Sun Pharmaceutical Industries Are Releasing Dangerous And Deadly Drugs That Keep Getting Recalled In America And Abroad

December 9. 2025

Sun Pharmaceutical Industries

For background information on this article please read: "The FBI Is Stonewalling Congress On Releasing FBI File In Madonna Human Rights Abuse Case (Congressional Documents)" and "The FBI Has Been Criminally Going Into Hospitals And Medical Clinics In America Damaging And Killing Patients For Political And Financial Gain (Videos, Medical Documents, Photos)."

As stated on the site previously, my mother became ill due to a questionable series of events that were highly unethical, criminally negligent and worthy of indictment. It began on August 31, 2023 with Cano Health in Miami, Florida where we reside. I wrote about the incident concerning the perplexingly poor and terrible medical care Cano Health gave my mother, which nearly killed her (the October 2023 article The FBI Has Been Criminally Going Into Hospitals And Medical Clinics In America Damaging And Killing Patients For Political And Financial Gain (Videos, Medical Documents, Photos)).

Sun Pharmaceutical Industries

Several months after my aforementioned article on this site, Cano Health declared bankruptcy and cited $1 billion in losses (Cano Health Closes Locations After Filing For Bankruptcy). The pharmaceutical drug that Cano Health prescribed my mother which severely damaged her is called Bactrim (Trimethoprim-sulfamethoxazole). It was prescribed by a Cano Health doctor at their Miami Shores location. The physician is Dr. Isamar Caro Cortes (whom I can no longer find listed anywhere at all and Cano Health recently said, "She left when the practice closed down").

My my mother trusted Cano Health only for them to engage in inexplicable behavior that nearly cost my mom her life. The day my mom was prescribed Bactrim, Dr. Caro Cortes, was acting strangely. She was usually upbeat, nice and chirpy during medical visits and at that point my mom had been to her for appointments at least a dozen times. However, on that day, August 31, 2023, for the first time she was grim and withdrawn. I immediately noticed a change in her demeanor. Something was wrong.

Cano Health

I later learned that Bactrim is a very damaging drug. However, when you go into a doctor's office, you want to trust what they are telling you. One really does not want to be second guessing a doctor, because a nefarious third party is lingering in the background ("The FBI Has Been Criminally Going Into Hospitals And Medical Clinics In America Damaging And Killing Patients For Political And Financial Gain (Videos, Medical Documents, Photos)).

It should be noted, Madonna has sent members of her cult to follow my mom and I into medical appointments, such as when my mom had her cataracts surgery in 2020 (in Aventura which is a city in Miami) and in 2016 when I went for treatment at a cardiologist's office in North Miami Beach at a location that is a part of Jackson North Medical Center, later written about here: The FBI Has Been Criminally Going Into Hospitals And Medical Clinics In America Damaging And Killing Patients For Political And Financial Gain (Videos, Medical Documents, Photos)).

There were other incidents as well. Madonna's cult members would harass us in the waiting rooms of medical offices. During an incident after one of my mom's medical appointments at Cano Health in Miami Shores, one of Madonna's deranged Kabbalah cult members tried to run us off the road on the highway of all places. It happened at the curvy Golden Glades interchange in Miami. Cano Health's medical transportation was returning my mom home (I had accompanied her on the medical visit).

One of Madonna's cult members was driving a dark red/burgundy vehicle and had another woman in the passenger seat. She kept aggressively trying to run us off the road. She kept screaming at the Cano Health driver calling him a "fa*got" over and over again, and also putting up her middle finger in an obscene gesture. He hadn't done anything to her and was alarmed by her deranged behavior. We all could have been killed because that lunatic kept trying to run us off the road for a couple minutes. She was in heavy pursuit and kept aggressively and suddenly veering to her right, which forced the Cano Health driver to repeatedly steer to his right to avoid her crashing into the vehicle. He began speeding up to get away from her. Then she would speed up to catch him and immediately start aggressively veering her vehicle to the right as if to hit us, in trying to force us off the road. If someone forces you off the Golden Glades Interchange in Miami it is about a 50 foot drop to the road below or into the grass.

