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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
Black-Box Warning Added To Stavzor Label Announced By FDA In March 2014, Almost Full Year After Similar Label Change For Depakote Hepatotoxicity (Posted by Tom Lamb at DrugInjuryWatch.com) Stavzor, a lesser known valproic acid medication from Noven Therapeutics, LLC apparently had a so-called "Black-Box" Warning, or Boxed Warning, about Hepatotoxicity and hepatic failure, or liver failure, added to its label in March 2014. This is 10 months after a substantially identical Black Box Warning was added to Depakote, Depacon, and Depakene -- also valproic acid medicines -- by AbbVie Inc. (formerly Abbott) back in May 2013. Here is the Stavzor Boxed Warning about hepatic failure cases, some ending in deaths, which seems to have been added by in March 2014: Hepatotoxicity, including fatalities, usually during first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at high risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter. [(See: 5. WARNINGS AND PRECAUTIONS -- 5.1 Hepatotoxicity)] We say "seems to have been added in March 2014" based on this FDA MedWatch announcement: "Stavzor (Valproic acid) - Liver Failure Black Box Warning, March 2014". From viewing the... Continue reading
Posted 3 days ago at Drug Injury Watch
An August 2013 Label Change Mandated By The FDA For All Fluoroquinolone Antibiotics Was Intended To Raise The Profile Of This Relatively Unknown Risk (Posted by Tom Lamb at DrugInjuryWatch.com) In August 2013 the FDA mandated a label change to increase the warning about peripheral neuropathy or serious nerve damage caused by Levaquin, Cipro, and Avelox, as well as other antibiotic medications in the fluoroquinolone antibacterial class of drugs. Peripheral neuropathy as an increased risk, or side effect, of using Levaquin, Cipro, Avelox, and the like was added to the "Warnings" or "Warnings and Precautions" sections of the Package Insert for these fluoroquinolone medicines way back in 2004. However, since that time the FDA has continued to receive numerous reports of peripheral neuropathy from doctors and patients. As a result, in August 2013 the FDA determined that -- although the risk of peripheral neuropathy has been described in the respective Package Insert, or label, of these fluoroquinolone antibiotic drugs for years, now -- the (1) potential rapid onset and (2) risk of permanence aspects of this serious nerve damage side effect were not adequately described. _____________________________________________________________________ Avelox / Cipro / Levaquin Free Case Evaluation Strictly Confidential, No Obligation. ______________________________________________________________________________ From... Continue reading
Posted Apr 10, 2014 at Drug Injury Watch
Quoted from http://www.reviewjournal.com/news/crime-courts/las-vegas-judge-denies-attempt-remove-herself-actos-lawsuit Las Vegas judge denies attempt to remove herself from Actos lawsuit By CARRI GEER THEVENOT LAS VEGAS REVIEW-JOURNAL April 8, 2014 A Las Vegas judge will not remove herself from a civil case filed by two women against the maker of the diabetes drug Actos.“ I absolutely see no evidence that there’s any appearance of impropriety by me,” District Judge Kerry Earley said Tuesday. The judge made the ruling after attorney Daniel Polsenberg, who represents defendant Takeda Pharmaceuticals, asked her to step down or declare a mistrial in the case. Polsenberg said a front-page story in Sunday’s... Continue reading
Quoted from http://www.nbcnews.com/health/health-news/viagra-may-boost-risk-deadly-skin-cancer-study-finds-n73976 Viagra May Boost Risk of Deadly Skin Cancer, Study Finds By JoNel Aleccia Men who use Viagra to get a boost in the bedroom could find that the little blue pill also increases the risk of developing melanoma, the deadliest form of skin cancer, a preliminary study finds. Researchers found that men who took sildenafil, best known as Viagra, were about 84 percent more likely to develop melanoma than men who didn’t take the drug. Because it’s just one early study, no one is suggesting that men stop taking Viagra to treat erectile dysfunction, said Dr. Abrar... Continue reading
