Drug Injury Watch

Rexulti Warnings For Compulsive Behavior And Impulse Control Problems Added To Drug Label

FDA: Patients Using Rexulti At Risk For Experiencing Intense Urges For Gambling And Inability To Control Conduct

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Rexulti® (brexpiprazole) was initially approved by the FDA in 2015 for the adjunctive treatment of major depressive disorder (MDD) and the treatment of schizophrenia.

As shown in a February 9, 2018 FDA letter to Otsuka Pharmaceutical Company, Ltd., the agency approved some label changes for Rexulti for the addition of warnings about pathological gambling and other compulsive behaviors:

Please refer to your Supplemental New Drug Application (sNDA) dated and received June 23, 2017....

This Prior Approval supplemental new drug application provides for a new subsection under the Warnings and Precautions section entitled Pathological Gambling and Other Compulsive Behaviors and corollary revisions to the Highlights, Adverse Reactions, Patient Counseling Information, and Medication Guide.

__________________________________________________________________

Rexulti

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

And from the FULL PRESCRIBING INFORMATION Revised: 02/2018 document for Rexulti (accessed 5/22/18) we get the text of what was added to the Warnings and Precautions section:

5.7 Pathological Gambling and Other Compulsive Behaviors

Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking REXULTI. Other compulsive urges, reported less frequently, include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors. Because patients may not recognize these behaviors as abnormal, it is important for prescribers to ask patients or their caregivers specifically about the development of new or intense gambling urges, compulsive sexual urges, compulsive shopping, binge or compulsive eating, or other urges while being treated with REXULTI. In some cases, although not all, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Compulsive behaviors may result in harm to the patient and others if not recognized. Consider dose reduction or stopping the medication if a patient develops such urges.

The drug companies responsible for Rexulti in the US are Otsuka Pharmaceutical Co., Ltd. (Japan), Otsuka America Pharmaceutical, Inc. (Maryland), and Lundbeck (Illinois).

Our law firm is investigating possible products liability lawsuits against those companies for people who have experienced compulsive gambling behaviors while using Rexulti. Those cases would involve one or more of the following consequences: personal debt; bankruptcy; home foreclosure; divorce; unemployment; emotional trauma; and, damaged reputation.

If we can be of assistance to you or a loved one as regards a possible Rexulti drug injury legal compensation case, please do not hesitate to contact us.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Gadolinium Retention Warnings Added To Drug Labels For Gadolinium Contrast Agents Used During MRI / MRA

Label Changes Announced By FDA In December 2017 Finally Approved For Magnevist, Omniscan, And Other GBCAs In April 2018

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

Gadolinium based contrast agents (GBCAs) are substances that are injected into patients during a Magnetic Resonance Imaging (MRI) or Magnetic Resonance Angiography (MRA) in order to produce clearer radiology images.

Over the past couple of years drug regulators around the world have started to pay attention to so-called "side effect" of certain GBCAs called Gadolinium Deposition Disease (GDD), which is a form of gadolinium toxicity and sometimes called, instead, Gadolinium Storage Condition.

However, as seen from the following excerpt from our December 2017 article "Gadolinium-Containing Contrast Agents Omniscan And Magnevist Being Recalled In The United Kingdom In February 2018", the actions taken by the FDA are different from what is being done by some other regulators:

In comparison, at the present time FDA is only requiring that there be certain changes made to the Prescribing Information, or drug label, of all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) in the US. To be clear, none of these products will be recalled from the market here.

On December 19, 2017 this document was issued, "FDA Drug Safety Communication: FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings".

The gadolinium contrast agent label changes announced in December 2017, however, were not rolled-out until several months later. For example, the FDA waited until April 2018 to finally approved the new drug label for Omniscan.

__________________________________________________________________

Gadolinium-Containing Contrast Agents

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

From the FULL PRESCRIBING INFORMATION Revised: 04/2018 document for Omniscan (accessed 5/16/18) we get the "class warnings" label change mandated by the FDA:

5.4 Gadolinium Retention

Gadolinium is retained for months or years in several organs. The highest concentrations (nanomoles per gram of tissue) have been identified in the bone, followed by other organs (e.g. brain, skin, kidney, liver, and spleen). The duration of retention also varies by tissue and is longest in bone. Linear GBCAs cause more retention than macrocyclic GBCAs. At equivalent doses, gadolinium retention varies among the linear agents with Omniscan (gadodiamide) and Optimark (gadoversetamide) causing greater retention than other linear agents [Eovist (gadoxetate disodium), Magnevist (gadopentetate dimeglumine), MultiHance (gadobenate dimeglumine)]. Retention is lowest and similar among the macrocyclic GBCAs [Dotarem (gadoterate meglumine), Gadavist (gadobutrol), ProHance (gadoteridol)].

It is important to understand that symptoms of gadolinium-related medical conditions can first appear anywhere from just a few hours until several weeks after the MRI or MRA procedure when a GBCA dye was administered by injection.