During another incident that occurred during a separate medical visit, upon being driven home from the Cano Health appointment, one of Madonna's Kabbalah cult members was barreling down the road full speed and nearly slammed into the vehicle we were in. The Cano Health driver (not the same as the one mentioned above) was in shock, saw the car coming at us full speed and quickly reversed at the stop light outside the gated community my mom and I lived in, to avoid being hit. That would have been a horrible accident, as the other vehicle was going about 90 MPH, well above the speed limit.

It's the same gated community Madonna moved two of her cult members into, who approached me on the grounds and started spouting off her Kabbalah rubbish no one wants to hear. They told my cousin that Kabbablah moved them into their own apartment at the gated community and is paying all their bills. They were constantly targeting me in the complex. A few hundred people live in there yet they kept finding and approaching me with threatening speech. That was criminal stalking and harassment of the highest order.

I'm of the belief, based on what I was told by a credible source, Madonna's cult was criminally involved in my mom being prescribed Bactrim, which was dangerous for someone her age. A very credible and accomplished individual familiar with legal proceedings concerning Madonna's deranged Hollywood cult Kabbalah, alleged to me that Madonna interfered in my mom's healthcare. My mom's doctor is now nowhere to be found. Not even Cano Health, her employer at the time, knows where she has gone. Two of Cano Health's offices told me they don't know where the doctor has gone. It's weird as she is not listed at any other medical office or hospital in America. Something happened. What I don't know. Dr. Caro Cortes is definitely too young for retirement (in her mid-thirties).

What Cano Health has done in illegally hiding my mom's medical records for 2-YEARS to cover up what occurred with prescribing her Bactrim, which nearly killed her, is highly questionable on their part. My mom's medical records were formally requested twice in writing, even to Cano Health's headquarters. They promised to release the medical records but did not do so. They have violated HIPAA with this misconduct. In America, you are not permitted to withhold a patient's medical records, yet Cano Health has willfully done so in violation of HIPAA to hide their misconduct. And Cano Health knew Bactrim was killing people (please see the next paragraph for more information on this).

The more I researched what transpired and spoke to doctors and nurses not involved in the situation, the more it was confirmed that Bactrim was the culprit in what could have cost my mother her life. In September of this year I learned that Bactrim killed at least two kids (could be up to 30 according to one report) who were prescribed the drug for infections.

Abigail Caldwell

In 2019, a bubbly, pretty 10-year-old girl, Abigail Caldwell, of Springfield, Missouri, died after she was prescribed Bactrim for a scalp infection. Her mother revealed Abigail had no preexisting conditions. Abigail's family stated she was perfectly healthy before Bactrim gave her organ failure and she suddenly died (lung failure).

 Zei Uwadia

In 2019, Wichita teenager Zei Uwadia died due to being prescribed Bactrim. It created a deadly lung illness that killed the bright young girl. She had no preexisting conditions. The drug Bactrim created organ failure in both girls. Years later in 2023, the drug Bactrim began creating MULTIPLE organ failure in my mom. By God's grace I got her to the hospital in time or she would have died from multiple organ failure.

I also learned Bactrim killed over 320 people in tandem with another drug, as reported by the National Institute of Health in America (Trimethoprim-sulfamethoxazole and spironolactone). In fact in 2021 the U.S. Food and Drug Administration (FDA) sent out a warning of it causing sudden death. So clearly there is a problem.

My mom was prescribed Bactrim on August 31, 2023 by her doctor at Cano Health. After approximately a week of use my mom began speaking gibberish and losing consciousness. It happened suddenly one night. I'd never seen her like that before. When I called Cano Health they told me it is an allergic reaction to Bactrim. They asked me if I have any unopened antihistamine and I sad yes (I won't name the antihistamine, as the over the counter product had nothing to do with what occurred and I'm not trying to involve them in this). Cano Health told me to give my mom the antihistamine. They also told me to wait it out and don't take her to the hospital. After about 12-hours of not noticing any improvement in my mom's condition after the antihistamine and thinking to myself "how can an antihistamine possibly fix this" I dialed 911 and she was rushed to the hospital (I went with her in the ambulance).

Mom was immediately admitted into the emergency room then later the ICU. She was hospitalized for 10-days and nearly died because of Bactrim. Firstly, Bactrim did not work against the infection (she nearly lost her kidneys, with the baffled doctor telling me she would need dialysis from now on but God gave her a miracle and the problem reversed in four days). Secondly, Bactrim also produced terrible adverse reactions that were destroying her health in multiple ways. I prayed over the situation as it happened because it was terrible. I was literally in her hospital room praying all the time. In all my mother's many years of life nothing like this had ever happened to her regarding her health. I do not recommend the drug Bactrim.

