Drug Safety Developments

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. 

Textured Breast Implants Ban: Will the FDA Reevaluate?

 

Written by: Laura Beasley, Legal Assistant

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

As we have continuously discussed here, textured breast implants are being banned in some countries not including the U.S. You can refer to our most recent previous article on the topic, “U.S. FDA Refrains from Textured Implants Ban”, to explore what has happened thus far worldwide as regards banning textured breast implants due to the risk of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL).

 

The FDA’s Reasoning

It is our understanding that the FDA is choosing to not ban textured breast implants in the U.S. due to the lack of a strong causal relationship between this particular type of implant and BIA-ALCL.

In March of this year, the FDA sent out warning letters to both Allergan and Mentor because they did not conduct the necessary post-approval study requirements. An April 2019 article of ours, “March 2019 FDA Meeting on Breast Implants: A Summary Of What You Need To Know”, can provide you with the information contained in the warning letters and details about the post-approval studies.

 

Statements from the Manufacturers

Healio just published an article, “FDA weighs breast implant risks, benefits amid links to cancer, other illnesses”, which includes statements from representatives of both Allergan and Mentor defending their companies’ products.

Both vice presidents from Allergan and Mentor / Johnson & Johnson have expressed similar thoughts about their companies' products in response to the FDA's warning letters. Essentially, they both vouch that their breast implants are monitored and supported by large and long-term clinical studies. In response to the warning about their memory shape implants, Raina Dauria of Mentor / Johnson & Johnson adds:

The use of textured devices in the U.S. has decreased substantially, and Mentor has been challenged in enrolling this study group, despite taking steps to increase enrollment.

As regards the general discussion of potential risk of BIA-ALCL, Stephanie Manson Brown, MD, of Allergan shares: 

Patients with BIA-ALCL can have an excellent prognosis when identified early and treated appropriately... the leading hypothesis centers around biofilm and there are three likely factors that contribute to this, including procedure, product and patient.

This May 2019 Helio article also discusses the onset of symptoms of BIA-ALCL, from the perspective of The University of Texas MD Anderson Cancer Center, with delayed seroma as apparently being the most prominent symptom. Mark Clemens, MD, notes the association between specific brands of implants and the risk of BIA-ALCL. That risk is apparently 7.1 to 8.3 times higher with Allergan Biocell implants compared to all other manufacturers combined.

Canada in Contrast

Allergan may have only received a warning letter in the U.S., but in Canada its sales are being put to a halt. Two days ago Canada’s government website published the article, “Health Canada suspends Allergan's licences for its Biocell breast implants after safety review concludes an increased risk of cancer”, which informs that Health Canada has determined a much higher risk of BIA-ALCL in relation to macro-textured implants, this being 85% of the 26 confirmed cases in Canada. As a result, they have suspended the sale and import of Allergan’s Biocell breast implants and Allergan is voluntarily recalling such unused implants.

An article from Reuters published on the same day, “Allergan to recall textured breast implants in Canada” delivers this quote:

Health Canada’s decision is in contrast to public rulings and positions by other regulatory bodies around the world, including the U.S. Food and Drug Administration’s (FDA) recent position, Allergan said.

With such a strong conclusion from Health Canada regarding the risk of BIA-ALCL from textured implants and the hundreds of women who have been diagnosed, even some deaths occurring, we should wonder... is the FDA going to change its mind?

 

We encourage you to visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic of breast implants and BIA-ALCL.

U.S. FDA Refrains from Textured Implants Ban

 

Written by: Laura Beasley, Legal Assistant

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

 

In our most recent article on breast implants and their link to Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), “Textured Breast Implants Bans on the Rise” we left off wondering whether or not the U.S. was going to follow in the footsteps of Canada and France as regards banning textured implants.

 

No Ban in the U.S.- Why?

As of early May, we can now confirm that the U.S. will not be part of the ban at the current time.

The New York Times provided us with an article on May 2, 2019, “F.D.A. Won’t Ban Sales of Textured Breast Implants Linked to Cancer” which informs us that while most BIA-ALCL cases have occurred in relation to textured implants, the risk and data is still too low to prompt a ban. Smooth implants cannot be disregarded as a potential cause for the rare lymphoma.

