Do Recalls for Brand Name Drugs Affect Generic Versions?September 28, 2020
While many prescription and over-the-counter drugs are best known by their brand names, most can also be purchased as “generic” versions, which are distributed and packaged by a wide variety of manufacturers and companies. For example, the popular pain reliever Advil® can also be purchased under its generic name, ibuprofen.
However, when popular drugs are recalled, it can leave patients wondering if the generic brand is still safe to purchase. For a recent example, the popular heartburn medication Zantac® and its generics sold as ranitidine were both recalled in 2020.
The answer to this question depends on why the recall was issued.
What is a generic drug?
Generic drugs are drugs designed to be the same as an existing brand name drug in most every way, aside from appearance. They have the same intended use, use the same active ingredient, the same strength, last the same amount of time, and follow the same dosage recommendations and method of administration.
Numerous studies have shown that generic drugs are just as effective as brand name drugs. But since they use the same active ingredient, a generic drug will have the same risks as well as the same benefits of its brand name equivalent.
How do generic drugs get approved?
To be approved, generics must prove they are “bioequivalent,” meaning they are absorbed into the blood at the same rate and concentration, as the brand name they are based on within a 90% confidence level.
The FDA Generic Drugs Program puts generic drugs through very strict testing to ensure they match up with brand name drugs’ safety and efficacy. The program also conducts 3,500 inspections of generic drug manufacturing plants every year to make sure that generic drugs that are already on the market are still meeting safety standards after being initially approved.
Why brand name and generic drugs get recalled
Drugs are recalled when they are determined to be defective, making them dangerous to consumers.
Drugs can be defective for a number of reasons:
- They could have been contaminated during the manufacturing process
- They could have been mislabeled with the wrong strength or dosage recommendations
- There could be a defect in the design, making the drug’s side effects more dangerous than the health benefits
Learning why a drug has been recalled can help you determine whether the generic versions are safe to take.
For example, if the drug was contaminated or mislabeled at the manufacturing plant, then generics that were produced at different manufacturing plants likely will not share the same defects. However, some generic drugs are produced in the same manufacturing plant as their brand name version, in which case they might be affected.
If the drug is dangerous due to some defect in the design, its generic versions, which are designed to be identical to the brand name versions, likely share the same dangerous qualities.
As you can see, determining whether generic drugs will be affected by the recall of a brand name drug must be determined on a case-by-case basis. However, if you are unsure whether your preferred generic medication is safe, you should always confirm with your doctor or the FDA rather than assume.
How to find out if your preferred generic drug has been recalled
Recalls must be publicized to make it easier to reach anyone who may be affected, but there are several other ways patients may be notified about a recall. For example, the FDA, manufacturer, or dispensing pharmacy may notify patients if a medication they are prescribed has been recalled.
If a drug you take by prescription has been recalled, you should ask your doctor to switch you to a safer drug and follow their recommendations. Your doctor will be able to confirm whether the generic version of the brand name drug you are prescribed is safe to take.
When recalls are issued for over-the-counter medications, you should discard any of the affected medication in your home. As recalls that are a result of contamination or mislabeling usually only affect certain lots of that medication, you will first need to determine if the medication you purchased is part of an affected lot.
Affected lot numbers can be found on the manufacturer’s website after a recall is announced, or on the FDA website. The lot number on your medication can usually be found printed beside the expiration date.
If you suffered unanticipated side effects after taking a defective drug, we want to hear from you.
When a drug that was supposed to make you feel better actually makes your health worse, either through the manufacturer’s negligence in the manufacturing process or through their failure to publicize side effects, you deserve compensation. Contact our Louisiana defective drug attorneys today to talk about how a defective drug harmed you or someone you love and to learn how we can help.