Were you affected by the Zofran safety recall?

| May 7, 2018 | blog

Floyd County residents, like the rest of Americans, depend on their doctors to prescribe the right drugs to cure their ills when they get sick. For the most part, these medical practitioners do their best to ensure that patients receive the correct treatment protocols and medications that will soon have them on the fast track toward good health once again.

Unfortunately, the same can’t always be said for major pharmaceutical companies. With eyes focused on their companies’ bottom lines and profit margins, some who should know better in the industry ignore the warning signs that a drug may pose a significant safety risk to patients to whom it’s prescribed.

Intravenous Zofran and long QT Syndrome

A previous post addressed the dangers of Zofran when used off-market to treat morning sickness in pregnant patients. But that is not the only danger this drug can present.

Research indicates that when patients are given a 32 mg intravenous dose of Zofran, they are at an increased risk of developing long QT syndrome, a potentially lethal heart arrhythmia. Long QT syndrome, in turn, can develop into Torsades de Pointes, a condition that is frequently fatal. This risk is particularly dangerous in patients diagnosed with congenital long QT syndrome and other heart problems. Those whose lab results indicate a predisiposition to low blood levels of magnesium and potassium also share an enhanced risk.

In 2012, the Federal Food and Drug Administration (FDA), recognizing the dangers, announced the voluntary recall of all 32 mg intravenous dosage units of the drug, which was marketed by various pharmaceutical companies, including:

  • Claris Lifesciences
  • Baxter Healthcare Corporation
  • Teva
  • Hospira
  • Bedford Labs

Typically, patients who received that dosage and route of administration are undergoing chemotherapy or having surgery, as intractable nausea can result from both treatments.

Before the recall, the FDA alerted the public to the potential cardiovascular problems by releasing Drug Safety Communications that addressed the agency’s concerns.

Other Zofran dosages not affected

It should be noted that, to date, the oral forms of the medication, as well as smaller increments of the intravenous dosages, fall outside the parameters of the recall. Zofran continues to be prescribed and is still considered to be safe when properly dispensed.

If you or a family member suffered from an adverse heart arrhythmia after receiving a 32 mg dosage of Zofran, you may have legal options available to explore.