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Law Offices of Thomas J. Lamb

Beyaz / Safyral / YAZ / Yasmin: These Drospirenone Containing Birth Control Pills Have A Higher Risk Of Blood Clot Side Effects Than Older Options

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New Medical Journal Article Presents “Compelling Evidence” That These Newer Oral Contraceptives Are Associated With More Venous Thromboembolism Events

 
SUMMARY: From an Editorial piece published May 26, 2015 by the medical journal BMJ, “Fresh evidence confirms links between newer contraceptive pills and higher risk of venous thromboembolism”, we get this commentary from Susan S. Jick, of Boston University School of Public Health):

Notably, Vinogradova and colleagues also looked at the newer oral contraceptives, such as those containing desogestrel, gestodene, and cyproterone, as well as the newest pill containing drospirenone, where data have been limited and the magnitude of effects on the risks of venous thromboembolism remains controversial…. Vinogradova’s comprehensive study addresses important questions about the risk of venous thromboembolism in women taking oral contraceptives, concluding that the risk associated with newer pills is around twofold higher than the risk associated with older contraceptives.

The important new medical study that Dr. Jick is alluding to above is the subject of this article, “Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases”, published in the same edition of the BMJ medical journal.

Beyaz, Safyral, YAZ, and Yasmin are birth control pills which contain ethinyl estradiol (EE) and the progestin drospirenone (DRSP). These DRSP oral contraceptives have been associated with several different adverse side effects such as:

• Blood Clots
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Stroke or Cerebrovascular Accidents (CVA)
• Heart Attack or Myocardial Infarction

We will continue to watch for legal, medical, and regulatory developments as regards Beyaz, Safyral, YAZ, and Yasmin, as well as other DRSP birth control pills such as Gianvi and Ocella.

[Read this article in full at original source]

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May 2015 Diabetes Drugs – Ketoacidosis Link Warning By FDA Covers Invokana, Farxiga, And Jardiance, With Label Changes Possible

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Case Reports Of These Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors Causing Diabetic Ketoacidosis (DKA) Presented At Recent Medical Meeting

 
SUMMARY: The FDA is investigating a connection between a certain class of diabetes medicines and diabetic ketoacidosis (DKA), ketoacidosis, or ketosis. From “FDA Drug Safety Communication: FDA warns that SGLT2 inhibitors for diabetes may result in a serious condition of too much acid in the blood”, issued on May 15, 2012:

The U.S. Food and Drug Administration (FDA) is warning that the type 2 diabetes medicines [Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin)] may lead to ketoacidosis, a serious condition where the body produces high levels of blood acids called ketones that may require hospitalization….

Patients should pay close attention for any signs of ketoacidosis and seek medical attention immediately if they experience symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness….

In addition, at least one study presented at the 2015 annual meeting of the American Association of Clinical Endocrinologists found a connection between the SGLT2 inhibitors and diabetic ketoacidosis (DKA), according to this MedPage Today news report, “Three Diabetes Drugs Linked to Ketoacidosis, FDA Warns”,

We will continue to monitor the safety profile of these SGLT2 inhibitors — Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin) — as regards side effects such as cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients using these drugs as diabetes treatments.

[Read this article in full at original source]

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Testosterone Injections Or Shots Such As Depo-Testosterone Might Have Higher Risks Of Heart Attacks, Strokes, And Deaths

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New Medical Research Suggests The Safety Of A Testosterone Drug Might Depend On Its Form: Injections / Shots; Creams / Gels; Skin Patches

 
SUMMARY: According to a large retrospective cohort medical study published online by the JAMA Internal Medicine journal in May 2015, we learn that short-acting testosterone injections or shots — such as the Depo-Testosterone (testosterone cypionate) injection from Pharmacia and Upjohn Company (a division of Pfizer) — are associated with a higher risk of cardiovascular events, hospitalizations, and deaths when compared with gels or patches.

From a May 11, 2015 news report, “Testosterone Shots: Riskier Than Gels or Patches?” — with this sub-headline: “Spike in T levels from bolus injections may explain higher adverse outcome rates” — published online by MedPage Today, we get the following summary information and commentary about this testosterone drugs safety study:

“Different dosage forms lead to different serum testosterone levels over time — injections result in spikes and super-normal levels — possibly accounting for the observed risk of cardiovascular disease,” [J. Bradley Layton, PhD, an epidemiologist at the University of North Carolina Chapel Hill] and colleagues wrote….