Quoted from http://www.reuters.com/article/2014/04/08/us-takeda-pharm-actos-verdict-idUSBREA3708F20140408 Japan drugmaker Takeda to fight $6 billion damages imposed by U.S. jury By Daniel Levine and Edmund Klamann SAN FRANCISCO/TOKYO Tue Apr 8, 2014 SAN FRANCISCO/TOKYO (Reuters) - Takeda Pharmaceutical Co Ltd said it would contest $6 billion in punitive damages imposed by a U.S. federal jury in a case alleging Japan's largest drugmaker had concealed cancer risks associated with its Actos diabetes drug. Eli Lilly and Co, Takeda's co-defendant in the case, was ordered to pay $3 billion in punitive damages. "We intend to vigorously challenge this outcome through all available legal means, including possible post-trial... Continue reading
Quoted from http://www.reuters.com/article/2014/04/01/us-genericdrugs-idUSBREA3025V20140401 FDA defends generic drug label proposal at U.S. House hearing Tue Apr 1, 2014 7:00pm EDT (Reuters) - The U.S. Food and Drug Administration on Tuesday defended its proposal to require generic drugmakers to update the prescribing information on their products if they become aware of new safety information, a move the industry says will open them to product liability lawsuits and raise drug costs. Speaking at a hearing before a U.S. House of Representatives health subcommittee, Dr. Janet Woodcock, the FDA's top pharmaceuticals official, said the move is needed to "create parity" between branded and generic... Continue reading
Increasing Number Of AndroGel / Axiron / Testim Lawsuits Allege Heart Attacks And Strokes, With Highest Side Effects Risks Being For Older Men Or Those With Cardiac Conditions (Posted by Tom Lamb at DrugInjuryWatch.com) With the increasing number of drug injury lawsuits alleging testosterone-related heart attacks and strokes being asserted against various pharmaceutical companies, it comes as no surprise to legal observers that a so-called "MDL motion" to consolidate certain of those federal court cases has been filed. From this March 29, 2014 article, "Plaintiffs File Motion to Consolidate All Federal Lawsuits Linking AndroGel Testosterone Therapy to Heart Attacks, Strokes" (subscription required for full article), published by HarrisMartin: Plaintiffs in more than a dozen federal lawsuits accusing Abbott Laboratories and AbbVie Inc. of concealing cardiovascular risks associated with the testosterone replacement therapy AndroGel have filed a petition to have all similar cases around the country transferred to Illinois. In a brief submitted March 28, lawyers for plaintiffs in 13 of the 38 cases pending in Illinois, Pennsylvania and Colorado asked the Judicial Panel on Multidistrict Litigation (JPML) to create a docket in U.S. District Court for centralized management of the federal lawsuits.... _____________________________________________________________________ Free Testosterone Drugs Case Evaluation Strictly Confidential,... Continue reading
Posted Apr 1, 2014 at Drug Injury Watch
In Addition, Such Combined Use In Patients With Kidney Disease Or Diabetes Increases Risks Of Having A Stroke As Well As Fainting And Falling (Posted by Tom Lamb at DrugInjuryWatch.com) In February 2014 Health Canada issued new safety information about the drug Tekturna (aliskiren) as regards its use in combination with some other blood pressure medications. From "New warnings regarding blood pressure drugs" we get this drug safety guidance: Recent studies have demonstrated that any combination of [Tekturna (aliskiren)], [angiotensin-converting enzyme (ACE) inhibitor] or [angiotensin receptor blocker (ARB)] increases the risks of hypotension (low blood pressure), hyperkalemia (high levels of potassium in the blood) and kidney problems. ___________________________________________________________________ Free Tekturna Case Evaluation Strictly Confidential, No Obligation. ___________________________________________________________________________ Furthermore, [Tekturna (aliskiren)] should not be taken in combination with [any ACE] or with [any ARB] in patients with diabetes or kidney disease due to the additional risks of stroke and syncope (fainting) in these patients. We have written in more detail about the increased risks of serious side effects associated with Tekturna in this 2012 article: "Tekturna And Other Aliskiren Related Blood Pressure Medications Can Cause Renal Failure, Kidney Complications, And Strokes". As stated at the end of that earlier article, we... Continue reading
Posted Mar 25, 2014 at Drug Injury Watch
