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Generics as safe as brand-name drugs

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Don’t be worried by occasional recalls, pharmacists say.

The December 2012 recall of generic atorvastatin pills manufactured by Ranbaxy, an FDA-licensed company in India, reignited concerns about the safety of generic medications. Although there were no reported injuries from small glass particles that found their way into the product, people taking the medication were understandably worried that the tablets might be dangerous. The incident underscored the fact that Americans are generally skeptical of generic medications, often viewing them as inferior to brand-name products.

John Fanikos, a pharmacist at Harvard-affiliated Brigham and Women’s Hospital, would like to put concerns to rest. “I am quite comfortable in taking generics myself and in dispensing them for patients in my hospital,” he says.

Two separate issues

When it comes to the safety of generics, there are two issues to consider: are they comparable to name-brand drugs, and are they manufactured according to the same standards?

In the United States, a generic must have the same active ingredients and perform the same way in the body as the name-brand drug. Multiple studies have shown that generics perform as well as their name-brand equivalents.

The drug-manufacturing process, however, has room for error. As a result, Fanikos says recalls are common for both name-brand and generic products.

“Generally, the problems are harmless. Perhaps they haven’t filled the container with the right amount, or the color is off, or the size of the pill is wrong,” Fanikos says. “Sometimes a failure in the manufacturing process causes contamination of the product, and that’s what happened at Ranbaxy.”

According to FDA protocol, as soon as Ranbaxy realized they had a problem, they halted the manufacturing process and recalled the drug before anyone was injured by taking it.

Filling a need

The popularity of generics is attributed to their cost, which can be dramatically lower than that of the brand-name drug. Lipitor, for example, costs pharmacies $3.80 per pill, while generic atorvastatin costs them $0.13.

Value aside, generic drugs are necessary to meet demand for the billions of pills consumed worldwide every year. “Without these companies, we’d have a drug shortage,” Fanikos says.

The FDA monitors multiple manufacturers in the United States and abroad and oversees the manufacturing processes in these factories. Some major pharmaceutical companies—Pfizer, Sandoz, Novartis, and Abbott among them—sell their own brand-name products as generics under different names and at a lower price.

Wholesale cost of a name-brand medication and generic equivalent paid by Brigham and Women’s Hospital


Allaying fears

Will recalls continue to occur? Fanikos says the answer is certainly “yes.”

“There are always going to be small problems that arise, because manufacturing is not a perfect process. But with the infrastructure the FDA has put in place, and manufacturer quality controls, issues are caught relatively quickly. In the overall scope of manufacturing billions of pills every year, the number of problems is infinitesimally small,” he says.

Posted by: Dr.Health

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