Drug Safety Developments

Beovu Label Change Approved After Confirmation of Rare Adverse Side Effects

Retinal Vasculitis and Retinal Vascular Occlusion to be Added to Beovu Label

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

After a recent external safety committee review of Beovu, several adverse side effects of the drug were found that may lead to severe vision loss. The FDA recently approved a label change for Beovu to include "Retinal Vasculitis and/or Retinal Vascular Occlusion" to the Warnings and Precautions section of the Prescribing Information for Beovu.

Recent Adverse Side Effects of Beovu Confirmed

Since Beovu's approval by the FDA in October 2019, Novartis has received 14 reports of vasculitis occurring in patients who received the drug for treatment of wet age-related macular degeneration. Novartis, the manufacturing company for Beovu, confirmed a safety signal of rare adverse events including retinal vasculitis and retinal vascular occlusion. Both retinal vasculitis and retinal vascular occlusion can lead to severe vision loss.

The adverse events typically occurred in patients who showed signs of intraocular inflammation. Physicians are being advised to look for signs of intraocular inflammation before injecting Beovu, and should not administer the drug if signs of intraocular inflammation are present, according to a press release by Novartis.

 

Novartis' Findings on Adverse Side Effects

According to a June 2020 article written for Ocular Surgery News, the cases of Beovu-related retinal vasculitis and retinal vascular occlusion are rare:

According to post-marketing data, retinal vasculitis, retinal vascular occlusion or retinal vasculitis plus retinal vascular occlusion were evident in every 6.99 per 10,000 injections. Retinal vasculitis was evident in 1.69 per 10,000 injections, retinal vascular occlusion was evident in 1.57 per 10,000 injections, and retinal vasculitis plus retinal vascular occlusion was evident in 3.73 per 10,000 injections.

However, both retinal vasculitis and retinal vascular occlusion can lead to severe vision loss and even blindness.

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Label Change Expected

According to a June 11, 2020, Press Release by Novartis, the company is currently working with the FDA to make label changes and updates to the prescribing information for the drug:

Novartis announced today that the US Food and Drug Administration (FDA) has approved a label update for Beovu (brolucizumab) to include additional safety information regarding retinal vasculitis and retinal vascular occlusion.

A recent Beovu Label Change Approval Letter released by the FDA on June 9, 2020, notes the changes that are to be expected in the coming weeks:

This Prior Approval supplemental biologics application provides for the addition of “Retinal Vasculitis and/or Retinal Vascular Occlusion” to the Warnings and Precautions section of the Prescribing Information.

For a complete list of side effects or more information on Beovu, please visit our Beovu Drug Information Page. 

We will continue to monitor the issues surrounding Beovu and provide you with any new or relevant information.  Please feel free to share any information with us as well.

 

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Elmiron Potentially Linked to Severe Eye Disorders

Elmiron Side Effects Include Macular Degeneration and Pigmentary Maculopathy

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Elmiron (pentosan polysulfate sodium) was approved by the FDA on September 26, 1996, for the treatment of painful bladder syndrome (interstitial cystitis). More recently, however, Elmiron has been linked to cases of eye damage and vision-related injuries. 

 

Elmiron Studies on Side Effects

Several studies, including a May 2018 study and an April 2019 study conducted by Emory Eye Center, have shown a connection between Elmiron and severe eye disorders, such as macular degeneration (maculopathy), more specifically pigmentary maculopathy. Macular degeneration is a serious eye disorder, typically classified by symptoms such as central vision loss, blurred, dimmed or spotty vision, prolonged dark adaptation, and blindness.

According to a report from Science Direct, Kaiser Permanente conducted a study reviewing medical records from nearly 4.3 million patients taking Elmiron. The study found that as the quantity and dosage of Elmiron increased, so did the amount of the patient's eye damage, i.e., dose-response relationship.

 

Label Warning Discrepancies

The underlying claim for Elmiron lawsuits being filed against the manufacturing company Janssen Pharmaceuticals and other drug companies is a failure to properly warn doctors and patients about the potential risks of vision problems associated with Elmiron.