New Medical Evidence Is Presented In March 2014 That Suggests Adolescent Males And Boys Can Develop Breasts Due To Their Use Of Risperdal Or Invega (Posted by Tom Lamb at DrugInjuryWatch.com) Risperdal (risperidone) is a popular antipsychotic drug used in both younger and older adults. Recent medical reports have alluded to an increase in the risk of gynecomastia (enlargement of male breasts) with Risperdal use. Several case reports with gynecomastia being diagnosed in the setting of Risperdal use have been received by the FDA, also. Although case reports have alluded to this link between Risperdal and gynecomastia, or male breasts, we know that case reports alone cannot show a causal link between Risperdal and gynecomastia. Rather, large epidemiologic studies are needed to confirm this Risperdal - male breasts link. At this year’s American Association for Geriatric Psychiatry (AAGP) meeting in Orlando, on March 15, 2014, Dr. Mahyar Etminan, an epidemiologist at the University of British Columbia, presented data on a study he has led that looked at the risk of older men developing gynecomastia due to their use of Risperdal (risperidone) or Invega (paliperidone -- which is an active metabolite of risperidone). Having access to a large health claims database... Continue reading
Posted Mar 17, 2014 at Drug Injury Watch
While 2013 Annual Report Includes Gianvi And Ocella Drug Injury Cases, The Only Mention Of Beyaz And Safyral Legal Cases Is Regarding Patent Disputes (Posted by Tom Lamb at DrugInjuryWatch.com) The YAZ / Yasmin litigation which began back in 2009 is going on its fifth year. Here are the latest numbers made available by the defendant drug company about claims, lawsuits, and settlements. From the Bayer 2013 Annual Report which was issued recently: As of February 10, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,600 (excluding claims already settled). Claimants allege that they have suffered personal injuries, some of them fatal, from the use of Bayer’s drospirenone-containing oral contraceptive products such as Yasmin™ and / or YAZ™ or from the use of Ocella™ and / or Gianvi™.... As of February 10, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 8,250 claimants in the U.S. for a total amount of about US$1.69 billion. Bayer has only been settling claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism).... Such injuries are alleged by about 1,950 of the pending unsettled claimants.... Continue reading
Posted Mar 12, 2014 at Drug Injury Watch
In Addition, They Are Highly Critical Of Relationship The Sanofi Aventis Drug Company Had With Those Doctors Who Developed Prescribing Guidelines (Posted by Tom Lamb at DrugInjuryWatch.com) As we know, now, since being approved by the FDA in 2009 and soon becoming an often-prescribed atrial fibrillation drug, Multaq has been associated with increased risks of serious side effects, including liver failure, interstitial lung disease (ILD), stroke, and sudden cardiac death. In the February 2014 edition of JAMA Internal Medicine one finds this rather hard-hitting article, "Dronedarone for Atrial Fibrillation: The Limited Reliability of Clinical Practice Guidelines". From the Abstract for this recent medical journal article about the highly controversial heart drug Multaq, we get this information: Concerns have been expressed about the reliability of clinical practice guidelines. We analyzed 3 guidelines from medical specialty societies about [Multaq (dronedarone hydrochloride)], an antiarrhythmic drug related to amiodarone hydrochloride, for treatment of patients with atrial fibrillation.... In our analysis, as a rate control drug, [Multaq (dronedarone)] was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, [Multaq (dronedarone)] was associated with 13 (95% CI, -15 to 61) excess deaths per 1000 patients treated as compared with placebo.... Continue reading
Posted Mar 6, 2014 at Drug Injury Watch
