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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
Quoted from FDA says asthma drug Xolair raises risk of heart, brain problems September 26, 2014 5:14 PM WASHINGTON, Sept 26 (Reuters) - The asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain and blood clots in the lungs and veins, among other problems, though the extent of increased risk is unclear, the U.S. Food and Drug Administration said on Friday. The FDA said it has added information about the increased risk to the drug's label after analyzing findings from a five-year safety study submitted by the drug's manufacturer, Genentech, a unit of... Continue reading
August 2014 Label Change By AbbVie Inc. (formerly Abbott) For These Valproate Migraine, Epilepsy/Seizure, And Bipolar Medications Was Done Rather Quietly (Posted by Tom Lamb at Without much notice, e.g., no FDA Drug Safety Communication was issued, in August 2014 the Prescribing Information, or drug labels, for Depakote, Depakote CP, and Depakote ER (divalproex sodium), Depacon (valproate sodium), and Depakene (valproic acid) were updated by the drug company AbbVie Inc. (formerly Abbott) to add a warning about the potential risk for autism spectrum disorders (ASD). In the label approved by the FDA on August 20, 2014 for Depakote (accessed 9/25/14), this new warning about autism spectrum disorders can be found at Section 8.1 Pregnancy: An observational study has suggested that exposure to valproate products during pregnancy may increase the risk of autism spectrum disorders. In this study, children born to mothers who had used valproate products during pregnancy had 2.9 times the risk (95% confidence interval [CI]: 1.7-4.9) of developing autism spectrum disorders compared to children born to mothers not exposed to valproate products during pregnancy. The absolute risks for autism spectrum disorders were 4.4% (95% CI: 2.6%-7.5%) in valproate-exposed children and 1.5% (95% CI: 1.5%-1.6%) in children not... Continue reading
Posted 6 days ago at Drug Injury Watch
Key Advisory Panel Member Concedes It Is Medically Plausible That Testosterone Replacement Therapy Can Be Associated With Heart Attacks / Strokes Side Effects (Posted by Tom Lamb at On September 17, 2014 members of the FDA's Bone, Reproductive and Urologic Drugs and Drug Safety and Risk Management advisory panels considered the issue of whether the popular testosterone products Axiron, AndroGel, and Testim, as well as other so-called "Low-T" drugs, are safe. Not surprising -- but certainly unsettling -- was the outcome of their discussions, which was essentially that for most current users of testosterone replacement therapy (TRT) medications we do not know and cannot know, because no safety study has been done, yet. From a September 18, 2014 Healio EndocrineToday report, "FDA committees near-unanimous on need to investigate testosterone therapies": A key presentation by Shalender Bhasin, MD, of Harvard Medical School, with advisory board seats for two of the sponsors, broached the biggest topic of concern in the room during a presentation on cardiovascular events and testosterone therapies. “Testosterone’s effects in preclinical and clinical models are diverse,” Bhasin said. “Some effects are beneficial, and some may be potentially deleterious.” Bhasin conceded biologic plausibility for the association of testosterone with... Continue reading
Posted Sep 19, 2014 at Drug Injury Watch
Quoted from FDA panel backs limiting use of testosterone replacement drugs Wed Sep 17, 2014 By Toni Clarke Sept 17 (Reuters) - Testosterone replacement therapies should be reserved for men with specific medical conditions that impair function of the testicles, an advisory panel to the U.S. Food and Drug Administration concluded on Wednesday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. The panel also recommended that companies be required to conduct additional studies to assess the cardiovascular risk of their products for patients with age-related low testosterone. Prescriptions for "Low... Continue reading
Quoted from Possible Heart Risk With Testosterone Spurs Debate on Use By Caroline Chen Sep 16, 2014 Testosterone supplements used last year by about 2.3 million men are spurring debates over how necessary and safe they may be, even as U.S. regulators consider approving a new product. Food and Drug Administration advisers tomorrow will consider whether the drugs are being prescribed to the right people. They also will weigh whether the labels should change to reflect heart risks suggested by some studies, according to FDA briefing documents. [Article continues at original source] Related articles Testosterone Products Like AndroGel /... Continue reading
Perhaps The Slow-Going Over Past Year Will Be Changed By Upcoming Mediations With Two Special Masters Appointed Recently By Judge Herndon (Posted by Tom Lamb at In their Stockholders' Newsletter Financial Report as of June 30, 2014, Second Quarter of 2014 (PDF) Bayer informs at page 54 that as of July 2, 2014: Settlements with about 8,900 claimants for total of $1.8 billion; The number of pending claims with deep vein thrombosis (DVT) and/or pulmonary embolism (PE) -- the "venous clot injuries" -- is approximately 2400; and, There are an estimated 2,600 claims with other alleged drospirenone (DRSP) related injuries, such as arterial clots. Significant or not, in their latest quarterly report Bayer continues to only allude to YAZ, Yasmin, Ocella, and Gianvi cases -- while still making no mention of there being any Beyaz and Safyral cases filed (which there are, in fact). ______________________________________________________________________________ Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi Free Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ So where do things stand in comparison to our last article about the Bayer DRSP birth control pills litigation? From just looking below at the title and sub-title of this June 2014 item we can see that more new blood clot cases have been filed... Continue reading
