugs For Kidney Or Renal Failure (Posted by Tom Lamb at DrugInjuryWatch.com) According to a new FDA quarterly report, "Potential Signals of Serious Risks / New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): April - June 2017", a class of diabetes drugs referred to as dipeptidyl peptidase-4 inhibitors may be associated with rhabdomyolysis, a side effect which involves severe muscle damage. In more detail, rhabdomyolysis is the breakdown of muscle tissue that leads to the release of muscle fiber contents into the blood. These substances are harmful to the kidney and often cause kidney damage. This most recent FDA quarterly report was issued in early October 2017. It states that "FDA is evaluating the need for regulatory action" as regards this possible rhabdomyolysis side effect for these oral diabetes drugs: Glyxambi (empagliflozin and linagliptin) tablets Janumet (sitagliptin and metformin hydrochloride) tablets Janumet XR (sitagliptin and metformin hydrochloride extended-release) tablets Januvia (sitagliptin) tablets Jentadueto (linagliptin and metformin hydrochloride) tablets Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets Kazano (alogliptin and metformin hydrochloride) tablets Kombiglyze XR (saxagliptin and metformin hydrochloride extended-release) tablets Nesina (alogliptin) tablets... Continue reading
Posted Oct 11, 2017 at Drug Injury Watch
Based on study results, Johnson & Johnson's requests expansion of the Invokana, Invokamet, and Invokamet XR drug labels to include cardiovascular benefits. Continue reading
Posted Oct 9, 2017 at Drug Safety Developments
Rehospitalization Within 30 Days For Serious Bleeding Events Reported With 13% Of Pradaxa Patients Compared To 5% Of Warfarin Patients (Posted by Tom Lamb at DrugInjuryWatch.com) Medical researchers recently reviewed population-wide electronic medical records from the Clinical Data Analysis and Reporting System of the Hong Kong Hospital Authority to identify the 30-day readmission rates for patients with nonvalvular atrial fibrillation treated with Pradaxa (dabigatran) or warfarin. The bottom line for this retrospective cohort study is that the patients treated with Pradaxa appeared to be at higher risk for 30-day hospital readmission due to bleeding. This September 21, 2017 article, "Dabigatran associated with higher 30-day readmission rate for bleeding than warfarin", reports on some of the findings from this medical study: Subgroup analyses showed [Pradaxa (dabigatran)] use was associated with higher admission rate with gastrointestinal bleeding (2.9 vs. 2.1 per 100 patient-years; IRR = 2.21; 95% CI, 1.28-3.83) and a lower rate of intracranial hemorrhage (0.5 vs. 1.4 per 100 patient-years; IRR = 0.26; 95% CI, 0.12-0.55). Post hoc analysis showed an association between [Pradaxa (dabigatran)] use and a lower rate of bleeding among patients aged younger than 75 years (IRR = 0.59; 95% CI, 0.35-0.97) compared with those aged 75... Continue reading
Posted Oct 4, 2017 at Drug Injury Watch
The FDA recently launched a new public dashboard that allows the public to search for drugs or medical devices and their related adverse events. Continue reading
Posted Oct 2, 2017 at Drug Safety Developments
Doctors must adequately warn female patients taking Depakote / Depacon / Depakene about the potentially devastating fetal side effects. Continue reading
Posted Sep 27, 2017 at Drug Safety Developments