Earlier In February 2014 The Endocrine Society Of Medical Doctors Urged Caution In The Prescribing Of These Products To Certain Middle-Aged And Older Men (Posted by Tom Lamb at DrugInjuryWatch.com) On February 25, 2014 a so-called Citizen Petition was filed with the FDA requesting that a "Black-Box" warning about the increased risks of heart attacks, strokes, and other cardiovascular dangers, including cardiac deaths, be added immediately to the drug labels of testosterone replacement therapy (TRT) products such as AndroGel, Axiron, and Testim. From this February 2014 document filed by the Public Citizen group, "Petition to the FDA for Black Box Warnings on all Testosterone Products" (PDF format): We hereby petition the FDA to add a black box warning about the increased risks of heart attacks and other cardiovascular dangers to the product labels of all testosterone-containing drugs presently on the market in the U.S. We urge the FDA to ask manufacturers to send “Dear Doctor” letters to warn physicians of these serious adverse effects and to require that the FDA-approved Medication Guide for testosterone products, dispensed to patients when their prescriptions are filled, be updated to include this new warning.... The urgency for this action is highlighted by the massive... Continue reading
Posted Feb 25, 2014 at Drug Injury Watch
Quoted from http://hosted.ap.org/dynamic/stories/U/US_TESTOSTERONE_RISKS_FDA_PETITION Group wants heart attack warning on testosterone Feb 25, 2014 By MATTHEW PERRONE AP Health Writer WASHINGTON (AP) -- A consumer advocacy group is calling on the Food and Drug Administration to add a bold warning label to popular testosterone drugs for men in light of growing evidence that the hormone treatments can increase the risk of heart attack. The group Public Citizen says the agency should immediately add a "black box" warning - the most serious type - to all testosterone medications and require manufacturers to warn physicians about a higher risk of heart attack, stroke... Continue reading
Quoted from http://www.reuters.com/article/2014/02/20/us-health-testosterone-therapy-idUSBREA1J1CG20140220 Testosterone therapy for "low T" carries risk: endocrinologists By Kathleen Raven NEW YORK Thu Feb 20, 2014 10:09am EST NEW YORK (Reuters Health) - Older men considering taking testosterone for low libido, fatigue, irritability or muscle loss should be made aware of the heart-related risks of testosterone therapy, according to a statement from the Endocrine Society. Drug companies tout testosterone as a near panacea for such conditions. But the U.S. Food and Drug Administration (FDA) has approved testosterone products only for hypogonadism, when the testicles do not produce enough testosterone. "Testosterone isn't approved for age-related conditions and... Continue reading
To start, I apologize in my delay responding to your Comment. Of course, especially as a parent, I am saddened by the loss of your baby. 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 this situation. I wish you and your family the best in all aspects going forward. Tom Lamb
1 reply
Increased Risk Of PPHN When Women Use SSRIs Medications Like Celexa, Lexapro, Paxil, Prozac, And Zoloft After Their 20th Week Of Pregnancy (Posted by Tom Lamb at DrugInjuryWatch.com) A recent medical journal article, "Prenatal exposure to antidepressants and persistent pulmonary hypertension of the newborn: systematic review and meta-analysis", published by BMJ in January 2014, brought more attention to a serious but often overlooked drug risk presented by some popular antidepressant drugs like Celexa, Lexapro, Paxil, Prozac, and Zoloft. These prescription medications are in the Selective Serotonin Reuptake Inhibitors, or SSRIs, class of drugs. From the Abstract for that January 2014 BMJ article: Objective To examine the risk for persistent pulmonary hypertension of the newborn associated with antenatal exposure to antidepressants. Conclusions The risk of persistent pulmonary hypertension of the newborn seems to be increased for infants exposed to SSRIs in late pregnancy, independent of the potential moderator variables examined. A significant relation for exposure to SSRIs in early pregnancy was not evident. Although the statistical association was significant, clinically the absolute risk of persistent pulmonary hypertension of the newborn remained low even in the context of late exposure to SSRIs. This important finding, however, is not new. Back in 2006... Continue reading
Posted Feb 14, 2014 at Drug Injury Watch
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Quoted from http://www.reuters.com/article/2014/02/13/us-boehringer-pradaxa-idUSBREA1C0PW20140213 Article Comments (0) Boehringer facing more than 2,000 U.S. lawsuits over blood thinner FRANKFURT Thu Feb 13, 2014 7:03am EST FRANKFURT (Reuters) - German drugmaker Boehringer Ingelheim said on Thursday it is facing more than 2,000 lawsuits in the United States over claims its blockbuster drug Pradaxa, the first in a new class of stroke prevention pills, caused severe and fatal bleeding. The unlisted company confirmed the number of cases reported on Thursday by German newspaper Handelsblatt, adding the risk of side effects was known and had to be weighed against the drug's life saving potential. [Article... Continue reading
