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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
These Proton-Pump Inhibitors (PPIs) Are Linked To Acute Interstitial Nephritis, Chronic Kidney Disease, End Stage Renal Disease, And Kidney Failure (Posted by Tom Lamb at DrugInjuryWatch.com) In February 2017 the United States Judicial Panel on Multidistrict Litigation (JPML) denied a motion for centralization or consolidation of federal court lawsuits brought by plaintiffs in six proton-pump inhibitors (PPIs) cases alleging kidney injury. All of the defendant pharmaceutical companies in those lawsuits opposed that first effort to set up a Multidistrict Litigation (MDL) for these cases. But six months later, with more Prilosec, Prevacid, and Nexium cases filed and with some of the drug companies no longer in opposition, the JPML established IN RE: PROTON-PUMP INHIBITOR PRODUCTS LIABILITY LITIGATION (NO. II) – MDL No. 2789. From the JPML’s Transfer Order filed on August 2, 2017 we get these details: In the complaints in these 161 personal injury and wrongful death actions, plaintiffs allege that as a result of taking one or more proton-pump inhibitors (PPIs), they or their decedents suffered kidney injury (e.g., chronic kidney disease (CKD), acute interstitial nephritis, end stage renal disease, or kidney failure). Plaintiffs allege that defendants failed to adequately warn of the negative effects and risks associated... Continue reading
Posted yesterday at Drug Injury Watch
This New Medical Research Was Published Just Before "Black-Box Warning" About Lower Limb Amputations Added To Drug Labels (Posted by Tom Lamb at DrugInjuryWatch.com) In the final week of July 2017, the FDA issued a notification that it had approved a revised drug label for Invokana and Invokamet, as well as a revised Medication Guide for these two diabetes drugs from Janssen Pharmaceuticals. This label change was previewed in a May 2017 FDA Drug Safety Communication about an increased risk of leg and foot amputations. For more information on this recent development, see this earlier article: "Invokana - Amputation Side Effect Gets "Black-Box Warning" On Revised Drug Label Issued In July 2017". Just before this Invokamet / Invokana label change was finally done, The Lancet Diabetes & Endocrinology medical journal published this Correspondence item on July 18, 2017, "SGTL2 inhibitors and amputations in the US FDA Adverse Event Reporting System". From that item, we get these two excerpts: In summary, this pharmacovigilance analysis confirms that use of canagliflozin, but not dapagliflozin or empagliflozin, might be associated with an increased risk of amputations. However, [the US Food and Drug Administration (FDA) adverse event Reporting System (FAERS)] data analysis has important limitations... Continue reading
Posted 7 days ago 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
The Drug Safety Concern Is That Use Of These Gadolinium Contrast Agents Can Leave Gadolinium Deposits In Brain Tissues (Posted by Tom Lamb at DrugInjuryWatch.com) The European Medicines Agency (EMA) recently announced it is taking regulatory action on certain magnetic resonance imaging (MRI) contrast drugs containing gadolinium a couple of months after the U.S. Food and Drug Administration (FDA) decided otherwise. To understand these divergent paths, we start with the timeline of events giving rise to the EMA's suspension of the MRI drugs Magnevist, Omniscan, and OptiMARK in July 2017. In March 2017, following its assessment of gadolinium agents used in body scans, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the suspension of certain MRI drugs. This action was based on a review which found evidence of gadolinium deposits in the brain after MRI body scans, but no signs of harm. According to an April 2017 update to "PRAC concludes assessment of gadolinium agents used in body scans and recommends regulatory actions, including suspension for some marketing authorisations": Following the PRAC’s March 2017 recommendation, some of the marketing authorisation holders concerned by this referral procedure have requested a re-examination. Upon receipt of the grounds for their requests, the PRAC... Continue reading
Posted Aug 3, 2017 at Drug Injury Watch
We wish you and your family the best during this difficult time. Tom Lamb
1 reply
