Decoding the FDA Drug Recall Process

Noble McIntyre on August 5, 2016

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You probably hear fairly frequently about food and products that are subject to recalls, but it also happens with both prescription and over-the-counter medications. A pharmaceutical recall can be scary, because if you have taken a particular drug for many years (or even short-term), you could be worried about its long-term effects. Defective drug recalls are commonplace, and if you’ve experienced uncommon side-effects from a particular drug, you might be wondering how to handle that. In our two-part series, we’ll walk you through why an FDA drug recall is issued, how approval and reporting systems work, how the Food and Drug Administration evaluates claims, and more.

Drug Recalls, Part I: Why an FDA Drug Recall Happens

Often, a pharmaceutical recall is the result of a process in which harm could have been prevented. Make no mistake — a Big Pharma drug manufacturer is in business to make money… not because it cares about your health and well-being. The drug companies know that they hold the keys to keeping diseases at bay, which means that they can charge exorbitant amounts of money for their products, and we (the consumer) have no choice but to pay it. That’s why your insurance premiums are so high, why some of your prescription drugs might not even be covered by your insuance company — the list goes on. Because the drug manufacturers have such a money-maker in their hands, it’s in their best interests to rush their products to market. That means that sometimes a drug makes it to your pharmacy shelves before adequate testing has taken place, and sometimes even without full disclosure to the FDA of its risks.

What is a drug recall?

A drug recall is when a prescription or over-the-counter medication is removed from the market because it is defective or otherwise potentially harmful. Sometimes, this is because the FDA has determined that the drug has too many associated risks, but in other cases the manufacturer, itself, chooses to pull the drug from store shelves. Either way, a drug recall procedure would determine whether an FDA drug recall is necessary in that instance. With any of these circumstances, drug recall classes can indicate whether or not you would consider continuing to take the drug. Here are the drug recall classes you need to understand:

Class 1 recall: reasonable probability that continuing to take the drug would cause serious harm or death.

Class 2 recall: continuing to take the drug might cause temporary or reversible medical issues, but the possibility of serious consequences is low.

Class 3 recall: even though the drug recall procedure requires the drug be pulled from shelves, continuing to use would not likely cause health problems.

Of course, drug recall classes are not absolute, and you should always check with your provider before continuing to take any drug that has been subject to a recall.

It’s important to know how to check for recalls, and why a recall might be in effect. A drug could be recalled for the following reasons:

  • Health risks
  • Newly discovered drug interactions
  • Manufacturing error
  • Packaging information error


Health risks

Drugs go through rigorous testing well before they get to the store shelves. But, there are situations in which a drug’s risks are not understood or recognized until it has been used for many years. Sometimes this happens because the studies and trials were not lengthy enough to see the long-term effects. It could also happen when the trials do not account for the range of patients that the drugs will ultimately be used to treat; for example, it might not look at patients with preexisting conditions that might be affected by the new drug. While the FDA always does extensive research and testing, drug recall actions can happen because in some  cases a patient would need to take a drug for many years — maybe even decades — before a negative effect would start to show symptoms.

One example is the drug Bendectin, which was approved by the FDA in 1956 to treat nausea and vomiting in pregnancy. By the 1960s, it had become the leading treatment in the U.S. for those symptoms. But, in the mid-1970s, reports began surfacing about the possibility of birth defects in children born to women who had taken the drug for its intended purpose. While some studies showed that Bendectin led to birth defects, several analyses indicated that it was safe. Still, manufacturer Merrell Dow Pharmaceuticals pulled the drug from the market in 1983 because of the backlash of legal and liability issues. Still, because numerous studies have suggested that the components in Bendectin are safe for pregnant women, although the drug itself is no longer available, other medications on the market today do contain its active ingredients. Note that while a particular medication might fall into one of the drug recall classes above for its intended use, pregnant and breastfeeding women have another set of classifications for risks. If you are pregnant or breastfeeding, talk with your provider to verify the risk category or if alternate drug recall classes exist for any drug or supplement you’re taking.

When health risks for a particular drug are discovered, it can be pulled from the market. Alternately, the manufacturer might revise the recommendations provided to doctors and consumers about how the medication is used, for what purpose and what the long-term effects might be. While it’s difficult to find a medication that would have absolutely no chance for ill effects in some people because of biological and genetic differences, it’s up to the manufacturer to advise doctors so that patients can be warned of any potential effects.