Despite claims of eye damage from Elmiron, the label and prescribing information for Elmiron in the US remarkably still states "Warnings: None". In October 2019 Health Canada required the Elmiron label to be changed,with pigmentary maculopathy added to the "Warnings and Precautions", "Post-market Adverse Drug Reactions", and "Consumer Information" sections of the label. The United States, however, the FDA has not required any such changes be made to the Elmiron label.

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Case Criteria and Current Litigation

There are currently several pending Elmiron lawsuits. The first lawsuit was brought against Teva Branded Pharmaceutical Products R&D, Teva Pharmaceuticals USA, Inc., Janssen Pharmaceuticals, Inc, and Johnson & Johnson, Inc.  This Elmiron lawsuit in the United States District Court for the District of Connecticut. 

The typical Elmiron lawsuit involves a woman between the ages of 30 to 60 who had ingested Elmiron for at least one year at a dosage of at least 100mg. The patient who is the plaintiff in the Elmiron lawsuit was diagnosed with a vision-related Elmiron side effect such as wither pigmentation maculopathy, pigmentation macular degeneration, pigmentation maculitis, retinal maculopathy or dry macular degeneration. Significantly, the patient does not need to be taking Elmiron up until the time of their Elmiron side effect diagnosis, unlike most drug injury cases.

Our law firm is currently investigating cases involving a vision-related Elmiron side effect as a possible drug injury lawsuit against the responsible pharmaceutical companies.

 

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Tasigna's Potential Effects on Treating Parkinson's Disease

Despite Side Effects, Does Tasigna Provide Any Medical Benefit to Parkinson's Disease Patients?

 

Written by: Lauren Schwab, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Recent studies on Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) drug Tasigna (nilotinib) have shown it has no significant effects on individuals with Parkinson's disease. 

 

Studying Tasigna's Effects On Parkinson's Disease

According to a May 2020 Medpage Today article, "Leukemia Drug for Parkinson's: A Second Look", researchers have found:

Over 6 months, [Tasigna (nilotinib)] had no effect on symptoms or disease progression in people with moderate to advanced Parkinson's in the phase IIa study, though it appeared safe and tolerable at both 150 mg and 300 mg doses in a population with very stringent inclusion criteria, reported Tanya Simuni, MD, of Northwestern University in Chicago.

The study came about following a small, proof-of-concept study regarding the effects of Tasigna on Parkinson's patients conducted by researchers at Georgetown University in 2016. The Georgetown study suggested possible benefits of the drug on the motor function and quality of life of Parkinson's patients.

 

Tasigna's Safety and Tolerability

Currently, Tasigna is approved by the FDA for adult or pediatric patients diagnosed with Ph+ CML in the chronic phase, adult patients diagnosed with Ph+ CML resistant or intolerant to prior therapy that included imatinib, or pediatric patients diagnosed with Ph+ CML with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy. Recently, there have been studies examining the impact of the drug on Parkinson's patients, though it is not currently approved by the FDA for use by patients afflicted by Parkinson's disease.

The study found that most Parkinson's disease patients found the drug to be tolerable, despite its lack of potential benefits. The drug was found to be tolerable at both the 150 mg and 300 mg doses, however one treatment-related serious adverse event did occur within the 300 mg group.

 

Tasigna's Side Effects and Potential Dangers

Tasigna has been linked to some serious drug side effects.  One is atherosclerosis, a disease that results in the thickening, hardening, and blocking of the arteries due to a buildup of plaque. In addition, Tasigna's side effects include heart attacks, strokes, lower limb amputations, aneurysms, and more.

For a complete list of side effects or more information on Tasigna, please visit our Tasigna drug information page. 

We will continue to monitor the issues surrounding Tasigna and provide you with any new or relevant information.  Please feel free to share any information with us as well.

 

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MiraLAX: The Quest to Get Answers from the FDA

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Over the past few years we have monitored the issues surrounding the popular over-the-counter drug MiraLAX, whose active ingredient is PEG 3350, that is often used to relieve severe or chronic constipation in children.

We have focused on the adverse reactions that have impacted children as a result of long-term usage of MiraLAX and the lack of action by the FDA to conduct the proper studies, particularly on the possible connection of developing neuropsychiatric problems.