She was given another drug at the hospital and within 2-days my mom regained full consciousness and stopped speaking gibberish. The shaking and convulsions that began happening that morning in the hospital also stopped. The red rash caused by Bactrim also began improving. She was still weak and distressed but at least she was conscious and speaking in clear sentences again. Within 4-days her kidneys began improving to the point the nephrologist who had spoken to me on the Monday my mom was admitted to the emergency room, who warned something was trying to destroy her kidneys (he was genuinely baffled and wondering if a pharmaceutical drug was doing the damage) came back on Thursday and told me her kidneys are now fine and she won't need dialysis.

When my mom was admitted to the hospital in September 2023, right away I contacted my cousin in London who is a top doctor (she has two practices, chaired medical committees, worked in Parliament as part of a medical advisory board and was head of medicine of a borough in London). I told her my mom is sick and in the hospital. I told her what happened and what she was prescribed. My cousin immediately wanted to know why she was prescribed Bactrim because, "It does more harm than good." She also explained there were parliamentary hearings on Bactrim in Britain. I looked it up and people testified how Bactrim severely damaged them. I could not believe Cano Health gave my mother such a damaging drug. It is clearly very damaging and poses a high risk to children and the elderly in particular.

When my mom was discharged from the hospital, her doctor from Cano Health called and apologized for what happened. However, the whole episode had already done extraordinary damage. My mom who loved to cook, visit her friends and go shopping, was so weakened and damaged from Bactrim and its failures as a medication, she became withdrawn and unable to follow in full things she understood before. In the space of a couple weeks Bactrim had done cognitive damage.

For example, there are two shows in particular that my mom loved to watch each weekday. After taking Bactrim then getting out of the hospital, which was about a month in total, mom had trouble using the remote control, which she had no issues with before, and she didn't understand some of the things on her favorite shows she had watched since the 1990s. She remembered the names of the characters but at different points in the show she would ask "what does that mean?" and "what do they mean by that?" when she understood these things perfectly before. Even jokes on different television shows or those told to her by others that she would understand before, she didn't anymore and wouldn't laugh. She'd literally ask me what different jokes meant when she understood these types of things before.

She began confusing left with right, up with down, move backward with move forward. She'd try to turn the television up using the remote but instead pressed the down key and vice versa. She'd mean to press the channel up key on the remote but pressed the channel down key instead. She would get flustered. All this happened in the space of one month because of Bactrim. I looked at the whole situation alarmed and angry. So at that point I wanted everyone involved on the wrong side of my mother's preventable health crisis to be renditioned, water boarded and sent to Guantanamo Bay.

In September 2025, in response to something I had filed, I was contacted by Sun Pharmaceutical Industries, who are located in New Jersey, and own the patents for Bactrim. Sun Pharmaceutical Industries also distributes Bactrim in America (they bought the patents from Roche). The name of the Sun Pharmaceutical Industries representative who called me is Samantha. Sun Pharmaceutical Industries contacted me because they saw I had initiated legal action against them on behalf of my mother. However, I had not served them yet. I kept asking how she knew but she wouldn't tell me. She apologized profusely and repeatedly for what happened to my mom, and asked me a series of questions about it. She asked for my email address to send a questionnaire on the matter. I gave her my email address, she sent the questionnaire and I completed it.

Weeks later a lawyer from the Pietragallo law firm, also located in New Jersey, contacted me and stated he represents Sun Pharmaceutical Industries. Again, I was confused as to how he knew about the case, as I hadn't served them yet. The lawyer also profusely apologized for what happened to my mom due to Bactrim. That's the third person apologizing for what happened to my mom (Cano Health doctor, Sun Pharmaceutical Industries' representative, and their lawyer). I state this because they all know that drug Bactrim did this damage to my mother. People don't apologize for something that did not occur.

Here's another problem. Not only did they mess up my mom's health with Bactrim and bad medical advice/care, they severely damaged mine as well in taking care of her these past 2-years. As they rendered my mom an invalid via Bactrim and the bad medical care/advice, I had to take care of her, which meant a lot of lifting/helping her up in bathing, clothing, feeding and giving her physical therapy beginning in 2023. At that point she was still walking (though much slower than before due to Bactrim). Mom's insurance paid for a therapist for a 2-week stint (6 sessions) in 2023. Then another 2-week session in 2024. That was insufficient for the damage that had been done by Bactrim.

