Certainly, when we take prescription medications, we hope they will help us without harming us. But all drugs have side effects – no drug is absolutely safe. In fact, “safe” in this sense means that the benefits of the drug appear to outweigh the known risks. So, that begs the question – can you trust prescription medications?
In my opinion, I think we can generally trust prescription medications. However, there are many situations in which medications could cause us harm. For instance, our doctors may mistakenly prescribe medications we don’t need. Or we might unknowingly take tainted, dangerous medications, or we may experience an adverse drug reaction. Lastly, we might take medications that may provide no help since they have never been proven clinically effective.
Can we trust prescription medications to work as intended? Sadly, not always.
The FDA approval process.
The US Food and Drug Administration (FDA) is responsible for making sure medications are safe and effective for their proposed use. Generally, an FDA review team of doctors and scientists scrutinizes every step of medication development in a long and rigorous process. Their analysis includes reviewing the design of clinical trials, the severity of side effects, and even the conditions under which the medication will be made.
However, in addition to the traditional process, the FDA also has an accelerated approval pathway. This program allows for faster approval of medications created to address the unmet medical needs of patients with serious or life-threatening conditions.
The accelerated program conditionally approves medications based on a “surrogate endpoint”, which is a measure thought to predict clinical benefit, but is not an actual measure of clinical benefit. After accelerated approval, the FDA requires drug manufacturers to confirm clinical effectiveness by conducting clinical trials.
Does the accelerated process help or harm patients?
Can you trust prescription medications the FDA approved without clinical trial data?
A 2020 analysis of the 253 medications approved through the FDA’s accelerated approval pathway found that 112 drugs were never shown to be clinically effective. Yet, patients have used many of these medications for years.
Alarmingly, at the end of 2020, 24 of the unproven 112 medications have been on the market for more than 5 years. Moreover, some have been used by patients for over 20 years!
However, it’s not all bad. The accelerated process can also help patients with serious or life-threatening illnesses by providing earlier access to medications when there are no other options.
How do unproven medications remain on the market?
Even though the FDA requires that medications approved through the accelerated process undergo studies to confirm the medications work as intended, it doesn’t always work that way.
For instance, although the FDA can rescind their approval if confirmation trials show no benefit, or if manufacturers have not conducted trials in a timely manner, they rarely do. In fact, the FDA has only withdrawn approval for 16 medications approved through the accelerated program. Yet, as mentioned above, there are 112 unproven medications available to patients. Why hasn’t the FDA insisted on proof of effectiveness or rescinded approval on more drugs?
How can unproven medications impact you?
Certainly, taking a medication that does not work as intended will most likely not make you better. Moreover, since every medication comes with risks, including those with no proven benefits, the more medications you take, the higher your risk of side effects and/or adverse drug reactions.
A controversial quick approval.
As you likely saw on the news, the FDA recently approved Biogen’s Alzheimer’s medication (Aduhelm) through the accelerated approval pathway. Although some hope this medication will help those suffering from this terrible disease, others argue that there is a lack of evidence showing that the medication slows the progression of Alzheimer’s.
Are you taking unproven medication?
You can look up your medications on the FDA’s Drugs@FDA website to see if they have FDA approval. Importantly, Drugs@FDA does not include FDA-approved biologics, including vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy products. For a list of approved biologics, use the Center for Biologics Evaluation and Research website.
Adverse drug reactions.
Can you trust prescription medications to not make you sicker? Even if you only take trustworthy prescription medications, adverse drug reactions can make you sick – sometimes sick enough to need hospitalization. Unsurprisingly, the more medications you take, the greater the risk of a serious, potentially life-threatening drug reaction.
What is an adverse drug reaction (ADR)?
An adverse drug reaction (ADR) occurs when there is an unexpected or dangerous reaction to a medication. You can develop an ADR after a single dose of medication, after the prolonged use of a drug, or when there is a negative interaction between 2 or more medications.
There are several other names for these incidents: adverse drug event (ADE), adverse effect and adverse event. To minimize confusion, I will use the term adverse drug reactions, or ADRs.
What is the difference between an adverse drug reaction and a side effect?
An adverse event is an unexpected reaction from correctly taking a medication. These unpredictable reactions are generally due to patient-specific susceptibility factors such as drug allergies and intolerances.
Conversely, side effects are more predictable undesired effects from taking medications. As such, doctors usually warn patients about potential side effects.
What are the symptoms of an adverse drug reaction?
ADS can lead to a wide variety of unpleasant and/or dangerous symptoms. And unfortunately, you can even die from an ADR.