 

PEG 3350 Study Attempts

We continue today to emphasize how the FDA has failed to provide the public, especially concerned parents, with the scientific data regarding PEG 3350 and the pediatric population.  This has been ongoing for more than 20 years, with endless delays.  

 

The Beginning of the Mess

The company who created MiraLAX, Braintree Laboratories, Inc., conducted studies on their powdered laxative product “851" PEG 3350 back in 1996.  A Medical Officer Review by Dr. Robert Prizont, MD, at the Division of Gastrointestinal and Coagulation Drug Products gives us information on the studies.  Apparently, amidst the study, stool samples were difficult to collect and even lost.  Even with the lack of evidence, the company concluded that most of the PEG was non-absorbed in the intestines, stating, “<1 %, is absorbed, and either lingers in the extracellular space for short periods or is rapidly eliminated in the urine.”

 

Braintree and PREA Waivers

Then in 2010, a Medical Review was published by John E. Hyde, Ph.D., M.D., Clinical Team Leader, DGP at the Center For Drug Evaluation and Research.  This time on Braintree Labs product SUPREP Bowel Prep Kit, discussing that a PREA (Pediatric Research Equity Act) waiver could not be applied because it was a completely new drug and there was no prior historical use.  The Pediatric Research Committee (PeRC) recommended that studies on the pediatric population should be required. This included comparisons to NuLytely, the only PEG-containing bowel prep product that was approved based on literature review.  The lack of information from the SUPREP study resulted in deferral of its Pediatric development plan.

In October 2012, a Memorandum by Erica Radden, M.D., Pediatric and Maternal Health Staff, Office of New Drugs at the Department of Health and Human services, was published.  This was in response to Braintree Labs request for a PREA waiver for their product BLI850 (aka "Suclear"), containing sodium sulfate, potassium sulfate, magnesium sulfate, and PEG-3350.  Radden supported denial of the waiver, adding, “Furthermore, BLI850, unlike Suprep, contains polyethylene glycol 3350. We are aware of potentially neuro-tox related Aes (e.g., seizures) associated with MiraLax (PEG 3350) in pediatric patients.”

NASPGHAN Q & A on PEG 3350

A January 2015 document titled, “Polyethylene Glycol 3350 (PEG 3350) Frequently Asked Questions” written by the NASPGHAN (North American Society For Pediatric Gastroenterology, Hepatology & Nutrition) Neurogastroenterology and Motility Committee, can be found on the GiKids website. The purpose of this document is to detail what PEG 3350 is, how and why it is used, and its safety.  Two of the questions and answers outlined in this document really stood out to me,

6. Is PEG 3350 safe for use in children long-term?
Several research studies have shown PEG 3350 to be safe in children when used for severalweeks to several months.  Currently there have been no studies specifically on the use and safety of PEG 3350 in children for longer periods of time.  In clinical practice, however, it is common for pediatric gastroenterologists to prescribe PEG 3350 for chronic use and there have been no reports of serious, long-term side effects in the medical literature.

It leaves us to wonder, if there is so much concern from parents about the long-term side effects, why are there no reports in the medical literature?

8. Why is the FDA sponsoring a new study on the safety of PEG 3350 and what new
information do they hope to find out?
The FDA is interested in investigating the safety of PEG 3350 use in children and for prolonged periods. Although PEG 3350 is a very large molecule which is not absorbed by the gut due to its size, there are concerns that smaller compounds, such as ethylene glycol or diethylene glycol, could be found as impurities in the manufacturing process of PEG 3350 or formed when PEG 3350 is broken down within the body.  The FDA is investigating if these smaller compounds are absorbed by the gut and accumulated in the bodies of children taking PEG 3350.  Some families have reported concerns to the FDA that some neurologic or behavioral symptoms in children may be related to taking PEG 3350. It is unclear whether these side-effects are due to PEG 3350.  This study is the first step towards trying to determine if there is truly a link.

An article of ours from November 2019, "How drugs Like MiraLAX Can Affect The Microbiome," provides some information on how drugs are broken down and can alter our bodies. 