Then in a separate matter, Mom was injured earlier this year in the month of April, due to misconduct by the FBI and Madonna, which caused her to stop (FBI Informant Severely Sickens Mom In Deliberate Food Poisoning that Leads To Dangerous Infection then Weeks Later Someone Tried To Poison Me Resulting In Hospitalization). I will disclose more about that in a future item.

In taking care of my mom since Bactrim severely damaged her health, I developed terrible sciatica (impacts the back and legs). I sprained my wrists at different times. I accidentally tore the rotator cuff in my left arm a few months ago while taking care of her, as she no longer walks and I had to lift her up (she will be getting more physical therapy soon and more often, which will help her walk again).. I kept getting injured because the insurance company would not pay for the care mom needs since the Bactrim incident. So I have been providing said care at great expense to my health and finances. However, she's my mom; I'm not going to abandon her.

Sun Pharmaceutical Industries and their lawyer keep apologizing for what happened to my mom but have not offered to pay for her medical care to get her the help she needs. My mom needs two home health aides to work in shifts, a highly skilled orthopedic surgeon due to de-conditioning caused by Bactrim (in August 2023), and then sepsis (in April 2025).

See, this is how people's villain origins story get started. You mind your own business, yet unscrupulous people violate your rights and or that of those close to you. No, I wouldn't do anything illegal, but I do believe in messing up people's money when they cause me or my family damage. I believe in waging boycotts. Because there's nothing rich people hate more than losing money and even worse being made poor.

Something is not right at Sun Pharmaceutical Industries, who are traded on the stock market. They are putting profits ahead of people. Since the time I initiated legal action against them in September, they've had a drug recall. Last month when I was reading the Daily Mail, there was a headline about a drug recall. When I clicked the article link it was another Sun Pharmaceutical Industries drug, but this one is called Mesalamine Delayed-Release tablets. It is for ADHD and even given to children. It is being recalled due to "microbial contamination." A product with "microbial contamination" can kill. There is clearly a problem with product safety and quality control at Sun Pharmaceutical Industries. The company has been the subject of SEVERAL product recalls in America and the international community. They've got too many recalls, and Bactrim was pulled from approved use in Britain (is no longer on the approved medicines list).

I've tried to sort this matter out with Sun Pharmaceutical Industries. They keep apologizing for what happened, but someone informed me that sex trafficker and washed up singer, Madonna, and the FBI have criminally interfered in this legal matter. Madonna and the FBI have been financially damaging me and my mom for years and trying to bankrupt us over my copyrights they are stealing, even by causing costly medical injury (as mentioned in this article: The FBI Has Been Criminally Going Into Hospitals And Medical Clinics In America Damaging And Killing Patients For Political And Financial Gain (Videos, Medical Documents, Photos)). It warrants an international investigation.

This is occurring all because of my my Library of Congress registered copyrights Madonna, her cronies in Hollywood, and the FBI are obsessed with infringing, in a matter that not even then Senator Marco Rubio, who is now Secretary of State, could obtain the files for under the  Freedom of Information Act (The FBI Is Stonewalling Congress On Releasing FBI File In Madonna Human Rights Abuse Case (Congressional Documents)).

Someone responsible for some of my of my site exclusives that later proved true and correct, informed me that Madonna in particular has been criminally interfering in the legal matter concerning Sun Pharmaceutical Industries in bids at derailing a settlement that could get my mom the medical care she needs. It has been very difficult taking care of my mom, as it is a lot of hard work, plus I've had to do this while completing two complex college degrees, and working (mostly online).

The FBI are criminals

Remember on the site a few weeks ago when I wrote about an FBI informant, Ms. A. Kelly (I'm withholding her first name for now), whom the FBI has been using in criminal acts against me and my mom. I wrote about how she gave my mom food poisoning that could have resulted in death (the food poisoning also resulted in a dangerous infection that could have killed her and has worsened my mom's mobility issues). My mom had to be treated by a nurse and doctor for food poisoning, as they feared she would become dehydrated and die. The food poisoning has messed up my mom's stomach and she still has trouble keeping food and drink down. She now has Post IBS because of the incident, which is serious and damaging her health. That damaging food poisoning was a criminal assault by the FBI informant.