This Label Change Was Previewed In A May 2017 FDA Drug Safety Communication About Increased Risk Of Leg And Foot Amputations (Posted by Tom Lamb at DrugInjuryWatch.com) A June 2017 article, "Invokana Shown to Have Heart Benefits, but Elevated Amputation Risks", posted on our Drug Safety Developments site, was the last time we addressed the still relatively new Invokana side effect involving lower limb amputations. Earlier, posted on that same site, was a May 2017 article, "Risk of Lower Limb Amputations Doubled with Invokana and Invokamet Use", which reported on the background of this still emerging drug safety issue for this diabetes drug Invokana (canagliflozin). This earlier Drug Safety Developments report was published the day after the "FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)" document was issued on May 16, 2017. Essentially, the issue here is that two clinical trials showed that leg and foot amputations occurred about twice as often in patients treated with Invokana or Invokamet compared to patients treated with placebo. In more detail, amputations of the toe and middle of the foot were the most common. Amputations involving the leg, below... Continue reading
Posted Jul 27, 2017 at Drug Injury Watch
There has been much debate on whether Hepatitis C drugs have an increased risk of liver cancer. A new study provides more information on this topic. Continue reading
Posted Jul 13, 2017 at Drug Safety Developments
In June 2017 The FDA Announced It Is Evaluating Possible Drug Label Changes And The Need For Other Regulatory Actions (Posted by Tom Lamb at DrugInjuryWatch.com) According to the document "Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS): January - March 2017", the FDA is evaluating the extent of ocular toxicities including vision loss and retinal detachment associated with Keytruda (pembrolizumab), Opdivo (nivolumab), and Yervoy (ipilimumab). More information about this developing drug safety issue is presented in this news report, "FDA Considers Label Changes for Keytruda, Opdivo and Yervoy", which was posted July 12, 2017 on the Regulatory Affairs Professional Society (RAPS) website. Here are some contextual details provided by reporter Zachary Brennan in this article: The consideration for changing the labels of Yervoy, Opdivo and Keytruda comes as FDA says it has completed post-marketing reviews for sight-threatening complications such as retinal detachment and vision loss with the three treatments. Tralisa Colby, an FDA public affairs specialist, explained to Focus: "Regulatory discussions are ongoing regarding PD-1 pathway blocking antibodies in attempts to improve the consistency and effectiveness of the information regarding immune-mediated ARs provided in the labels. Those labeling changes may include... Continue reading
Posted Jul 13, 2017 at Drug Injury Watch
The FDA recently approved a new anticoagulant drug called BevyxXa. Like other anticoagulants, this drug also carries a significant risk of bleeding events. Continue reading
Posted Jun 30, 2017 at Drug Safety Developments
June 2017 Investigative Article Published By STAT Calls Into Question FDA Oversight After Drugs Are Approved By Agency (Posted by Tom Lamb at DrugInjuryWatch.com) Actemra (tocilizumab) is approved by the FDA for the treatment of several different medical conditions: Moderately to severely active rheumatoid arthritis in adult patients who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs); Giant Cell Arteritis (GCA) in adult patients; Polyarticular Juvenile Idiopathic Arthritis (PJIA) in patients 2 years of age and older; and, Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older. An insightful article by reported Charles Piller, "Failure to warn: Hundreds died while taking an arthritis drug, but nobody alerted patients"(subscription required), published June 5, 2017 online by STAT, put the spotlight on some serious but little-known side effects associated with this medicine from Genentech, Inc. From that recent article we get this rather alarming safety information about Actemra: ... STAT analyzed more than 500,000 side-effect reports on rheumatoid arthritis drugs, and found clear evidence that the risks of heart attacks, strokes, heart failure, and other conditions were as high or higher for Actemra patients than for patients taking some competing drugs. Most of... Continue reading
Posted Jun 26, 2017 at Drug Injury Watch
Despite recent published studies and articles, the FDA has yet to confirm whether SGLT-2 inhibitor diabetes drugs lead to an increased risk of strokes. Continue reading