You can also refer to our previous articles "Will the FDA Ever Push the MiraLAX Pediatric Study?" or "MiraLAX: Offical Science Effort Regresses while the Public's Investigation Progresses", for more background information on the literature surrounding the issues of PEG 3350 and its studies that have still not yet been completed

We will continue to monitor the issues surrounding MiraLAX and provide you with any new or relevant information.  Please feel free to share any information with us as well.

 

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Zantac (Ranitidine) Recalls Due to NDMA Levels

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

The Reason for Recalls

As described in the FDA article, "Questions and Answers: NDMA impurities in ranitidine (commonly known as Zantac)", the FDA is advising recalls of ranitidine if NDMA (N-nitrosodimethylamine) levels show above 96 ng or 0.32 parts per million, also known as the acceptable daily intake.  Companies are recalling a ton of ranitidine products, whether test results show high NDMA levels or there are no test results- just the potential for risk is enough for some.  Recalls have only applied to store shelves, so if you already have the medicine at home you may not know about the levels of NDMA in that product.  

Companies choosing to recall the product just due to risk potential also means that there are stores and pharmacies doing the equivalent by not selling it for the same reason.  The article notes, “Some pharmacies decided to remove ranitidine from their shelves out of an abundance of caution.  This does not necessarily mean the medicines were recalled.”

In the FDA Q & A article, one question that is addressed is whether or not a person should stop taking ranitidine medicines.  The following answer was given, 

FDA does not have scientific evidence to recommend whether individuals should continue or stop taking ranitidine medicines at this time...

Patients taking prescription ranitidine who wish to discontinue use should talk to their health care professional about other treatment options.  People taking OTC ranitidine may consider using other OTC products approved for their condition.

The FDA has provided a list of other options to take instead of Zantac (ranitidine) that are used for the same medical purpose: Pepcid (famotidine), Tagamet (cimetidine), Nexium (esomeprazole), Prevacid (lansoprazole), or Prilosec (omeprazole)

 

Lawsuits

The September FDA Statement on this issue warned about NDMA's classification as a "probable human carcinogen (a substance that could cause cancer)".  This sparked the filing of lawsuits for some people who have been diagnosed with specific cancers possibly related to the use of ranitidine medicines, those cancers being: stomach, colon, rectal, bladder, kidney, and pancreatic.  You can refer to our November 2019 article, "Zantac FDA Warning In September 2019 Leads To Lawsuits For Patients Diagnosed With Cancer", for more information.

 

Details on Zantac (Ranitidine) Recalls

By visiting the FDA Drug Recalls page on their website, you can find the Companies (Drug Brand Names) and Product Description for recalled Zantac / Ranitidine medicines since September 23, 2019:

    • Amneal Pharmaceuticals, LLC: Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup 15          mg/mL

    • Precision Dose Inc.: Ranitidine Oral Solution, USP 150 mg/10 mL

    • GSMS, Inc.: Ranitidine HCl 150mg and 300mg Capsules

    • American Health Packaging: Ranitidine Liquid Unit Dose Cups

    • Aurobindo Pharma USA, Inc.: Ranitidine

    • Lannett Company, Inc.: Ranitidine Syrup 15mg/mL

    • Novitium Pharma: Ranitidine Hydrochloride Capsules 150 mg and 300 mg

    • Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s, Kroger, Walgreens, and others): Ranitidine Tablets &        Capsules

    • Perrigo Company plc: Ranitidine (all pack sizes)

    • Apotex Corp.: Ranitidine Tablets 75mg and 150mg

    • Sandoz Inc.: Ranitidine Hydrochloride Capsules

    • Sanofi: Zantac 150, Zantac 150 Cool Mint, Zantac 75 (OTC Products)

 

What Will the FDA Do Now?

A December 5, 2019 FDA Statement, "Statement from Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.", gives the following insight,

The FDA will continue to investigate the source of these impurities, but it is important to note that there are multiple reasons why NDMA can be present in drugs.  Previously, we found the source of NDMA can be related to the drug’s manufacturing process or its chemical structure or even the conditions in which they are stored or packaged.  As food and drugs are processed in the body, nitrosamines, including NDMA, can be formed.  The FDA continues to test and research possible sources for the several drugs found to contain NDMA.

 

Our law firm will continue to monitor the Zantac (ranitidine) situation and how the FDA handles this issue from here on.  We will share any new or relevant information, especially regarding the drug's possible relation to specific cancers. 

