Are Generic Drugs Safe?

What are generic drugs?

When a pharmaceutical company develops a new medicine, it takes out a patent to ensure its exclusive right to produce and market that drug. Once this patent has expired (usually about 10 years later), other drug companies can jump in and produce a bioequivalent generic version of the drug. Bioequivalence means the medication contains the same active ingredients and meets the same government standards for safety and efficacy as the original brand-name medicine does. The pill or potion might be blue instead of orange, or oval instead of round, but its effect on the body is the same, and the generic drug manufacturer has to prove that its version has the same effect as the existing brand-name medication.

What about side effects?

Australia has a good report card for the sound use of generic medicines. According to GMIA CEO Kate Lynch, generics are just as safe as the original drug and “would be expected to have the same amount of adverse reactions”. Yes, a medication’s active ingredients can cause such reactions, but so can its inactive ingredients, and these can differ from brand to brand. Inactive substances hold tablets together (binders and fillers), add colour and flavour to cough preparations, and form capsules’ smooth coatings, among other functions.

Such ingredients pose no harm to most of us, and bad reactions to them are rare. When a person switches to a generic drug and suffers an undesirable reaction, it’s usually because they’re hypersensitive or allergic to an ingredient that the original brand’s formula doesn’t contain, explains Geraldine Moses, consultant clinical pharmacist and Prevention adviser.

Rare exceptions

Generic alternatives may not be the right choice for you, for other reasons. For example, two generic brands of the blood-thinning drug warfarin are available in Australia, but scientists have not yet shown these to be bioequivalent, so your doctor won’t substitute them for warfarin.

Some experts also believe that doctors and patients should exercise caution when switching to a generic version of epilepsy meds. “To control seizures, anti-epileptic drugs frequently need to be at specific concentrations in the blood. Switching drug brands can cause the patient’s blood levels of the inhibiting substance to drop, which can provoke seizures,” advises Moses.

When a drug raises a red flag, your doctor has most likely taken all factors into account before prescribing it, but it’s worth questioning any change to your treatment.

The Final Word

Problematic drug reactions are uncommon, and most experts agree that we should feel confident about the medications available to us. “Generics are generally close enough to the original brand to be a safe and effective substitute,” says Moses, who adds that generics have been used in Australian hospitals for more than 20 years and have rarely caused complications.

Talk to your doctor and then choose the medication that appeals to you at the pharmacy. You can protect your health and also save a few dollars (or a small fortune!) over time.

MORE: GET THE MOST OUT OF GENERICS