Drugs and medical devices always have the potential to be harmful. They are expected to have the potential to cause side effects while treating conditions and symptoms because it is impossible to make medications that perfectly target just one thing. For most people with most devices and medications, side effects are mild, tolerable, and worth the benefits of using that device or drug.
On the other hand, sometimes the risks are not worth the benefits and patients suffer terribly. When a drug or device manages to get past the testing of a drug company, or that company intentionally lets it get through, and it is found to cause an unacceptable level of harm, it may be recalled. Dangerous drug and product recalls may be instigated by the drug company or issued by the U.S. Food and Drug Administration (FDA). Either way, these recalls often come too late for some patients.
What is a Recall?
A recall is a way that a device or medication can be either corrected or removed from the market. A correction occurs when a device or drug is modified, repaired, inspected, or relabeled to remove the risk to the public. Most recalls are voluntary, which means a drug or device company has become aware of a problem with a product and decides without being forced, to recall that product. Companies are supposed to do this voluntarily as part of the responsibility to patients and the public.
Only in rare cases does the FDA mandate a recall. If the FDA finds that there is a drug or device in violation of its regulations or that is known to be unacceptably harmful and the company has made no moves to recall it, the agency may step in and force a recall. When this happens the FDA issues a statement ordering a company to cease distribution, it notifies health professionals of the problem, and gives the company a chance to show up at a regulatory hearing.
Some recalls may be over a specific lot. For instance, the antipsychotic drug Risperdal underwent a recall by parent company Johnson & Johnson because of manufacturing issues. One lot of the drug, which included more than 70,000 doses, had to be recalled because some tested positive for mold contamination. These kinds of recalls are limited, but can still lead to a big loss for the company.
L-citrulline is another example of a medical product recalled over manufacturing issues. This is a product that can be used over the counter as a nutritional supplement, but in prescription form is an important drug for children with rare urea cycle disorders. Without the drug in the correct amount, these children can die. Medisca, a manufacturer of pharmaceutical-grade L-citrulline was the subject of a recall when the FDA announced that certain lots were found to be sub-potent. This put children at serious risk of not getting an adequate does of life-saving medication. Some tested samples were even found to have no L-citrulline at all.
Faulty Design Recalls
In some cases a drug or device may be found to be faulty in its design, not because of any manufacturing errors. An example is the power morcellator, a device used to cut tissues to be removed during surgery into smaller pieces. The design of some of the devices increased the risk of a certain type of cancer in women and so many companies recalled their morcellators entirely. Some may redesign the device, while others may simply remove it from the market for good.
Other medical devices that have been recalled over faulty designs are hip replacement systems. A number of companies, including Stryker, DePuy, Zimmer, and others, designed metal-on-metal artificial hips that proved to be seriously problematic. These newer hip designs were supposed to be more durable and to last longer in more active patients.
Some of the hips or components, like Zimmer’s Durom cup, had specific faults in their designs. The Durom cup, for instance, was supposed to sit in the cup on the pelvis that holds the hip joint, but the material was found to adhere poorly and could slip painfully out of position once inserted. Other hips were simply faulty for being made all of metal. The metal components rubbing against each other caused numerous problems in some patients, including metal poisoning, hips slipping out of place, infections, and serious and debilitating pain.
Recalls that Never Occurred
In some instances, the public or advocacy groups have pushed for a particular dangerous drug or product to be recalled without success. Such has been the case with the birth control medication Yaz made by Bayer. Yaz is a fourth-generation oral contraceptive with a synthetic hormone called drospirenone, which has been found to increase the risk that a woman will develop a dangerous, potentially fatal, blood clot.
All oral contraceptives come with this risk, but it was only ten years after Yaz came on the market that the FDA issued a warning that the risk was greater with this drug. The risk may be as much as three times greater when compared to other, similar drugs. Many women suffered from taking Yaz and some even died because of blood clots that led to pulmonary embolism, heart attack, or stroke.
An FDA advisory committee investigated and decided not to recall Yaz, but certain advocacy groups criticized this result. They accused the FDA’s committee of including members that had biased ties to Bayer. Since then, many people have pushed for a total recall of Yaz because of the risk it poses for women, but these attempts have not been successful. Only a small recall over a manufacturing issue has ever been instituted for Yaz.
Dangerous drug and product recalls are not that common in terms of how many medications and devices are on the market. However, when a product is found to be too harmful to be worth any of the purported benefits, either the manufacturer or the FDA should issue an alert and then a recall. When this doesn’t happen, the public and advocates for consumers may continue to put pressure on drug makers and the FDA.