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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
Onglyza, Nesina, Januvia, and Tradjenta Are Included In This Popular Class Of Type-2 Diabetes Medications (Posted by Tom Lamb at DrugInjuryWatch.com) In April 2016 the FDA took regulatory action by mandating label changes with new warnings about an increased risk of heart failure for these relatively new diabetes medicines in the dipeptidyl peptidase-4 (DPP-4) inhibitor drug class: Onglyza (saxagliptin) Kombiglyze XR (saxagliptin and metformin) Nesina (alogliptin) Kazano (alogliptin and metformin) Oseni (alogliptin and pioglitazone) Qtern (dapagliflozin and saxagliptin) In connection with that DPP-4 diabetes drug label change as well as related earlier FDA actions, some medical researchers recently took a look at heart-related side effects reports submitted to FDA Adverse Event Reporting System (FAERS) from 2006 to 2015. From the Abstract for a subsequent medial journal article with their findings, in the Conclusions section: Postmarketing surveillance of DPP‐4i through FAERS suggest increased reporting of [major adverse cardiac events (MACE)], supporting the current FDA warning of heart failure risk. This suggests the need for additional longitudinal, observational research into the association of [dipeptidyl peptidase‐4 inhibitors (DPP‐4i)] and other [major adverse cardiac events (MACE)]. That article, "Cardiovascular safety signals with dipeptidyl peptidase‐4 inhibitors: A disproportionality analysis among high‐risk patients", was published April... Continue reading
Posted yesterday at Drug Injury Watch
A recent study compared three classes of diabetes drugs in order to determine their effect on the risk of death. While two reduced the risk, one did not have any effect. Continue reading
Posted yesterday at Drug Safety Developments
The FDA recently restricted the sale of Essure, a permanent birth control device, in light of serious side effects being reported consistently to the agency. Continue reading
Posted Apr 11, 2018 at Drug Safety Developments
This Relatively New Parkinson's Disease Drug Already Been Implicated In Hundreds Of Death Cases, While Only Being On Market Since 2016 (Posted by Tom Lamb at DrugInjuryWatch.com) Two years ago the FDA approved Nuplazid (pimaveanserin) as a new kind of antipsychotic drug which is intended to treat hallucinations, delusions, and other symptoms of psychosis among patients with Parkinson’s disease. Reportedly, for this particular medical condition there is a patient population numbering in the hundreds of thousands with a typical onset around age 65. A report about Nuplazid published in the November 1, 2017 edition of the Institute for Safe Medication Practices (ISMP) QuarterWatch, however, has raised some serious concerns about the safety of this still relatively new Parkinson's disease drug. Building upon that 2017 ISMP QuarterWatch report, more recently CNN covered this emerging drug safety issue in this April 2018 news story, "FDA worried drug was risky; now reports of deaths spark concern". An FDA Advisory Committee considered whether to recommend approval of Nuplazid in March 2016. In more detail, according to the April 2018 CNN Investigates story: The committee voted 12-2 and recommended that the FDA approve Nuplazid for the treatment of Parkinson's disease psychosis based on a six-week... Continue reading
Posted Apr 10, 2018 at Drug Injury Watch
You can send an email to druginjury@gmail.com Thank you.
