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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
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 6 days ago 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
Synvisc-One knee injections have recently been recalled due to microbial contamination. Sanofi is working to round up the contaminated syringes before any more adverse side effects occur. Continue reading
Posted Jan 9, 2018 at Drug Safety Developments
Researchers in the Netherlands completed a new study on the risks of developing BIA-ALCL, a rare type of lymphoma associated with breast implants. Continue reading
Posted Jan 9, 2018 at Drug Safety Developments
Colleen: If you have not already, I suggest you see this more recent Fosamax article I wrote a few months back: "Merck Wants The US Supreme Court To Reverse A Federal Appeals Ruling In Fosamax - Femur Fractures Litigation" (9/18/17) http://www.drug-injury.com/druginjurycom/2017/09/merck-petitions-supreme-court-review-fosamax-femur-fractures-lawsuits-ruling-third-circuit-federal-appeals-court.html Tom Lamb
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Written by: Heather Helmendach, Legal Assistant Law Offices of Thomas J. Lamb, P.A. At the Law Offices of Thomas J. Lamb, we are committed to providing up-to-date information on matters pertaining to drug injury law. Over the course of 2017, we have reviewed countless medical studies and journals, and reported the significant medical, legal, and regulatory developments through our two blogs. Attorney Tom Lamb's blog, Drug Injury Watch, consists of articles related to serious side effects of prescription drugs, and major developments in some of the current drug litigations. My blog, Drug Safety Developments, reports and elaborates on the information contained in medical and legal news concerning the safety of brand-name prescription drugs. Below, I have provided an index of the articles published on the Drug Injury Watch blog in 2017. These articles are organized categorically, and listed in the following section. Click on the categories below to jump to that section of the page, then click on the title of the article to view it in full at its source. Categories: SGLT-2 Inhibitors Diabetes Drugs Hepatitis C Treatment Drugs Anticoagulants / Bloodthinners Breast Implants Osteoporosis Treatment Drugs Erectile Dysfunction (ED) Drugs Heartburn / Acid Reflux Drugs Multiple Sclerosis (MS)... Continue reading
Posted Jan 5, 2018 at Drug Injury Watch
A recent study suggests that patients with COPD who use long-acting inhaled bronchodilators have a 50% increased risk of heart attacks and strokes. Continue reading
Posted Jan 3, 2018 at Drug Safety Developments
Lawsuits alleging that incretin-based diabetes drugs Byetta, Bydureon, Januvia, Janumet, and Victoza cause pancreatic cancer have been reinstated by a recent federal appeals court ruling. Continue reading
Posted Jan 2, 2018 at Drug Safety Developments
The FDA recently approved new type-2 diabetes drugs, Steglatro, Steglujan, and Segluromet. These drugs will become available in January 2018, and include many of the same side effects of other SGLT2 inhibitor diabetes drugs. Continue reading
Posted Dec 28, 2017 at Drug Safety Developments
As more patients suffer from major bleeding events due to Pradaxa, Eliquis, Savaysa, and Xarelto, doctors must find more treatment options or antidotes. Continue reading
Posted Dec 20, 2017 at Drug Safety Developments
In Comparison, This December 2017 Regulatory Action By FDA In The US: "new class warning... for all gadolinium-based contrast agents" (Posted by Tom Lamb at DrugInjuryWatch.com) There seems to be a consensus among the United States FDA and the United Kingdom MHRA drug safety agencies that low levels of gadolinium can be retained in the brain and other tissues after administration of gadolinium-based contrast agents (GBCAs) for months to years after receiving these drugs. Another point of agreement between those agencies is that certain linear GBCAs -- such as Magnevist, Omniscan, and OptiMARK -- result in more gadolinium retention in the body than macrocyclic GBCAs. There is a difference, however, between FDA and MHRA in terms of the regulatory actions being taken with respect to this class of drugs, now. On December 14, 2017 the Medicines and Healthcare products Regulatory Agency (MHRA) issued this document, "Gadolinium-containing contrast agents: removal of Omniscan and iv Magnevist, restrictions to the use of other linear agents", which includes the following statement: There is currently no evidence that gadolinium deposition in the brain has caused adverse neurological effects in patients; however, licences for gadodiamide (Omniscan) and intravenous gadopentetic acid (also known as gadopentetate dimegulumine; Magnevist)... Continue reading
Posted Dec 19, 2017 at Drug Injury Watch
The EU has called for strengthened warnings on the drug label for Gilenya in light of new information released in recent reviews of the drug. Continue reading
Posted Dec 19, 2017 at Drug Safety Developments
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 Dec 12, 2017 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) UPDATE: Primus Pharmaceuticals Inc. Finally Removes Its Osteoarthritis Capsule Limbrel From The Market ... "We are not shipping. We're not promoting. We're not sampling doctors," said Primus President and CEO James Weir. "We have terminated all of those activities in good faith even though we don't believe our product is life threatening." Primus sells Limbrel as a "medical food," but the FDA said last month that the product is an unapproved drug linked to 194 adverse events over the last decade. [Article continues at original source] (1/5/18) 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... Continue reading
Posted Dec 8, 2017 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
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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