The Food & Drug Administration (“FDA”) oversees the regulation and safety of prescription drugs, over-the-counter drugs, and medical devices. It also oversees the regulation and safety of many food items and cosmetic products. Below are recent notifications by the FDA concerning the safety of drugs and medical devices:
Amgen’s Prolia® (denosumab)
The FDA approved Prolia for the treatment of osteoporosis. Notably, it is prescribed to increase bone mass in patients undergoing treatment for prostate cancer and breast cancer. Recently realizing that use of the drug may cause hypocalcemia, or dangerously low blood calcium levels, the FDA decided to strengthen the warning label on Prolia.
A Boxed Warning, also called a Black Box Warning, will be added to Prolia’s package inserts to warn of the risk of hypocalcemia. Importantly, this type of warning is reserved for drugs with the most serious side effects. It is meant to alert users of significant risk of severe side effects.
Robitussin Cough Syrup
The manufacturer of Robitussin Honey CF Max cough syrup, Haleon, has issued a recall. The cough syrup was recalled due to microbial contamination. Specifically, the contaminated cough syrup contains elevated and unsafe levels of yeast. The recalled products have expiration dates between October 2025 and June 2026. People with immunocompromised systems are especially at risk of developing life threatening infections. For a full list of recalled lot numbers, click here.
CPAP Machines
Philips, the manufacturer of breathing devices and ventilators used to treat sleep apnea, will no longer sell new devices in the United States. The company originally recalled millions of devices in 2021. The recall was initiated after Philips realized that foam in the breathing machines may degrade and become toxic. This can lead to serious injuries such as infections, pneumonia, and cancer.
Now, the FDA has reached an agreement with Philips prohibiting Philips from selling the machines in the United States. In order to resume sales, Philips must meet certain conditions. Fortunately, conditions include making improvement to the products and their manufacturing facilities. Normally, conditions in these types of agreements take years to meet.
If you think you have been injured by one of these products, contact the FDA.
