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Tom Lamb
Wilmington, NC, USA
Tom Lamb is an attorney, or lawyer, who represents patients and their families in drug injury lawsuits.
Interests: law, news, information, drugs, legal, medical, fda, pharmaceutical, medications, side-effects, drug-injury, drug-safety, regulatory
Recent Activity
Health Canada Orders Label Change For Testosterone Drugs In July 2014: Must Warn About Increased Risks Of Side Effects Including Blood Clots, DVTs, PEs (Posted by Tom Lamb at The safety issues concerning the popular testosterone replacement therapy (TRT) products AndroGel, Axiron, and Testim continue to be be debated with mixed decisions in different arenas. We will start with the FDA, which on July 17, 2014 issued this "September 17, 2014 Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement": Agenda: The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. We note that the Bone, Reproductive and Urologic Drugs Advisory Committee was formerly known as the Reproductive Health Drugs Advisory Committee. Next, on July 15, 2014 Health Canada issued this "Information Update - Possible cardiovascular problems associated with testosterone products": Health Canada is advising patients and healthcare professionals of new safety information regarding testosterone hormone replacement products and a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems.... Health Canada has recently completed a safety review on testosterone replacement... Continue reading
Posted Jul 18, 2014 at Drug Injury Watch
Quoted from FDA committee to discuss adverse effects of testosterone products Thu Jul 17, 2014 (Reuters) - The U.S. Food and Drug Administration has called an advisory committee meeting on Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of testosterone replacement therapy. The FDA has called for a joint meeting of the bone, reproductive and urologic drugs advisory committee and the drug safety and risk management advisory committee. ( [Article continues at original source] Continue reading
Quoted from Heart Warnings for Low T Drugs? Health Canada Says ‘Yes,’ but FDA Isn’t Sure July 17, 2014 By Ed Silverman File this under ‘a study in contrasts.’ Within 24 hours, two regulatory agencies took notably different positions on the virtues of low testosterone medications. Although widely touted for boosting male sex drive, moods and energy, they have also been controversial because some studies found the medicines may pose cardiovascular risks. Yesterday, Health Canada asked drug makers to update product labeling after a review “found a growing body of evidence from published literature and case reports… for serious... Continue reading
This Severe Diarrhea Side Effect Is Caused By Olmesartan, Which Is Also Found In Azor, Tribenzor, And Benicar HCT Blood Pressure Medications (Posted by Tom Lamb at Back in May 2014 we made reference to this medical article, "A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease", published online by the Journal of Pharmacy Practice, in our post entitled Benicar (Olmesartan) Associated With Sprue-Like Enteropathy, Which Is A Chronic / Severe Diarrhea Condition That Can Be Misdiagnosed As Celiac Disease. More recently, in June 2014, on the Family Practice News Digital Network, we found this news report, "Olmesartan can cause celiac disease mimicker". The antihypertensive agent olmesartan is associated with increased risk of a severe sprue-like enteropathy, as highlighted in a nationwide French cohort study. This olmesartan-related illness is characterized by villous atrophy, severe chronic diarrhea, and weight loss, with negative serology for celiac disease. The hospitalization rate for this disorder is time dependent. The risk doesn’t increase significantly until after the first year on therapy but climbs steeply thereafter, Dr. Myriam Mezzarobba reported at the annual Digestive Disease Week. Importantly, angiotensin receptor blockers other than olmesartan (Benicar) were not associated with an increased risk... Continue reading
Posted Jul 14, 2014 at Drug Injury Watch
All Testosterone Therapy Drugs Need To Warn About Blood Clots Side Effects Like DVT And PE; Older Depo-Testosterone Product May Be Safer Than New Gels Such As AndroGel And Testim (Posted by Tom Lamb at In the first part of this summer there has been a flurry of drug-safety activity as regards the popular testosterone replacement therapy (TRT) products like Axiron, AndroGel, Testim, and Depo-Testosterone. We will start with two recent FDA developments: 1. Testosterone: Drug Information Update- FDA adding general warning to testosterone products about potential for venous blood clots [Issued 6/19/14] The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE).... Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products. 2. Potential... Continue reading