Some of the more common symptoms reported by patients are: 

• Severe pain in the bones, joints, arms, and legs
• Sensation of sharp pins and needles, cutting, or burning
• Thickening of soft-tissue, tendons, and ligaments
• Tightness in the hands and feet
• Nausea / vomiting
• Cognitive impairment
• Clouded mentation (“brain fog”)
• Persistent headache

Our law firm is investigating possible products liability lawsuits against the pharmaceutical companies responsible for the gadolinium-based contrast agents, or contrast dyes, which might cause any of these symptoms.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)

Some MRI Contrast Agents Containing Gadolinium Can Cause Problems Ranging From "Brain Fog" To Permanent Disability

Gadolinium Deposition Disease Symptoms Typically Begin Couple Of Months After Use And Can Continue For Many Years Without Any Diagnosis

 

(Posted by Tom Lamb at DrugInjuryWatch.com)

 

During MRI and MRA procedures patients often receive injections of gadolinium-based contrast agents (GBCAs).  Some of those contrast agents with gadolinium are classified as linear GBCAs -- as opposed to macrocyclic gadolinium contrast agents.

Some of the more popular linear contrast agents are Magnevist, Omniscan, and Multihance.  The Radiology Report medical record document for an MRI or MRA "with contrast" usually shows the brand name of the GBCA injected for the procedure.

A person who received an injection of Magnevist, for example, may develop some symptoms in the couple of months following their MRI or MRA procedure.  These various gadolinium-related symptoms include:

• Persistent headache;
• "Brain fog";
• Skin that appears spongy or rubbery, which is actually subcutaneous soft tissue thickening;
• Tendons and ligaments which are painful and have a thickened appearance;
• Bone and joint pain;
• Tightness in hands and feet; and, 
• Pain described as burning, cutting, or "pins and needles" in the arms or legs and the torso.

If a person starts experiencing one or more of these symptoms within two months after a linear gadolinium contrast agent was used, they may have developed gadolinium toxicity or poisoning due to the GBCA injection they received for their MRI.  This serious medical condition was rarely recognized in the medical community until the past couple of years, when it has begun to be diagnosed and labelled as "gadolinium deposition disease".

Where gadolinium toxicity is suspected by a patient or a doctor, testing for retained gadolinium is the next step in determining whether the symptoms are, in fact, due to the gadolinium contrast agent used for the MRI or MRA.  There are two types of tests which might be used:

1. 24-hour urine gadolinium test; and 
2. Heavy metal testing using blood, hair or nail samples, or urine.

If one or both of these tests are "positive" for gadolinium, the symptoms experienced by that person may be diagnosed by a doctor as related to the contrast agent injected before their MRI or MRA.

__________________________________________________________________

Gadolinium-Containing Contrast Agents

Free Case Evaluation

Strictly Confidential, No Obligation.

__________________________________________________________________

 

For background we direct you to this medical journal article, "Gadolinium in Humans: A Family of Disorders", by Richard C. Semelka, MD, et al., published in the August 2016 edition of American Journal of Roentgenology.

In large part, as seen in the two excerpts set forth which follow, it is this 2016 medical article by Dr. Semelka that raised the profile of this relatively new set of side effects associated with gadolinium-based contrast agents (GBCAs).

We begin with a diagnostic label suggested by Dr. Semelka for the constellation of symptoms that are listed above:

“Gadolinium deposition disease” is the name we propose for a disease process observed in subjects with normal or near normal renal function who develop persistent symptoms that arise hours to 2 months after the administration of [gadolinium-based contrast agents (GBCAs)]. In these cases, no preexistent disease or subsequently developed disease of an alternate known process is present to account for the symptoms.

Then we take a closer look at those various symptoms:

In our experience, symptoms of gadolinium deposition disease are similar but not identical to those observed in [nephrogenic systemic fibrosis (NSF)]. Typical clinical features include persistent headache and bone and joint pain. Patients often complain of clouded mentation that many describe as a “brain fog.” More distinctive features are comparable with those observed in NSF but of lesser severity; patients often experience subcutaneous soft-tissue thickening that clinically appears somewhat spongy or rubbery without the hardness and redness observed in NSF. Tendons and ligaments in a comparable distribution may also be painful and have a thickened appearance. Patients may complain of tightness of the hands and feet that resembles the feeling of being fitted with extremely tight gloves or socks. Patients may experience excruciating pain, typically in a distal distribution, of the arms and legs but that may also be in the torso or generalized in location. This pain is often described as feeling like sharp pins and needles, cutting, or burning.

For more about this still-developing drug injury situation, you might want to visit our Gadolinium Based Contrast Agents Side Effects information page.  As indicated there, our law firm is investigating possible products liability lawsuits against the pharmaceutical companies responsible for the linear gadolinium-based contrast agents, or contrast dyes, which might cause any of the several symptoms that fall under the gadolinium deposition disease diagnosis label.

DrugInjuryLaw.com: Medical & Legal Information About Drug Side Effects  (All website content by attorney Tom Lamb)

Drug Injury Case Evaluation - Free. Confidential. No Obligation.  (Case review done by attorney Tom Lamb)