October Through December 2013
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October through December 2013 precautions about the risk of blood clots and severe Updated Warnings—Current Drugs narrowing of blood vessels, revise recommendations about dosage and administration of Iclusig, and update the patient Medication Guide. We are also requiring a risk Mass Destruction Muscle Growth—Safety Risk: The evaluation and mitigation strategy (REMS). In addition, FDA is advising consumers to immediately stop using a the manufacturer of Iclusig, ARIAD Pharmaceuticals, must product called Mass Destruction, marketed as a dietary conduct postmarket investigations to further characterize supplement for muscle growth. The product is labeled to the drug’s safety and dosing. contain at least one synthetic anabolic steroid and has been On October 31, 2013, FDA requested and ARIAD agreed to linked to at least one reported serious illness. The product’s voluntarily suspend marketing of Iclusig. FDA’s request ingredients are undergoing further analysis by the FDA. resulted from FDA’s investigation, which revealed a steady Liver injury is generally known to be a possible outcome of increase in the number of serious vascular occlusion events using products that contain anabolic steroids and steroid- identified through continued safety monitoring of the drug. like substances. In general, anabolic steroids may cause This observation represented a significant change in the other serious long-term consequences in women, men, and safety profile of Iclusig as the proportion of patients on the children. These include adverse effects on blood lipid lev- drug experiencing vascular occlusion events such as blood els, increased risk of heart attack and stroke, masculiniza- clots and severe narrowing of blood vessels was tion of women, shrinkage of the testicles, breast enlarge- significantly greater than the proportion reported at the ment, infertility in males, and short stature in children. time of its approval in December 2012 (see data summary). The FDA was alerted by the North Carolina Department of During the marketing suspension, Iclusig treatment has Health and Human Services of a serious injury associated been available through single patient or emergency with use of Mass Destruction. The report described a previ- investigational new drug applications (INDs). Patients ously healthy 28-year-old male with liver failure requiring should continue to receive Iclusig under their authorized transplant after several weeks of product use. Mass De- IND until marketing of Iclusig is resumed. FDA is working struction is manufactured for Blunt Force Nutrition in closely with ARIAD on the new safety measures and Sims, N.C. and sold in retail stores, fitness gyms, and on anticipates these will be in place by the end of January the Internet. An investigation is underway to identify the 2014. Once that process is complete, patients being treated product’s manufacturer. under these INDs can be transitioned back to receiving the Consumers who suspect they are experiencing problems marketed Iclusig product. (12/20/13) associated with Mass Destruction or other body building products should consult a health care professional, espe- Methylphenidate Medications for ADHD—Safety cially if they have experienced unexplained fatigue, ab- Risk: The FDA is warning that methylphenidate products, dominal or back pain, discolored urine, or any other unex- one type of stimulant drug used to treat attention deficit plained changes in their health. (12/23/13) hyperactivity disorder (ADHD), may in rare instances cause prolonged and sometimes painful erections known as New Safety Measures for Iclusig: The FDA is priapism. Based on a recent review of methylphenidate requiring several new safety measures for the leukemia products, the FDA updated drug labels and patient drug Iclusig (ponatinib) to address the risk of life- Medication Guides to include information about the rare threatening blood clots and severe narrowing of blood but serious risk of priapism. If not treated right away, vessels. Once these new safety measures are in place, the priapism can lead to permanent damage to the penis. manufacturer of Iclusig is expected to resume marketing to Priapism can occur in males of any age and happens when appropriate patients. Health care professionals should blood in the penis becomes trapped, leading to an review these additional safety measures and carefully abnormally long-lasting and sometimes painful erection. consider them when evaluating the risks and benefits of Another ADHD drug, Strattera (atomoxetine), has also Iclusig for each patient. been associated with priapism in children, teens, and The required safety measures involve label changes to adults. narrow the indication, provide additional warnings and www.AmericanHealthCare.com For informational purposes only, consult a physician for any drug changes. “FDA” stands for the United States Food and Drug Administration. Even with FDA approval, drug availability depends on each manufacturer. 1 Priapism appears to be more common in patients taking care professionals carefully consider the timing of spinal atomoxetine than in those taking methylphenidate catheter placement and removal in patients taking products; however, because of limitations in available anticoagulant drugs, such as enoxaparin, and delay dosing information, FDA does not know how often priapism of anticoagulant medications for some time interval after occurs in patients taking either type of product. catheter removal to decrease the risk of spinal column Healthcare professionals should talk to male patients and bleeding and subsequent paralysis after spinal injections, their caregivers to make sure they know the signs and including epidural procedures and lumbar punctures. symptoms of priapism and stress the need for immediate These new timing recommendations, which can decrease medical treatment should it occur. Younger males, the risk of epidural or spinal hematoma, will be added to especially those who have not yet reached puberty, may not the labels of anticoagulant drugs known as low molecular recognize the problem or may be embarrassed to tell weight heparins, including Lovenox and generic anyone if it occurs. enoxaparin products and similar products. Encourage your patients to read the Medication Guide they Epidural or spinal hematomas are a known risk of receive with every filled prescription. Use caution when enoxaparin in the setting of spinal procedures and are considering switching patients from methylphenidate to already described in the Boxed Warning and the Warnings atomoxetine. Patients should not stop taking a and Precautions sections of the labels for Lovenox and methylphenidate product without first discussing it with generic enoxaparin products. However, these serious your health care professional. (12/17/13) adverse events continue to occur (see Data Summary). To address this safety concern, FDA worked with the Boxed Warning Revised for Hydroxyethyl Starch manufacturer of Lovenox, Sanofi-Aventis, to further Solutions: Hydroxyethyl starch solutions, indicated to evaluate this risk and to update the Warnings and treat hypovolemia in patients where plasma volume Precautions section of the Lovenox label with these expansion is desired, has had its boxed warning modified additional timing recommendations. The labels for generic by the FDA to include all of the following: enoxaparin products will also be revised accordingly, as • patients receiving open heart surgery associated with will those of other low molecular weight heparin-type cardiopulmonary bypass should be monitored for status products. of coagulation due to excessive bleeding being reported It is important to note that all anticoagulants carry the risk when hydroxyethyl starch products were used of causing spinal bleeding when used in conjunction with • patients who have severe liver disease should not use epidural/spinal anesthesia or spinal puncture. We are hydroxyethyl starch solutions continuing to evaluate the safety of other anticoagulants to • liver function should be monitored in patients receiving determine if additional label changes are needed. hydroxyethyl starch solutions Health care professionals and institutions involved in Recommendations from the FDA for medical professionals performing spinal/epidural anesthesia or spinal punctures also consisted of all of the following: should determine, as part of a preprocedure checklist, • adult patients who are severely ill (including patients whether a patient is receiving anticoagulants and identify with sepsis and patients who have been admitted into the appropriate timing of enoxaparin dosing in relation to the intensive care unit) should not be given catheter placement or removal. To reduce the potential risk hydroxyethyl starch products of bleeding, consider both the dose and the elimination • use should be avoided in patients who have preexisting half-life of the anticoagulant: renal dysfunction • For enoxaparin, placement or removal of a spinal • at the first sign of renal injury, hydroxyethyl starch catheter should be delayed for at least 12 hours after solutions should be discontinued administration of prophylactic doses such as those used • renal replacement therapy has been needed for some for prevention of deep vein thrombosis. Longer delays patients up to 90 days after administration of this (24 hours) are appropriate to consider for patients medication; continuation of renal monitoring for at least receiving higher therapeutic doses of enoxaparin (1 90 days in all patients is necessary