Posted Jul 7, 2014 at Drug Injury Watch
Benicar, Azor, Tribenzor, Benicar HCT, And Other Blood Pressure Medicines Containing Olmesartan: Cardiovascular Mortality In Not A Side Effect Risk, Or Is It (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE: "FDA Once Again Reaches Conclusions At Odds With Its Own Staff" (Forbes, Larry Husten, 7/14/14) Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the FDA scientists who performed the study that provided the basis for the review. And now outside experts are also raising concerns about the drug.... (7/15/14) ______________________________________________________________________________ UPDATE: Recent Benicar label change according to the June 13, 2014 FDA Letter: Under ADVERSE REACTIONS/Post-Marketing Experience, the following test [sic] was added: Data from one controlled trial and an epidemiologic study have suggested that high-dose olmesartan may increase cardiovascular (CV) risk in diabetic patients, but the overall data are not conclusive.... Overall, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. There are, however, concerns with the... Continue reading
Posted Jun 30, 2014 at Drug Injury Watch
Quoted from FDA asks for wider warning on testosterone products June 20 Fri Jun 20, 2014 June 20 (Reuters) - The U.S. Food and Drug Administration said all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins. The regulator cited post-market reports of such clots for the warning. The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia. ( Continue reading
Recent Canadian Study Published In BMJ Medical Journal Suggests The Increased Risk Of Diabetes Seems To Be Highest In The First Four Months Of Statin Use (Posted by Tom Lamb at According to the Parke-Davis, Division of Pfizer, Prescribing Information for Lipitor (accessed 6/18/14): [LIPITOR pills are:] White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg atorvastatin calcium. The recommended starting dose of LIPITOR is 10 or 20 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once daily. In our January 2014 article, "Pfizer's Lipitor Statin Drug For Treatment Of High Cholesterol Linked To An Increased Risk Of Type-2 Diabetes In Some Older And Post-Menopausal Women", we listed some of the medical journal articles reviewed by the FDA prior to issuing its February 2012 Lipitor - diabetes warning. More recently, in May 2014, BMJ (formerly known as the British Medical Journal) published this article, "Higher potency statins and the risk of new diabetes: multicentre, observational study of administrative databases", which further implicates higher doses of Lipitor as a possible cause of new-onset Type-2 diabetes in some adult women. From the Abstract for this May 2014 BMJ aritcle: Results In the first two... Continue reading
Posted Jun 18, 2014 at Drug Injury Watch
Quoted from Bayer faces law suits in United States over Xarelto -paper FRANKFURT, June 14 Sat Jun 14, 2014 FRANKFURT, June 14 (Reuters) - Germany's Bayer AG faces its first law suits in the United States over anti-clotting drug Xarelto, one of its top five medicines, the Frankfurter Allgemeine Zeitung newspaper reported on Saturday, citing company sources. There are fewer than ten suits so far, the paper cited one company insider as saying. It gave no details of the suits. A Bayer spokesman declined to comment on the newspaper's report but said the drug's safety profile since its launch... Continue reading
Bayer Reports That As Of April 8, 2014 Settlement Negotiations Have Resolved "approximately 8,560 claimants in the U.S. for a total amount of about US$1.74 billion" (Posted by Tom Lamb at Soon before the first federal court MDL trial was scheduled to start back in January 2012 Bayer decided to begin to attempt to negotiate settlements for YAZ / Yasmin / Ocella / Gianvi blood clot lawsuits, e.g., deep vein thrombosis (DVT) or pulmonary embolism (PE), on a case-by-case basis. And while Bayer has settled a significant number of these cases over the past two years, there are still thousands of more drospirenone (DRSP) birth control DVT and PE lawsuits that have not been negotiated to a final settlement agreement, yet. As of early April 2014 there were reportedly about 2000 unresolved YAZ / Yasmin / Ocella / Gianvi claims -- and that number apparently does not include the filed and unfiled Beyaz and Safyral blood clot cases, as there is not any mention of those cases by Bayer in recent their recent DRSP drug injury litigation updates. ______________________________________________________________________________ YAZ/Yasmin/Ocella/Gianvi/Beyaz/Safyral Free Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ From the Stockholders’ Newsletter First Quarter 2014 (PDF document) issued by... Continue reading
Posted Jun 11, 2014 at Drug Injury Watch
