As a pharmacologist and lifetime advocate for consumer health, I’ve been one of the biggest champions of generic drugs for more than 25 years. They can cost much less than brand-name drugs. And the FDA assures us that their stringent oversight guarantees generics are as effective and safe as brand-name products. Along with most doctors and pharmacists, I believed the FDA. But no more.
From carcinogenic contaminants…to an increased incidence of side effects…and/or even poor efficacy, there can be problems with generic drugs, ranging from blood pressure and antiseizure drugs to heartburn medications and antidepressants.
What can go wrong with generics
There are three main reasons why generic drugs may not be as effective and safe as the FDA promises—possibly because generic drugs have thinner profit margins, with less money available for quality control. The issues are…
• Instant release vs. timed-release. Decades ago, most prescription drugs were instant release—the active ingredient was immediately released into the bloodstream. To maintain an effective level of medicine in the blood, you had to take pills two or three times a day. But in the 1980s and 90s, companies began to market timed-release or extended-release formulations, allowing for a once-daily dose. Today, most popular drugs are available in a timed-release form.
A hidden threat: The approval process the FDA uses for generic drugs is still based on the decades-old concept of instant release. If a generic drug reaches a “maximal concentration” in the bloodstream that is similar to its equivalent brand-name drug, the FDA approves it. But the hour-by-hour level of the drug in the blood may be quite different from the brand-name drug, possibly reducing effectiveness and increasing side effects.
• Foreign manufacturing. About 80% of drug ingredients—the active pharmaceutical ingredients (APIs)—are now made in foreign countries, including India, China, Thailand, Turkey, Brazil, Mexico, Bangladesh, Slovakia and others. Many pills are also manufactured abroad.
Unfortunately, FDA oversight of the foreign production of APIs and pills is inadequate. In the US, for example, the FDA makes unannounced inspections of drug manufacturers. Abroad, the FDA usually schedules its visits, allowing companies to prepare in advance. This contrasting oversight has led to products with inadequate levels of the active compound, contamination and falsification of testing data.
• Transportation. The FDA has stringent temperature and humidity guidelines for the transportation of drugs (generic and brand-name versions) to ensure that they stay intact. But the FDA exercises little oversight of those guidelines. For example, what happens if an API is manufactured in China…goes to India to be formulated into pills, which travel by container ship to Houston…then get shipped to a wholesaler or distributor in San Diego or Phoenix…and are finally distributed to pharmacies? No one knows the consequences of this odyssey.
How to protect yourself
It’s difficult to figure out if a generic drug you’re taking could harm your health. Complicating matters is the fact that there are no specific categories of generics that are worse than others. Problems have been found in many classes of generic drugs.
Case in point: Some of the worst offenders are foreign-manufactured angiotensin II receptor blockers (ARBs). There have been repeated reports of these popular medications, such as losartan, irbesartan and valsartan, typically used for high blood pressure and heart failure, being contaminated with carcinogens (nitrosamines). The FDA has now recalled untold numbers of these pills and has published a list of ARBs it considers safe. To see the list, go to FDA.gov and search “ARB Drug Products.”
To minimize potential harm…
• Assume nothing. Don’t assume that your generic drug is flawed—but don’t assume that it’s perfect either. Because of the failure of the FDA to protect us from harmful generic drugs, you need to personally evaluate the safety and effectiveness of your generic drug.
• Ask for lab results. You and your physician need to monitor your health with all of the data that is available. With that in mind, make sure your physician supplies you with all lab results so you can track any changes. Example: HbA1c, a measure of long-term blood sugar levels—if it rises but you haven’t made any changes in your diet or lifestyle, your generic diabetes drug may not be working.
• Keep records. Once you have your lab results, be sure to record them so you can closely track the effectiveness of the drug. If those numbers stay steady, it’s likely the medicine is working. If they change significantly after you start a generic substitution or get a refill, tell your doctor immediately. You may need to revert to the brand-name drug or a different generic manufacturer.
Smart ideas:If you revert to the brand-name drug, consider buying from a Canadian online pharmacy, which will have lower prices. (You will most likely have to pay out of pocket, but the drug may be covered by a private insurer if you submit a receipt.) Important: To make sure it’s a reliable pharmacy, visit the website PharmacyChecker.com.
If you switch generics, ask your pharmacist for an “authorized generic drug”—a type of generic that is identical to the original brand-name drug. (The authorized version is often made by the same manufacturer that makes the brand-name version.) Example: Pfizer makes Viagra, and a Pfizer subsidiary makes its authorized generic, sildenafil.
• Monitor symptoms. Some conditions aren’t measured in numbers. Examples: You’re taking a generic prostate drug for urinary symptoms, but you still have to get up several times a night to urinate—a sign the drug isn’t working. Or you switch to a generic pain reliever, and your arthritis pain comes roaring back. In both cases, the generic drug is the likely culprit.
• Challenge and rechallenge. This is a time-honored way to assess your reaction to medication. If generic drug X causes a headache, going back on the brand name should solve the problem. To confirm that the problem lies with the generic, take the same one you used before to see if the symptom reappears. If it does, it’s highly likely the generic is at fault.
• Find out the manufacturer. There may be dozens of different companies making your generic medicine. Ask the pharmacist to always put the name of the generic manufacturer on your prescription bottle. If a generic drug from a particular manufacturer works, stick with it…and ask your pharmacy to keep it on hand or order it just for you—not all drugstore chains, however, will be able to fulfill this request.
• Seek allies. If you decide not to use the generic, ask your doctor and/or pharmacist to go to bat for you if your insurance company balks at paying for the brand name. (If your doctor or pharmacist insists that all generic drugs are identical to their brand-name counterparts, ask him/her to read this article.)
Helpful: To find out the latest on recalled drugs, sign up for recall alerts at FDA.gov/safety/recalls.