The study is well-designed and done by a reputable group, said Bradley Anawalt, MD, an endocrinologist and professor of medicine at the University of Washington Medical Center, in an email to MedPage Today. But it only included short-acting forms of injectable testosterone (testosterone cypionate, enanthate, and propionate) and not the longer-acting testosterone undecanoate which is the most common form used in Europe and which was recently approved in the U.S.

The short-acting forms of injectable testosterone are associated with higher spikes in testosterone levels, said Anawalt, who was not involved with the study.

We will continue to watch for new medical research about testsoterone drugs safety especially as regards heart attacks or myocardial infarction (MI), strokes, and cardiovascular deaths which might be caused by so-called “Low-T” testosterone therapy products such as Depo-Testosterone injections or shots.

[Read this article in full at original source]

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YAZ / Yasmin Litigation Update For March 2015: According To Bayer’s 2014 Annual Report, “Additional lawsuits are anticipated.”

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Bayer Claims It Settled About 300 Of These Cases While Another 1300 Lawsuits Were Filed From Mid-October 2014 To The End Of January 2015

 
SUMMARY: From this earlier article, “December 2014 YAZ / Yasmin Litigation Update: Still Over 2000 DVT And/Or PE Cases Not Settled According To Bayer’s Most Recent Financial Report”, we get these previous numbers:

  • As of October 13, 2014, the number of claimants in the pending lawsuits and claims in the United States totaled about 4,000 (excluding claims already settled).
  • As of October 13, 2014, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 9,200 claimants in the U.S. for a total amount of about US$1.8 billion.

And from the PRODUCT-RELATED LITIGATION part of Bayer’s Annual Report 2014, we get these more recent numbers:

  • As of January 31, 2015, the number of claimants in the pending lawsuits and claims in the United States totaled about 5,000 (excluding claims already settled).
  • As of January 31, 2015, Bayer had reached agreements, without admission of liability, to settle approximately 9,500 claims in the U.S. for venous clot injuries (deep vein thrombosis or pulmonary embolism) for a total amount of about US$1.9 billion.

While the Bayer DRSP birth control pills Beyaz and Safyral are not mentioned in this part of the Annual Report, we know lawsuits for women who developed blood clots, including some who died, have been filed against the drug company in addition to YAZ, Yasmin, Gianvi, and Ocella cases involving DVT and/or PE side effects.

[Read this article in full at original source]

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Various Drug Safety Issues Continue To Be Associated With Novartis Multiple Sclerosis (MS) Medication Gilenya

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ISMP QuarterWatch Report From 2014 States Adverse Events Reports Show That Gilenya Cardiac Risks “were neither rare nor hypothetical”

 
SUMMARY: Last fall, from the September 24, 2014 edition of the ISMP QuarterWatch publication, we received more data and information about the various safety risks associated with Gilenya.

Given the extent and severity of the adverse events reports about Gilenya disrupting normal heart rhythm, we go into more depth on the cardiac-related risks associated with this still relatively new MS drug from Novartis. And from the September 2014 QuarterWatch from ISMP we get additional information about the heart-related problems patients have had when using Gilenya.

The safety profile for the Novartis drug Gilenya (fingolimod) has been controversial for some time now, and the concerns about adverse reactions and side effects continue.

We will continue to watch for reports of heart-related side effects with Gilenya and monitor the activity of drug regulators in the US, Canada, and Europe as regards the safety profile of this controversial Novartis MS drug.

[Read this article in full at original source]

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Xolair Is Associated With Higher Than Expected Reporting Of Arterial Thrombotic Events Such As Strokes And Cardiovascular Deaths

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While European Drug Regulators Have Been Concerned About This Aspect Of Xolair Safety, FDA Has No Warning About Arteriothrombotic Risks Of Xolair

 
SUMMARY: In this post we consider a medical journal article which suggests that Xolair is associated with an increased risk of arterial thrombotic events, predominantly cardiovascular deaths and strokes.

