Drug recalls: What are they?
The Medicines and Healthcare products Regulatory Agency (MHRA) makes sure the medicines we take are safe. There are around 20,000 different medicines available in the UK. Once a medicine is on the market, the MHRA and the drug manufacturers continue to monitor it for any unforeseen problems. Should an issue develop, or the safety of a medication come into question, the agency has the power to withdraw a product from the market, a recall, and to suspend production.
The MHRA works closely with the European regulator, the European Medicines Agency (EMA), which licenses medicines and medical devices across Europe.
When is a drug recall announced?
A drug recall occurs when a prescription or over-the-counter medicine is removed from the market because it is found to be either defective or potentially harmful.
The MHRA’s Defective Medicines Report Centre (DMRC) issues alerts to healthcare professionals, hospitals, GP surgeries and wholesalers to tell them when a medicine is being recalled or when there are concerns about the quality that will affect its safety or effectiveness. These alerts are graded according to the seriousness of the threat to the public’s health.
Class 1 requires immediate recall because the product poses a serious or life-threatening risk to health.
Class 2 specifies a recall within 48 hours because the defect could harm the patient but is not life-threatening.
Class 3 requires action to be taken within five days because the defect is unlikely to harm
patients and is being carried out for reasons other than patient safety.
Class 4 advises caution to be exercised when using the product but indicates the product poses no threat to patient safety.
Most recalls fall into classes two or three.
Why are drugs recalled?
A number of factors can cause a drug to be recalled. A recall may be issued if a medicine is:
A health hazard. Unfortunately, some health risks associated with certain medications are not realised until after they become widely used. For example, in 2007 lumiracoxib (Prexige), a medicine used to treat painful symptoms of osteoarthritis, was withdrawn from the UK market. This followed a review of the balance of risks and benefits of the drug, in particular concerns relating to worldwide data on spontaneously reported cases of serious liver toxicity associated with lumiracoxib.
Mislabelled or packaged poorly. Sometimes a medicine is recalled because of confusing dosing instructions or a problem with the dosing tool provided with the drug.
Potentially contaminated. During production or distribution, a medicine may become contaminated with a harmful or non-harmful substance.
Not what it says. For example, you may think you are taking a pain reliever based on the package material, when in fact what is inside the box is something else.
Poorly manufactured. Manufacturing defects related to a product’s quality, purity and potency may be to blame for a drug recall.