Merck Corporate SEC Filing for First Quarter 2014 Provides Information About Numbers Of Lawsuits In Various Court Jurisdictions Being Worked Up For Some Possible Trials In The Future (Posted by Tom Lamb at We have our first 2014 update from Merck on the Fosamax - femur fracture litigation. From the Merck SEC Form 10-Q for the quarterly period ended March 31, 2014 (at page 19 of PDF document): [In the Fosamax Femur Fracture MDL] Judge Pisano set a May 5, 2014, trial date for the bellwether trial of a case in which the alleged injury took place after January 31, 2011. Following the completion of fact discovery, the court selected Sweet v. Merck as the next Fosamax Femur Fracture MDL case to be tried on May 5, 2014, but plaintiffs subsequently dismissed that case. As a result, the May 2014 trial date was withdrawn. As of March 31, 2014, approximately 2,785 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Higbee in Atlantic County Superior Court. As of March 31, 2014, approximately 525 cases alleging Femur Fractures have been filed in California state court. A petition was filed seeking to coordinate... Continue reading
Posted Jun 6, 2014 at Drug Injury Watch
Quoted from $100 million NuvaRing settlement finalized By Associated Press, June 5, 2014 ST. LOUIS — A $100 million settlement involving NuvaRing, a birth-control device linked to sometimes-fatal side effects, will stand now that the vast majority of claimants have chosen to opt into the agreement, those involved in the lawsuits said Thursday. U.S. District Judge Rodney W. Sippel of St. Louis approved the settlement in February, but NuvaRing maker Merck & Co. had the right to abandon the deal if less than 95 percent of eligible claimants opted in. The lead attorney for the claimants, St. Louis lawyer... Continue reading
Adverse Events Monitoring Data And Medical Studies Have Identified Possible Increased Risk For Cardiovascular Problems Including Arrhythmias (Posted by Tom Lamb at In early May 2014 the European Medicines Agency's (EMA's) Pharmacovigilance Risk Assessment Committee (PRAC) announced it was reviewing the safety of hydroxyzine-containing medicines because of cardiac concerns. Hydroxyzine is a medicine used generally by mouth or sometimes by injection for: relief of anxiety disorders; premedication before surgical procedures; relief of urticaria or various other conditions associated with pruritus (itching); and, treatment of sleep disorders. In the US, hydroxyzine-containing drugs include Atarax (Roerig, a division of Pfizer) and Vistaril (Pfizer Labs and Roerig, each a division of Pfizer). From this May 8, 2014 EMA Announcement, "Review of hydroxyzine-containing medicines started": The review was requested by the Hungarian medicines agency (GYEMSZI-OGYI) over concerns about the side effects of these medicines on the heart. This followed an examination of the benefits and risks by a marketing authorisation holder for hydroxyzine. Data from drug safety monitoring (pharmacovigilance) and published experimental studies identified a potentially increased risk of alterations of the electrical activity of the heart and arrhythmias (irregular heartbeats).... The European Medicines Agency will now review the available data on the... Continue reading
Posted Jun 5, 2014 at Drug Injury Watch
PTC/IIH Symptoms Include Migraines With Blurred Or Double Vision, Temporary Blindness, Other Visual Problems, And Wooshing Or Ringing In The Ear (Posted by Tom Lamb at Mirena is an intrauterine system (IUS) from Bayer Healthcare Pharmaceuticals, Inc. that releases 20 μg/day of levonorgestrel. Basically, the Mirena releases levonorgestrel, a synthetic progestogen, directly into the uterus for birth control. The FDA approved Mirena in December 2000 and it is used by more than 2 million women in the US. The Prescribing Information for Mirena (accessed 5/30/14) does not warn about neurological conditions such as pseudotumor cerebri (PTC), also known as idiopathic intracranial hypertension (IIH) or benign intracranial hypertension. In fact, the Mirena Prescribing Information (also known as the package insert or label) makes no mention of PTC/IIH, despite a known link between levonorgestrel and PTC/IIH. Pseudotumor cerebri or idiopathic intracranial hypertension (PTC/IIH) is a non-stroke neurological condition that develops in the skull when a person’s cerebrospinal fluid becomes elevated, causing increased pressure. PTC/IIH symptoms include: severe migraines or migraine-like headaches with blurred vision diplopia (double vision), temporary blindness, blind spots, or other visual deficiencies papilledema, or optic disc swelling, due to increased intracranial pressure a “whooshing” or ringing in the... Continue reading
Posted May 30, 2014 at Drug Injury Watch