This may have you questioning whether or not a ban on textured implants should occur, since the potential risks have been made well-known and other countries have already banned them. This May 2019 New York Times article educates us that, “Only about 10 percent of the implants used in the United States are textured, but in other countries the figure can be as high as 80 percent” 

Additionally, on May 3, 2019, The Washington Post published an article, “FDA won’t ban breast implants linked to cancer at this time” which shared information similar to the article from The New York Times, but gives some additional insight:

The FDA does not believe the product — a kind of textured implant — meets the legal standard for being banned at this time, based on available data and information, according to a statement issued Thursday by Amy Abernethy, FDA principal deputy commissioner, and Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

Measures to be Taken Rather than a Ban

An NBC news article from May 3, 2019, “FDA will not ban textured breast implants at this time” tells us that the FDA plans to make label changes and requirements for reporting incidents:

The agency says it plans to work with patient groups and manufacturers to make changes to the labels of textured implants that could include a black box warning - the FDA’s strictest caution. Manufacturers will also be required to submit adverse event reports instead of the current practice of quarterly summary reports, and details of these will now be made available to the public.

The May 2019 Washington Post article reiterates the possibility of the black-box warning to come and adds that the FDA “may require doctors and patients to sign risk checklists to make sure patients have the necessary information to make an informed decision.”

In furtherance, the FDA is going to require individual medical device reports to be filed by the manufacturing companies if any problems occur with the breast implants. This will ensure that the presence of these breast implant problems is made more available to the public.

 

Even without an FDA ban, it seems like women may steer away from textured implants altogether now because of the associated risks. Rest assured that we will continue to monitor the situation of textured breast implants and report any new information as regards the FDA's plan considering there will be no ban. You can visit our Breast Implants Lymphoma Cancer page on our website for more information on the topic.

MiraLAX: Official Science Effort Regresses while the Public's Investigation Progresses

 

Written by: Laura Beasley, Legal Assistant

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

 

Recent Communication with the FDA and CHOP

If you have kept up with our previous articles on MiraLAX, or follow the issue in general, you may have noted the ongoing delay in the Children's Hospital of Philadelphia (CHOP) PEG 3350 study and the lack of information from both CHOP and the FDA on the matter. Refer to our earlier article, “Efforts to Advance MiraLAX Studies and Innovations to Inform the Population”, to grab some details of the study.

Now it appears the same problem is occurring. Those who advocate for and investigate the MiraLAX issue have been in communication with CHOP and the FDA, urging both to provide some sort of an answer as to what is going on with the CHOP study. Ultimately, why children still are not even enrolled when the study was supposed to be completed in 2018.

The FDA’s press has said, “assays required to analyze the data that will be gathered raise novel scientific issues and will be challenging to develop...the FDA is providing additional assistance with this... we have asked CHOP to give more frequent updates”

Meanwhile, a representative from CHOP has said they are, “actively working with the FDA to finalize methods of this study and an announcement will be made once we start enrolling patients”

 

FAERS and OpenFDA Inconsistencies

It has come to our attention that running MiraLAX and polyethylene glycol (PEG) 3350 on the FDA Adverse Event Reporting System (FAERS) and OpenFDA gives very different results. FAERS shows the total cases for MiraLAX at 24,413 and PEG 3350 at 26,924. On the other hand, OpenFDA shows the total reports in its database for MiraLAX at 43,340 and PEG 3350 at 64,125.

This huge data discrepancy was sent to the Center for Drug Evaluation and Research as an inquiry. The response was that, “All data in FAERS public dashboard is based on FAERS data. We are not familiar with the source for OpenFDA reports. FAERS public dashboard shows ONLY suspects [sic] drugs. That could be one of the reasons for the discrepancy since OpenFDA could show both suspect and concomitant [drugs].”

 

Film for Thought

An upcoming film, "My Kid is Not Crazy", takes an interesting perspective on the issue of neuro-psychiatric problems in young children.