 

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How Drugs Like MiraLAX Can Affect The Microbiome

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

The recent UPI article, “Common Meds Alter Microbiome, Increase Antibiotic Resistance Risk”, informs that there are classes of popular medications that can have an effect on a person’s gastrointestinal tract by altering its bacterial composition of approximately 1,000 species. Several health conditions have been a result of this interaction, such as: obesity, diabetes, liver diseases, cancer, and neurodegenerative diseases. In knowing this, Arnau Vich Vila, lead researcher at the University Medical Center Groningen, noted that, "It is crucial to understand which are the consequences of medication use in the gut microbiome".

 

The Study

We learn from the UPI article that Dutch researchers studied 41 common categories of drugs, 18 of which had significant effects on the gut microbiome and 8 that increased the risk of antimicrobial resistance. Some of these were laxatives that are used to treat and prevent constipation. We know MiraLAX (PEG 3350) to fall under this category.

A part of the study they, "assessed 1,883 fecal samples from people who did and didn't take the drugs, including some with irritable bowel syndrome, or IBS, and inflammatory bowel disease, IBD".

According to the article, Arnau Vich Vila stated the following in a news release, 

Our work highlights the importance of considering the role of the gut microbiota when designing treatments and also points to new hypotheses that could explain certain side-effects associated with medication use.

 

How to Connect MiraLAX

When the gut is "off" per-say, many other things in the body can, in turn, be "off" as well. So, we can see how this might point to the possible connection between MiraLAX and neuropsychological problems. 

It is refreshing to see that there is a study such as this one, that can give some sort of perspective on how the use of a category of medications like laxatives may result in effects other than what is intended. You can refer to our August article, "Will the FDA Ever Push the MiraLAX Pediatric Study?" to learn more about the concerns of PEG 3350 affecting children's health.

 

For Parents and the Curious Public

If you are a parent or other family member that has concerns about a child in the family taking MiraLAX, you may want to consider joining the Facebook group called “Parents Against Miralax”.

 

As always, we will continue to monitor the MiraLAX situation and provide you with any new or relevant information. 

 

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Hepatitis C Drugs Causing Rare But Serious Liver Damage

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Hepatitis C drugs, designed to decrease liver damage, have been scrutinized for escalating the problem.  In the past, our articles have discussed the possible association between some specific hepatitis C drugs and liver cancer.  Recently, the FDA has identified three hepatitis C drugs that may pose a threat to patients' liver function.

 

New Drug Warnings

On August 28, 2019, the FDA In Brief report, "FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease" discusses the hepatitis C drugs Mavyret, Zepatier, and Vosevi, which have recently been found to cause worsening liver conditions. There have been 63 confirmed cases of patients taking these drugs and having this side effect. 

The same day, Reuters published the article, "FDA flags serious risks with hepatitis C drugs from AbbVie, Gilead and Merck", identifying the manufacturers at the forefront of the situation and stating that they had not provided any comments on the issue.

According to the FDA, these hepatitis C drugs are approved for people with little to no liver damage but not for those with moderate to severe liver damage. The medicine will work safe and effectively on those with less damage.

 

Possible Rare but Severe Side Effects

The FDA In Brief article, brings to attention that when someone who already has moderate to severe liver damage takes these drugs, the result may be the worsening liver function called decompensation. This can lead to liver failure or even death.

The corresponding FDA Drug Safety Communication, "FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease", informs that patients who are at risk should look out for signs of worsening liver conditions which are: "fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools". 

The FDA conveyed in the FDA In Brief article that,

In some cases, patients were reported as having no cirrhosis, or liver scarring, or cirrhosis with mild liver impairment (compensated cirrhosis) but had indications of advanced liver disease or risk factors for liver impairment, such as decreased platelets, portal hypertension (increased pressure in the portal vein, the vein that carries blood from the digestive organs to the liver) caused by a blockage in the blood flow through the liver, alcohol abuse or other serious medical illnesses associated with significant liver problems before starting treatment. In most patients, symptoms resolved or new onset worsening liver function improved after stopping the medicine.