1 reply
New Study Finds Overall 75% Increase In Risk Of IBD, And Association Peaked Between 3 And 4 Years Of Use (Posted by Tom Lamb at DrugInjuryWatch.com) According to an observational study published on March 21, 2018 by The BMJ -- formerly known as British Medical Journal -- the use of dipeptidyl peptidase-4 (DPP-4) inhibitors for treatment of type 2 diabetes is associated with increased risk for inflammatory bowel disease (IBD). The following diabetes medicines are in the dipeptidyl peptidase-4 (DPP-4) inhibitor class of drugs: Januvia (sitagliptin) Janumet (sitagliptin / metformin HCl) Janumet XR (sitagliptin / metformin HCl) Tradjenta (linagliptin) Jentadueto (linagliptin / metformin HCl) Glyxambi (empagliflozin / linagliptin) Onglyza (saxagliptin) Kombiglyze XR (saxagliptin and metformin) Qtern (dapagliflozin and saxagliptin) Nesina (alogliptin) Kazano (alogliptin and metformin) Oseni (alogliptin and pioglitazone) Diabetes Drugs Side Effects Free Case Evaluation Strictly Confidential, No Obligation. From the Discussion part of this March 2018 BMJ article, "Dipeptidyl peptidase-4 inhibitors and incidence of inflammatory bowel disease among patients with type 2 diabetes: population based cohort study": To our knowledge, this is the first observational study to specifically investigate the association between the use of dipeptidyl peptidase-4 inhibitors and the incidence of inflammatory bowel disease. Use of dipeptidyl... Continue reading
Posted Mar 22, 2018 at Drug Injury Watch
Though data has been limited on the association between breast implants and a rare type of lymphoma cancer, the FDA released an updated report on the current number of cases. Continue reading
Posted Mar 21, 2018 at Drug Safety Developments
A gout treatment drug, Uloric, was recently shown to carry an increased risk of heart-related deaths when compared to other common gout treatment drugs. The FDA may pull Uloric from the market or mandate increased warnings in the drug label. Continue reading
Posted Mar 20, 2018 at Drug Safety Developments
Recent Findings Come From The CARES Trial, A Postmarketing Safety Study Requested By FDA Back When Uloric Was Approved In 2009 (Posted by Tom Lamb at DrugInjuryWatch.com) At the recent American College of Cardiology (ACC) 2018 Annual Scientific Session meeting, the gout drug Uloric (febuxostat) was the subject of some safety concerns due to findings about a higher risk of death when compared to an alternative gout drug, allopurinol. However, the mechanism behind this difference was not readily apparent. Allopurinol, approved by the FDA in 1966, and Uloric, approved in 2009, are two commonly prescribed medicines for gout. Takeda Pharmaceuticals is the drug company responsible for Uloric. The findings presented at this 2018 ACC meeting came from the Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Comorbidities (CARES) trial, or drug study, sponsored by Takeda Pharmaceuticals as an FDA postmarketing requirement. From this March 12, 2018 MedPageToday news article, "Gout Drug Raises Safety Concerns With Death Excess in Trial", we get some commentary about this emerging drug safety issue for Uloric: At this point, there is no known explanation for the mortality risk seen with [Uloric (febuxostat)], William White, MD, of the University of Connecticut in... Continue reading
Posted Mar 19, 2018 at Drug Injury Watch
Despite Evidence That Tasigna Accelerates Atherosclerosis, Novartis Does Little To Warn Doctors And Patients In The US (Posted by Tom Lamb at DrugInjuryWatch.com) In a recent article, "Tasigna Side Effects Include Ischemic Cerebrovascular Events, Ischemic Heart Disease, And Peripheral Arterial Occlusive Disease", our primary focus was on the difference between Tasigna drug safety warnings provided by Novartis in Canada (more) as opposed to the US (less). For this article we take a closer look at what had been discussed in the medical literature about the atherosclerosis side effect associated with Tasigna (nilotinib) no later than April 2013. We are doing this review because it was during April 2013 that Novartis Pharmaceuticals Canada Inc. took these actions: Sent a so-called "Dear Doctor" letter in Canada (but not the US) warning about some serious side effects associated with Tasigna; and, Issued a Tasigna drug label change in Canada (but not the US) with new information concerning those Tasigna side effects. For that purpose, we have selected a Letter to the Editor published online April 22, 2013 by the medical journal Leukemia, which was written by Ayalew Tefferi, MD, of the Mayo Clinic's Division of Hematology within its Department of Medicine at Rochester,... Continue reading
Posted Mar 6, 2018 at Drug Injury Watch
Eylea is an injectable drug indicated for the treatment of several diseases of the retina. There has been a recent spike in reports of Eylea injections side effects, but many details are still unknown. Continue reading
Posted Mar 5, 2018 at Drug Safety Developments
