Big pills big problem for Ethex?

The firm, a subsidiary of KV Pharmaceuticals, is withdrawing specific batches of the following five generic drugs: propafenone HCl; isosorbride mononitrate ER; morphine sulphate ER; morphine sulphate IR; and dextroamphetamine sulphate all of which were shipped before May 22.

The news comes at the end of what has been a difficult six month period for Missouri-headquartered Ethex. In October, the firm withdrew batches of its generic ADHD and narcolepsy treatment dextroamphetamine sulphate, while in June it recalled a batch of the generic painkiller morphine sulphate.

As with the previous withdrawals, Ethex’ concern is that the out-of-spec pills will contain higher amounts of their active pharmaceutical ingredients (API) increasing the potential for life-threatening overdose.

Adverse events experienced by those taking the oversized tablets may include arrhythmia, low blood pressure and respiratory depression, or for dextroamphetamine sulphate hypertension.

To date however, neither Ethex, the US Food and Drug Administration (FDA) nor any other regulatory bodies around the world have received reports of any such reaction associated with Ethex’ drugs.

Details of any specific problem have not been released, making it difficult to ascertain if the oversized pills are a result of a manufacturing deficiency or simply that more out-of-spec tablets are being detected than previously as the sensitivity of analysis methods continues to improve.

Either way however, the growing safety focus following recent high-profile problems with branded products, generics and APIs is likely to result in the identification of more out-of-spec tablets as levels of regulatory scrutiny are increased.

Out-of-spec drugs a widespread problem​

Ethex is not the only firm to have been hit by multiple manufacturing issues and dosing problems this year. In April, Actavis withdrew all batches of the cardiac drug Digitek (digoxin) after it emerged that they contained twice the intended amount of API.

Prior to that, the FDA asked Caraco, a subsidiary of Sun Pharmaceuticals, to remove several batches of its diabetes treatment metformin from US shelves after it was discovered that some of the tablets did not meet with approved specifications.