There are many physical signs and symptoms of an ADR – far too many to list here. However, symptoms can include rashes, itching, bleeding, joint pain, heart problems, confusion, hallucinations, over-sedation, falls, difficulty breathing, dizziness, depression, and diarrhea.
You can see a full list of ADR symptoms here.
How do adverse drug reactions occur?
ADRs occur for several reasons, including:
- When patients take too much of a medication. For example, a pharmacist or nurse may make an error in dispensing medication. Or patients take the wrong number of pills at home.
- When a medication is mixed with something it should not be mixed with, including an additional medication. For example, one doctor may prescribe a medication that dangerously interacts with a medication prescribed by a different doctor.
Are ADRs preventable?
In many cases, ADRs can be prevented. In fact, researchers analyzed data from 24 studies and found that:
- Among non-hospitalized adults, 52% of adverse drug reactions were preventable.
- For hospitalized adults, 45% of adverse drug reactions were preventable.
How can you minimize your risk of an adverse drug reaction?
Importantly, follow these steps to minimize your risk of an ADR:
- Make sure each doctor knows ALL the medications you are taking, including over the counter medications and herbal supplements.
- Check your medications on WorstPills.org to see if you take medications considered risky. Discuss any findings with your doctor. But do not stop taking medications without talking to your doctor.
- Always carry your list of medications with you, either on a piece of paper in your wallet, or on your phone.
- Use the same pharmacy for all your medications, so they can identify possible ADRs. And you can ask your pharmacist to review your list of medications, including over-the-counter and supplements, to identify any potential issues.
- At least once a year, bring a complete list of all medications, including over-the-counter drugs, to your primary care doctor for review. Importantly, ask if any of the medications can negatively interact. Furthermore, ask if you can stop taking any medications, or if you can take a lower dosage of any of your medications.
- Make sure you properly understand when and how to take each medication.
- Since it’s easy to make mistakes, set up a system to organize your medications.
- Use an alarm system, on your cell phone, watch or other timer, to remind you when it’s time to take each medication.
- For complicated medication regimens, keep track with the ZaggoCare Daily Medication Chart (scroll down to the footer for our downloadable chart).
For more information, read What’s an Adverse Drug Reaction?
Can you trust that your doctor only prescribes medications you need? Unfortunately, no. Medication overload is a widespread, dangerous problem in the US, especially for those 65+.
According to a Lown Institute report, medication overload is “the use of multiple medications for which the harm to the patient outweighs the benefit…the greater number of medications a person is taking, the greater their likelihood of experiencing harm, including serious adverse drug events.”
Health issues from medication overload can range from mild to life threatening. Additionally, medications for one ailment can make another condition worse. Interestingly, one study found that almost 23% of patients had received at least one medication that could worsen a preexisting condition.
What leads to medication overload?
Although many factors influence medication overload, the Lown Institute report identifies 3 overarching issues:
Culture of Prescribing
Doctors and patients want to believe there is a “pill for every ill”. This trend is fueled by many factors, including ads that encourage patients to seek prescription medications, rushed medical appointments, and our adoption of a medical approach to normal aging.
Additionally, both doctors and patients want to “do something” to improve patient health.
Information & Knowledge Gaps
Doctors and patients don’t always have the information and skills needed to evaluate the circumstances and make informed decisions regarding medications.
A widespread lack of communication among doctors and other healthcare providers can lead to fragmented care in which each of your doctors doesn’t know your diagnoses and treatments given by other doctors caring for you.
One common scenario: one doctor writes prescriptions for what seems like a new health condition but is actually a side effect from another medication prescribed by another doctor. This practice, referred to as “prescribing cascade”, can lead to a cycle of debilitating health and even death.
How can you reduce your risk of medication overload?
I suggest the following:
- Make sure all your doctors have an accurate list of all your medications, including over-the-counter. Do NOT assume that each doctor knows what your other doctors prescribe for you.
- When a doctor recommends a new medication, ask these questions:
- Is the medication absolutely necessary?
- What will happen if you don’t take it?
- Could your doctor be giving you a new medication to treat side effects from other medications you are taking?
- Are there lifestyle changes you can try first?
- Are you getting the smallest dose possible for your condition?
- Will this new medication interact negatively with other medications you’re already taking?
- Exactly how and when should you take it?
- Importantly, ask each of your doctors if you can eliminate, or reduce, any of your medications.
- Don’t push your doctor to prescribe medication. Push aside the temptation to get “a pill for every ill”.
For more information, read Doctors Prescribe Too Many Medications.
Can we trust prescription medications to be safe? Unfortunately, no. We can unknowingly get tainted or black market medications at a pharmacy or hospital which contain dangerous ingredients, the wrong medication, or the wrong dosage.