The FBI had Ms. A. Kelly spying on us and making terrible illegal threats on their behalf. She openly admitted the FBI brought her and her sister to their office in Miramar, Florida, which is a few minutes away from Miami. We've known her family for decades but the FBI approached her and turned her into an informant, engaging in criminal conduct because of my valuable copyrights and forthcoming patents. They were trying to use her to control me and my mom, but it failed. They also had her do things like stealing my U.S. mail, regarding an item from the Internal Revenue Service (IRS), which ended up costing me a $2,800 tax refunded I needed to help care for my mother.

One day she showed up at me and my mom's apartment and told me to come outside to look at something. We were friends so I went outside to see what she was talking about over the phone. When I reached outside she told me to look up. I did so. It was an FBI drone hovering a few feet above my head. She was not controlling the drone. The FBI was and in doing so wasting taxpayer money in acts of criminal intimidation and harassment.

On another occasion when the FBI thought I was working on a science patent for free energy (I was not) the FBI had her threaten me that it would get me killed by them. The FBI had her make other threats to my face. Threats such as demanding I not go to medical school or I would be killed (the FBI kept interfering in my schooling trying to stop me from getting an education: The FBI Criminally Meddled In Miami Dade College Stealing Funding And Illegally Changing Answers To Tests In Acts Of Academic Sabotage). This is what the FBI is doing with U.S. taxpayer money and it is a criminal waste of funds and resources. They should be made to pay back the taxpayers.

The FBI had her make threats to me about not leaving America to go back to live in my homeland of Jamaica or the FBI would blow up the commercial airliner (the FBI and CIA have criminally blown up commercial airliners before). Threats to amputate my leg which is not medically necessary (as written about here: The FBI Has Been Criminally Going Into Hospitals And Medical Clinics In America Damaging And Killing Patients For Political And Financial Gain (Videos, Medical Documents, Photos)). They keep criminally harming us to try to physically incapacitate us in efforts at blocking us from leaving America. The FBI also had other people make threats to me about leaving America.

They're evil and devilish. These are some very sick and deranged people wasting taxpayer money. Their conduct is completely illegal and inexcusable. I reported the FBI's misconduct in this regard to Congress in writing, under penalty of perjury, and Ms. A. Kelly got upset about it. She confronted me about it, upset her name went before Congress. The FBI told her about it, because I sure did not.

The FBI is the same corrupt agency who under former FBI Director, Robert S. Mueller, hired pedophile Jeffrey Epstein to work as an informant, as did the CIA, which was confirmed in Congress (Congresswoman Jackie Speier Asks The FBI If Pedophile Jeffrey Epstein Was One Of Their Informants But He Was Actually In The CIA).

The FBI helped Epstein and his pedophile girlfriend, Ghislaine Maxwell, traffic over 1,000 underage girls, over the course of approximately 20-years, to use it for political and financial leverage in gaining dirt to blackmail and extort influential people (The FBI Sued By Victims Of Jeffrey Epstein Over The Law Enforcement Agency's 20-Year Cover Up Of Their Informant's Pedophilic Crimes Against Underage Girls While Using Him To Blackmail The Rich And Famous).

Madonna, who is a pedophile, is also connected to pedophiles Epstein and Maxwell (Flight Logs Reveal Pedophile Madonna Was Visiting Jeffrey Epstein's 'Pedophile Island' Where Sex Orgies With Minors Occurred And She Is In His Address Book). Any group of people who do something so reprehensibly evil, are capable of any wickedness.

My mom has not been getting the medical care she needs (not even with Medicare and after she work hard and paid taxes into the system for 50-years). The FBI and Madonna have criminally meddled in her medical care and brought her great injury and suffering. One has to be appalling gutter trash to harm the elderly or children. Only the worst in society do such things. The FBI and Madonna do both.

I applied for medical visas to get mom care abroad, because her health is being damaged in America by the aforementioned people. However, as the visa office in question is staffed by people connected to the Trump administration/FBI, they've been trying to thwart the processing of the visas, even though I've already paid for them and medical appointments in another nation. That's how sick the Trump administration/FBI is...they're trying to block a very sick elderly woman  from getting the medical care she needs abroad, even though she is suffering. What kind of sick, demonic people do something that. I'm going to write more and in great detail about this visa interference, as it is criminal. My mother's life is at stake and I'm not amused.

