RX Buyer Beware

Have you ever thought about the medications you take and where they come from?  You don’t have to be a transplant recipient to take prescription medication.  Most people, especially those of us above a certain age, are taking something for high blood pressure or cholesterol or other chronic ailments.  Every month, we fill our prescriptions, and every day we swallow our pills.

Next time you get that bottle from the pharmacy, look at the label, locate the manufacturer name, and do a little Google search.  You might be surprised to find out where your drugs are made. Recently, I have been reading the book “Bottle of Lies” by Katherine Eban.  

The book was recommended to me by a friend when we discussed anti-rejections drugs, specifically tacrolimus manufactured by a company called “Dr. Reddys.”  After reading this book, I began to search online for further information on the subject.

Below is an excerpt from the article “These Pills Could Kill You” by Katherine Eban, published in the Boston Globe May 24, 2019.  Link to full article: These pills could kill you – The Boston Globe

“In late 2013, pharmacists at the Cleveland Clinic made a striking decision: The health system would no longer stock a generic version of an immunosuppressant drug, tacrolimus, made by the Indian company Dr. Reddy’s Laboratories.

The internal announcement surprised Dr. Randall Starling, a Cleveland Clinic heart failure specialist. Starling regularly treated patients who received heart transplants; immunosuppressant drugs were critical to the success of these procedures.

The Dr. Reddy’s version of the immunosuppressant on which his patients’ lives depended was by far the cheapest, priced far below the $3,000 per month price tag of the brand name drug, Prograf, made by Astellas. But the Cleveland Clinic’s pharmacists — who did wide-ranging research to determine which drugs the hospital should or shouldn’t use — were growing uncomfortable with the number of recalls of Dr. Reddy’s drugs.

Over the next six months, the physician worked with his staff to make sure that none of their patients was taking the Dr. Reddy’s tacrolimus and that the hospital’s inpatient and outpatient pharmacies no longer carried it. But he couldn’t control what his patients took once they left the clinic’s grounds.

Soon enough, his worst fears were realized.

In October 2014, Cedric Brown, a 48-year-old patient who’d undergone a successful heart transplant 18 months earlier, was admitted to the hospital with symptoms of acute organ rejection. Despite Brown’s successful transplant and recovery, by the time he landed back in the hospital’s intensive care unit, he had gained 50 pounds and felt terrible.

Cleveland Clinic pharmacists developed a confidential blacklist of drugs it would no longer buy, dominated by generic drugs manufactured in India.  The Dr. Reddy’s tacrolimus went on that blacklist.

The Cleveland Clinic’s doctors were not alone in their concerns about Dr. Reddy’s tacrolimus. In October 2013, a pharmacist at the Loma Linda University Medical Center in California reported to the FDA, through its online complaint database Medwatch, that “multiple patients” who used the Dr. Reddy’s tacrolimus had “unpredictable levels leading to inadequate immunosuppression and subsequent transplant failure.” The report from Loma Linda noted, “This has only been seen with the Dr. Reddy’s brand of Prograf.”

In a more recent article from APB News dated March 7, 2023, Dr. Reddy’s has issued a recall of tacrolimus.  Link to full article:  Dr Reddy’s Laboratories Recalls Over 4,000 Bottles Of Tacrolimus Capsules In The US

“Dr Reddy’s Laboratories is recalling over 4,000 bottles of a generic drug in the US due to a packaging error. The Hyderabad-based drug major is recalling 4,320 bottles of Tacrolimus Capsules which are used to prevent the body from rejecting a transplanted organ.”

I have a deeply personal reason to be interested in this topic.  Dr. Randall Starling was my doctor at the Cleveland Clinic when I began my transplant journey, but due to logistics, I ended up having my first heart transplant at the University of Michigan.

My first transplanted heart was perfect.  In a rare but wonderful occurrence, the nerves grew back, and it functioned like I was born with it.  I could run like a track star.  Okay, maybe more like the comic relief at the track meet due to my lack of coordination, but I could run.  I never was allowed to run as a child because of how bad my heart was, so running was as miraculous as flying.  I loved it.  I went back to work full time in less than a year after my transplant surgery.  In 2012, I was fired from that job because I got sick too much due to immunosuppression.

In 2013, I purchased a supplemental insurance policy to go with my Medicare so my meds would be covered.  That insurance policy denied name brand Prograf, and I was put on generic Tacrolimus through their mail order pharmacy.  The generic brand was Dr. Reddy’s.  That summer, I started having trouble with shortness of breath.  It was a hot and humid summer, and I was told it was probably my asthma and given an inhaler.  In the fall, when it cooled down, my lungs burned when I ran.  I told my cardiologist at U of M, and they did a pulmonary test.  My lungs looked fine.

October 2014, I nearly passed out at work and drove myself to the ER.  U of M testing found stage IV (end stage) vasculopathy in my previously perfect heart.  June 2015, I arrived at the ER in grade 3 cardiac rejection.  Thereafter, I went in and out of rejection for the next 3 years until I received my second heart transplant in October 2018, exactly four years after the diagnosis of vasculopathy.  Since the second transplant, I’ve stayed on name brand Astagraf, extended-release Tacrolimus manufactured by Astellas, and have experienced zero episodes of rejection. 

Words cannot express my anger at the thought that my perfect heart was probably destroyed by Dr. Reddy’s shoddy drugs. Knowing that the pain and suffering and expense of the second transplant could have been avoided if I hadn’t been forced by insurance to take only generic tacrolimus drives me here to alert all of you.  Hopefully, I can save others from the same fate.

Please, I implore you, get to know where each one of your medications is manufactured.  If you are interested in learning more about the deep and dirty secrets of generic drugs, get a copy of “Bottle of Lies” by Katherine Eban today.