Let’s get one thing straight. We are mad as hell about drug shortages. There is no question that important medicines have been in short supply for years and the FDA has done very little to help correct this tragic situation. All we get from the agency is an FDA Drug Shortages list that is updated regularly. It does not help resolve the problem. At last count, there are over 100 different medicines in short supply. Below you will read a complaint from a pharmacist about levothyroxine shortages. The trouble is, we haven’t detected any recent oral levothyroxine shortages.
Are Levothyroxine Shortages to Blame for Switching Manufacturers?
Q. I wanted to respond to your column about generic levothyroxine. The person writing to you had taken levothyroxine from three different manufacturers within six months. She worried that such switching might pose a problem.
I am a pharmacist. The reason patients have been getting levothyroxine from different manufacturers is due to shortages, particularly of Mylan medicines. Believe me, pharmacists want patients to stay on levothyroxine from the same company. However, when the product is unavailable, we have to switch manufacturers, or the patient gets nothing.
Why don’t you write about all the shortages of common drugs? The public needs to understand we pharmacists are on their side, but sometimes our hands are tied.
A. We share your sense of frustration about drug shortages. This crisis has been going on for years. Although the FDA publishes a list of medicines in short supply, it has not offered solutions to this supply-chain difficulty.
When drug makers have quality-control problems, they frequently recall substandard medicines. Such has been the case with blood pressure pills like losartan and valsartan. This is challenging for pharmacists, patients and physicians.
Yet Another Losartan Recall:
FiercePharma reports (April 22, 2019) that:
“India’s Torrent Pharmaceutical recalled 104 lots of losartan [and losartan plus hydrochlorothiazide] over the weekend because they contained an impurity suspected of causing cancer.”
This is just the latest in the never-ending recall of ARB blood pressure medicines that started last July. We have lost count of the number of lots of irbesartan, losartan and valsartan that have been pulled off the market.
In case you might think that 104 lots are not that many, think again. It represents more than one million bottles of blood pressure meds. If there were only 30 pills in a bottle, that would represent at least 30 million pills. But many of these bottles contain 90 pills and quite a few contain 1,000 pills. That means a huge number of losartan pills have just been recalled. That could mean shortages. Here is the FDA’s announcement from the company.
What About Levothyroxine Shortages?
The pharmacist who contacted us was responding to a comment from one of our readers. She had been switched from levothyroxine made by Mylan to levothyroxine from Lannett and then levothyroxine from Sandoz. This all took place in less than six months. This person was concerned about potential variations between generic formulations of levothyroxine.
We searched the FDA’s drug shortages list over the last six months. We could not find any mention of levothyroxine shortages, although there was a shortage about a year and a half ago.
We fear that many large chain pharmacies are always searching for the best deal they can get. Since the FDA reassures doctors, pharmacists and patients that all generic drugs are identical, price becomes a key factor in buying decisions.
While we cannot prove that the switching this person encountered with levothyroxine was driven by price, we could not link it to levothyroxine shortages either. We wish we could believe that all FDA-approved generic drugs were of the highest quality. But recent recalls challenge that viewpoint.
Should you wish to read about our investigation into the FDA’s generic drug approval process and our concerns about quality control, we recommend our book, Top Screwups. It is available at this link. You will learn how to protect yourself from generic drug problems. Sadly, there is no simple solution to the drug shortages disaster.
Share your own thoughts about drug shortages. What has been your experience regarding being switched from one generic drug manufacturer to another by your local pharmacy? Please report your experience in the comment section below.
