Warnings and label changes
A labeling change on sibutramine hydrochloride (Meridia) stating that it is contraindicated in patients with a history of cardiovascular disease because the drug has been associated with an increased risk of heart attack and stroke in these patients.
Changes to the label and medication guide for natalizumab (Tysabri) to note that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received. Information about the occurrence of immune reconstitution inflammatory syndrome in patients who have developed PML and subsequently discontinued natalizumab has also been added.
A change to the prescribing information for olanzapine (Zyprexa) reminding clinicians to consider the increased potential for weight gain and hyperlipidemia in adolescents as compared with adults.
A warning added to the label of didanosine (Videx/Videx EC) of an association between use of the drug and development of non-cirrhotic portal hypertension.
New prescribing information for bortezomib (Velcade) noting that patients with hepatic impairment should be treated at reduced starting doses and closely monitored for toxicities.
Recalls of insulin syringes and infusion needle sets by manufacturer Nipro Medical Corporation. Glucopro syringes may have needles that detach and then become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection, and inspections revealed coring in the needles of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets.
A class I recall of Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical because the sheath tip may break off and separate while the sheath is inside a blood vessel.
A recall of the Aquarius Hemodialysis System for a software upgrade due to reports of clinically significant fluid imbalances and users repeatedly overriding the fluid imbalance alarm.
A class I recall of Hettich Centrifuges with 2050 and 2076 plastic rotors because the plastic centrifuge rotor may crack, break apart and be forcefully ejected through the plastic centrifuge housing at a high rate of speed.
A recall of automated external defibrillators (AEDs) by manufacturer Cardiac Science Corp because the devices, including Powerheart 9300A, 9300E, 9300P, 9390A, 9390E, CardioVive 92532 and CardioLife 9200G and 9231 may not be able to deliver therapy during a cardiac resuscitation attempt.
A recall of certain lots of BD Q-Syte Luer Access Devices because they may cause an air embolism or leakage of blood or therapeutic product.
A new indication for rosuvastatin (Crestor) for the primary prevention of cardiovascular disease in individuals who have no clinically evident heart disease but are at an increased risk of heart disease due to the combined effect of older age, high CRP and the presence of at least one additional risk factor.
Collagenase clostridium histolyticum (Xiaflex), the first drug approved to treat Dupuytren's contracture, a progressive hand disease. It is a biologic drug that works by breaking down the excessive buildup of collagen in the hand.
Dalfampridine extended-release tablets (Ampyra) to improve walking in patients with multiple sclerosis. The most common adverse reactions reported include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin. The tablets should not be used in patients with moderate to severe kidney disease.
Liraglutide (Victoza) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug is a glucagon-like peptide-1 (GLP-1) receptor agonist dosed as a once-daily injection. It is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise, and pancreatitis occurred more often than with other diabetes medications.
The first percutaneous heart valve, the Medtronic Melody Transcatheter Pulmonary Valve and Ensemble Delivery System. The valve can delay the need for open-heart surgery in adults and children with previously implanted, poorly functioning pulmonary valve conduits.
Morphine sulfate oral solution for the relief of moderate to severe acute and chronic pain in opioid-tolerant patients in doses of 100 milligrams per 5 mL or 20 milligrams per 1 mL. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine were not FDA-approved until now.
Long-acting beta-agonists (LABAs) will be subject to a risk management program, additional clinical trials and changes in their use as asthma treatments, after an FDA analysis found an increased risk of severe exacerbation of asthma symptoms, leading to hospitalizations and some deaths. LABAs are available in single-ingredient products (Serevent and Foradil) and combination products containing inhaled corticosteroids (Advair and Symbicort). LABAs are now contraindicated without the use of an asthma controller medication and should only be used long-term in patients whose asthma cannot be adequately controlled.
An FDA initiative will strive to reduce unnecessary radiation exposure from computed tomography (CT), nuclear medicine studies and fluoroscopy by requiring more safeguards on devices, including quality assurance practices into accreditation for imaging facilities, and recommending the development of radiation reference levels and national registries.
A risk management program is now required for erythropoiesis-stimulating agents (ESAs), sold under the brand names Epogen, Procrit, and Aranesp, in response to studies showing that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer and increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions. The program includes a medication guide and specific training and certification for oncology health care professionals.
Per the FDA's request, the name and packaging of Maalox Total Relief will be changed to make it clearer that the over-the-counter medication is an upset stomach reliever and anti-diarrheal medication, not an antacid.