Dr. Susan Swedo with the National Institute of Health dedicated her time to researching, understanding, and finding the cure for the condition she calls “Pediatric Autoimmune Neuropsychiatric Disorder Associated with Streptococcal Infections (PANDAS)” You can visit the film’s website to learn more about what PANDAS is.

It appears the main takeaway that the audience will get from this film is that children who develop the symptoms of PANDAS may often be diagnosed with a mental illness. As a result, they may be given medications or other treatments to combat their “neuropsychiatric issue”. Doctors are quick to settle on such a diagnosis and pharmaceutical companies are happy to make money off of the medications.

To understand how this film relates to the MiraLAX issue, you can read the May 2017 article of ours, “Growing Concern About Reports Of Children Who Developed Neuro-Psychiatric Problems After Taking MiraLAX”. Both PANDAS and MiraLAX present the same sort of issue in the behavior of young children.

 

We will continue to monitor the MiraLAX issue, including new developments and study updates. As always, we are open to any relevant information parents and medical researchers may have and intend to keep the public as informed as we are. 

 

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Textured Breast Implants Bans on the Rise

 

Written by: Laura Beasley, Legal Assistant

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

 

As previously stated, we have been keeping up with what is going on as regards the dangers of breast implant procedures in relation to the rare blood cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma. For more a more extensive background of BIA-ALCL in relation to breast implants, visit our Breast Implants Lymphoma Cancer page on our law firm's website.

 

Numbers Update

An NBC News Article, “French authorities call for ban of Allergan textured breast implants” provides us with recent data on this issue. The number of BIA-ALCL diagnoses has gone from one per million to one per 2,832. The total number of cases now is 457 in the U.S. and approximately 700 worldwide. The number of deaths has risen from 9 to 16.

 

BIA-ALCL Education is a Necessity

Earlier this month, a MedPage Today article, “Breast Implant-Associated Lymphoma on the Rise” asserts the need for doctors and patients to understand the risks, signs, and symptoms of BIA-ALCL prior to any breast implant procedure, but especially ones with textured implants. This way, patients are able to give educated, informed consent before undergoing a procedure. Patients have been previously misdiagnosed due to the lack of awareness or failure to conduct appropriate practice recommendations. The earlier BIA-ALCL is diagnosed, the better. 

 

Ban on Textured Implants

The February 2019 NBC News Article informs that in the beginning of February, France banned Allergan’s textured breast implants. 85% of the French market comes from textured breast implants, but they have become too increasingly associated with BIA-ALCL. The ban was put in place two days after the FDA’s public investigatory hearing regarding the health risks surrounding breast implant devices. You can refer to our recent article from early April, “March 2019 FDA Meeting On Breast Implants: A Summary Of What You Need To Know” for a concise version of what took place at the meeting.  

We learn from the ICIJ article, “Canada Halts Sales of Cancer-Linked Breast Implants, as Global Scrutiny Grows” that now two more countries, Canada and the Netherlands, are following France's decision.

A recent February article of ours, “Breast Implants Lymphoma Cancer Cases Updates For United States And Canada: February 2019" provides information as to the earlier stages of this issue in Canada. Now, Canada has announced its plans to ban textured breast implants, with intent from Health Canada to alert Allergan of the upcoming suspension of implant sales. 

In the Netherlands, the Dutch National Plastic Surgery Association has voluntarily suspended macro-textured and polyurethane implants, in response to an urgent request from the Dutch health minister.

This ICIJ article also highlights new findings and developments on breast implant risks:

According to one forthcoming study, Silimed polyurethane textured implants pose a 23-times higher risk of ALCL, and Allergan Biocell textured implants pose a 16-times higher risk of ALCL, than lower surface area Siltex textured implants by Johnson & Johnson. Based on data from Australia and New Zealand, the study will appear in the May issue of the journal Plastic and Reconstructive Surgery.

This issue is evidently becoming increasingly troublesome in the United States and other countries around the world. As always, we will continue to monitor new information and developments in the BIA-ALCL literature, and to see if the U.S. may follow in the decision to ban textured implants.