Most of your drug labels lack critical information

Open your cupboard and you will find lot numbers on canned goods, crackers, macaroons, mayonnaise, soup and many other items. There is a lot number on your Advil, aspirin, Metamucil and other OTC medicines. But unless the pharmacy dispenses your pills in the original packaging from the manufacturer, you won’t find a lot number on your prescription bottle.

Because more than 80 percent of prescriptions are now generic, it is increasingly common for pharmacists to take pills out of very big bottles and repackage them in little pill containers. Most states do not require pharmacists to put the original lot number on your label.

Why does it matter? In November 2012, the Indian pharmaceutical firm Ranbaxy recalled millions of atorvastatin (generic Lipitor) pills because of contamination with particles of glass. The Food and Drug Administration put the affected lot numbers on its website so that patients could theoretically trade in their cholesterol-lowering drug if it was included in the recall.

According to the FDA, the atorvastatin recall did not lead to any serious injury. But what if a more dangerous problem arose? In the past, manufacturing problems have affected the dose of critical medications.

A heart medicine called digoxin (generic Lanoxin) has a very narrow range of safety. Too much or too little can lead to serious, if not fatal, outcomes.

In April 2008, it was discovered that one company had manufacturing problems with its digoxin pills. The Institute for Safe Medication Practices issued a report on the problem: “More than 1,000 patient deaths have now been reported in connection with the recall of 800 million digoxin tablets manufactured in New Jersey by the Actavis Group. The tablets were recalled because of the possibility that the strength of tablets was greater than labeled and might provide a potentially lethal overdose to patients taking the drug to aid failing hearts” (QuarterWatch, May 7, 2009).

Because lot numbers are not required on labels, it was hard for patients to know if their pills were part of the recall. Since pharmacists are not required to keep track of the manufacturer or the lot number of the pills they dispense, they have a hard time contacting people who might be affected by a recall.

In our high-tech world of computers and bar codes, one would think that this is a solvable problem. If OTC medications and mayonnaise can carry lot numbers, perhaps it is time for pharmacies to make sure lot numbers also are added to prescription-drug labels.

Q: I’m concerned about generic Wellbutrin (bupropion) manufactured by a company in India called Wockhardt. My mother has been on Wellbutrin for a decade. She did well on the initial generic when her insurance company stopped paying for the brand name Wellbutrin.

A few weeks ago, I realized that she appeared anxious and depressed. She wanted to eat all the time, just as she did before she started on the antidepressant.

I checked her prescription and found that the most recent generic refill was from Wockhardt instead of Mylan. When I searched Wockhardt online, I found a record of trouble with the FDA.

These pills smell terrible. How can I tell if there is something wrong with them?

A: We talked with the quality-control chemist on the original team that developed Wellbutrin. He told us that when this drug deteriorates, it has a distinct unpleasant odor.

Many people reported a bad smell with their generic Budeprion XL 300 tablets (bupropion). The FDA eventually found this formulation was not equivalent to the brand name Wellbutrin XL 300.

You are correct that the Indian drug company Wockhardt has recently run afoul of the FDA. An inspection in March uncovered many violations of good manufacturing practice at its facility in Waluj, India. That is where it makes bupropion. Because of quality concerns, an import ban has been imposed on products from that plant.

“The People’s Pharmacy with Joe and Terry Graedon” airs Saturday at 7 a.m. on WVTF (89.1 FM) and at 4 p.m. Saturdays and Sundays on RADIO IQ (89.7 FM). Joe and Teresa Graedon’s column runs in Tuesday’s Extra.

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