Posted Sep 12, 2014 at Drug Injury Watch
Hemorrhages And Gastrointestinal (GI) Bleeds Are Eliquis And Xarelto Side Effects That Can Cause Deaths (Posted by Tom Lamb at Eliquis and Xarelto are new anticoagulants, i.e., blood thinners, that -- unlike Coumadin (warfarin) -- do not require regular INR monitoring and dose adjustments. Eliquis (apixaban) and Xarelto (rivaroxaban) are "factor Xa" drugs and they work differently from warfarin. These new blood thinners reduce thrombin production by inhibiting an enzyme called factor Xa instead of inhibiting vitamin K's clotting ability. A real danger or problem that Eliquis and Xarelto share with another new blood thinner drug, Pradaxa (dabigatran), however, is the absence of an approved drug that can reverse their effects. That is, at the present time there is no antidote to stop serious bleeding events. From a July 23, 2014 MedPage Today article, "Monitoring, Dose Adjustment for Pradaxa?", we get this important discussion about the safety issues surrounding Eliquis and Xarelto: While there's no extensive data published to prove it, variability in blood concentrations is likely for the other newer oral anticoagulants -- such as apixaban (Eliquis), rivaroxaban (Xarelto), and edoxaban (Savaysa) -- too, according to a letter from Boehringer employee Paul Reilly, PhD, and RE-LY study authors... Continue reading
Posted Sep 5, 2014 at Drug Injury Watch
Quoted from FDA: Little evidence to support testosterone drugs September 3, 2014 By MATTHEW PERRONE, AP Health Writer WASHINGTON — The Food and Drug Administration says there is little evidence that testosterone-boosting drugs taken by millions of American men are beneficial, though the agency is also unconvinced by studies suggesting the hormone carries serious risks. The agency posted its review online Wednesday ahead of a public meeting to discuss the benefits and risks of treatments that raise levels of the male hormone. Regulators agreed to convene the September 17 meeting after two federally funded studies found links between testosterone... Continue reading
State Superior Court Judge Nelson Johnson Now Presiding Over About 2880 Cases, According to Merck SEC Report Filed In August 2014 (Posted by Tom Lamb at There is some news but not much to report about the New Jersey Multicounty Litigation where the Fosamax femur fracture lawsuits are centralized. Judge Carol Higbee, who was moved to a New Jersey appellate court position in the spring of 2014, has been replaced by the Honorable Nelson C. Johnson, of the New Jersey Superior Court in Atlantic County. According to the New Jersey Courts web site page for this Fosamax lawsuits consolidation, there were 3071 Fosamax cases filed as of August 23, 2014 (accessed 8/29/14). From that document alone one cannot determine how many of those lawsuits may be for cases alleging oseteonecrosis of the jaw (ONJ) as the Fosamax drug injury as opposed to atypical femur fracture events. However, we get an idea of the current number of Fosamax - femur fracture lawsuits filed in the New Jersey Multicounty Litigation from the Merck SEC Form 10-Q for the quarterly period ended June 30, 2014 (filed on or about 8/7/14) at pages 19-20 of this PDF document, in particular: "As of June... Continue reading
Posted Aug 29, 2014 at Drug Injury Watch
Quoted from Takeda, Lilly lose bid to overturn $9 bln award for hiding cancer risk Fri Aug 29, 2014 1:10am EDT Aug 28 (Reuters) - Takeda Pharmaceutical Co Ltd and Eli Lilly & Co lost a bid to overturn a combined $9 billion punitive damage award by a U.S. jury for hiding cancer risks associated with their Actos diabetes drug, according to a court ruling. "Plaintiffs have pointed to sufficient evidence from which the jury could have concluded that the 'information' about bladder cancer contained in Actos labels did not adequately warn of the increased risk of cancer," U.S.... Continue reading
Neurology Medical Journal Article Reports Two-Times Increased Risk For This Nerve Damage Side Effect For New Users Of These Antibiotics (Posted by Tom Lamb at The popular antibiotics Levaquin (levofloxacin), Cipro (ciprofloxacin), Avelox (moxifloxacin) are in a class of drugs called "fluoroquinolones". These antibiotics are commonly used for a verity of community and hospital acquired infections. In recent years case reports have linked Levaquin, Cipro, and Avelox with peripheral neuropathy, or serious nerve damage. As a result of the large number of cases of peripheral neuropathy in patients using Avelox, Cipro, and Levaquin being reported to the FDA, it issued this warning in August 2013: "FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection". Further, the FDA ordered the the manufacturers of these fluoroquinolone antibiotics -- Avelox: Bayer / Schering Plough / Merck; Cipro: Bayer; Levaquin: Janssen -- to increase their warnings about this adverse drug event on their respective product's labels. For example, this language was added to the Levaquin drug label (accessed 8/22/2014) in September 2013: 5.8 Peripheral Neuropathy Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or... Continue reading