Gadolinium-Based Contrast Agents (GBCAs) have been the subject of drug safety regulatory actions by the FDA for the past twelve years. Here is a detailed timeline of these regulatory actions. Continue reading
Posted Feb 28, 2018 at Drug Safety Developments
Less Warning About These Atherosclerosis-Related Diseases By Novartis In The US, It Seems, Compared To What Has Been Done By The Drug Company In Canada (Posted by Tom Lamb at DrugInjuryWatch.com) Tasigna (nilotinib) was approved by the FDA in 2007 for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). In April 2013 a so-called "Dear Doctor" letter was sent out in Canada by the responsible drug company warning about some serious side effects associated with Tasigna and a drug label change with new information concerning those Tasigna side effects, or adverse events. Relevant parts of this April 9, 2013 letter from Novartis Pharmaceuticals Canada Inc. are set forth below: Dear Healthcare Professional: Subject: Updated information regarding the possible risk of developing atherosclerosis-related diseases with the use of TASIGNA* (nilotinib) Novartis Pharmaceuticals Canada Inc. (“Novartis”), in collaboration with Health Canada, would like to inform you of important information regarding reports of atherosclerosis-related diseases in patients treated with TASIGNA* (nilotinib). TASIGNA* belongs to the pharmacological class of protein-tyrosine kinase inhibitors.... Cases of atherosclerosis-related diseases have been reported during clinical trials and post marketing experience with the use of TASIGNA*. Patients should be monitored for... Continue reading
Posted Feb 27, 2018 at Drug Injury Watch
Gadolinium-Based Contrast Agents (GBCAs) can lead to retention of toxic gadolinium in the brain, bones, and other tissues. This can result in Nephrogenic Systemic Fibrosis (NSF) in patients with kidney problems or Gadolinium Deposition Disease in patients with no kidney problems. Continue reading
Posted Feb 23, 2018 at Drug Safety Developments
Esmya, a uterine fibroids medication, is under review for approval in the US, but is being investigated in Europe due to reports of severe liver injuries. Continue reading
Posted Feb 22, 2018 at Drug Safety Developments
Current Number Of Drug Injury Lawsuits Filed In Each Of These Ongoing Federal Court MDL Cases: February 2018 JPML Report (Posted by Tom Lamb at DrugInjuryWatch.com) At the present time there are four federal court Multidistrict Litigation (MDL) cases for drug injury lawsuits concerning several different types of diabetes medicines with unique sets of side effects. From the February 15, 2018 version of this document, "MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending" (accessed 2/21/18), published by the United States Judicial Panel on Multidistrict Litigation (JPML), we get the current number of cases filed in each of these diabetes drugs MDL cases. We supplement that information provided by the JPML with the primary side effects that are the subject of personal injury lawsuits and wrongful death lawsuits filed in each of these diabetes drug MDL cases. IN RE: Incretin-Based Therapies Products Liability Litigation MDL-2452 Number of lawsuits pending: 936 Diabetes drugs in this MDL case: Byetta (exenatide) Bydureon (exenatide) Victoza (liraglutide) Januvia (sitagliptin) Janumet (sitagliptin) Janumet XR (sitagliptin) Juvisync (sitagliptin) Primary side effect for these cases: Pancreatic Cancer, also known as Pancreas Cancer Get more information about these drug injury cases and/or free case evaluation. IN... Continue reading
Posted Feb 21, 2018 at Drug Injury Watch
This Diabetes Drugs Litigation Involves Heart Failure, Myocardial Infarction, And Other Cardiovascular Problems (Posted by Tom Lamb at DrugInjuryWatch.com) In February 2018 the United States Judicial Panel on Multidistrict Litigation (JPML) established MDL No. 2809, IN RE: ONGLYZA (SAXAGLIPTIN) AND KOMBIGLYZE XR (SAXAGLIPTIN AND METFORMIN) PRODUCTS LIABILITY LITIGATION. According the the February 2, 2018 Transfer Order issued by the JPML: [W]e find that these actions involve common questions of fact, and that centralization under Section 1407 in the Eastern District of Kentucky will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. All actions share numerous factual questions, inasmuch as plaintiffs allege that the use of Onglyza or Kombiglyze XR caused them or their decedent to develop heart failure or other conditions such as congestive heart failure, myocardial infarction and/or cardiovascular injury. According to that JPML Transfer Order the Defendants -- AstraZeneca Pharmaceuticals LP, Bristol-Myers Squibb Co., and McKesson Corp. -- opposed centralization of approximately 80 Onglyza and Kombiglyze lawsuits into this new MDL: Defendants oppose transfer by arguing that plaintiffs’ allegations are supported by a single study (the SAVOR study), which itself supports only claims regarding heart failure – not... Continue reading
Posted Feb 12, 2018 at Drug Injury Watch
