Unfortunately, it is common for product recalls to happen in the prescription drug industry. These are typically the result of manufacturer- or FDA-identified issues with a product or batch of products. While some of these are minor in nature, there are cases where they could be very dangerous.
The two most common types of recalls are retail and patient level recalls. Retail-level recalls apply to pharmacies and other providers that stock the recalled product. In this recall, the requirement is that establishments that have the product on hand quarantine and no longer distribute the product. In a patient level recall, the recall not only applies to pharmacies and other providers, but also patients or consumers. In the case of a patient level recall, patients or consumers who may be at risk are required to be notified by the pharmacy or provider that supplied the medication. In addition, the affected product must be quarantined as it is in a retail-level recall.
In the case of ranitidine, which was also the case for blood pressure medications like irbesartan, losartan, and valsartan, the FDA determined products were contaminated with NDMA (N-nitrosodimethlamine). What first started out as a retail level recall, then escalated into a patient level recall once more testing was completed. The FDA is continuing the investigation to see how much NDMA is in the ranitidine, the potential risk to patients, and the source of the active ingredient. Preliminary testing from the FDA has also indicated that certain nizatidine (Axid®), a medication in the same therapeutic class as ranitidine, products may also be affected, but no recalls have been announced at this time. NDMA is something that most people are exposed to even if not taking one of these medications, as there are small amounts in water and common foods such as bacon, grilled meats, and dairy products.
The FDA continues to work on enforcing standards as both generic and brand name drugs are often made from or include ingredients from overseas. They continue to work with manufacturers and global regulators to ensure safe, effective, and high-quality drugs for the American public. Unfortunately, these investigations and policy changes take time, so it is important for the agency to enforce the current standards to limit the potential for situations like this to arise.
The ranitidine recall will certainly not be the last major recall we hear about. Hopefully, as the FDA continues to push forward in enforcing standards and becomes more sophisticated in testing methods, the frequency of these recalls will be reduced. As a reminder, if you or someone you know is affected by a drug recall we encourage you to speak with your physician.
Thanks for stopping in and see you next month.