The subject article is “Assessing the association between omalizumab and arteriothrombotic events through spontaneous adverse event reporting”, initially published online by the Journal of Asthma and Allergy back in May 2012.

According to the authors, their study is the first pharmacovigilance analysis to detect from a spontaneous event reporting database such as the FDA AERS a strong safety signal for Xolair as regards cardiovascular death and stroke events.

Numerous times throughout their article the authors acknowledge the limitations of their research methods and state that epidemiological studies are necessary to further explore the apparent association of Xolair with cardiovascular deaths, strokes, and other arterial thrombotic adverse events.

[Read this article in full at original source]

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Xolair Asthma Drug Associated With Higher Rate Of Heart Attacks, Pulmonary Hypertension, Blood Clots Causing PEs And/Or DVTs, And Brain Blood Vessel Problems

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Since FDA Early Communication About An Ongoing Safety Review Of Xolair Was Issued In 2009, The Agency Has Been Examining Xolair Safety Profile But FDA Is Still Unsure If This Drug Is Safe Or Not

SUMMARY: From this document issued in September 2014, “FDA Drug Safety Communication: FDA approves label changes for asthma drug Xolair (omalizumab), including describing slightly higher risk of heart and brain adverse events”, we get the latest news on the Xolair drug safety issue.

It was back in July 2009, when the FDA issued its Early Communication about an Ongoing Safety Review of Omalizumab (marketed as Xolair), that the agency first started reviewing interim safety findings from a study of the asthma drug omalizumab (Xolair) which suggested that the medication may be associated with increased risk for ischemic heart disease, arrhythmias, cardiomyopathy, cardiac failure, pulmonary hypertension, cerebrovascular disorders, and thromboembolic and thrombophlebitic events.

[Read this article in full at original source]

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Testosterone Drugs FDA Meeting In September 2014 Reveals That The Safety Of Products Like Axiron, AndroGel, And Testim Is Uncertain Or Unknown At Present Time

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Key Advisory Panel Member Concedes It Is Medically Plausible That Testosterone Replacement Therapy Can Be Associated With Heart Attacks / Strokes Side Effects

 
SUMMARY: In mid-September 2014 members of two FDA advisory panels in a joint meeting considered the issue of whether the popular testosterone products Axiron, AndroGel, and Testim, as well as other so-called “Low-T” drugs, are safe.

We have to wait to see what regulatory action the FDA will take, if any, concerning the possible increased risks of heart attacks and strokes that some link to these testosterone replacement therapy drugs.

The outcome of their discussions was essentially that for most current users of Axiron, AndroGel, Testim, and other “Low-T” drugs we do not know and cannot know if they cause such cardiovascular side effects because no safety study has been done, yet.

[Read this article in full at original source]

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AndroGel / Axiron / Testim: Heart Attacks, Strokes, And Other Cardiovascular Problems Will Be Subject Of FDA Advisory Panel Meeting In September 2014

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Health Canada Orders Label Change For Testosterone Drugs In July 2014: Must Warn About Increased Risks Of Side Effects Including Blood Clots, DVTs, PEs

 
SUMMARY: 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.

Next, on July 15, 2014 Health Canada issued this “Information Update – Possible cardiovascular problems associated with testosterone products”.

[Read this article in full at original source]

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Summer 2014 Update: Testosterone “Low-T” Drugs: New FDA Safety Warnings; Recent Medical Journal Article About Heart Risks Of Injectable TRT Product

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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

 
SUMMARY: 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]

2. Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January – March 2014 [Page / List Updated 6/16/14]

Now we shift to the medical journals and, in particular, an article published online July 2, 2014 by the Annals of Pharmacotherapy, “Risk of Myocardial Infarction in Older Men Receiving Testosterone Therapy”.

We will continue to monitor this still emerging drug safety issue concerning Depo-Testosterone, Testim, AndroGel, Axiron, and other testosterone products — also called TRT and/or “Low-T” drugs.

[Read this article in full at original source]

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Law Offices of Thomas J. Lamb, P.A.
1908 Eastwood Road, Suite 225
Wilmington, North Carolina 28403
910-256-2971 | 800-426-9535
TJL@LambLawOffice.com