Quick Hits: Warnings on 2 OTC Drugs & More

Despite warning labels, the FDA is receiving reports about bleeding associated with over-the-counter (OTC) antacids that contain aspirin.The medications, which are sold under well-known brand names such as Alka-Seltzer, Medique Medi Seltzer and Bromo Seltzer, are used to treat heartburn, sour stomach, acid indigestion, or upset stomach. The FDA warns that consumers may have a higher risk of serious bleeding when taking the aspirin-containing antacid products if they have one or more risk factors such as being 60 years or older, have a history of stomach ulcers or bleeding problems, take a blood thinner or steroid medication, drink alcohol or take OTC pain medications known as NSAIDs (non-steroidal anti-inflammatory drugs). Posted June 6, 2016. Via FDA.

The OTC anti-diarrhea medication Imodium can lead to serious heart problems that can be fatal if abused, the FDA is warning. Combining a higher dosage of loperamide with other OTC medications, as well as intentionally abusing and misusing the drug can trigger life-threatening side effects, such as abnormal heart rhythms. Most of the reported heart problems were found in people who were deliberately taking higher doses of Imodium. and consciously misusing the drug in order to achieve a feeling of euphoria. Posted June 6, 2016. Via FDA.

The FDA has made it easier for patients with life-threatening illnesses to receive experimental drugs more quickly.The release form for the agency’s “compassionate use” policy on experimental drugs initially consisted of 26 questions. Now it is down to 11 questions, and should now take physicians only 45 minutes to complete. The formatting of the application has been redesigned from an all-purpose format that aimed to evaluate a large group of patients to a simpler version that aligns with individual patients. Doctors may have initially been deterred from applying for the compassionate access policy due to its complicated nature, according to an FDA spokeswoman. Posted June 8, 2016. Via Kaiser Health News.

Many patients are continuing to take powerful OTC opioid painkillers (such as OxyContin, Vicodin and Percocet) months after joint replacement surgery.With opioid overdoses in the United States increasing at a rapidly fast rate, the findings are significant because joint replacement surgery is becoming increasingly common. A new study examined 574 patients undergoing knee or hip replacement surgery. Before their surgery, approximately 30% of those patients were taking opioid painkillers. Despite improvements in their knee and hip pain, 53% of knee patients and 35% of hip patients were still taking painkillers 6 months after their surgery. Posted June 3, 2016. Via HealthDay.

A patch to treat migraines may leave some people at risk of serious burns or permanent scars.The FDA said it has received reports of reporting from users who experienced burns or scars on the skin where the Zecurity (sumatriptan) patch was applied. Some descriptions included in the reports were, “severe redness, pain, skin discoloration, blistering, and cracked skin.” While the FDA investigates this safety issue further, they encourage users to remove the Zecurity patch immediately if they are experiencing side effects and contact their health professional. Posted June 2, 2016. Via FDA.

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