The FBI thinks we are slaves. They have been demanding more copyrights from me to infringe, not content with all they helped Hollywood steal already. These people are greedy beyond words and will never be satisfied. Like I've stated on the site before, I see how slavery happened in America and why it lasted much longer here than anywhere else in the world. The U.S. government, via agencies like the FBI and CIA, still deem Black people slaves and property, who are for exploitation and must only reach so far in society, and be under their control. They haven't changed one bit since slavery.

Imagine a group of people so evil and depraved they fight to deny medical care to a sick and suffering elderly lady they deliberately made ill. They have abused my mother so much (they've abused me as well). This is what the FBI is doing...wasting taxpayer money on sick, criminal acts. They FBI are a bunch of misogynistic scum attacking defenseless women all the time.

The FBI and Hollywood, along with select companies in the corporate sector, are going to take America down with the terrible things they are doing. They are criminally meddling in so many things they do not belong such as banking, medicine, science, education, the judicial system and politics. They are meddling in climate science. They are even illegally meddling in America's nuclear programs, which they have no understanding of or congressional mandate to be in.  They are going to bring massive disasters and destruction on America with the unchecked madness they are engaging in. My predictions constantly prove correct (site exclusives). America is in trouble and it's all due to a sick, greedy elitist cabal.

Side Bar: I joined the Twitter (now X) premium ad program to raise money to help me pay for my mom's healthcare. My page on X is ready by many people. I've gotten approximately 14 million views in the last 6-months. Yet, X has not paid me a dime. I've seen other accounts post proof of way less views than mine and the checks/deposits they received from X. The FBI is still meddling in Twitter (X) as written about previously on the site, in felonious acts criminally targeting me to cause financial loss (Elon Musk And Missouri Attorney General Eric Schmitt Expose FBI Corruption Regarding The Law Enforcement Agency Meddling In And Controlling Twitter Which Confirms Previous Site Claims).

Not only that, Madonna's cult hacker hacked my X social networking page and tried to get it suspended as spam, because millions of people have been reading it.One of Madonna's hackers hacked my X page and kept flashing it over and over again to trigger a suspension on X while I was viewing someone else's page about Israel. I quickly shut the computer down to avoid it when the X software flagged it as "suspicious activity" but on my account when I didn't do anything. They were trying to slow down traffic to my page and get it suspended. However, it failed. Not to mention, even more people read this site than my X page. I also have new sites in the works. My point is grow up and stop trying to censor and silence people in a democracy. It makes you look deranged and pathetic. You're an embarrassment.

STORY SOURCE

Nationwide recall issued for ADHD medication taken by millions... FDA warns of 'adverse health risks'

11:08 EST, 12 November 2025 | UPDATED: 11:56 EST, 12 November 2025 - Millions of Americans who rely on medication to manage attention deficit hyperactivity disorder (ADHD) may be impacted by a new nationwide drug recall. Sun Pharmaceutical Industries has issued a voluntary recall of several lots of lisdexamfetamine dimesylate capsules, a generic version of an ADHD treatment prescribed for patients aged six and older. It is commonly known as Vyvanse and Arynta. The FDA classified the action as a Class II recall, meaning use of the product 'may cause temporary or medically reversible adverse health consequences,' though the risk of serious harm is considered remote.

According to the FDA, the recall was prompted by a failure in laboratory testing, as the affected lots of medication did not dissolve properly during quality control tests. This defect could affect how the drug is absorbed in the body, potentially leading to patients receiving a lower dose than prescribed and reduced therapeutic effectiveness. This could worsen ADHD symptoms and trigger fatigue or concentration problems. Prescriptions for lisdexamfetamine dimesylate have risen substantially in the US over recent years. Data shows that from 2012 to 2023, overall stimulant prescriptions grew by about 60 percent, and in 2023 lisdexamfetamine accounted for roughly 19 percent of all stimulant prescriptions. Millions of Americans who rely on medication to manage attention deficit hyperactivity disorder (ADHD) may be impacted by a new nationwide drug recall...

https://www.dailymail.co.uk

FDA issues new warning following Springfield girl's death after taking antibiotic

Nov. 13, 2019 at 3:24 PM EST A young girl from Springfield had lung failure shortly after taking a very common antibiotic, Bactrim. Since then, the FDA is issuing a new warning of acute respiratory failure associated with that drug, which some patients believe caused death. After being prescribed Bactrim for a scalp infection, Abigail Caldwell, 10, of Springfield, suffered severe respiratory failure and later died in the hospital. She became part of a nationwide study to determine if Bactrim could be to blame.