This Ocaliva Label Change Follows September 2017 Dear Doctor Letter Sent By Intercept Pharmaceuticals (Posted by Tom Lamb at DrugInjuryWatch.com) An earlier blog post, "Will Ocaliva Get Black-Box Warning For Liver Injury Side Effects After September 2017 FDA Report?", received its answer last week. On February 1, 2018 the FDA issued this Safety Alert, "Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing", from which we get this information: ISSUE: FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury. To ensure correct dosing and reduce the risk of liver problems, FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva. FDA is adding a new Boxed Warning, FDA’s most prominent warning, to highlight this information in the prescribing information of the drug label. FDA is also requiring a Medication Guide for patients to inform them about this issue. As a condition of approval, FDA required the manufacturer of Ocaliva, Intercept Pharmaceuticals,... Continue reading
Posted Feb 5, 2018 at Drug Injury Watch
Saxenda Dose Contains Twice As Much Liraglutide As Diabetes Medicine Victoza, Also Linked To Malignancy In Pancreas (Posted by Tom Lamb at DrugInjuryWatch.com) In 2014, the FDA approved Saxenda (liraglutide) for the treatment of obesity. Novo Nordisk is the responsible pharmaceutical company. Liraglutide, the active ingredient for Saxenda, is a glucagonlike peptide-1 (GLP-1) receptor agonist. More generally, Saxenda is in the incretin mimetic class of drugs. Four years earlier, the FDA approved another liraglutide-containing medicine, Victoza, which is a popular Type-2 diabetes drug. Like Victoza, Saxenda has been associated with an increased risk of pancreatic cancer, or pancreas cancer, in patients using this still relatively new obesity, or weight-loss, drug. However, the alarming difference between Saxenda and Victoza is that the standard dose of Saxenda for obesity contains 3.0 mg of liraglutide, while the standard doses of Victoza for diabetes are 1.2 mg or 1.8 mg of liraglutide. So the patient using Saxenda is getting about two-times more liraglutide than the patient using Victoza. While the current Prescribing Information, or drug label, for Saxenda (accessed 1/30/18) has a so-called "Black-Box Warning" for the risk of thyroid C-cell tumors, a type of thyroid cancer, and pancreatitis is mentioned in the Warnings... Continue reading
Posted Jan 30, 2018 at Drug Injury Watch
Additional information concerning the potentially harmful side effects of Viberzi and Actemra was released over the course of 2017, and we will continue to monitor the situation in 2018. Continue reading
Posted Jan 23, 2018 at Drug Injury Watch
Additional information concerning the potentially harmful side effects of the Mirena IUD and Ocaliva was released over the course of 2017, and we will continue to monitor the situation in 2018. Continue reading
Posted Jan 18, 2018 at Drug Injury Watch
The study conducted on MiraLax use in the pediatric population is projected to be completed in 2018. Unlike previous studies, this one looks specifically at behavioral changes in children using MiraLax. Continue reading
Posted Jan 18, 2018 at Drug Safety Developments
A recall of osteoarthritis medical food, Limbrel, has been initiated by the manufacturer, Primus Pharmaceuticals, after the FDA urged them to do so. This Limbrel recall was instituted due to side effects such as drug-induced liver injury, hypersensitivity pneumonitis, and pancreatitis. Continue reading
Posted Jan 12, 2018 at Drug Safety Developments
The Mirena IUD has been associated with the neurological side effect pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension. Continue reading
Posted Jan 11, 2018 at Drug Safety Developments
This Relatively New Idiopathic Pulmonary Fibrosis (IPF) Pill Is Clearly On The Radar Of Drug Safety Regulators (Posted by Tom Lamb at DrugInjuryWatch.com) OFEV (nintedanib) capsules were approved by the FDA in 2014 for treatment of idiopathic pulmonary fibrosis (IPF). Boehringer Ingelheim Pharmaceuticals, Inc. is the drug company responsible for OFEV in the US. On January 11, 2018 Health Canada issued a Dear Healthcare Professional Letter communication titled "OFEV (nintedanib) - Risk of Drug-Induced Liver Injury and the Need for Regular Monitoring of Liver Function". From the Background Information section of that new Health Canada document we get this overview of the safety issue: OFEV (nintedanib) is used to treat idiopathic pulmonary fibrosis (IPF). Cases of [drug-induced liver injury (DILI)] have been observed with OFEV treatment in the post-marketing setting since the product was launched in 2014. The overall cumulative [idiopathic pulmonary fibrosis (IPF)] patient exposure to OFEV from marketing experience is estimated to be over 32,000 patient-years. As of October 15, 2017, 32 cases of DILI have been reported worldwide in patients treated with OFEV, including one in Canada. In 24 of the 32 cases, the outcome of the DILI events was reported. In the majority (17) of these... Continue reading
Posted Jan 11, 2018 at Drug Injury Watch