Drug Injury Watch

In Canada, ADHD Drugs Like Adderall, Concerta, And Ritalin Are Getting New Warnings About Suicide-Related Adverse Events

Increased Warning About The Risk Of Suicidal Thoughts And Behaviors Being Added To Attention Deficit Hyperactivity Disorder (ADHD) Drug Labels

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 30, 2015 Health Canada issued an Information Update document with new safety information about Adderall, Concerta, Ritalin, and similar medications titled "ADHD drugs may increase risk of suicidal thoughts and behaviors in some people; benefits still outweigh risks".

From that item we get this description about the emerging ADHD drugs safety issue:

The new warnings advise that there have been reports of suicide-related events in patients treated with ADHD drugs. The reports involved thoughts of suicide, suicide attempts, and in a very small number of cases, completed suicide. These events have been reported at various times during treatment, particularly at the start or during dose changes, and also after stopping the drug treatment....

New information has emerged since to suggest that the risk of suicidal thoughts and behaviours may apply to all other ADHD drugs. There is little evidence to establish that these drugs cause suicidal thoughts and behaviours, but it is possible that they may contribute to the risk....  [emphasis added]

The following is a list of some brand name ADHD drugs to which this warning about suicide-related events in patients applies:

• Adderall XR (mixed salts amphetamine extended-release)
• Biphentin (methylphenidate controlled release)
• Concerta (methylphenidate extended release)
• Dexedrine (dextroamphetamine sulfate)
• Intuniv XR (guanfacine extended release)
• Ritalin (methylphenidate)
• Ritalin SR (methylphenidate extended release)
• Strattera (atomoxetine) [the warning was added to this drug label back in 2005]
• Vyvanse (lisdexamfetamine dimesylate)

The March 2015 update about important safety information concludes with this critical comment:  "It is Health Canada's view that the benefits of these drugs in the effective management of ADHD continue to outweigh their risks."

We will continue to monitor the benefit - risk profile of ADHD drugs like Adderall, Concerta, Ritalin, and Strattera, as well as watch for any corresponding regulatory action by the FDA here in the US.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Case review done by attorney Tom Lamb)

Diabetes Drugs Bydureon And Victoza: Thyroid Cancer Label Change In March 2015 Comes Without Much Notice

FDA Letters To AstraZeneca And Novo Nordisk Approve Addition Of Information About Increased Risk For Medullary Thyroid Carcinoma (MTC)

(Posted by Tom Lamb at DrugInjuryWatch.com)

The diabetes drugs Bydureon (exenatide extended-release) for injectable suspension and Victoza (liraglutide [rDNA origin]) injection) were the subject of March 2015 FDA letters concerning the supplemental approval about labeling revisions.

Each of these FDA letters, to AstraZeneca and to Novo Nordisk respectively, contain this paragraph: 

We also refer to our letter dated October 7, 2014, notifying you, under Section 505(o)(4) of the FDCA, of new safety information that we believe should be included in the labeling for long-acting GLP-1 receptor agonist products. This information pertains to the risk of medullary thyroid carcinoma.

__________________________________________________________________

Diabetes Drugs Pancreatic Cancer 

Byetta / Victoza / Januvia

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

In both AstraZeneca's Bydureon Prescribing Information and Novo Nordisk's Victoza Prescribing Information, the March 2015 label revisions concerning medullary thyroid carcinoma (MTC) can be seen in the so-called "Black Box" warning at the beginning of that document as well as at part 5.1 Risk of Thyroid C-cell Tumors in the Warnings and Precautions section.

As you may know, these diabetes drugs, Bydureon and Victoza, are alleged to have caused thyroid cancer and pancreatic cancer in drug injury lawsuits filed against the responsible pharmaceutical companies.

We will continue to watch for further developments about the safety profile of Bydureon and Victoza from the FDA or other drug regulatory agencies around the globe.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Case review done by attorney Tom Lamb) 

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

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

(Posted by Tom Lamb at DrugInjuryWatch.com)

For establishing a baseline as regards the current progress (or lack thereof) being made by Bayer to resolve the YAZ / Yasmin litigation which began back in 2009, from this 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 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.

___________________________________________________

Beyaz/Safyral/YAZ/Yasmin/Ocella/Gianvi
Free Case Evaluation
Strictly Confidential, No Obligation.

____________________________________________________

 

Next, we go to the PRODUCT-RELATED LITIGATION part of Bayer's Annual Report 2014 (at pg. 311 of the PDF document): 

Yasmin™ / yaz™: 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).  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™, generic versions of Yasmin™ and yaz™, respectively, marketed by Barr Laboratories, Inc. in the United States. Claimants seek compensatory and punitive damages, claiming, in particular, that Bayer knew, or should have known, of the alleged risks and should be held liable for having failed to disclose them or adequately warn users. All cases pending in U.S. federal courts have been consolidated in a multidistrict litigation proceeding for common pre-trial management....

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. Bayer will continue to consider the option of settling such claims after a case-specific analysis of medical records. At present, about 2,000 such claims are under review....

Additional lawsuits are anticipated....

Again, the Bayer DRSP birth control pills Beyaz and Safyral are not mentioned -- but we know lawsuits for women who developed blood clots, including some who died, have been filed against the drug company.

