Are medications safe? Americans take billions of pills and other medications every year. Almost 50% of US adults take at least one prescription medication. And many millions take over the counter medications.
We rely on medications to keep us healthy and to cure both serious and minor ailments. In many cases, people would not survive without their medications. But are our medications safe? Should we worry about tainted drugs? Sadly, our medications are not as safe as well all assume.
Where are our medications made?
The drug industry has seen a huge increase in overseas drug manufacturing, by both foreign-owned and US-based companies. Why?
Firstly, environmental regulations regarding the disposal of chemicals and solvents used in the manufacturing process are laxer overseas. Secondly, companies using overseas manufacturing save substantial money with lower costs for labor, ingredients and other expenses.
For brand-name medications sold in the US, over 70% of the ingredients are manufactured outside of the US, largely in India and China. But for generic medications sold in the US, India and China manufacture most of the actual medications, not just the ingredients.
The increased reliance on overseas manufacturing has opened the door for an increase in tainted drugs, although US facilities can make and sell dangerous drugs as well.
What are tainted drugs?
Tainted drugs are medications which are not 100% perfect. Tainted medications may contain foreign objects, such as tiny glass particles, or they may contain dangerous contaminants, such as dangerous bacteria, mold, or carcinogens. Or the medications might have too much or too little of the drug’s active ingredient.
What are some examples of tainted drugs?
A Kaiser Health News (KHN) investigation described
Here are a few recent examples of tainted drugs:
- The dangerous bacterium B. cepacia was found in docusate sodium, an over-the-counter stool softener routinely given to almost every hospital patient, including children.
- The HIV drug Atripla contained foreign substances, including glass-like shards, black rubber-like particles, plastic-like particles, small stone or pebble-like particles, metal shards, and red silicone rubber particulates.
- NDMA, a dangerous, probable carcinogenic chemical, was found in the widely used blood-pressure medicine valsartan. Several drug companies bought the active ingredient for their valsartan from one of China’s biggest generic companies. Since this initial finding, the FDA found NDMA and similar compounds in at least six drugs that tens of millions of people take every year.
- NDMA was also found in Zantac and its generic equivalents. Moreover, the FDA found that NDMA levels increase under normal storage conditions and increase significantly at higher temperatures. Also, the testing found that NDMA levels increased in the medication over time.
What kinds of harm can tainted medications cause?
Patient harm from tainted medications ranges from mild to severe. Patients can develop dangerous infections, which in some cases can be fatal. And patients could develop cancer from drugs containing carcinogens.
Additionally, drugs with either too much or too little of the active ingredients can lead to delays in healing, worsening in condition, or serious, sometimes fatal, complications.
How often do tainted drugs harm patients?
It’s nearly impossible to figure out how often tainted drugs cause patient harm or deaths. Unfortunately, no government agency tracks tainted drug cases unless there is a link to a significant outbreak among patients.
And, figuring out this link can be very difficult. Typically, when a patient’s condition worsens, his/her doctor doesn’t suspect tainted medication as the cause. After all, the patient was sick to start with.
Furthermore, it’s not readily obvious that a tainted drug caused a spate of seemingly random illnesses, often in patients all over the country.
Additionally, detecting illnesses caused by medication is hard because the government doesn’t require drug makers to share information regarding where they manufacture specific products. In fact, it can be almost impossible to track down the origins of medications.
Why is it so hard to track tainted drugs?
There is a lot of mystery surrounding the details of medication manufacturing. Every step of the manufacturing process is a closely held secret:
- Ingredients – Drug makers do not have to disclose where they buy the ingredients they use to make medications.
- Production – Drug makers consider the manufacturing location of each drug a trade secret. Therefore, the Food and Drug Administration (FDA) reports often won’t reveal which drugs come from facilities with identified manufacturing hazards.
- Labeling – Laws only require medication labels to include one of the following – the manufacturer, the packer or the distributor – not all three.
All of these secrets make it hard for even experienced drug buyers in hospitals and pharmacies to know the origin of specific drugs. Therefore, it is quite difficult for buyers to avoid drugs coming from facilities with spotty records and/or a history of recalls.
Drug companies sometimes voluntarily recall tainted medications.
In some cases, drug manufacturers recall a medication after they discover a problem. Although it’s great that these recalls occur, it’s unfortunately, late in the process. By this point, many patients have taken the tainted drugs.
The KHN investigation found that between 2013-2018, US and foreign drug companies recalled about 8,000 medicines that were being sold in the US. This represents billions of tablets, bottles and vials that had already made their way into American homes and hospitals. Although these numbers seem extremely high, these recalled medications only represent a fraction of all the medications shipped each year.
