What Dogs? Novartis, Vets And Product Mix-Ups
January 31st, 2012 // 1:50 pm @ marquee
Earlier this month, Novartis recalled an unspecified number of over-the-counter drugs – including Excedrin, No-Doz and Bufferin – due to complaints about incorrect or chipped tablets and broken gelcaps. This came on the heels of an FDA inspection last summer that found a host of manufacturing problems, as well as repeated failures to follow up on consumer complaints or file reports with the agency .
As a result, the Lincoln, Nebraska, plant has been closed, although Novartis maintains it should reopen by the end of the year. That may be optimistic. The FDA has just completed another inspection and a new report dated January 20 found the same problems. These included a failure to do the following: train employees in quality systems, extend investigations of known problems to all products affected; assure processes remain in a current validated state and have an adequate number of trained staff in the quality unit (here is the most recent 483 report).
Meanwhile, the drugmaker is on track to lose hundreds of millions of dollars in lost sales, since the plant also made some Animal Health meds and conducted contract manufacturing for clients such as Endo Pharmaceuticals (read here). The troubles have been widely reported, by the way, and Novartis has issued at least one press release about the problems with over-the-counter meds (see this).
However, more than two weeks after Novartis alerted the public to the embarrassing problems, the drugmaker has finally gotten around to informing veterinarians that similar issues exist with one of the Animal Health meds that were made at the plant. The drug in question is Clomicalm, which is used to treat separation anxiety in dogs. A letter was sent on January 25 to vets to say that “there is a rare possibility that a wrong tablet may be found in bottles of Clomicalm with the enclosed lot numbers†(here is the letter).
This offers an ironic twist on concerns over separation anxiety: not only will dogs become more anxious with the wrong med, but now their owners – and even some vets – may become anxious as well. We asked Novartis why vets were not alerted earlier to the possibility that dogs could be exposed to the same sort of hazard as humans, given that the drugmaker was aware of the problems for months, suspended production weeks ago and notified its two-legged customers three weeks before vets were told about potential product mix-ups. No explanation was offered.
So far, Novartis emphasizes that it has not received any reports of adverse events or product mix-ups, but urges vets and pet owners to open and examine each bottle for tablets that are broken or incorrect in color, shape or size, according to the letter (which you can read here).
A Novartis spokesman wrote us to say the letter was sent “due to a rare possibility that a tablet from a different medicine may be found in Clomicalm bottles that have been distributed to clinics or dispensed to their clients… While we have no reason to believe that there were any mix-ups related to Clomicalm on the packaging line, we are taking this step to stay on the side of total caution.â€
