There are many things to keep track of when it comes to medications, like how much you should take, how often you take it, and what side effects it can cause. One thing many people don’t pay attention to is if a medication is recalled. However, it’s something that you should! Why do they happen? How do you find out about them?
Each year over 2 million serious adverse reactions to medications take place in the United States. Of this number, an estimated 100,000 people die. Unfortunately, many safety problems appear after drugs have received Food and Drug Administration (FDA) approval. Medications are rigorously tested for safety and effectiveness before becoming available to the consumer. The quality and safety standards are defined and regulated by the FDA.
Once a drug is on the market, the FDA and pharmaceutical companies continue to monitor it for unforeseen problems. If an issue develops or the safety of a medication comes into question, a recall may be issued. The majority of drug recalls are done voluntarily by the drug’s manufacturer since they’ve got a high incentive to recall a drug that has a potential risk to consumers to avoid litigation and financial liability. If, for some reason, a manufacturer doesn’t issue a recall, the FDA can.
It doesn’t matter where the recall originated; the FDA ensures that it’s handled properly and promptly. In addition, they’re responsible for alerting the public, classifying the type of drug recall, and safely removing the affected product from the market.
Drug recalls occur routinely every year. Typically, it’s because the medicine is found to be defective or potentially harmful. According to the Kaiser Health News (KHN), from January 2013 to October 2018, close to 8,000 medications were recalled by pharmaceutical companies. It’s estimated that for every 100 new drugs, there are 27 market withdrawals and new severe safety warnings, known as black box warnings (BBWs), within the first 16 years.
It’s important to note that not all recalls are dangerous. There are a variety of reasons that can cause a drug to be recalled. Besides being harmful, a recall may be issued if a medicine is mislabeled or packaged poorly, potentially contaminated, not what it says, or poorly manufactured. The FDA has three classes for recalls based on how serious the problem is.
- Class I is the most severe type and is defined as a recall involving “a dangerous or defective product that could cause serious health problems or death.”
- Class II recalls are the most common type of recall and apply to “products that might cause a temporary health problem or pose only a slight threat of a serious nature.”
- Class III recalls are the least serious and include “products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws.”
Once a recall is classified, the FDA works with the manufacturer to develop a strategy to address the depth of the recall, public warning, and effectiveness checks. For a recall to be considered complete, the company’s corrective actions are reviewed by the FDA and deemed appropriate. If a recall is determined to be ineffective, the FDA will request additional measures. The agency also makes sure that the product is destroyed or suitably reconditioned. In addition, they investigate why the product was defective in the first place.
Why are all these recalls happening?
There are several reasons why all these recalls are happening. One is the FDA approves new drugs significantly faster than the regulatory bodies of Europe, Canada, and Japan. Most European Union countries require that new medicines go through a secondary review process comparing their efficacy to the existing standard of care. Furthermore, these countries prohibit direct-to-consumer advertising, which is known to increase prescribing of the advertised drug. The United States doesn’t do either of these. In fact, in 1997, the FDA relaxed regulations on direct-to-consumer advertising. As a result, pharmaceutical spending on advertising increased more than three-fold.
Another problem is there are special FDA programs that allow for the expedited review of some drugs. This process was initiated in the 1980s to allow for rapid approval of HIV drugs. The point of these programs was to approve drugs used in exceptional circumstances: for life-threatening, untreatable, or rare diseases. However, the process is now commonly used in non-exceptional cases.
Pharmaceutical firms have to register all studies in advance (not just the ones with favorable results). The problem is research studies with adverse outcomes are still being filed away without public oversight. This explains why some drugs on the market don’t have the same benefits and safety margin as the pre-marketing studies submitted to the FDA. The companies are supposed to have close post-marketing surveillance, but that seems to disappear once the drug is approved.
A different part of the problem is that the generic drug supply is incredibly fragile. Generic drugs are recalled most often, not because they’re less safe but because there are so many more of them on the market. This means the FDA has to decide between enforcing quality at a plant and avoiding a drug shortage. If there’s a drug shortage, patients won’t have the medication they need to be healthy. So, depending on the severity of the problem, the agency waits long enough to issue a recall until remediation steps can be put in place to ensure enough medication is available. Basically, quantity has to come before quality.
One example of this was the recall of generic ARBs (angiotensin II receptor blockers) from close to two dozen drugmakers. This recall occurred between July 2018 and mid-October 2019 after unsafe levels of several carcinogens were discovered in them. These medications are used to treat high blood pressure and congestive heart failure and to help prevent strokes. Just how popular are ARBs? According to government statistics, in 2016, there were more than 79 million prescriptions for them. So, there was a significant amount of concern about what would happen to the individuals who take the medication if it was immediately taken off the market rather than ensuring they could manage their conditions.
There’s another issue with generics. Since they’re sold at a low cost, many American facilities won’t manufacture them because it doesn’t make good financial sense to produce them in our high-wage, high-tech environment. Instead, they’re made overseas, where they’re much harder to regulate.
Roughly 80% of Americans’ medications contain some component manufactured abroad, primarily in China and India. It’s estimated that American and European countries save somewhere between 30-40% by outsourcing to these countries. China and India are responsible for 13 and 18% (respectively) of all active pharmaceutical ingredients (API) worldwide. While this helps keep the cost of medications down, it makes ensuring supply chain safety incredibly challenging. The consequences of having poor-quality APIs can be far-reaching since generics account for close to 90% of all prescriptions.
