Where do your pills come from?

There was a time when most prescription drugs were made in the USA. That included both brand-name and generic medications. The Food and Drug Administration made a concerted effort to inspect manufacturing facilities on a regular basis. These visits were not announced in advance.

Over the past two decades, though, the pharmaceutical industry has changed dramatically. Manufacturing of many medications has shifted overseas because it is cheaper to make medicines in China, India, Thailand, Slovakia or Brazil.

The FDA was slow to respond to this migration. It took years for the agency to figure out how it might assess foreign-based facilities. Countries such as China and India require notice far in advance before an inspection can take place.

We’ve never understood why the FDA tolerates such limitations. If a country wants to export its pharmaceuticals to the USA, shouldn’t it have to meet the same standards as American-based manufacturers?

Even with advance notice, many foreign manufacturers have received warning letters from the FDA. They include Wockhardt, Ranbaxy, Dr. Reddy’s Laboratories, Aurobindo, Sun Pharmaceutical Industries and Fosun Pharma. The agency detected deviations from good manufacturing processes and kept some of their drug products from being sold in the U.S.

This summer, valsartan blood pressure pills were subject to a worldwide recall. The problem pharmaceuticals contained an active ingredient made by Zhejiang Huahai Pharmaceutical Company in Linhai, China. The company had changed its manufacturing process, and as a consequence, the medicine was contaminated with a probable carcinogen, NDMA. This problem had gone undetected for years.

More recently, a recall was issued by a U.S. subsidiary of an Indian company, Accord Healthcare, for a single lot (PW05264-46632) of mislabeled bottles of blood pressure medication. The label said hydrochlorothiazide 12.5 mg. The pills actually contained spironolactone 25 mg. For some patients, this mistake could have been a life-threatening error. These two drugs have very different effects on the mineral potassium. Hydrochlorothiazide depletes the body of potassium, while spironolactone can raise potassium levels.

One reader wrote: “HCTZ was prescribed to lower my idiopathic high potassium level. I am beyond grateful for your column addressing the recall of Accord’s generic formula. I’m concerned that this medicine could be having the opposite effect of its intended one.”

Many people would appreciate knowing where their pills come from. One woman tried to do her homework: “I take losartan. With the recall of valsartan, I wanted to see where my own drugs were manufactured. I happen to have two generics in my cabinet, one being a new refill.

“I called CVS. The pharmacist could find the location of only one of the drugs. It came from India, although it had a U.S. drug company on it until you probed further. She could not find the origin of the other generic pill, but she gave me the phone number for the drug company. I called, and they would not tell me where the drugs where manufactured. They said it was basically their secret.

“The drug companies do not have to make the country of origin public knowledge. I am appalled by this. It needs to change!”

Another reader expressed an opinion that many share: “All drugs sold in the U.S. should be labeled as to country of origin for all ingredients. We need Congress to pass a LAW to that effect ASAP!”

Joe Graedon is a pharmacologist. Teresa Graedon has a doctorate in medical anthropology and is a nutrition expert. Their syndicated radio show can be heard on public radio. In their column, Joe and Teresa Graedon answer letters from readers. Write to them in care of King Features, 628 Virginia Drive, Orlando, FL 32803, or email them via their website: www.PeoplesPharmacy.com.

2018 King Features Syndicate