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Tag: fda

  • Eye Drops Recalled For Possible Fungal Contamination That May Affect Eyesight: FDA Warns

    Eye Drops Recalled For Possible Fungal Contamination That May Affect Eyesight: FDA Warns

    The U.S. Food and Drug Administration (FDA) has sounded the alarm on a nationwide recall of Systane brand eye drops, citing potential fungal contamination that could pose serious risks to eyesight.

    Systane Lubricant Eye Drops Ultra PF, commonly used to temporarily relieve burning and irritation caused by dry eye symptoms, is now at the center of a nationwide recall. The product was distributed to multiple retail stores and online platforms.

    Manufacturer Alcon Laboratories initiated the voluntary recall after a consumer reported foreign material inside a sealed single-use vial, which was later identified as fungal contamination.

    “Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the FDA stated in a news release.

    The FDA has confirmed that no adverse events related to the recall have been reported so far. However, individuals experiencing quality issues or adverse reactions after using the product are encouraged to report them through the FDA’s MedWatch Adverse Event Reporting program. Complaints can be submitted online, by downloading and mailing the form, or via fax at 1-800-FDA-0178.

    Each cardboard box of the product contains 25 sterile, single-use vials of lubricant solution for ophthalmic use. “The affected Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count is limited to lot number 10101, expiration date 2025/09. The product can be identified by the green and pink carton design, the presence of “Systane” and “ULTRA PF” brand names on the front of the carton, and the “25 vials” package size,” the news release stated.

    Consumers who still have the products with them are advised to stop usage immediately and return to the place of purchase for a replacement or refund. Those who experience any issues potentially linked to the use of these eye drops should seek advice from a healthcare provider without delay.

    As Alcon conducts its investigation, a spokesperson told NBC News that “the presence of foreign material appears to be isolated to the single unit returned by a customer.” They emphasized that the recall is being carried out, “out of an abundance of caution to prioritize consumer safety.” Those who have issues with the product can also contact them at 800-241-5999.

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  • FDA Proposes To Ban Popular Decongestant In Cold Medicines Citing ‘Not Effective’

    FDA Proposes To Ban Popular Decongestant In Cold Medicines Citing ‘Not Effective’

    The U.S. Food and Drug Administration(FDA) has proposed to ban oral phenylephrine, an active ingredient in popular decongestants and cold medications, citing its lack of effectiveness.

    Several cold medications, including Advil, Vicks NyQuil, Sudafed PE, Robitussin, Benadryl Allergy Plus Congestion, Tylenol, and Theraflu, contain oral phenylephrine. In some, it is the only active ingredient, while others combine it with acetaminophen or dextromethorphan.

    Officials clarified that the proposed ban is unrelated to the safety of phenylephrine and does not affect the nasal spray form of phenylephrine.

    Companies may continue selling products containing oral phenylephrine until the order is finalized. The public can submit feedback on the FDA’s proposal until May 7, 2025. However, after this comment period, if the FDA finalizes its decision to revoke oral phenylephrine’s status as “generally recognized as safe and effective” (GRASE), manufacturers would need to either remove or reformulate products containing the ingredient. The FDA stated it would allow manufacturers an appropriate transition period in such cases.

    “It is the FDA’s role to ensure that drugs are safe and effective, Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) in a news release.

    Meanwhile, officials urge consumers to be mindful of the ingredients in over-the-counter (OTC) medications, advising them to read the drug facts label and follow important warnings and directions for use.

    “Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold. Consumers can also talk to their doctor or pharmacist about ways to treat these symptoms,” said Dr. Theresa Michele, director of the Office of Nonprescription Drug Products in CDER.

    However, the Consumer Healthcare Products Association’s (CHPA) officials said they are “disappointed” with the proposed ban and maintained its position that “no changes to the GRASE status of oral PE (Phenylephrine) for nasal decongestion are warranted.”

    “PE should remain an available option for consumers because Americans deserve the option to choose the safe and effective OTC medicines they prefer and rely on,” CHPA said in a news release.

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  • FDA Wants To Further Reduce Salt Levels In Packaged, Processed Food

    FDA Wants To Further Reduce Salt Levels In Packaged, Processed Food

    The U.S. Food and Drug Administration has announced a milestone in its voluntary sodium reduction program by completing the Phase I target and issuing draft guidance for Phase II. In this next phase, the FDA plans to further reduce sodium levels in packaged and processed food by 20%, to bring the average intake to about 2,750 milligrams per day.

    According to the U.S. Dietary Guidelines, a person should not consume more than 2,300 milligrams of sodium per day, which is about one teaspoon of salt. The FDA launched its sodium reduction program in 2021, setting a 2.5-year target. The goal for Phase I was to lower the average daily sodium intake from 3,400 milligrams to 3,000 milligrams.

    High sodium intake is linked to health issues such as increased blood pressure, a major risk factor for heart disease and stroke. Studies have shown that reducing sodium intake could prevent hundreds of thousands of premature deaths and illnesses. However, to effectively lower sodium consumption, changes need to be made in the food supply itself, as more than 70 percent of sodium comes from processed and prepared foods.

    “Reducing sodium in the food supply has the potential to be one of the most important public health initiatives in a generation. The early successes we’re seeing with sodium level reduction in certain foods is encouraging and indicative of the impact we believe our overall nutrition approach can have on the wellbeing of society,” FDA Deputy Commissioner for Human Foods Jim Jones said in a news release.

    Phase II will continue to target sodium levels in commercially processed, packaged, and prepared foods in the marketplace.

    “In addition to our sodium reduction efforts, the FDA is also actively working on a forthcoming final rule updating the definition of the claim ‘healthy,’ a proposed rule for front-of-package nutrition labeling and exploring ways to reduce added sugars consumption. The FDA’s sodium reduction and other nutrition initiatives are central to a broader, whole-of-government approach to help reduce the burden of diet-related chronic diseases and advance health equity,” Jones added.

    The American Heart Association (AHA) advises limiting sodium intake to no more than 2,300 milligrams per day, with an ideal limit of 1,500 milligrams for those with high blood pressure. They suggest that reducing daily sodium intake by 1,000 milligrams can significantly improve blood pressure and heart health.

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