It's not very often that an old drug-- one on the market for 45 years-- gets a new warning put out by the FDA, with such serious potential risk. But a grieving mom, who is also a nurse, Aimee Caldwell, says she is thankful that others might now get the warning that she never did. "They tested her for everything. No bacteria, no viral, no fungus," explained Aimee of her daughter's illness. In only 19 days last year, Abigail went from a perfectly healthy 10 year old to her grave. Now Aimee wonders if the popular drug Bactrim had something to do with it. "When your child dies that's bad enough, but then to not know why was just another layer of agony." Fast forward 18 months after Abigail's death, and Bactrim has a new, and serious warning attached to it.

"It is the acute respiratory failure. That has not been common in the practice of pharmacy where physicians and the healthcare system and pharmacist involved, we have become aware of that until now," said pharmacist Dr. Miguel Nunez, RPh. He says the entire healthcare system should take note. "I have been a pharmacist for 32 years and I have not come across the severe risk of using and taking Bactrim," Nunez explained. He says in the last four months or so, four dozen medications have new findings, but this one is surprising. "It causing the acute respiratory failure is brand new, yes."

Aimee's goal is to make sure every every pharmacist, every doctor, every patient and every parent is well aware. "They worked from the education that they had and so I am trying to give more education so that if another mom calls a doctor's office and their kid had been on Bactrim, and they have a fever, that this time instead of being pushed off, it will be taken seriously and we don't know, but let's stop the Bactrim and start something else," Aimee said. Abigail's case is one of now over 30 patients total who have had severe side effects after taking Bactrim, or even death, and have contacted a doctor in Kansas City who has been investigating if there is a possible link.

https://www.ky3.com

Preventing Deadly Antibiotic Reactions in Children Two Children’s Mercy doctors on a crusade to address Bactrim-related lung failure

 Zei was Patient Zero. A healthy high school student, Zei, quickly became dramatically ill and was life-flighted to Children’s Mercy. A teenage girl with a tube in her nose and in her neck smiles in a hospital bed. Zei Uwadia Zei’s lungs were failing and she required the highest level of life support, ECMO, to survive, but every diagnostic test came back “normal.” Doctors were stumped. As Zei made national headlines and was hospitalized for 457 days, Dr. Jenna Miller made a startling discovery – before becoming ill, Zei had been prescribed Bactrim for a urinary tract infection.

In the first ever reported case, Dr. Miller diagnosed Zei with Bactrim-Associated Lung Failure. Sadly, Zei passed away from this deadly drug reaction. Today, there are 30 confirmed cases of Bactrim-Associated Lung Failure, but we know it is underreported and often underrecognized, which is why we need your help! Jenna O. Miller, MD, FAAP and Jennifer L. Goldman, MD Meet the team Two women physicians in Kansas City are leading the fight against easily preventable death. Meet the remarkable team led by Dr. Jenna Miller and Dr. Jen Goldman. A journey to stop preventable death Bactrim is an often-prescribed medication for bacterial infections, including as treatment for acne, UTIs and much more. But it can lead to life-threatening lung failure.

Children’s Mercy is at the forefront of this discovery, the only institution leading Bactrim-Associated Lung Failure diagnosis, treatment and advocacy: Action plan World-leading experts at Children’s Mercy are hard at work to prevent this life-threatening drug reaction. With a $5 million funding goal, your gift will: Scale patient identification to help more patients across the country and world. Enroll and evaluate patients throughout the country. Manage a research database to further understand this deadly reaction. Perform world-leading genomic analysis to diagnosis more children before it’s too late. Create treatment protocols for hospitals around the country and world to use treating this reaction. Provide a genomic test prior to prescribing Bactrim to ensure all children with a genetic-predisposition to a life-threatening drug response don’t receive the medication.

https://www.childrensmercy.org/bactrim/

Breakthrough in Wichita teen's death

Kansas City,November06,2019 - For nearly a year, KAKE News has been following the story of a Wichita teen who died after spending 457 days in a Kansas City hospital. Now, a major breakthrough has been made with the FDA. "Zei would be so proud. I think she would be fighting maybe in a different way than I do. She's so strong," says Brie Kerschen, Zei Uwadia's mom. For months, doctors were stunned by Wichita teen, Zei Uwadia's mystery lung illness. Zei died early this year after a long stay in a Kansas City hospital. After her story reached national news, other patients with the same symptoms contacted her doctors.

