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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
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 6 days ago 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 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 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 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 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 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 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 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
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 Apr 26, 2016 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 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 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 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 ________________________________________________________________________________ UPDATE: "Health Canada Warns About Link Between DKA & Popular Diabetes Drugs" (5/19/16) ________________________________________________________________________________ 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,... 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 ________________________________________________________________________________ UPDATE: "Health Canada Warns About Link Between DKA & Popular Diabetes Drugs" (5/19/16) ________________________________________________________________________________ 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... 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 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 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