Quoted from Boehringer Pays $650 Million to End Blood Thinner Cases By Jef Feeley - May 28, 2014 Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths. Boehringer, slated to face the first trial in September of claims there was no antidote to stop bleed-out deaths among Pradaxa patients, is seeking to settle about 4,000 suits, company officials said in a statement today. That would provide an average per-case payout of $162,500. The settlement... Continue reading
More Than 2000 Pradaxa Lawsuits Have Been Filed Against Boehringer, And A Company Official Has Admitted That More Than 1400 Patients Bled To Death (Posted by Tom Lamb at ______________________________________________________________________________ UPDATE: Boehringer Pays $650 Million to End Blood Thinner Cases (5/28/14, Bloomberg) Boehringer Ingelheim GmbH, the German family-owned drugmaker, agreed to pay $650 million to settle the majority of lawsuits filed over its blood-thinning drug Pradaxa, which has been linked to more than 500 patient deaths.... (5/28/14) ______________________________________________________________________________ Earlier this month the drug company Boehringer Ingelheim said a new analysis of a company-funded study of 18,000-patients, known as RE-LY -- which the company used to win FDA approval of its controversial blood thinner Pradaxa -- turned up 22 "new" serious bleeding events that were not included in the original study report. According to a May 14, 2014 news article, "Boehringer Says New Bleeding Cases Found in Pradaxa Study": Any correction to the original study, which was published in the New England Journal of Medicine in September 2009, would have to come from the researchers, Smith said. If a correction is made, it would be the second to the trial. The researchers issued a correction in November 2010, saying they... Continue reading
Posted May 21, 2014 at Drug Injury Watch
Quoted from Lawyers ask for $60 million for Clark County women who took diabetes drug (Jeff Scheid/Las Vegas Review-Journal) By DAVID FERRARA LAS VEGAS REVIEW-JOURNAL A pair of Clark County women deserve at least $60 million after developing bladder cancer from taking the diabetes drug Actos, one of their attorneys told a jury Monday. The lawyers for Delores Cipriano, 81, and Bertha Triana, 80, have said they plan to seek billions of dollars more in punitive damages from the Japan-based drug maker Takeda as the case wraps up this week. After a three-month trial that started in Las Vegas... Continue reading
Quoted from Medtronic's Infuse Moves From Operating Room to Courtroom Published: May 18, 2014 By John Fauber, Reporter, Milwaukee Journal Sentinel/MedPage Today Three years after back surgery, Grace Nestler-Bramm learned that a drug designed to repair her spine was causing new bone growth, growth that was wrapping around the spine and compressing nerves. By then it was too late. The bony overgrowth associated with Infuse already had done irreparable damage. She is now disabled by pain, and has difficulty walking -- often needing a cane or wheel chair when she leaves her home. Doctors have told her that additional... Continue reading
Bloomberg News By Michelle Fay Cortez - May 14, 2014 Boehringer Ingelheim GmbH said a new analysis of a company-funded study used to win approval of the blood thinner Pradaxa found 22 serious bleeding events that weren’t included in the original report. Additional events were found in patients in each of the three arms of the 18,000-patient study known as RE-LY. Five more complications were seen among those taking a 110-milligram dose of the drug, 11 among those on a 150-mg dose and six in the patients using warfarin. Pradaxa became the first alternative to warfarin, the standard of care... Continue reading
This Diarrhea With Weight Loss Is Also A Side Effect Of Benicar HCT, Azor, And Tribenzor -- Other Blood Pressure Medicines Containing Olmesartan (Posted by Tom Lamb at An association between the serious side effect sprue-like enteropathy and the oral angiotensin-receptor blockers (ARBs) Benicar, Benicar HCT, Azor, and Tribenzor and has been getting increased attention in the medical literature. As pointed out by the FDA in July 2013 when it issued this MedWatch alert, "FDA Drug Safety Communication: FDA approves label changes to include intestinal problems (sprue-like enteropathy) linked to blood pressure medicine olmesartan medoxomil", severe and chronic diarrhea with substantial weight loss has been reported in patients taking Benicar and the other related drugs months to years after they first started using these blood pressure pills. _____________________________________________________________________ Free Benicar Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ The most recent medical article we have seen on this still emerging drug safety issue was published online by the Journal of Pharmacy Practice in late March 2014. From the Abstract for "A Review of Current Evidence of Olmesartan Medoxomil Mimicking Symptoms of Celiac Disease" we get this information: Objective: To review the evidence of an association between [Benicar, Benicar HCT, Azor,... Continue reading
