Medication Monitor

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  • March 27, 2018

    FDA is warning consumers not to purchase or use drugs advertised nationwide as a “healthy man alternative to the little blue pill” or “healthy man,” or “the power pill” for erectile dysfunction on broadcast and internet radio platforms such as iHeart Radio, as these drugs have not been approved by FDA.

    These drugs, purchased without a prescription, contain 100 mg of sildenafil, the active ingredient in Viagra. This is a dangerous dosage strength for certain patients, including older adults and those with impaired liver and kidney function. When sildenafil interacts with nitrates in some prescription drugs, such as nitroglycerin, a person’s blood pressure can reach dangerously low levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

    The label on the blister packs for these unapproved drugs states that the products are manufactured in India by Acme Generics. The label also bears the name Sun Pharma.

    FDA is concerned the seller may also be distributing to U.S. consumers unapproved tadalafil as a generic for the prescription drug Cialis.

    To date, FDA is not aware of any adverse events associated with these particular unapproved versions of sildenafil or tadalifil. 

  • March 27, 2018

    FDA is alerting consumers of a voluntary recall of Bayer’s Alka-Seltzer Plus products because of labeling errors.

    Bayer is voluntarily recalling Alka-Seltzer Plus packages that 1) were sold only in the United States at Walmart, CVS, Walgreens, and Kroger (including Dillons Food Stores, Fred Meyer, Fry's Food Stores, Ralphs, King Soopers, and Smith's Food and Drug) after February 9, 2018; and 2) can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

    The affected packages are being recalled because the ingredients listed on the front sticker of the carton may be different from the ingredients listed on the back of the carton as well as the product in the carton. This may lead consumers to ingest an ingredient to which they are allergic, or should not be taking because of the potential for serious health consequences.

    Consumers who purchased packages of Alka-Seltzer Plus that are being recalled should stop using the product immediately and contact their physician or health care provider if they experience any problems that may be related to using this drug product.

    Consumers can contact Bayer at (800) 986-0369 with questions, to report any issues they experienced with the product, or for instructions about how to receive a refund.

    FDA has not received any adverse event reports related to these recalled products.  

  • March 2, 2018

    FDA is alerting health professionals and patients not to use drug products produced by Cantrell Drug Co. of Little Rock, AK, including opioid products and other drugs intended for sterile injection.

    The agency is concerned about serious deficiencies in Cantrell’s compounding operations, including its processes to ensure quality and sterility that put patient safety at risk. Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.

    FDA has also sought legal action to prevent the company from further producing and distributing drugs and to require the company to recall all nonexpired drug products on the market. 

    Health professionals should immediately check their medical supplies, quarantine any drug products from Cantrell Drug Co., and not administer them to patients. Examples of some of the drugs Cantrell has compounded include opioids and common antibiotics.


  • March 1, 2018

    FDA is advising caution before prescribing the antibiotic clarithromycin to patients with heart disease because of a potential increased risk of heart problems or death that can occur years later.

    FDA's recommendation is based on a review of the results of a 10-year follow-up study of patients with coronary heart disease from a large clinical trial (the prospective, placebo-controlled CLARICOR trial) that first observed this safety issue.

    An unexpected increase in deaths occurred among patients with coronary heart disease who received a 2-week course of clarithromycin that became apparent after patients had been followed for 1 year or longer. There is no clear explanation for how clarithromycin would lead to more deaths than placebo.

    Some observational studies also found an increase in deaths or other serious heart-related problems, while others did not.

    All the studies had limitations in how they were designed. Of the six observational studies published to date in patients with or without coronary artery disease, two found evidence of long-term risks from clarithromycin, and four did not.

    As a result, FDA added a new warning about this increased risk of death in patients with heart disease and advised prescribers to consider using other antibiotics in such patients. 

    FDA also added the study results to the clarithromycin drug labels. As part of FDA’s usual ongoing safety monitoring of drugs, the agency is continuing to monitor safety reports in patients taking clarithromycin.

  • February 12, 2018

    FDA warned that obeticholic acid has been incorrectly dosed daily instead of weekly in patients with moderate to severe primary biliary cholangitis (or PBC), a rare chronic liver disease, increasing the risk of serious liver injury.

    To ensure correct dosing and reduce the risk of liver problems, the agency is clarifying the current recommendations for screening, dosing, monitoring, and managing patients with PBC with moderate to severe liver disease who are taking obeticholic acid. FDA is adding a new boxed warning to highlight this information in the prescribing information of the drug label and are also requiring a Medication Guide for patients to inform them about this issue.

    Obeticholic acid works by increasing bile flow from the liver, suppressing bile acid production in the liver, and reducing exposure of the liver to toxic levels of bile acids. Progressive PBC can lead to liver failure or death. Treatment of PBC with obeticholic acid may delay or prevent disease progression.

    Health professionals should follow the obeticholic acid dosing regimen in the drug label, which is based on calculating a Child-Pugh score in PBC patients with suspected liver cirrhosis before treatment to determine their specific classification and starting dosage. Close monitoring is recommended for patients at an increased risk of liver decompensation.

    Educate patients and caregivers about the symptoms of worsening liver function. Temporarily stop obeticholic acid in patients with laboratory or clinical evidence of worsening liver function that may indicate decompensation and monitor the patient’s liver function. If a patient’s condition returns to baseline, weigh the risks and benefits of restarting obeticholic acid. Reinitiate using the recommended starting dosage based on Child-Pugh classification.

    As a condition of approval, FDA required the obeticholic acid manufacturer, Intercept Pharmaceuticals, to continue studying the medication in patients with advanced PBC. FDA expects to receive results from these clinical trials in 2023.

    FDA said it will continue to monitor this medication and update the public if new information becomes available.