Source: Chris Smith
Drug recalls aren’t unusual, and we’ve recently seen quite a few of those. When manufacturers discover issues with certain products, like incorrect dosage, they recall the medicine to prevent it from harming patients. But this is the first time we have seen a top COVID-19 drug recall.
Gilead’s Veklury, better known as remdesivir, was the first medicine approved to treat patients infected with the novel coronavirus. Unlike other recent recalls, the remdesivir warning doesn’t concern dosage. Instead, Gilead found some lots of the drug to contain traces of glass particulates. Needless to say, this can pose significant health risks to patients. Also, unlike other recent drug recalls though, this COVID-19 medicine isn’t the kind you have at home. It can only be administered by injection at a hospital.
The remdesivir recall
Gilead recently announced a voluntary nationwide recall of two lots of Veklury. The US Food and Drug Administration (FDA) shared the announcement on its website, as is customary for such recalls.
The company explained that it issued the COVID-19 drug recall after investigating a customer complaint. Some vials contained glass particulates, which can pose a health risk to patients. Glass particles can sometimes end up contaminating products, which leads to recalls when it’s discovered. Gilead explains:
The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.
However, Gilead also noted that it has not received any reports of adverse events related to the remdesivir recall.
The first COVID-19 breakthrough drug
Remdesivir turned out to be the first significant breakthrough drug of the pandemic, although the COVID-19 therapy is far from perfect. Studies have found the anti-viral to hasten recovery in some patients, especially if administered early after infection. But the drug isn’t a life-saving medicine that can significantly reduce the risk of death.
Also important to note is that remdesivir isn’t a drug you can take at home. Medical professionals administer it intravenously. That’s why the COVID-19 drug recall will not impact patients directly. You won’t have to throw out remdesivir vials or return them to the manufacturer because only hospitals get them. It’s still important to be aware of recalls like this, however.
The recalled COVID-19 drug is distributed in single-dose clear vials in powder form. Hospital pharmacies then reconstitute it on-site for intravenous injection.
Gilead explained that Veklury lots 2141001-1A and 2141002-1A are part of the COVID-19 drug recall. Vials from these two lots were available nationwide in the US.
What you need to do
The COVID-19 drug recall will not impact any patients directly. Gilead notified hospitals of the recall. Furthermore, the company will facilitate the return of any remaining vials from the two lots. Gilead instructed the hospitals that have supply from those lots to stop using them. They should return the product vials to Gilead.
Coronavirus patients will not have to deal with the drug recall themselves. The same goes for anyone else. Again, this COVID-19 drug is only available after admittance to a hospital following a positive COVID-19 diagnosis.
COVID-19 survivors who received remdesivir during their hospitalization can talk to their doctors to ensure they’re not from the recalled lots. Anyone who suspects an adverse reaction can contact Gilead and the FDA’s MedWatch Adverse Event program. The COVID-19 drug recall announcement includes all the contact information — check it out at this link.