Are all FDA-approved drugs safe and effective? Nope. - (6/15/2021)

By Dr. Ron Gasbarro 

"What do you mean my medication has been recalled?" Mr. Jackson asked the pharmacist. "I've been taking it for years!" The pharmacist explained to his patient that recalls can occur at any time after a drug has entered the open market. "Before the FDA approves a drug, the number of people tested during clinical trials may be only hundreds, maybe thousands," the pharmacist said. "Once doctors start writing for it, a million people may be taking it. That's when unusual side effects begin to pop up. If these side effects are considered dangerous, the manufacturers of safety agencies have no choice but to pull it off the shelf." "Why can't these drug companies get it right the first time?" Mr. Jackson lamented. 

The pharmacist clarified that drug and medical device recalls are not as uncommon as the average person thinks. Each year, roughly 4,500 drugs and devices are removed from pharmacy and hospital shelves, even though the US Food and Drug Administration (FDA) had approved these products. In fact, not only were the items released to the market, but they were also, in many cases, widely ingested, injected, or implanted before being recalled. The FDA classifies each recall based on the seriousness of the injury that the product may cause. A Class 1 Recall is the most urgent type of recall because there is a real possibility that the product will cause serious side effects or death. Products such as pacemakers, heart devices, and certain drugs fall into this category. The lesser Class 3 recalls apply to minor product defects that are not likely to inflict harm on someone's health. Most recalls fall into this class. 

In 2019, the FDA pulled from the market the stomach drug ranitidine (Zantac®). This recall was because the drug disintegrated over time into a potential cancer-causing agent known as NDMA (N-nitrosodimethylamine). The agency decided that the impurity in some ranitidine products increased when stored at higher than room temperatures (like your kitchen window shelf?). Hence, consumers were in danger of being exposed to the carcinogenic agent. Zantac was first marketed in the US in 1983 and was enormously popular as a stomach acid and heartburn reducer for 36 years. Arguably, millions were saved from ulcer surgery by this medication. As of June 2021, 7,526 cancer cases are pending in that litigation, according to Drugwatch, a consumer advocacy group. 

What can you do if you are the victim of a drug injury? The drug manufacturer bears a great deal of responsibility, particularly if the drug has been financially successful over a long period. Another typical defendant is the doctor who prescribed the medication, a claim based on a medical malpractice theory. Similarly, you might sue a hospital or clinic if it provided you with the drug. Patients also sue a pharmacy if they failed to receive proper counsel when obtaining a prescription. 

Can you minimize the chances of having your drug recalled? (Can you stop an asteroid from slamming into Earth?). However, a few guidelines can be helpful. Avoid new drugs if you can. Indeed, if you have been prescribed various medications for your condition in the past, and they are not working, the brand-new one might help. However, if you are newly diagnosed with a condition that will require consistent control, such as high blood pressure, then ask for a tried-and-true generic. Minimize the number of prescriptions you take. If you are taking 9 or 10 prescription drugs, perhaps it's time for you to contact the pharmacist for a drug review. Even though his drug recall inconvenienced Mr. Jackson, he understood the consequences. The pharmacist made sure that he was prescribed another medication that would control his condition safely. 

Ron Gasbarro, PharmD, is a recovering pharmacist and writer-in-residence at Rx-Press.


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