Tainted medications may contain foreign objects, such as tiny glass particles, or dangerous contaminants (e.g., mold or carcinogens). And tainted medications might have too much or too little of the drug’s active ingredient.
Importantly, tainted medications – which are manufactured in FDA approved facilities – are sold legally to pharmacies, hospitals, and other healthcare institutions. In contrast, black market medications (see below) are sold illegally.
What are some examples of tainted drugs?
A Kaiser Health News (KHN) investigation highlighted recent examples of tainted drugs:
- The HIV drug Atripla contained foreign substances, including shards resembling glass, rubber, plastic and pebbles.
- NDMA, a dangerous, probable carcinogenic chemical, was found in the widely used blood-pressure medicine valsartan. The FDA also found NDMA and similar compounds in at least six drugs that tens of millions of people take every year.
What kinds of harm can tainted medications cause?
Harm ranges from mild to severe. In the extreme, patients can develop dangerous, sometimes fatal, infections. 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.
It’s hard for hospitals and pharmacies to identify 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, including the ingredients and the production process. Moreover, labels only have to include either the manufacturer, the packer, or the distributor.
These secrets make it hard for even experienced drug buyers in hospitals and pharmacies to know the origin of specific drugs. Therefore, buyers may unknowingly buy drugs from facilities with spotty records and/or a history of recalls.
Can the FDA keep our medications safe?
Although the FDA inspects facilities throughout the world that make drugs for the US market, the inspection system does not function as well as it should, with inspectors missing serious hazards.
Additionally, some drug companies will do whatever it takes to pass an inspection, with some companies “stage-managing” inspections or fabricating data. Other companies deny access to FDA officials.
Interestingly, many cases of tainted drugs only come to light after a whistleblower speaks up.
The FDA has limited power.
Alarmingly, even when inspectors find issues, the FDA cannot force drug makers to make improvements and/or change their ways, although they can cite safety violations, issue warning letters, and block imports from certain foreign plants.
This lack of power can lead to repeat offenders. For instance, between 2008-2018, the FDA penalized 70 drug making facilities, mostly domestic, for the same violation at least four times.
Generic medications may be less safe than brand-name.
Can you trust generic prescription medications? Although 90% of all medications prescribed to Americans are generics (low-cost alternatives to brand-name medicines), generic drugs receive less scrutiny from the FDA. Therefore, some experts feel generics may not be as safe and effective as brand-name medications.
For more information, read Are Medications Safe?
Black market medications.
Black market medications are sold illegally, outside of the government’s watch. These dangerous medications are either stolen, expired, contaminated, or fake. Often referred to as counterfeit, you can get black market medications in pharmacies, hospitals, nursing homes, and doctor’s offices.
What are the dangers of black market drugs?
Experts state that “counterfeit drugs are a global problem with significant and well‐documented consequences for global health and patient safety, including drug resistance and patient deaths”.
For instance, counterfeit drugs may contain dangerous, potentially deadly, ingredients, such as fentanyl. Additionally, the drugs may contain foreign objects or dangerous bacteria, mold, or carcinogens. Lastly, counterfeit medications might have too much or too little of the drug’s active ingredient.
For more information on black market medications, read Dangers of Black Market Medications – More Common Than you Think.
How can you avoid tainted or black market medications?
Importantly, you cannot blindly trust that your prescription medications are safe. Instead, shop carefully, and check your medications before taking them.
Make careful purchases.
When buying medications, only use pharmacies located in the US, even when shopping online.
Before you buy medications online, visit the FDA’s BeSafeRx Website for tips and to check if your online pharmacy is state-licensed. If it’s not licensed, don’t use it!
For more tips regarding online purchases, visit the FDA’s website: The Possible Dangers of Buying Medicines over the Internet.
Additionally, no matter where you buy your medications, 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.
Examine your medications.
Importantly, realize many tainted and counterfeit medications look identical to the real pills. However, you can reduce your risk:
- If a medication looks or smells different, don’t take it. Contact your pharmacist and doctor right away.
- Be wary of medications that come in packaging that looks different than usual.
- Look online to see photos of medications to visually check for discrepancies. Helpful sites include pill identification sites run by WebMd and RxList. Additionally, a Flickr site run by the FDA has photos comparing real and counterfeit medications.
And notify your doctor and pharmacist if you experience new or unusual side effect.
My final thoughts…
Many of us need prescription medications to maintain our health or heal from an illness or injury. Although this post outlines several issues that you can face when taking prescription medications, I believe that for the most part, we can trust prescription medications. However, I suggest you don’t take medications without considering the issues described above.