Posted Aug 22, 2014 at Drug Injury Watch
FDA Drug Alert Warns That Linzess Should Not Be Used In Children Under Age 6 And Neither Safety Nor Efficacy Established For Those Under 18 Years Old (Posted by Tom Lamb at Linzess (linaclotide) was approved by the FDA in 2012 for irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation. It is from Forest Pharmaceuticals, Inc., who has advertisements for this relatively new drug on television and in magazines. As announced by the FDA by means of an August 15, 2014 MedWatch Safety Information email alert, in July 2014 there were several major label changes made to the following sections of the Linzess Prescribing Information (accessed 8/18/14): -- Boxed Warning; -- Contraindications (4); -- Warnings and Precautions, Pediatric Risk (5.1); and, -- Warnings and Precautions, Diarrhea. The new Linzess "Black-Box" Warning states: WARNING: PEDIATRIC RISK LINZESS is contraindicated … in nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. …The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age _____________________________________________________________________ Free Linzess Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ And here is another one of the... Continue reading
Posted Aug 18, 2014 at Drug Injury Watch
While Prolia Is An Alternative To Bisphosphonates Such As Fosamax, It Has Similar Increased Risk Of Low-Stress Femur Fractures Side Effect (Posted by Tom Lamb at The association between stress fractures of the femur, or atypical femoral fractures, and the use of bisphosphonate osteoporosis drugs such as Fosamax (alendronate) is relatively strong. It has been hypothesized that bisphosphonates cause an oversuppression of bone remodeling which contributes to atypical fracture of the femur. Prolia (denosumab) is an alternative approach to the treatment of osteoporosis that was approved by the FDA in 2010. Like bisphosphonates, Prolia is an antiresorptive drug. As such, it is not surprising that we are starting to hear about cases of stress fractures or low-stress fractures of the femur in patients using Prolia. And given the short time it has been on the market, we fully expect the number of femur fracture cases associated with Prolia to increase. Here are three recent case reports from themedical journals Bone and Acta Orthopaedica regarding Prolia and femur fractures: Bilateral atypical femoral fractures in a patient prescribed denosumab - a case report. Bone. 2014 Apr; 61:44-7. Epub 2013 Dec 31. "... A 59 year old woman sustained an atypical fracture... Continue reading
Posted Aug 12, 2014 at Drug Injury Watch
Quoted from Pfizer confronts surge of lawsuits over Lipitor By Jessica Dye Fri Aug 8, 2014 1:22am EDT (Reuters) - Pharmaceutical giant Pfizer is facing a mounting wave of lawsuits by women who allege that the company knew about possible serious side effects of its blockbuster anti-cholesterol drug Lipitor but never properly warned the public. In the past five months, a Reuters review of federal court filings shows, lawsuits by U.S. women who say that taking Lipitor gave them type-2 diabetes have shot up from 56 to almost 1,000. Lawsuits began to be filed not long after the Food... Continue reading
Benefit / Risk Assessment Of Statins Like Lipitor May Depend On Whether It Is A Medically Necessary Drug Therapy For The Particular Patient (Posted by Tom Lamb at There is an ongoing debate in the medical community about whether cholesterol drugs like the very popular Lipitor from Pfizer is over-prescribed in part due to aggressive marketing by the drug company. Certainly, there is a population of patients for which a statin drug like Lipitor is medically necessary to maintaining their health. On the other hand, however, some people would probably be better off addressing their cholesterol problem with a healthier diet and more exercise rather than by just taking a pill as the "fix" for the rest of their life. This is especially true when regularly taking a statin drug such as Lipitor forever going forward can cause the person to develop type 2 diabetes or diabetes mellitus. In fact a recent medical journal article reported on a medical study that had as its objective to investigate the relationship between the regular use of statins such as Lipitor and the risk of developing diabetes. From this article, "Statins and the Risk of Diabetes: Evidence From a Large Population-Based Cohort... Continue reading
Posted Aug 1, 2014 at Drug Injury Watch
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] Related articles AndroGel / Axiron / Testim: Heart Attacks, Strokes, And Other Cardiovascular Problems Will Be Subject Of FDA Advisory Panel Meeting... 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 ______________________________________________________________________________ UPDATE: Summer 2014 Update YAZ / Yasmin / Ocella / Gianvi Litigation: Bayer Reports On Total Settlements And Number Of Pending Claims (9/12/14) ______________________________________________________________________________ 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... Continue reading
Posted Jun 11, 2014 at Drug Injury Watch