Understanding a Pharmaceutical Recall

Noble McIntyre on August 30, 2016


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A pharmaceutical recall is never taken lightly, and a drug could be recalled from the market for specific reasons. Among them: health risks, newly discovered drug interactions, manufacturing errors and/or errors in packaging information.

Drug Recalls, Part II: What is a pharmaceutical recall?

Although the reasons are specific, a drug could meet one of those criterion in many different ways. And, if you’ve taken a drug that has been recalled, you need to know your level of risk and what to do about. It doesn’t matter whether it’s a drug that you took for a short time for one ailment or if it’s a treatment that you use for an ongoing, long-term medical condition. One of the reasons for a pharmaceutical recall is because risks are sometimes discovered many years after a drug has been on the market. Often, this is what leads to drug recall lawsuits. Recalls also occur because of manufacturing defects that could affect a single batch or set of batches. In other words, you need to be aware that recent recalls could happen any time and for any drug — both prescription and over-the-counter.

What is the drug recall procedure?

The drug recall procedure is the process by which the agency records and manages reports of drug side-effects. The Food and Drug Administration (FDA) keeps track of any reports of side-effects from the users of prescription and non-prescription (i.e. over the counter, or “OTC”) drugs. This FDA recall database is known as the FDA Adverse Event Reporting System (FAERS), which holds medication error reports that are submitted to the agency. The FDA, along with other national and international agencies, continually reviews the information submitted to the FDA recall database in order to ensure that the drugs that have already been approved for market continue to be safe. When it is determined years later that a drug was, in fact, not safe, drug recall lawsuits are the consumer’s next course of action. But, long before it gets to that point, the drug recall procedure is in place to thoroughly and accurately ensure a patient’s safety.

If the agency sees reports that indicate a pattern of unsafe effects from a particular drug, it could determine that additional evaluation is necessary. At that point, it could be handled a few different ways, with FDA recalls being the last resort:

1. Update the product’s label information
2. Restrict the use of the drug for certain conditions or individuals
3. Advise the public of new safety information
4. Remove the drug from the market

So, how does FAERS get the information? It’s submitted by either healthcare professionals (such as doctors, nurses or pharmacists) or consumers. If you are currently suffering from a drug side-effect that is negatively affecting your health, your first call should be to your healthcare provider. If it is urgent or life-threatening, visit the nearest emergency department for help.

Although anyone can submit a report to FAERS, doing so does not mean that the drug would be subject to a pharmaceutical recall (or even evaluated). It also doesn’t mean that you will receive any kind of assistance or compensation for your harm through drug recall lawsuits. If you do believe that you are entitled to compensation as a result of a defective drug, you need a drug liability lawyer who can work with you to make your claim.

A FAERS submission does not require that you prove the link between the drug and the symptom or reaction, and sometimes submissions don’t have enough information for the FDA to even evaluate each an event. But, the drug recall procedure dictates that when reports meet certain criteria, the agency will reevaluate a drug’s safety.

How do you hear about a relevant pharmaceutical recall?

The public can hear about recent pharmaceutical recalls a few different ways. Public access to the FDA recall database is one option. There are three ways to view FAERS drug safety data:

1. Statistics: You can view numbers that include the volume of reports (domestic and foreign), and the type of reporter (healthcare professionals or consumers)
2. Outcomes: You can view the number of serious outcomes such as death, hospitalization, disability, and others.

You can also view actual data contained within the FAERS database. While actually using and interpreting the data can only be done by individuals who have advanced knowledge of relational databases, anyone can view a summary report by making a Freedom of Information Act (FOIA) request to the agency. This would allow you to receive individual case reports and quarterly data files.

There are other ways to find drug safety information, though. The FAERS releases a quarterly report that outlines new risks, which is available without your having to search the database yourself.

Drug Safety: Market Withdrawals and Recalls

If there is a pharmaceutical recall because the FDA has determined that a drug is unsafe, the agency will advise the public through notices to media, pharmacies and physicians. Not every recall is publicized through a press release, however. So, if you hear that a drug you take is under scrutiny, what does your recall mean? That depends.

The first thing you should do is look at any relevant FDA recalls to see why your medication is being recalled. If it’s something such as a labelling error, then you need to double-check with your provider and pharmacy about your dosage and any possible effects.

If the recent recalls are due to one or more defective batches of a drug, call the pharmacy where the prescription was filled or the medication was purchased. It could be that the pharmacy can simply take back any unused medication and exchange it for new ones. If it’s a bigger issue than that, the pharmacy should have instructions from the manufacturer about how to handle it. If not, call the manufacturer or check the website to see what consumers are being told to do.

If it turns out that the FDA recalls affecting your drugs are because they have been newly discovered to have long-term complications, effects or interactions that could be detrimental to your health, call your doctor immediately. It’s important for you and your doctor to evaluate whether it’s a drug that you want to continue to take or if there is a safer alternative.

If you’ve suffered harm from a defective drug

If you’ve suffered any medical harm as a result of taking a defective drug, whether it was from a manufacturing defect or later-discovered side-effects, contact McIntyre Law today. Our legal team has decades of experience with drug recall lawsuits and will work with you every step of the way towards getting compensation for your harms at the hands of drug manufacturers.


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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