The Food and Drug Administration has issued a new warning this June about certain over-the-counter acne medications. According to an FDA Consumer Update alert, some patients have reported serious and potentially life-threatening reactions after using acne products.
Patients who use over-the-counter acne products should review the FDA information carefully to understand the potential risks associated with the use of these therapies. The FDA’s warning is also a reminder that even over-the-counter medications can be dangerous to patients. From denture creams to Tylenol to testosterone therapy, many medications have proven to cause unexpected side effects that can forever change the life of patients. Those affected by a dangerous drug or medication should consult with a Boston defective drug for more information on how to obtain compensation for losses.
Over-the-Counter Acne Medication Risks
According to Time, the FDA has received 131 adverse reaction reports related to acne medications. The medications that have caused reported side effects including Proactiv, MaxClarity, Neutrogena, Ambi, Oxy, Aveeno and Clean & Clear. Any medication that has the active ingredients salicylic acid or benzoyl peroxide could potentially be a cause of a potentially life-threatening adverse reaction. These medications come in different forms including face washes, cleansing gels, lotions and face scrubs.
In around 40 percent of the reported incidents, the FDA indicated the patient experienced symptoms similar to an allergy attack after using the topical-acne treatment. Specific symptoms reported included tightness of the throat; difficulty breathing; wheezing; shortness or breath; and lower-than-normal blood pressure. Fainting and collapsing occurred in some patients. Others experienced facial swelling or broke out in hives.
Approximately 42 percent of the patients who had a bad reaction from using the acne medications experienced symptoms within 24 hours of using the treatment. Although there have not yet been any reported deaths due to the use of acne treatment products, approximately 44 percent of the adverse reactions reportedly necessitated that the patient be hospitalized.
The FDA has issued its warning about the potential dangers because patients are currently not being adequately informed of the risk. An FDA spokesperson said in a statement: “There is currently no mention of the possibility of these very severe allergic reactions on the product label.” The FDA believes it is important for consumers to know about the risks so they can be on the alert for symptoms and so they can react quickly and appropriately when an adverse reaction occurs.
Although the medications are topical and not ingested, this does not remove the manufacturer’s obligations to alert the users of the treatment of the risk. Just like with prescription drugs, pharmaceutical companies have a legal duty to tell patients about side effects so patients can give informed consent before using the drug. If a pharmaceutical company’s product causes unexpected harm or if the drug company failed to warn patients of possible dangers, legal action can be taken to obtain compensation. Patients or their family members can file a personal injury or wrongful death claim to obtain monetary damages.
Call the Boston Law Offices of Jeffrey S. Glassman for a free and confidential appointment — 1-888-367-2900.
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