Have You Been Harmed By A Medication? How It Happens And What To Do
The FDA has been in the press a lot lately as they work to bring multiple COVID-19 vaccines to market, but the FDA does a lot more than just approve vaccines. They also approve medical devices and prescription and OTC medications, oversee clinical trials and much more. Unfortunately, despite this hard work, sometimes dangerous medications and devices still make it to market. This can happen for a variety of reasons, but it ultimately falls to the FDA to prevent and, when it does happen, to remediate.
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Risk Versus Reward
Any time the FDA approves a new medication or device, they have to weigh the potential risks against the benefits. With devices, that often means fast tracking items that are essentially similar to products already on the market, while requiring more thorough testing for new devices. With medications, on the other hand, any alteration typically requires much greater testing and even manufacturing a generic medication in a new location requires careful oversight of the manufacturing facility.
Defects Versus Contaminants
Once a medication is approved for market, the two major concerns patients need to consider are, first, that the medication may have an underlying defect that was not identified during the trial phase and, second, that the medication may be contaminated during the production process. The former of these – an underlying defect – is what happened with the drug Elmiron, which was found to cause vision problems after decades on the market. Other medications, however, end up causing problems for patients because of contaminants, as occurred with particular batches of metformin, as well as with Zantac and its generic equivalents.
The Recall Process
When the FDA is alerted to an issue with a medication, they then have to decide how to proceed. In fact, there are several different classes of recalls, depending on the severity of the issue. For example, Zantac was pulled from the shelves, but as a largely generic, OTC treatment, making sure patients stopped taking it wasn’t a high priority; a few more doses were unlikely to significantly change a user’s cancer risk. With more dangerous medications, on the other hand, particularly with prescriptions, patients may be contacted by their pharmacy or another group to inform them of the risk and connect them with resources.
In some cases recalls can also be complicated by the timelines involved, as has been the case with Elmiron. Patients experiencing drug-related macular damage were typically those who had used the drug for at least 5 years, but their vision condition often did not occur until several years after the drug had been discontinued. The medication is now clearly labeled, but the manufacturers are now facing numerous lawsuits, and it’s too late for patients to reverse the damage.
Patients often don’t know what to do when one of their medications is recalled, but the most important thing is not to panic. When there is a problem with a medication, the best thing to do is to check the reason for the recall using the FDA website, report any issues you’ve noticed yourself, and safely dispose of any questionable medications. If you’re not sure how to do this, you can contact a local pharmacy for help. If the recalled medication is a prescription or if you are concerned about unusual symptoms, you should also contact your doctor immediately.
Dealing with a medication recall is scary, but it’s only truly dangerous in the minority of cases thanks to the hard work of the FDA. In general, medications are carefully vetted before they come to market and that’s enough to keep users safe – in fact, that is the bond of trust between the FDA and consumers that keeps the system working.
Author: Anna Johansson
