FDA MedWatch Alerts
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January 9, 2012
Audience: Consumer, Pharmacy. ISSUE: Novartis Consumer Health Inc. is voluntarily recalling all lots of over-the-counter products Exedrin, Bufferin, Gas-X Prevention and NoDoz. Reports were received of chipped and broken pills and inconsistent bottle packaging clearance practices at the Lincoln, Nebraska facility, which could result in the bottles containing foreign tablets, caplets, or...
Read More...January 9, 2012
Audience: Pharmacy, Consumers. Including the following products:
Opana ER (oxymorphone hydrochloride) Extended-Release Tablets CII
Opana (oxymorphone hydrochloride) CII
Oxymorphone hydrochloride Tablets CII
PERCOCET (oxycodone hydrochloride and acetaminophen USP) Tablets CII
PERCODAN (oxycodone hydrochloride and aspirin, USP) Tablets CII
ENDOCET (oxycodone hydrochloride and acetaminophen...
Read More...December 22, 2011
Audience: Consumer. Include the products Gotu Kola (Centella Asiatica), Bladderwrack (Fucus Vesiculosus)
ISSUE: Eclectic Institute is voluntarily recalling specific lots of its freeze-dried capsules containing Gotu Kola (Centella asiatica) and Bladderwrack (Fucus vesiculosus) capsules because of potential Salmonella contamination.
Salmonella is an organism which can cause serious and sometimes...
Read More...December 22, 2011
Audience: Pediatrics, Consumers, Pharmacy. [Posted 12/22/2011]
ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80...
Read More...December 20, 2011
Audience: Neurology, Patients. [Posted 12/20/2011]
ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this...
Read More...December 19, 2011
Audience: Healthcare professionals, consumers. [UPDATED 12/19/2011] FDA completed a safety review of Multaq (dronedarone). This review showed that Multaq increased the risk of serious cardiovascular events, including death, when used by patients in permanent atrial fibrillation (AF). The review was based on data from two clinical trials, PALLAS and ATHENA. FDA is providing new information and...
Read More...December 15, 2011
Audience: Family Practice, Cardiology, Pharmacy. Simvastatin sold under the brand-name Zocor, as a single-ingredient generic product, and sold in combination with ezetimibe as Vytorin and in combination with niacin as Simcor
[UPDATED 12/15/2011] FDA notified the public that it has revised the dose limitation for simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug...
Read More...December 14, 2011
Audience: Psychiatry, OB/GYN, Family Practice. Including Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone)
ISSUE: FDA notified healthcare professionals and the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by...
Read More...December 7, 2011
Audience: Cardiology, Pharmacy, Hematology. ISSUE: (FDA) is evaluating post-marketing reports of serious bleeding events in patients taking Pradaxa (dabigatran etexilate mesylate). Bleeding that may lead to serious or even fatal outcomes is a well-recognized complication of all anticoagulant therapies. The Pradaxa drug label contains a warning about significant and sometimes fatal bleeds. In a...
Read More...November 14, 2011
Audience: Consumer. ISSUE: FDA lab analysis for Lot 10090571 found Virility Max to contain sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA approved drug for erectile dysfunction (ED), making Virility Max an unapproved drug. The active drug ingredient is not listed on the product label. The undeclared ingredient may interact with nitrates found in some...
Read More...November 9, 2011
Audience: Family Practice, Cardiology, Pharmacy. ISSUE: FDA notified healthcare professionals the cholesterol-lowering medicine Trilipix (fenofibric acid) may not lower a patient's risk of having a heart attack or stroke. FDA reviewed the data from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid trial. The ACCORD Lipid trial found no significant difference in the risk of...
Read More...November 4, 2011
Audience: Rheumatology, Gastroenterology, Oncology, Dermatology.
[UPDATED 11/04/2011] Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include:
patient characteristics (age, gender, no patient identifiers)
risk factors for malignancy
exposure to other immune...
Read More...November 4, 2011
Audience: Endocrinology, Cardiology. includes Avandia, Avandamet, and Avandaryl
[UPDATED 11/04/2011] Healthcare providers must enroll in the Avandia-Rosiglitazone Medicines Access Program if they wish to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities after November 18, 2011.
[UPDATED 05/18/2011] FDA notified healthcare professionals and the public...
Read More...October 27, 2011
Audience: OBGYN, Family Practice, Patient. [UPDATED 10-27-2011] FDA notified healthcare professionals of release of the final report of the FDA-funded study that evaluated the risk of blood clots in users of several different hormonal contraceptives. The link is provided below. FDA’s review of the results of this study, specifically those results related to drospirenone-containing birth control...
Read More...October 25, 2011
Audience: Critical Care Medicine. ISSUE: FDA notified healthcare professionals and the public that on October 25, 2011, Eli Lilly and Company announced a worldwide voluntary market withdrawal of Xigris [drotrecogin alfa (activated)]. In a recently completed clinical trial (PROWESS-SHOCK trial), Xigris failed to show a survival benefit for patients with severe sepsis and septic shock.
BACKGROUND:...
Read More...October 24, 2011
Audience: Healthcare professionals, consumers. Audience: Healthcare professionals, consumers
[UPDATE 10/24/2011] FDA has reviewed the results from two FDA-sponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline). Neither study found a difference in risk of neuropsychiatric hospitalizations...
Read More...October 21, 2011
Audience: Consumer, Pharmacy. ISSUE: Insight Pharmaceuticals, LLC recalled one lot (lot #11G075, UPC Code 6373673005, 34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia. Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic...
Read More...October 21, 2011
Audience: Emergency Medicine, Critical Care Medicine, Psychiatry. [UPDATED 10/21/2011] FDA updated healthcare professionals and the public on the potential drug interaction between methylene blue and serotonergic psychiatric medications. Most cases from the FDA's Adverse Event Reporting System (AERS) of serotonin syndrome in patients given serotonergic psychiatric medications and methylene blue...
Read More...October 21, 2011
Audience: Infectious Disease, Psychiatry, Family Practice. [UPDATED 10/21/2011] The FDA updated information on the potential drug interaction between linezolid and serotonergic psychiatric medications. Not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with linezolid. Most cases from the FDA's Adverse Event Reporting System (AERS) of serotonin syndrome with...
Read More...October 11, 2011
Audience: Hematology, Oncology. ISSUE: FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In...
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