Posted May 14, 2014 at Drug Injury Watch
Viagra Is Associated With A Higher Incidence Of Invasive Melanoma; This Side Effect May Apply Also To Cialis and Levitra, Two Other Popular ED Drugs (Posted by Tom Lamb at Viagra (sildenafil), the most common drug prescribed for male erectile dysfunction (ED), appears to increase the risk for invasive melanoma but not cutaneous squamous cell carcinomas nor basal cell carcinomas. Essentially, Viagra acts by inhibiting phosphodiesterase 5 (PDE5). Experimental in vitro studies show that PDE5 inhibition augments tumor cell invasiveness, supporting this new Viagra side effect finding. From the Abstract for the underlying medical journal article, "Sildenafil Use and Increased Risk of Incident Melanoma in US Men: A Prospective Cohort Study", published by JAMA Internal Medicine in April 2014 (as an Online First item): Importance The RAS/RAF/mitogen-activated protein kinase and extracellular signal–regulated kinase (ERK) kinase/ERK cascade plays a crucial role in melanoma cell proliferation and survival. Sildenafil citrate (Viagra) is a phosphodiesterase (PDE) 5A inhibitor commonly used for erectile dysfunction. Recent studies have shown that BRAF activation down-regulates PDE5A levels, and low PDE5A expression by BRAF activation or sildenafil use increases the invasiveness of melanoma cells, which raises the possible adverse effect of sildenafil use on melanoma risk. Objective... Continue reading
Posted May 8, 2014 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 your brother the best in all aspects going forward. Tom Lamb
1 reply
This Uncertainty About Drug Safety Of AndroGel, Axiron, Testim, And The Like Is Causing Concern Among Doctors (Posted by Tom Lamb at For patients and doctors who have questions about whether cardiovascular side effects associated with testosterone products are real or not, they may be looking forward to the results from the Testosterone Trial in Older Men clinical study (known as the T Trial) that was sponsored by the US National Institutes of Health. Unfortunately, however, the lead investigator on that study, Dr. Peter J. Snyder, of the University of Pennsylvania, has already warned that this T Trial, designed to enroll fewer than 800 men, will only be large enough to detect the benefits of testosterone drugs, but not any of the risks. From this April 4, 2014 Philadelphia Inquirer article, "As testosterone use grows, questions on risks await answers": In another echo of the female hormone saga, the federal government has stepped in to do the kind of costly, rigorous, placebo-controlled clinical trial that drug companies have no incentive to do. The $50 million Testosterone Trial is now wrapping up and will present results next year, said the leader, University of Pennsylvania endocrinologist Peter J. Snyder. But size... Continue reading
Posted May 1, 2014 at Drug Injury Watch
This Cardiovascular Side Effect Issue Also Involves Kombiglyze XR, A Saxagliptin - Metformin Combo Diabetes Medication (Posted by Tom Lamb at AstraZeneca's diabetes drugs Onglyza and Kombiglyze, both of which contain the active ingredient saxagliptin, are under scrutiny by the FDA for an apparent association with heart failure hospitalizations which was pointed out by a New England Journal of Medicine (NEJM) study. From the February 2014 "FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)" Safety Announcement: The U.S. Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. Our request resulted from a study, ["Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus", published in the October 3, 2013 NEJM edition], which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. _____________________________________________________________________ Onglyza and Kombiglyze XR Free Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ For some commentary and contextual information... Continue reading
Posted Apr 24, 2014 at Drug Injury Watch
Quoted from Families suing drug maker of blood thinner over bleeding risks Avis Favaro and Elizabeth St. Philip, CTV News Published Monday, April 21, 2014 10:00PM EDT Susan Garau, 61, was down with the flu last year when she was found incoherent and bleeding from her mouth while in bed. By the time Garau arrived at Seven Oaks General Hospital in Winnipeg, the grandmother was hemorrhaging from several parts of her body including her mouth, intestines and brain. "They were draining blood from the stomach, she was bleeding from her mouth … and by that evening she slipped into... Continue reading