The FDA notes that these three hepatitis C drugs are safe to continue prescribing to those as needed but if the patient is showing signs of worsening liver function, the drug should be stopped. Additionally, the risk should be known to the public but it is a rare occurrence and no one should stop the drug unless told by their doctor. 

We will continue to provide any new or relevant information regarding the topic of hepatitis C drugs Mavyret, Zepatier, and Vosevi, and the risk of worsening liver conditions.

 

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Breast Cancer Drugs: Beneficial But May Cause Rare and Serious Lung Complications

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

The topic of breast cancer is extensive because it has different forms, which means there are different treatments depending on the type a person has. MedPage Today recently published an article, "FDA: Novel Breast Ca Drugs Linked to Severe Lung Illness", which discusses how some specific drugs used to treat breast cancer can cause severe lung issues and even death.

The FDA put out this warning on September 13th, 2019 after the release of data from completed and ongoing post-marketing trials on the drugs Ibrance, Kisqali, and Verzenio. These drugs were approved by the FDA just a few years ago: Ibrance in 2015, Kisqali in 2017, and Verzenio in 2017.

These kinds of drugs are called CDK4/6 inhibitors and are, "used in combination with hormone therapies for patients with advanced or metastatic hormone receptor-positive, HER2-negative breast cancer."

In the recently published September 13th, 2019 FDA Drug Safety Communication, "FDA Warns About Rare but Severe Lung Inflammation with Ibrance, Kisqali, and Verzenio for Breast Cancer", the FDA now recognizes there may be some rare but troublesome side effects from these breast cancer drugs, specifically regarding lung issues other respiratory issues.  As a result, the FDA describes that:

Health care professionals should monitor patients regularly for pulmonary symptoms indicative of pneumonitis or interstitial lung disease. Signs and symptoms may include hypoxia, cough, dyspnea, or interstitial infiltrates on radiology exams in patients in whom infectious, neoplastic, and other causes have been excluded.

These breast cancer drugs are viewed by medical professionals as more beneficial than harmful, however, respiratory and lung issues need to be taken into serious consideration here. The FDA Drug Safety Communication notes that symptoms such as "difficulty or discomfort with breathing and shortness of breath while at rest or with low activity" should be monitored.

As always, we will continue to provide information and updates on the broad topic of breast cancer as new developments come along.

 

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Will the FDA Ever Push the MiraLAX Pediatric Study?

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

Throughout our previous articles on the topic, we often discuss how the Children’s Hospital of Philadelphia (CHOP) has had a seemingly endless delay in their study on the effects of PEG 3350 (the main ingredient in MiraLAX) in children.  A study that was originally supposed to be completed in 2015 and then by the end of 2018, is still incomplete.  You can read our January 2018 article, “MiraLax Pediatric Study on Psychiatric Side Effects Projected to be Completed in 2018", for more details about the study itself.

 

Concerns Resurfacing

An interesting New York Times article from 2015 was recently brought to our attention.  Within the article, “Scrutiny for Laxatives as a Childhood Remedy”, is what the FDA had to say about the then-upcoming CHOP study:

The new study in Philadelphia will address how PEG 3350 is metabolized by children and whether they have evidence of toxins in their blood.  "Due to the frequent use of PEG 3350 products in children," Mr. Ventura said, "we believe further study is warranted to understand the absorption of [ethylene glycol (EG)] and [diethylene glycol (DEG)] by pediatric patients who take these products."

According to this article, scientists of the FDA actually found trace amounts of these chemicals in MiraLAX back in 2008 during testing, as seen here:

Buried in the agency’s brief to researchers, issued [in 2014], was some disquieting news. The F.D.A. said that it had tested eight batches of Miralax and found tiny amounts of ethylene glycol (EG) and diethylene glycol (DEG), ingredients in antifreeze, in all of them. The agency said the toxins were impurities resulting from the manufacturing process.

Those tests were conducted in 2008, but the results were not disclosed. Jeff Ventura, an F.D.A. spokesman, said batches were tested because “many of the reported adverse events were classic symptoms of ethylene glycol ingestion.”

To be clear, what happened here is that the FDA did their tests on MiraLAX in 2008, but the FDA never disclosed their findings of EG and DEG until the release of this New York Times article in 2015.

