Drug recalls are extremely scary for those taking the recalled medicine. Unfortunately many patients aren’t sure what they should do beyond returning the drug. While this is an important step, it’s not the only one patients need to take.
Patients should first understand why pharmaceutical companies recall products. This can happen for any number of reasons, including something as simple as package defects or as serious as contamination of a product, improper testing, or other safety problems that could harm the patient in the short or long term.
But even packaging slip-ups can be a big deal. In 2012 Pfizer recalled close to 1 million birth control pills after it found out that some packages contained placebo pills. This instantly put hundreds, if not thousands, of women at risk of unintended pregnancies.
There are three different types of recalls, according to a three-tier system administered by the FDA. The three recalls are:
- Class I Recalls: There is a “reasonable probability” that using or being exposed to a violative drug will cause harm.
- Class II Recalls: Using or being exposed to a violative drug “may cause temporary or medically reversible” health effects on the patient.
- Class III Recalls: These types of recalls are much less serious than the first two but still should not be ignored by patients. Products of class III recalls are unlikely to cause adverse health effects.
It’s important that you know your rights once a drug you’ve been taking has been recalled.
Patients should also understand that only the FDA can approve product recalls, not the manufacturing company. This is different than products in other markets, such as the automotive industry, where the manufacturer can quickly issue a recall if a vehicle has a defect. In the pharmaceutical field, a company can issue a recall, but only after the FDA clears it to do so. The FDA will require the company to provide certain information including the name of the product, its National Drug Code, approval number, lot/unit number, strength and route of administration. The company will also have to explain the reason it needs to recall the drug.
If you’ve used a drug that has recently been recalled, the first thing to do is not panic. Do a little more research, contact the company and then contact your doctor. For medical and legal reasons, it’s important to have a medical record on file.
Once you’ve met with your doctor, call The Advocates. We have a significant amount of experience dealing with pharmaceutical companies who recalled harmful drugs. It’s important that you not only return the drugs and talk with your doctor, but that you understand your rights.