Finally, they connected the dots. Zei and the other patients had all been prescribed Bactrim, or its generic equivalent. "The numbers continue to increase for people who are interested in learning about whether their reaction had anything to do with this drug," says Dr. Miller. Zei's doctor at Children's Mercy in Kansas City. Now, another breakthrough. The Food and Drug Administration is recognizing the research. "The drug has been around since the 70s and we suspect there are several more injuries," says Kerschen. Before now, Acute Respiratory Failure was never listed as a possible reaction, but in a recent report, the FDA officially added Bactrim and its generic equivalents to its Watchlist. "By the FDA acknowledging that Bactrim causes acute respiratory failure in some patients is a big leap," says Kerschen.

https://news.childrensmercy.org

Warning: Trimethoprim-Sulfamethoxazole and Acute Respiratory Failure

 2021 Aug 16 - The Food and Drug Administration (FDA) approved revised labeling for Septra and Septra DS (double strength) tablets, Bactrim and Bactrim DS tablets and Bactrim injection and pediatric suspension.1 Labeling for other TMPSMX products is being updated with the new safety information. The updated includes new safety information on acute eosinophilic pneumonia, acute and delayed lung injury, interstitial lung disease and acute respiratory failure resulting in prolonged mechanical ventilation, extracorporeal membrane oxygenation (ECMO), lung transplantation or death. The warnings come after a case series described severe acute respiratory failure related to TMP-SMX treatment in five previously healthy adolescents within days to weeks of TMP-SMX initiation.

2 Four patients required prolonged ECMO, one underwent a heart and lung transplant, and two died. Four of the adolescents had been prescribed TMP-SMX for treatment of acne vulgaris, an unapproved indication. The mechanism of pulmonary toxicity related to TMP-SMX, particularly in previously healthy individuals, has not been elucidated. Clinicians should obtain a history of TMP-SMX exposure in otherwise healthy pediatric and adult patients presenting with severe acute respiratory failure of unclear etiology. References 1.

https://pmc.ncbi.nlm.nih.gov/articles/PMC8372854/

Trimethoprim–sulfamethoxazole and risk of sudden death among patients taking spironolactone

Trimethoprim–sulfamethoxazole increases the risk of hyperkalemia when used with spironolactone. We examined whether this drug combination is associated with an increased risk of sudden death, a consequence of severe hyperkalemia. Methods: We conducted a population-based nested case–control study involving Ontario residents aged 66 years or older who received spironolactone between Apr. 1, 1994, and Dec. 31, 2011. Within this group, we identified cases as patients who died of sudden death within 14 days after receiving a prescription for trimethoprim–sulfamethoxazole or one of the other study antibiotics (amoxicillin, ciprofloxacin, norfloxacin or nitrofurantoin).

For each case, we identified up to 4 controls matched by age and sex. We determined the odds ratio (OR) for the association between sudden death and exposure to each antibiotic relative to amoxicillin, adjusted for predictors of sudden death using a disease risk index. Results: Of the 11 968 patients who died of sudden death while receiving spironolactone, we identified 328 whose death occurred within 14 days after antibiotic exposure. Compared with amoxicillin, trimethoprim–sulfamethoxazole was associated with a more than twofold increase in the risk of sudden death (adjusted OR 2.46, 95% confidence interval [CI] 1.55–3.90).

Ciprofloxacin (adjusted OR 1.55, 95% CI 1.02–2.38) and nitrofurantoin (adjusted OR 1.70, 95% CI 1.03–2.79) were also associated with an increased risk of sudden death, although the risk with nitrofurantoin was not apparent in a sensitivity analysis. Interpretation: The antibiotic trimethoprim–sulfamethoxazole was associated with an increased risk of sudden death among older patients taking spironolactone. When clinically appropriate, alternative antibiotics should be considered in these patients.

https://pmc.ncbi.nlm.nih.gov/articles/PMC4347789/

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