Posted Jun 21, 2017 at Drug Safety Developments
The FDA Briefing Materials For A June 2017 Advisory Committee Meeting On Victoza Include A Discussion Of This Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) On June 20, 2017 there will be an FDA Advisory Committee meeting to discuss Novo Nordisk's supplemental New Drug Application (sNDA) for approval of Victoza® (liraglutide) injection to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and high cardiovascular risk, given as an adjunct to standard treatment of cardiovascular risk factors. In more detail, this FDA Advisory Committee will discuss the results of the so-called LEADER trial: “Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A long-term, multi-center, international, randomized double-blind, placebo-controlled trial to determine liraglutide effects on cardiovascular events.” In advance of this meeting we reviewed the FDA Briefing Document for this Endocrinologic and Metabolic Drugs Advisory Committee Meeting (EMDAC), which includes a section titled "ONCOLOGY CONSULT: PANCREATIC CANCER". Before we get into that material, here are some previous articles which provide background information: Pancreatic Cancer As A Side Effect Of Diabetes Drugs Bydureon, Byetta, Januvia, And Victoza Byetta / Januvia / Victoza: Update... Continue reading
Posted Jun 19, 2017 at Drug Injury Watch
Debra: To start, I am sorry to hear about the unfortunate loss of your husband. As regards your question, I am not aware of any such lawsuits -- but that is not to say there aren't any. I wish you the best in all aspects going forward. Tom Lamb
1 reply
If the drug you are inquiring about is metformin, then "No" I do not know any lawyers handling these cases. Tom Lamb
1 reply
A recent study revealed that type 2 diabetes drug Invokana has significant cardiovascular benefits, but double the risk of lower-limb amputations. Continue reading
Posted Jun 13, 2017 at Drug Safety Developments
AbbVie, the manufacturer of bipolar drug Depakote, was recently forced to pay $15 million to a child born with spina bifida due to Depakote exposure. Continue reading
Posted Jun 12, 2017 at Drug Safety Developments
Study Compared Newly Initiated Use Of SGLT2 Inhibitor To New Initiation Of Another Class Of Diabetes Drugs To Assess The DKA Side Effect (Posted by Tom Lamb at DrugInjuryWatch.com) All of these newer diabetes medicines are part of the Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors class of drugs: Invokana (canagliflozin) Invokamet (canagliflozin and metformin) Invokamet XR (canagliflozin and metformin extended-release) Farxiga (dapagliflozin) Xigduo XR (dapagliflozin and metformin extended-release) Qtern (dapagliflozin and saxagliptin) Jardiance (empagliflozin) Glyxambi (empagliflozin and linagliptin) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) The SGLT2 inhibitor class of diabetes drugs is approved by the FDA for treatment of type 2 diabetes (T2D). A "To the Editor" letter in the June 8, 2017 edition of The New England Journal of Medicine (NEJM), titled "Risk of Diabetic Ketoacidosis after Initiation of an SGLT2 Inhibitor", is likely causing some concerns among doctors and patients about the safety of Jardiance, Invokana, Farxiga, and the other SGLT2 inhibitors. From the start of that letter we get some introductory information about this drug-safety concern raised for these newer diabetes drugs: Inhibitors of sodium–glucose cotransporter 2 (SGLT2) decrease plasma glucose by blocking the reabsorption of glucose at the proximal tubule. Case reports have... Continue reading
Posted Jun 8, 2017 at Drug Injury Watch
The FDA recently warned that IBS drug Viberzi can cause serious pancreatitis in patients without a gallbladder, resulting in hospitalizations or death. Continue reading
Posted Jun 6, 2017 at Drug Safety Developments
Health Canada calls for warnings on the connection between diabetes drugs and severe joint pain based on existing medical literature and the FDA's warnings. Continue reading
Posted Jun 2, 2017 at Drug Safety Developments