We will continue to monitor developments in the YAZ / Yasmin / Beyaz / Safyral / Gianvi / Ocella litigation, especially as regards deep vein thrombosis (DVT) cases and pulmonary embolism (PE) lawsuits pending against Bayer in the federal court MDL and other US courts.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Case review done by attorney Tom Lamb) 

Cardiovascular Safety Issues For Onglyza And Kombiglyze Will Be Discussed At April 2015 FDA Advisory Committee Meeting

These Two New AstraZeneca Diabetes Medications With Saxagliptin Are Part Of The Incretin Mimetic Class Of Drugs

(Posted by Tom Lamb at DrugInjuryWatch.com)

At an April 14, 2015 meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee, results of the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus (SAVOR) trial for for AstraZeneca's relatively new diabetes drugs Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin and metformin HCI extended-release) will be discussed.

For some background, one might want to read this article, "Possible Link Between Heart Failure And Onglyza Diabetes Type 2 Drug Is Being Investigated By FDA, As Announced In February 2014", which we posted about a year ago.

From a March 2015 statement issued by AstraZeneca in connection with this upcoming Kombiglyze XR / Onglyza FDA Advisory Committee Meeting:

The SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus) clinical trial of Onglyza (saxagliptin) was a randomised, double-blind, controlled trial evaluating the effect of saxagliptin on the incidence of major adverse cardiovascular events in patients with type 2 diabetes mellitus and at an elevated risk for CV events. The SAVOR study was conducted as part of the Postmarketing Requirement for the US New Drug Application approval of Onglyza in accordance with the 2008 FDA guidance, “Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” The primary objective of this trial was to determine that the addition of saxagliptin to standard of care in this patient population did not significantly increase the incidence of major cardiovascular events as compared to placebo.

_____________________________________________________________________

 

Free Onglyza / Kombiglyze Case Evaluation 

Strictly Confidential, No Obligation.

______________________________________________________________________________

And from the FDA announcement about this Endocrinologic and Metabolic Drugs Advisory Committee Meeting, as regards the Agenda:

During the morning session, the committee will discuss the results of the cardiovascular outcomes trial (CVOT), Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus, for new drug application (NDA) 22350, Onglyza (saxagliptin) and NDA 200678, Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets manufactured/marketed by AstraZeneca AB.

Further, according to this FDA announcement the background material for that Advisory Committee Meeting should be available to the public no later than 2 business days before the meeting on the 2015 Meeting Materials, Endocrinologic and Metabolic Drugs Advisory Committee page at FDA’s website.

Besides saxagliptin (Onglyza, Kombiglyze XR), other diabetes drugs in the incretin mimetic class besides include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).

We will watch for further developments surrounding the safety profile of Onglyza and Kombiglyze XR as well as these other incretin mimetic diabetes drugs.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Case review done by attorney Tom Lamb) 

First 2015 Update On Fosamax Femur Fracture Litigation: Not Much New Information To Report Out

With New Jersey State Court Fosamax Lawsuits Now Assigned To Judge Mayer, We Hope These Cases Get Back On Track

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

---

UPDATE: On March 22, 2017 the Third Circuit Court of Appeals reversed the dismissal by U.S. District Court Joel Pisano of all the pending federal court Fosamax - femur fracture cases nationwide on federal preemption grounds. The Third Circuit significantly held that the ultimate question of whether the FDA would have rejected a Fosamax label change by Merck for the increased risk of femur fractures is a question of fact for the jury, rather than for the court, to decide.

(3/23/17)

---

 

In our last update, "December 2014 Fosamax - Femur Fracture Litigation Update: In The Fosamax Federal Court MDL There Are Dismissals, Appeals, And Court-Ordered Mediations", we only mentioned in passing the New Jersey state court Fosamax femur fracture litigation.

Even though there is little new information about those cases, this is where we begin in our first Fosamax update for 2015.

From Merck's Form 10-K Annual Report For the Fiscal Year Ended December 31, 2014 we get this information about the femur fracture aspect of the Fosamax products liability litigation (at pp. 110-111 of the PDF document):

As of December 31, 2014, approximately 3,005 cases alleging Femur Fractures have been filed in New Jersey state court and are pending before Judge Jessica Mayer in Middlesex County. The parties selected an initial group of 30 cases to be reviewed through fact discovery. Two additional groups of 50 cases each to be reviewed through fact discovery were selected in November 2013 and March 2014, respectively.

The current number of these Fosamax lawsuits means there were about 85 femur fracture cases filed from the end of September 2014 to end of December 2014.

_____________________________________________________________________

 

Fosamax / Boniva / Actonel

Free Case Evaluation 

Strictly Confidential, No Obligation.

______________________________________________________________________________

Meanwhile, over at the New Jersey Courts website for the Fosamax Multicounty Litigation (accessed 3/2/15) we see some rather disappointing status information: "At this time, there are no events scheduled." 

Going back to the Merck Annual Report for 2015, we get these three additional facts from the drug company:

• As of December 31, 2014, approximately 515 cases alleging Femur Fractures have been filed in California state court.
• Additionally, there are four Femur Fracture cases pending in other state courts.
• Discovery is ongoing in the Fosamax Femur Fracture MDL and in state courts where Femur Fracture cases are pending and the Company intends to defend against these lawsuits.

As previewed at the outset, there is not much new to report at the present time.

Here are our two other 2014 Fosamax updates, in addition to the one referenced above:

End Of Summer 2014 Update: Fosamax - Femur Fracture Lawsuits In The New Jersey Consolidation / Multicounty Litigation

June 2014 Fosamax – Femur Fracture Litigation Update: Thousands Of Cases Pending, But No Trial Dates Currently Scheduled In Federal Court MDL Nor New Jersey Multicounty Litigation

Hopefully in the coming months there will be some positive developments for women who suffered a Fosamax - femur fracture event and have filed a drug injury lawsuit against Merck.

______________________________________________________________________________

DrugInjuryLaw.com: Legal Information And News About Prescription Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free & Confidential  (Case review done by attorney Tom Lamb)