Originally published on U.S. News and World Report.
We can all likely agree we’re lucky drugs aren’t recalled as frequently as cars.
But when the Food and Drug Administration or a manufacturer recalls medicine, it’s particularly troublesome because getting to the patient who is prescribed that medicine is not as easy as informing people who drive a Chevy Cobalt with a faulty ignition, or one of 34 million owners with defective air bags.
An unthinkable accident happened again in May when Mylan (Nasdaq: MYL), the maker of a popular generic medicine called methotrexate, issued a voluntary recall for the injectable form of this drug, and three others, because of particulate matter in its vials. It recalled methotrexate in Canada in March.
This is not an isolated incident. It has happened twice in less than five years with methotrexate in the U.S.
Shards of glass were found in the vials the first time, and patients are still waiting for an apology. This time, Mylan did not even return a phone call or an inquiry made through its website regarding comment and information about the affected drugs.
With the latest drug recall, particulate matter in a handful of vials that, at most, a couple hundred thousand people take for a disease, unfortunately doesn’t break through today’s news cycle. In addition, the manufacturers of the medicines don’t always go out of their way to notify the public or draw attention to their potentially fatal error. Luckily, social media – driven by patients and patient organizations like CreakyJoints – help efficiently and effectively get the word out. Unfortunately, that too can fall short because not every patient is active on social media.
Before we go any further, if you or someone you know takes an injectable form of methotrexate to treat cancer or autoimmune diseases like rheumatoid arthritis, click here for details about the recall. Mylan is also recalling three other drugs: gemcitabine, carboplatin and cytarabine. Note the lot number, expiration date and other specifics in the FDA announcement, and check to see if you have a recalled drug.
It’s worrisome that some drug manufacturers are not doing enough to protect consumers in the event of a recall, as this latest incident suggests.
Is it really our responsibility to promote a recall? The news media generally ignores recalls, and unlike the Department of Transportation, the FDA does not require the manufacturer to tell patients.
According to safercar.gov, a Department of Transportation website, “…If a safety defect is discovered, the manufacturer must notify NHTSA, as well as vehicle or equipment owners, dealers and distributors. The manufacturer is then required to remedy the problem at no charge to the owner. …”
FDA requires that customers be notified, but the definition of a customer does not include a patient. A customer can be a pharmacy, physician, insurance company, pharmacy benefit manager or other entity.
Some entity known to Mylan knows who is taking its prescription drug that has been recalled. Mylan, in this case, should be financially and legally responsible for notifying every patient, just as auto manufacturers are. One of many possible solutions is a confidential electronic record, updated automatically when a prescription is filled, allowing immediate notification, through a third-party, without loss of privacy. But some companies, including Mylan, are fighting important current discussions that would make it easier to notify patients.
Without full responsibility for patient safety, it is too easy for manufacturers to continue to save dollars instead of lives.