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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
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 yesterday 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 2 days ago 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 4 days ago 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
19 Patients Have Died While Using This New Liver Disease Drug, Some When Prescribed Higher-Than-Recommended Doses (Posted by Tom Lamb at DrugInjuryWatch.com) Intercept Pharmaceuticals Inc's Ocaliva (obeticholic acid) was approved by the FDA in May 2016 for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA. While this relatively new liver disease medication has not been widely prescribed yet, there are expectations it could become a very significant drug product for Intercept. From this September 21, 2017 article, "FDA Warns Doctors After 19 Deaths on Intercept Liver Drug", by reporter Robert Langreth, we get the following sales-related information: About 15,000 prescriptions for Ocaliva have been written since it was introduced, according to data from Symphony Health Solutions compiled by Bloomberg Intelligence. The drug is Intercept’s only commercial product and was approved in the U.S. in May last year. It brought in $30.4 million in sales last quarter. Rival treatments in testing at other drugmakers could threaten Ocaliva’s market potential if they don’t have the same risks. Intercept is in the final stages of testing Ocaliva for nonalcoholic steatohepatitis, or... Continue reading
Posted Sep 26, 2017 at Drug Injury Watch
Depakote, Depakene, and Depacon may cause devastating fetal side defects if they are improperly prescribed to women who become pregnant. Continue reading
Posted Sep 22, 2017 at Drug Safety Developments
At Issue Is Whether Failure-To-Warn Claims By Plaintiffs Are Blocked By Federal Preemption Legal Doctrine, As Merck Contends (Posted by Tom Lamb at DrugInjuryWatch.com) In March 2017 the Third Circuit Court of Appeals decided to reverse a ruling by U.S. District Court Joel Pisano which had dismissed all the federal court Fosamax - femur fracture cases on federal preemption grounds. In turn, hundreds of those Fosamax lawsuits have been reinstated at the trial court level. Now, by means of an August 2017 legal filing, Merck wants the U.S. Supreme Court to reverse this appeals court decision reinstating those cases. As background, from our article about that development, "Fosamax - Femur Fracture Lawsuits In Federal Court MDL: March 2017 Appellate Court Ruling Reinstates Lawsuits": Essentially, the Third Circuit held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck to warn about an increased risk of femur fractures is a question of fact for the jury -- rather than for Judge Pisano -- to decide.... Certainly the Third Circuit's ruling on the Fosamax appeals is a positive development for the patients who suffered femur fractures after long-term Fosamax use and filed drug injury lawsuits... Continue reading
Posted Sep 18, 2017 at Drug Injury Watch
The SGLT2 inhibitors class of diabetes drugs may be the cause of lower limb amputations, but other risk factors must be ruled out. Continue reading
Posted Sep 15, 2017 at Drug Safety Developments
Nikki: I am saddened to hear about the recent loss of your husband. We would like to investigate this matter as a possible wrongful death lawsuit against the drug company,if you are interested in pursuing such a legal case. We wish you the best in all aspects going forward. Tom Lamb
1 reply
In US There Was A "Black-Box Warning" Added On Revised Drug Label Issued In July 2017 But Without Any Such Letter, It Seems (Posted by Tom Lamb at DrugInjuryWatch.com) The "FDA Drug Safety Communication: FDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)" document which was issued in May 2017 previewed a drug label change with increased warnings about the risk of these lower limb amputations. In an article published here earlier, "Invokana - Amputation Side Effect Gets 'Black-Box Warning' On Revised Drug Label Issued In July 2017", we reported on that revised label for Invokana (canagliflozin) and Invokamet (canagliflozin and metformin). Up in Canada, it was back in October 2016 that the Product Monographs for Invokana and Invokamet were updated to include a warning about the risk of toes, foot, and leg amputations. This action was based on interim results of the Canagliflozin Cardiovascular Assessment Study (CANVAS) study. Now, in September 2017 it seems that Health Canada is moving more aggressively than the FDA by requiring Janssen, the drug company responsible for Invokana and Invokamet, to send a Dear Healthcare Professional Letter -- commonly referred to as a "Dear Doctor"... Continue reading
Posted Sep 7, 2017 at Drug Injury Watch
While a recent study suggests that use of heartburn drugs has a weak association with chronic kidney disease, other studies provide evidence to the contrary Continue reading
Posted Sep 7, 2017 at Drug Safety Developments
At Same Time, The American Society For Aesthetic Plastic Surgery Seems To Downplay The Significance Of This Apparent Safety Issue (Posted by Tom Lamb at DrugInjuryWatch.com) Breast implant associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare non-Hodgkin lymphoma of T-cell origin that usually is found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself. According to the FDA, in most cases the ALCL cells were found in the effusion fluid (seroma) surrounding the implant or contained within the fibrous scar capsule. Earlier this year we wrote a couple of articles here about this still-emerging medical issue: The Rare Lymphoma (Blood Cancer) Linked To Breast Implants Which Has Caused Nine Patient Deaths (March 2017) The Association Between Breast Implants And Anaplastic Large Cell Lymphoma (ALCL) Is Better Understood In Recent Years (April 2017) In the August 2017 edition of the European Journal of Surgical Oncology (EJSO) we found this article on the issue, "Breast implant associated anaplastic large cell lymphoma: The UK experience. Recommendations on its management and implications for informed consent". From the Abstract for this August 2017 EJSO article we get this new information about the situation as it has developed... Continue reading
Posted Sep 1, 2017 at Drug Injury Watch
While there have been conflicting results in studies concerning the link between Hepatitis C drugs & liver cancer, the studies do share some findings. Continue reading
Posted Sep 1, 2017 at Drug Safety Developments
There Is An Approximate Two Times Increased Risk Of NAION According To Recent Medical Study, Which Is Consistent With Some Earlier Medical Research (Posted by Tom Lamb at DrugInjuryWatch.com) As reported previously, the erectile dysfunction (ED) drugs Cialis (tadalafil), Levitra (vardenafil hydrochloride), and Viagra (sildenafil citrate) have been associated with a type of sudden vision loss called Nonarteritic Anterior Ischemic Optic Neuropathy (NAION). In July 2005 the FDA ordered warnings be put on the package insert labels of these ED drugs, or impotence drugs, to the effect that some users of Cialis, Levitra, and Viagra have developed NAION, a form of blindness. At the same time, however, the FDA stated that it is impossible at present to know if NAION is a side effect of these ED drugs, or an unrelated medical condition. In June 2006 Health Canada issued a Public Communication alerting Canadians that the drug companies Eli Lilly (Cialis), Bayer (Levitra), and Pfizer (Viagra) were in the process of sending a so-called "Dear Doctor" letter to inform healthcare providers in Canada about changes to the respective package insert, or label, for these drugs regarding this vision loss, or NAION, side effect. Now, 11 years later, in August 2017,... Continue reading
Posted Aug 24, 2017 at Drug Injury Watch
Patient Advisory: The prescription drugs discussed on this site are approved for use by the the Food and Drug Administration (FDA). Patients should not stop taking any prescription drug without seeking the advice of their medical doctor. Tom Lamb
1 reply
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 Aug 16, 2017 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 Aug 10, 2017 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