 

Safe or Unsafe?

A previous article of ours, “Inconclusiveness of MiraLAX Studies Leading to Frustration for Parents”, discussed a new study which aimed to find out about the long-term use of PEG 3350 in children since the CHOP study was failing.

Within this study there was mention that DEG and EG are “compounds which are neurotoxic at high concentrations” and, back to the New York Times article, we learn:

As it turns out, extremely small amounts of DEG and EG are permitted in finished drug products, and the F.D.A considers the laxatives ‘safe to use in accordance with approved labeling’ - that is, only by adults for not longer than seven days.

Okay so that goes for adults but what about children?

Yet no one knows if small amounts of EG or DEG found in the laxatives or present once metabolized might harm children, especially those given the laxatives chronically.

 

With the information from this New York Times article alongside the information we've talked about in various articles published previously by our firm, we are not left with a whole lot of clarity on the MiraLAX situation.  Our understanding is that this CHOP study which was introduced so long ago has failed in developing the necessary components to complete the study and produce some answers for the very concerned public -- especially parents whose children are suffering. 

From our perspective, now is the time for FDA to actually put forth some effort and get this CHOP study finished.  Or, in the alternative, create a new study about the safety of pediatric MiraLAX use since this CHOP study has seemingly failed for too long.

 

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Xeljanz Safety Concerns and New Precautions

 

Written by: Laura Beasley, Legal Assistant

Law Offices of Thomas J. Lamb, P.A.

 

You may have read our previous articles about Xeljanz and its risk of leading to Pulmonary Embolism or even death.  In June, we posted "Xeljanz Related Blood Clots Can Cause Pulmonary Embolism (PE) Or Deep Vein Thrombosis (DVT) With Patient Deaths Possible" that provides information on the serious side effects found out through a post-marketing study on the drug.  The FDA has finally put in place the “Black Box Warning" to draw attention to these serious risks.

 

Treatment and Trials

Xeljanz can be used to treat ulcerative colitis as well as psoriatic or rheumatoid arthritis.  The recent article, “FDA Requires Box Warnings for Pfizer Drug Xeljanz”, relays information from the FDA that the 10 mg dosage twice a day should not be used for the aforementioned types of arthritis, just ulcerative colitis.  Even further, it should only be used for ulcerative colitis if other medications are not sufficient for the patient.

The use of Xeljanz for the treatment of rheumatoid arthritis was discussed in the Milwaukee Journal Sentinel article, “FDA puts stringent warning on the Pfizer drug Xeljanz because of clots and deaths”, noting that:

The FDA also released data from a safety trial of the drug in people with rheumatoid arthritis, showing there were 19 blood clots in the lungs in those who got higher-dose Xeljanz compared with three who got other drugs known as TNF blockers. There also were 45 deaths in those who got high-dose Xeljanz compared with 25 who got TNF blockers.

The "Black Box Warning" came five months after this clinical trial.  The FDA has received public criticism, such as from physician Michael Carome with Public Citizen, for "moving more slowly and less aggressively to protect public health relative to regulators in other countries"

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New Safety Precautions

Medscape also just published an article on the subject, “FDA Adds Boxed Warning on Risk for PE, Death With Higher Dose Tofacitinib (Xeljanz)”, which reports that in May, health officials in Europe had already advised physicians against the twice a day 10 mg dose of the medicine due to high risk of PE.

Edward V. Loftus, Jr., MD, the Chief Medical Editor of Healio Gastroenterology and Liver Disease, notes:

Based on what I have read, I do not know what the actual magnitude of that risk is, in other words, what’s the relative risk or absolute risk for thromboembolism?

But, there must have been some signal at the higher dose that they saw this signal and so, the European's put out the warning and now the FDA is basically putting out the same warning and they are making it a boxed warning.

While this is confusing, we just have to be cognizant of the warning, which is use the lowest dose possible that keeps your patient in remission.

 

As more information and developments arise regarding the safety of Xeljanz, we will make sure to provide updates whenever possible.

You can visit our law firm's website to submit a free case evaluation if you think you or someone you know may have a personal injury or wrongful death lawsuit as a result of Xeljanz side effects.