Over-the-counter and prescription medications are commonly used to treat muscle aches and back pain. Most of them are safe, but a common prescription medication is being recalled due to cancer risk.
On March 21, 2017, pharmaceutical company Sandoz issued a recall for the Orphenadrine Citrate 100 mg extended-release tablets due to a nitrosamine impurity. The FDA considers nitrosamines carcinogenic, and has set an acceptable daily intake limit of 26 ng/day for these drugs. The Sandoz drug exceeded this limit, but the company has not received any reports of adverse effects from its customers despite the recall.
About Orphenadrine Citrate
According to WebMD, this medication is commonly used to treat muscle spasms and pain. It’s also used alongside other treatments such as physical therapy. The drug is also sold as Norflex. However, the recall only affects Orphenadrine Citrate 100mg ER tablets sold by Sandoz Inc. The affected lots were shipped to customers from August 2019 to April 2021, and the FDA posted details about this product on its website.
In 2020, the FDA established industry-wide limits for the impurities in nitrosamine drugs. The agency noted that these limits are not expected to increase a person’s risk of cancer. However, it still encourages people to avoid taking these drugs for extended periods.
Next Steps
Following the recall of the Orphenadrine Citrate tablets, the FDA issued a press release that stated users should immediately stop using the medication and consult with their doctor if they have concerns about its effects. The agency also encourages those using the recalled drug to report any issues to the FDA.