Drug Regulatory Agency Has Requested Additional Safety Information From Some Manufacturers Of Direct-Acting Antivirals (DAAs) (Posted by Tom Lamb at DrugInjuryWatch.com) The May 2017 edition of Health Product InfoWatch included this report, "Summary Safety Review - Direct-Acting Antivirals - Assessing the Potential Risk of Liver Cancer Recurrence", which was issued on April 27, 2017 by Health Canada. From the Key Messages part of this drug safety report concerning Sovaldi, Harvoni, and other Direct-Acting Antivirals (DAAs), we get these three main points: Direct-acting antivirals (DAAs) are prescription drugs authorized for sale in Canada to treat chronic hepatitis C virus (HCV) infection in adult patients, which is a serious condition that can result in decreased liver function, serious scarring of the liver (cirrhosis) or liver cancer. Health Canada reviewed the potential risk of liver cancer coming back (recurrence) with the use of DAAs, following the publication of a study suggesting this potential risk. Health Canada’s review concluded that there was not enough information to establish a link between DAAs and liver cancer recurrence. Health Canada has requested additional safety information from some manufacturers of DAAs. In more detail, from the Safety Review Findings part of same report we get this additional information:... Continue reading
Posted Jun 1, 2017 at Drug Injury Watch
Contrary to prior studies conducted on the subject, a new study suggests that there is no link between erectile dysfunction drugs and melanoma skin cancer. Continue reading
Posted May 30, 2017 at Drug Safety Developments
Ocrevus - Progressive Multifocal Leukoencephalopathy (PML) Reported As Possible Side Effect In Germany, Says Drug Maker Roche (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2017 the FDA approved Ocrevus (ocrelizumab injection) for the treatment of adult patients with relapsing or primary progressive forms of multiple sclerosis (MS). According to this May 22, 2017 article, "Top 8 New Drugs to Watch for 2021", Ocrevus is projected to be a so-called "blockbuster drug" within the next several years: The 2017 “Drugs to Watch” report from Clarivate Analytics Cortellis Competitive Intelligence, predicts that Ocrevus (ocrelizumab, from Genentech and Roche), will be a top seller in coming years. “Twice yearly injection reduces the rate of relapse of the disease by 46% more than that of the former standard of care, Rebif,” wrote Alexandra Kibble, senior editor for Clarivate, in a blog post. As a result, Ocrevus will produce a projected $3.33 billion in sales in 2021. In addition, Ocrevus is the first drug to prove effective in primary progressive MS, an aggressive form. “The drug also delays disease progression and reduces the number of new brain lesions,” Kibble wrote However, this May 24, 2017 Reuters news report, "Deadly brain infection in German MS... Continue reading
Posted May 25, 2017 at Drug Injury Watch
Current U.S. Version Of Full Prescribing Information Document For Aranesp Mentions Skin Rash Among Other Serious Allergic Reactions (Posted by Tom Lamb at DrugInjuryWatch.com) Aranesp (darbepoetin alfa) products for subcutaneous and intravenous use are approved by the FDA for two indications: (1) anemia due to chronic kidney disease; and, (2) anemia due to chemotherapy in patients with cancer. From the Warnings and Precautions section of the current Full Prescribing Information document for ARANESP® (darbepoetin alfa) injection (accessed 5/18/17): 5.7 Serious Allergic Reactions Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp. Immediately and permanently discontinue Aranesp and administer appropriate therapy if a serious allergic or anaphylactic reaction occurs. [emphasis added] However, it seems that Health Canada wants a more clear or stronger warning about skin-related adverse reactions associated with Aranesp use. __________________________________________________________________ Aranesp Free Case Evaluation Strictly Confidential, No Obligation. __________________________________________________________________ On May 5. 2017 the Canadian drug regulatory agency issued this Dear Healthcare Professional Letter: "ARANESP - Risk of Severe Skin Reactions: Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis". From this recent Health Canada Aranesp alert we get this updated drug safety information: In some patients, ARANESP has been associated with severe skin... Continue reading
Posted May 18, 2017 at Drug Injury Watch
After conducting several studies on the effects of diabetes drugs like Invokana / Invokamet, researchers found that the risk of amputations has doubled. Continue reading
Posted May 17, 2017 at Drug Safety Developments
With the emergence of the theory that bacterial contamination of breast implants is to blame for rare cancer, questions of accountability also arise. Continue reading
Posted May 15, 2017 at Drug Safety Developments