Interestingly, 65 manufacturing facilities recalled almost 300 medications within 12 months of passing an FDA inspection. Does this indicate the FDA inspectors missed crucial evidence of dangerous medications? Probably!
How does the FDA keep our medications safe?
Ideally, the manufacturers themselves and/or FDA inspectors would identify problems before medications make their way to pharmacies and patients. The FDA inspects facilities throughout the world that make drugs for the US market to identify and report problems. Additionally, the FDA claims it holds foreign plants to the same standards as US drugmakers, but experts say that’s not always the case.
Overall, the inspection system is not functioning as well as it should. Without a robust inspection process, we must ask ourselves – are medications safe?
KHN reviewed thousands of FDA documents, including inspection records, recalls, warning letters and lawsuits. Alarmingly, their research found that inspectors miss serious hazards. Equally alarmingly, even when the inspectors find issues, the FDA cannot force drug makers to make improvements and/or change their ways.
The KHN investigation found the following issues:
The FDA does not inspect all facilities.
Domestic and foreign factories making drugs for the US market are supposed to be inspected by the FDA every few years, based on a risk-assessment system. But, hundreds of drug making facilities haven’t been inspected for years, if ever. Which of course is a serious problem.
The KHN analysis found that between 2008-2018, over 2,500 facilities, both domestic and foreign, did not have an FDA quality inspection in 5+ years. Moreover, the FDA has no records of any quality inspections for that period for more than 1,200 domestic factories and almost 400 foreign factories.
Importantly, it’s not that the FDA doesn’t care. However, the FDA is overwhelmed and under-resourced, making it difficult to ensure the safety of overseas drug production. And to make matters worse, COVID-19 lead the agency to cancel most plant visits.
Hopefully the rate of inspections will improve, but as you will read below, inspections alone do not provide adequate protection.
The FDA inspections aren’t always adequate.
According to experts, the inspection methods themselves leave room for improvements. Inherent problems include:
- The FDA inspectors miss problems because of confusing regulatory terms and standards that are often decades out of date.
- The inspectors analyze what is occurring at a particular time, not what might happen in a week, month or year.
- Instead of analyzing the actual medications, the inspectors usually only examine the facility and the processes used.
- The inspection may occur when the facility is producing only one, or several, drugs, even though the factory produces dozens more.
- Most inspectors review paper records provided by the manufacturer, trusting that the information is true, instead of randomly testing medications themselves.
Interestingly, many cases of tainted drugs only come to light after a whistleblower speaks up.
Some drug companies try to game the system.
Some drug companies will do whatever it takes to pass an inspection. Many companies “stage-manage” inspections, so that factories are acceptable during the inspection, but once the inspectors leave, it’s a completely different story.
And access can be difficult. In one case, employees created a human barricade to physically keep an FDA official out of the factory. Another factory blocked the entrance with a phony worker strike; when the inspector finally got in, the lights were off making the task almost impossible.
Foreign inspections can be even trickier.
Inspecting facilities in foreign countries comes with even more potential pitfalls:
- FDA inspectors who must rely on translators hired by the drug companies may receive intentionally false or misleading information.
- A foreign official may tip off plants about “surprise” FDA inspections, or the FDA often announces its overseas inspections weeks in advance, giving factories time to cover-up issues, and fabricate data and results.
An NPR reporter documented several cases where foreign companies went to extreme lengths to thwart inspections. Her findings are alarming:
- FDA investigators in India were poisoned with undrinkable, tainted tap water during inspections, making them sick during the inspection process.
- Hotel rooms of investigators were bugged.
- Investigators were followed.
- Manufacturers tried to scan passenger lists in airports to determine exactly who was coming when.
The power, or lack thereof, of the FDA.
Right now the FDA has limited powers. They can issue enforcement actions against drug factories, which they’ve done thousands of times over the years. They can cite safety violations, issue warning letters and block imports from certain foreign plants.
In rare cases, they can seize drug products, which they have done 23 times in the past decade. But the FDA has limited ability to force companies to change – they cannot issue a mandatory recall, and their citations do not come with monetary fines.
Since the FDA cannot force a drug maker to fix problems or issue recalls, repeat offenders abound. In some cases, FDA inspectors flag the same violations, at the same location, over and over.
Between 2008-2018, the FDA penalized 70 drug making facilities, mostly domestic, for the same violation at least four times. And more than 1/3 of those facilities had issued a recall sometime in their past. Given that recalls are expensive, and expose patients to danger, why aren’t these companies making the necessary improvements?
Do FDA inspections reduce the number of recalled medications?