It’s tough to regulate anything, let alone medications, from other countries. If an FDA inspector goes to a drug manufacturing facility in America, the company must provide full access to its operations and records at a moment’s notice. The agency doesn’t have to warn the company either. If a company fails to comply, the consequences can be swift and severe.
In other countries, the FDA usually loses the element of surprise. To inspect a foreign facility, our State Department has to get permission from that country’s State Department. They also must know everything about the inspector’s trip. Often it takes six months before the trip is approved. By then, the information about the upcoming inspection is leaked to the company. So, it’s not a “surprise” inspection anymore.
Ideally, if American manufacturers want to work with a foreign supplier, they send their own inspectors to ensure the company’s process is up to standard. The process should be ongoing, with American companies auditing their suppliers continually. It’s important to note that the FDA requires documentation of this to confirm product quality and compliance before they approve drugs to be for sale. The issue is the cost of sending auditors overseas; some smaller American companies instead rely on communication and documentation from the supplier and confirmed internal test results.
How can the problem be fixed?
One way to address the problem of medication recalls is by focusing on preventing drug shortages. The FDA created its Drug Shortages Task Force to determine the root causes of deficiencies and make recommendations for improvement. One of their recommendations was a new system aimed at encouraging higher quality and advancing technology among American facilities, and this would alleviate shortages caused by manufacturing problems.
According to the agency, “advanced manufacturing technology, which FDA supports through its Enhanced Technology Program, has smaller facility footprint, lower environmental impact, and more efficient use of human resources than traditional technology.” These technologies, including continuous manufacturing and 3D printing, can “improve drug quality, address drug shortages of medicines and speed time-to-market.”
Another area of focus should be more testing of API imports. Many industry experts feel that every batch without exception, especially from foreign facilities, should be tested with prominently published results. This isn’t a requirement. Some experts also say that having product labeling stating where the components are sourced from would have an impact. The more people know where their medications come from, the less likely they’ll be willing to put up with lower-quality products. This also isn’t currently required.
Certainly, the scrutiny of the foreign supply chain will increase now that more people are aware of just how much is coming from outside the U.S. Hopefully, companies will start taking more responsibility instead of waiting until there’s a problem. In fact, maybe American manufacturers will use this as an opportunity to, despite the challenges, bring some low-cost drug production back to the U.S.
What should you do if your medication has been recalled?
The first thing to do if one of your medications has been recalled is not to panic. Remember, most recalls are for minor reasons. This is why until you have further information, continue taking it. The first step is to get as much information as possible. Part of this is to make sure that it’s your specific medication that has been recalled. Since generics are made by many companies, recalls often involve only certain ones.
While it’s common to learn about recalls from news outlets and online articles, you can look at the FDA’s website to get all the details. If you have specific questions or concerns, contact the agency at druginfo@fda.hhs.gov or through the following toll-free numbers: 1-855-543-3784 or 1-310-796-3400. It’s vital to point out that not all recalls are announced on the FDA website or via the news media. Public notification is typically released only if a recalled product has been extensively distributed or poses a serious health hazard.
If it’s prescribed medication, the FDA, manufacturer, or dispensing pharmacy often notifies patients by telephone, mail, fax, or email if a medicine has been recalled. Also, the manufacturer usually posts recall information on their website. If it’s over-the-counter medications, you won’t be notified. To get a copy of the FDA’s weekly Enforcement Report of recalls, subscribe to their newsletter to get it emailed to you every week. Also, the FDA has a Twitter profile, @FDArecalls, where they announce recalls.
When trying to determine if it’s your medication that’s affected, you’ll need to find your medication’s lot number. This is because drug recalls pertain to specific lots of the medicine that were made during a particular period. It can be tricky to locate the lot numbers on medication packaging. Over-the-counter bottles will usually print it next to the expiration date, which is by the barcode or underneath the dosing instructions. Blister packs list these on their foil backings. For creams and gels, lot numbers are printed on or right above the crimp at the end of the tube, on the back of the tube, or listed in the storage information text.
If it was a prescription from a pharmacy without a manufacturer label on it, call the pharmacy to find the lot number. Pharmacies keep records of which lots were used and when.
While many over-the-counter drugs can be discontinued without any consequences, some prescription drugs are critical for your health, so don’t stop them until your doctor finds a replacement for you. If your medication has been recalled, safely dispose of it. Not only will this reduce the chances of you or others accidentally taking it, but it’ll also prevent the drug from contaminating the environment.
Sometimes, medications came with specific disposal instructions; if so, follow them. Some medicines, like controlled substances, need to be taken to an authorized take-back site or flushed down the toilet. If your medication didn’t come with specific disposal instructions and there are no approved take-back sites near you, safely dispose of the medication in your household trash. Do this by mixing it with coffee grounds or something else you nor anyone else would eat.
While the FDA and drug manufacturers need to address medication recalls, it’s up to each of us to ensure that the medicines we’re taking are safe. This means being aware of recalls and knowing what to do when one occurs. We also need to insist that the quality of our medication supply is improved by holding the government and manufacturers accountable. All of these things are key to ensuring we have access to the best quality medications.