Quoted from http://www.reuters.com/article/2014/02/07/us-merck-nuvaring-idUSBREA1615F20140207 Merck to pay $100 million in NuvaRing contraceptive settlement Fri Feb 7, 2014 11:53am EST (Reuters) - Merck & Co said on Friday it will pay $100 million to resolve all U.S. product liability lawsuits alleging it downplayed serious health risks involving its NuvaRing intrauterine contraceptive device. The product, which contains the hormones estrogen and progestin commonly found in birth control bills, is associated with an increased risk of developing blood clots that can cause heart attacks, strokes or sudden deaths. Available to women in the United States since 2001, NuvaRing is one of several contraceptive products... Continue reading
Chronic Or Severe Diarrhea With Damage To The Intestinal Villi And Malabsorption Indicate Sprue-Like Enteropathy (Posted by Tom Lamb at DrugInjuryWatch.com) An association between the oral angiotensin-receptor blocker (ARB) Benicar (olmesartan) and the serious side effect sprue-like enteropathy has been noted in the medical literature and flagged by the FDA as we reported back in August with this article, "Blood Pressure Drug Benicar Causes Serious Intestinal Side Effects Such As Chronic And Severe Diarrhea Months Or Years After Starting Drug". We point out that the July 2013 FDA Drug Safety Communication about Benicar also applies to Benicar HCT, Azor, and Tribenzor, which are other high blood pressure, or hypertension medications from the drug company Daiichi Sankyo. An article from the January 2014 edition of the Pharmacy and Therapeutics (P&T®) medical journal includes an article, "Olmesartan and Drug-Induced Enteropathy" (PDF format), which provides some valuable information concerning the symptoms and diagnosis of this recently found Benicar side effect. From that article: Most often, diarrhea as a side effect of medications occurs independently of damage to the intestinal mucosa. However, when villous involvement and malabsorption are present, the damage is defined as sprue-like enteropathy. Symptoms of sprue-like enteropathy include severe, chronic diarrhea... Continue reading
Posted Feb 7, 2014 at Drug Injury Watch
Quoted from http://www.nytimes.com/2014/02/06/business/study-of-blood-clot-drug-pradaxa-unnerved-its-maker-documents-suggest.html Study of Drug for Blood Clots Caused a Stir, Records Show By KATIE THOMAS FEB. 5, 2014 The makers of the blood-thinning drug Pradaxa were so worried that an internal research paper would damage drug sales that some employees not only pressured the author to revise it, but suggested it should be quashed altogether, according to newly unsealed legal documents. The documents were made public last week by a federal judge in Illinois who is overseeing thousands of lawsuits filed by patients and their families, who say that Pradaxa’s manufacturer, the German company Boehringer Ingelheim, failed to... Continue reading
Quoted from http://www.cbc.ca/news/health/blood-pressure-drug-combination-increases-health-risk-health-canada-warns-1.2523251 Blood pressure drug combination increases health risk, Health Canada warns Warning for aliskiren, ACE inhibitors and ARBs CBC News Posted: Feb 04, 2014 Combining certain types of blood pressure medications can be risky, Health Canada is warning doctors and patients. The regulator said Tuesday that recent studies show any combination of aliskiren, a renin inhibitor, and two other classes of drugs, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB), can be risky. "Recent studies have demonstrated that any combination of aliskiren, ACEIs or ARBs increases the risks of hypotension (low blood pressure), hyperkalemia (high levels of... Continue reading
Quoted from http://well.blogs.nytimes.com/2014/01/29/study-adds-to-concern-about-cardiac-risks-for-older-men-taking-testosterone/ New Concern About Testosterone and Heart Risks By ANAHAD O'CONNOR New York Times, January 29, 2014 A large new study found that prescription testosterone raised the risk of heart attacks in older men and in middle-aged men with a history of heart disease, prompting some experts on Wednesday to call for more extensive warning labels on the drugs. The new study is one of several in recent years that have highlighted cardiac problems as a potential side effect of testosterone gels, patches, pellets and injections. The hormone is approved for low testosterone levels and is widely marketed... Continue reading