All of these factors make it hard for the FDA to determine what’s what. Is a drug recall really necessary? Or can the harm be mitigated just by changing some of the language on the package insert? Sometimes, it’s the latter, which is why in addition to knowing how to check for recalls, you should also routinely read the packaging when you’re about to take any new medication.

Another drug about which you might have heard is Accutane. Accutane was on the market for 27 years before being subject to drug recall procedure. Reports of birth defects, miscarriages and premature births for pregnant women, as well as inflammatory bowel disease and suicidal tendencies in non-pregnant individuals, began to arise . Over 7,000 lawsuits were filed, one of which reached a $10.5 million verdict, while two others resulted in $9 million verdicts.

Some drugs that have been recalled in recent years include Bextra (pain relief, recalled in 2005), Darvon and Darvocet (pain relief, recalled in 2010), Hismanal (antipsychotic, recalled in 1999), Meridia (appetite suppressant, recalled in 2010), Propulsid (heartburn associated with gastroesophageal reflux disease, recalled in 2000), Seldane (antihistamine, recalled in 1998), Vioxx (pain relief, recalled in 2004), Zelnorm (irritable bowel syndrome, recalled in 2007) and others.

Newly discovered drug interactions

Another cause for a drug to be recalled could be its interactions with other drugs. It’s also possible that another drug could be released that treats the same condition or symptoms, but that has been determined to be safer than the original.

Each time you take a drug, you risk changes based on age, underlying medical conditions or diseases and lifestyle. Drugs can be reactive with other drugs, food, alcohol, or health supplements such as vitamins.

How a drug is handled by the human body varies on an individual basis because each person’s absorption, distribution, metabolism and excretion of the drug will be different. That means that even that long list of side-effects printed on a drug package insert cannot include the entire range of possible interactions.

It’s important to always be sure that your physician knows exactly what drugs and supplements you’re taking when you are prescribed something new; likewise, if you’re purchasing an over-the-counter medicine, talk to the pharmacist. If the new drug has similar qualities or opposite qualities with another substance present in your body, the effects could be devastating. As well, adverse reactions can occur if a drug alters a substance that your body produces itself or that is normally present.

Although it’s common for drugs to have unexpected effects, and those drugs never get recalled, the scenario that would cause a drug recall is when the FDA finds that the potential for interactions is so high, or the effects so dangerous, that it is unreasonable for that drug to be on the market.

Manufacturing error

Sometimes a drug is inherently safe, but a mistake is made in the manufacturing process. When that happens, specific batches of the drug can be recalled, but production continues and it will eventually be returned to market. A manufacturing mistake could be some contaminant in the batch, bacteria, or even the wrong proportions of ingredients.

If a prescription drug is recalled, your pharmacy might attempt to contact you to let you know. If it’s an over-the-counter drug, the only way you would likely hear the information is on the news.

Packaging information error

On occasion, a drug can be recalled even though the drug, itself, is completely fine. When it comes to medications, though, the small print on those little inserts in the box is just as important as the medication. That’s because any medication, if taken at the incorrect dosage, or not to the correct specifications, can be dangerous or even lethal. It’s also why a drug recall might occur if a medication’s dosing instructions, ingredient list, list of common side-effects, interactions or other information is incorrect. It’s important that doctors, patients and pharmacists have accurate information when dosing and prescribing drugs so that each patient takes a medication appropriately for his or her treatment and medical conditions.

What if you’ve been affected by a drug recall?

Now you understand what is a drug recall, so the next step is how to handle it if you’re affected. In the next installment of our series on drug recalls, we’ll take a look at what to do if you find out that a drug you’re taking or have taken is subject to a recall. We’ll take a look at the reporting process, how the FDA evaluates complaints and what the manufacturers’ responsibilities are for when and how to remove a drug from the marketplace. Stay tuned!

Noble McIntyre

Noble McIntyre is the senior partner and owner of McIntyre Law who focuses primarily on drug litigation and catastrophic injury cases. He is currently representing clients injured by the drugs Paxil, Levaquin and testosterone therapy drugs and by clients affected by oil field injuries. His goal has and continues to be to work diligently on behalf of his clients to achieve the highest and best result for his clients’ injuries while maintaining professionalism and abiding by all ethical standards of his profession. Read more about Noble McIntyre.

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