Hard to say. Of the 8,051 recalls in between 2013-2018, almost 50% of the recalled medications were made in factories that the FDA cited for violations during their latest inspection. Does this indicate that drug companies do not take the FDA actions seriously? Are these companies as concerned about patient safety as we all expect and deserve? Hard to say.
It’s worth noting that almost 3,000 recalls were issued from facilities the FDA had not inspected since at least 2008. But 700 of the recalls came from facilities that had passed their last inspection.
Generic medications may be less safe than brand-name.
Generic drugs are low-cost alternatives to brand-name medicines. Importantly, generics are popular — 90% of all medications prescribed to Americans are generics. And many of us don’t have a choice – health insurance plans often require patients to use generic drugs to save money.
There are a few reasons why generic drugs might not be as safe, including:
The FDA approval for generics is less stringent.
To get approved by the FDA, a generic medication must be “bioequivalent” to its brand-name counterpart. Meaning the chemical recipe of the generic drug must be close to the brand-name recipe. However, generic manufacturers do not need to prove that the two versions are therapeutically equivalent.
In contrast, the FDA has a rigorous approval process for newly developed drugs. Companies must conduct clinical trials in humans over several years to prove a drug is safe and effective.
For generics, the entire manufacturing process is often overseas.
When pharmaceutical companies buy active ingredients for their brand-name medications, they generally don’t know much about the raw materials used in the manufacturing process, which could pose a safety issue. However, pharmaceutical companies can test for the safety, effectiveness and purity of the ingredients before they use them in their final product. In contrast, the generic drugs made overseas arrive in the US ready for the marketplace.
What about counterfeit, black-market medications?
In contrast to the potentially dangerous medications manufactured at authorized drug manufacturing facilities (as discussed above), black-market medications enter the US market without any FDA scrutiny.
Often referred to as counterfeit, black-market medications make their way to pharmacies, hospitals, nursing homes and doctor’s offices. Black-market medications, which are often dangerous, are either stolen, expired, contaminated, or fake.
For more information, read Dangers of Black-Market Medications – More Common Than you Think.
Are your medications safe? What should you do?
The dangers from tainted drugs is a complicated problem to fix.
Here’s what I think: We need the FDA to improve their inspection process and increase the frequency of inspections. The government needs to make sure US and foreign drug manufacturers follow strict guidelines for manufacturing high quality, safe medications. And drug companies should face serious consequences for tainted medication and faulty manufacturing processes in order to encourage compliance.
What can you do if you want to make sure your medications are safe? Sadly, not much. But calls and letters to your members of Congress can influence their mindset and may help drive stronger drug safety regulation.
There’s some good news.
Sometimes drug manufacturers recall tainted medications. Your pharmacy may call you regarding a recall, or you may hear from your doctor’s office. Or you might hear about a recall on the news. Pay attention to these recalls – don’t minimize their importance.
You can also check the FDA’s drug recall website to see if your medications are safe. You’ll need the name of the medication, the manufacturer, the dose, and the lot number. Finding the lot number can be tricky – here are some tips:
- For medications in bottles or vials, look for the lot number next to the expiration date, either by the barcode or below the instructions.
- Many blister packs have the lot numbers and expiration dates printed on their foil backings.
- For tubes of creams and gels, look for the number right above the crimp at the end of the tube. Or, you might find it on the back of the tube, sometimes within the storage information text.
- If you cannot find the lot number, call your pharmacy. They keep track of this information.
Additionally, once you find the manufacturer, you can search online with the manufacturer name and the phrase “FDA warning letter” to see if the FDA has cited them for issues related to not only your medication, but for other medications they make as well.
And some bad news.
Unfortunately, unless the FDA has recalled a medication, there is little we can do to reduce our risk of taking a tainted medication.
Additionally, even if you learn that regulators cited the factory your medication came from, your insurance company may not cover the brand-name drug or other alternatives.
Examine your medications.
If a pill looks or smells odd, or looks different than usual, do not take it! And if you have unexplained symptoms, consider asking your doctor if a tainted medication could be responsible.
Make careful purchases.
When buying medications yourself, only use pharmacies located in the US, even when shopping online.
Additionally, heed the warnings issued by the FDA, advising patients to beware of pharmacies that:
- Do not require a written prescription from your doctor.
- Offer steep discounts that seem too good to be true.
- Send you spam emails offering cheap medications.
Interested in learning more about medication-related issues?
Read my posts for more information on medications:
- Reduce Your Risk of Medication Errors.
- What’s an Adverse Drug Reaction?
- Tips to Take Medication as Prescribed.
- Are Antibiotics Helpful or Harmful? What You Need to Know.
- Doctors Prescribe Too Many Medications.
- Is Off-Label Medication Safe?