For "Low-T" Drugs Like AndroGel, Axiron, And Testim, Serious Side Effects Are Increased With Age -- Highest Risks In Men Over 65 And For Men With Pre-Existing Diagnosed Heart Disease (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products" FDA MedWatch Safety Alert issued January 31, 2014 (1/31/14) ______________________________________________________________________________ A new medical study regarding testosterone therapy (TT) medications like AndroGel, Axiron, and Testim published in January 2014 has found that a man's risk of having a myocardial infarction (MI) -- often referred to as a heart attack -- increases significantly in the first few months after he starts using the newly prescribed testosterone drug. In summary, researchers compared the incidence of non-fatal MI events in the year before a first prescription for testosterone therapy (pre-rate) with non-fatal MI events in the 90 days after filling that prescription (post-rate). The post-rate / pre-rate ratio for MI or heart attack was 1.36, increasing to 2.19 in those 65 and older, and to 3.43 in those 75 and older. Younger men with a history of heart disease also showed an increased risk of having a heart attack relatively soon after starting... Continue reading
Posted Jan 31, 2014 at Drug Injury Watch
Critics Of "Low-T" Drugs Like Axiron, AndroGel, And Testim Blame Medically Unnecessary Use Of Androgen Therapy On Drug Company Advertising (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products" FDA MedWatch Alert issued on January 31, 2014 "More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks" Drug Injury Watch article posted January 31, 2014 (1/31/14) ______________________________________________________________________________ Testosterone replacement therapy (TRT), also called androgen replacement therapy (ART), is medically recommended for men whose body makes too little of this male hormone. For those men who have been tested and diagnosed with this condition, which is called hypogonadism, testosterone drugs like Axiron, AndroGel, and Testim can serve to boost strength and sexual functioning. But how does one explain the fact that it is estimated the number of middle-aged men in the U.S. getting testosterone treatments has more than tripled over the last decade? At least according to one study, this may be due to advertising campaigns for testosterone products that are arguably aimed men who do not have clinically low testosterone levels, i.e., had not undergone a blood... Continue reading
Posted Jan 22, 2014 at Drug Injury Watch
Medical Studies Show An Increased Risk Of Cardiovascular Events In Older Men Prescribed Testosterone Medications Such As Axiron, AndroGel, And Testim (Posted by Tom Lamb at DrugInjuryWatch.com) ______________________________________________________________________________ UPDATE: "FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products" FDA MedWatch Alert issued on January 31, 2014 "More Evidence Supporting A Link Between Testosterone Therapy And Higher Risk Of Cardiovascular-Related Events Such As Myocardial Infarctions Or Heart Attacks" Drug Injury Watch article posted January 31, 2014 (1/31/14) ______________________________________________________________________________ Testosterone replacement therapy (TRT) is also referred to as androgen replacement therapy (ART) and male hormone replacement therapy. Older men who used testosterone gel, patch, or injection products for a medical condition called hypogonadism or for other reasons are more likely to have a serious cardiovascular event, some of which have been fatal, according to some medical research. Unfortunately, while it is estimated that the number of middle-aged men in the U.S. getting testosterone treatment has more than tripled over the last decade, the long-term risks are largely unknown. Some of the prescription testosterone drug products approved by the FDA and available for use to treat low testosterone, or "Low T" syndrome, include: •AndroGel •Androderm •Axiron •Bio-T-Gel •Delatestryl •Depo-Testosterone... Continue reading
Posted Jan 20, 2014 at Drug Injury Watch