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PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY November 2013 | Archived Issues

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Formulary Expanded; FDA Issues Warnings, Changes Labels for Several Drugs

Pharmacy Focus

The Pharmacy and Therapeutics Committee added ticagrelor (Brilinta®) to the formulary, along with other actions at its Oct. 1 meeting. The committee's actions are summarized in the PDF link below.

Also, the U.S. Food and Drug Administration has added a warning to human immune globulin products, has made recommendations regarding the use of spinal catheters in patients taking anticoagulant drugs, has issued warnings about two cardiac stress test agents, and has removed some restrictions on diabetes drugs containing rosiglitazone.

P and T Committee Actions - Oct. 1, 2013 (PDF)

FDA Revises Warning for Immune Globulin Products

The U.S. Food and Drug Administration has approved changes to the prescribing information for human immune globulin products to add a new boxed warning about the risk of thrombosis. The revised labels also include underlying risk factors for thrombosis, and recommendations for monitoring and managing patients on these products to mitigate the risk of thrombosis.

The FDA has analyzed recent data that has strengthened the association between the use of intravenous, subcutaneous and intramuscular human immune globulin products and the risk of thrombosis. Additional caution regarding the use of these products is warranted.

Human immune globulin products are used in a variety of conditions, both on- and off-label, by healthcare professionals who may not be aware of the thrombosis risk and measures that could be taken to mitigate this risk.

The information on thrombosis in the final approved boxed warning states:

  • Thrombosis may occur with immune globulin products.
  • Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity and cardiovascular risk factors.
  • Thrombosis may occur in the absence of known risk factors.
  • For patients at risk of thrombosis, administer immune globulin products at the minimum dose and infusion rate practicable.
  • Ensure adequate hydration in patients before administration.
  • Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Learn more at this FDA Web page.

Use Extra Care With Spinal Catheters in Patients on Anticoagulants, FDA Says

The U.S. Food and Drug Administration is recommending that healthcare professionals carefully consider the timing of spinal catheter placement and removal in patients taking anticoagulant drugs, such as enoxaparin, and delay dosing of anticoagulant medications after catheter removal to decrease the risk of spinal column bleeding and subsequent paralysis after spinal injections, including epidural procedures and lumbar punctures.

These new timing recommendations, which can decrease the risk of epidural or spinal hematoma, will be added to the labels of anticoagulant drugs known as low molecular weight heparins, including Lovenox, generic enoxaparin products and similar products.

Epidural or spinal hematomas are a known risk of enoxaparin in the setting of spinal procedures and are already described in the boxed warning and in the warnings and precautions sections of the labels for Lovenox and generic enoxaparin products. However, these serious adverse events continue to occur, so the FDA updated the warnings.

Learn more at this FDA Web page.

FDA Warns of Risks With Lexiscan, Adenoscan

Due to recent reports of serious adverse events, the U.S. Food and Drug Administration has approved changes to the drug labels for the cardiac stress test agents regadenoson (Lexiscan®) and adenosine (Adenoscan®), including a warning regarding the rare but serious risk of heart attack and death, as well as recommendations for use:

  • Screen all nuclear stress test candidates for suitability to receive Lexiscan or Adenoscan
  • Avoid use in patients with signs or symptoms of unstable angina or cardiovascular instability
  • Cardiac resuscitation equipment and trained staff should be available prior to administration

Learn more at this FDA Web page.

Sales of Iclusig Halted

The U.S. Food and Drug Administration has asked the manufacturer of the leukemia chemotherapy drug Iclusig (ponatinib) to suspend marketing and sales of Iclusig because of the risk of life-threatening blood clots and severe narrowing of blood vessels.

The drug manufacturer, Ariad Pharmaceuticals, has agreed to FDA’s request to suspend marketing and sales of Iclusig while the FDA continues to evaluate the safety of the drug.

The FDA will continue to evaluate the drug to further understand its risks and potential patient populations in which the benefits of the drug may outweigh the risks. Patients currently receiving Iclusig should discuss with their healthcare professionals the risks and benefits of continuing treatment with the drug.

Learn more at this FDA Web page.

FDA Changes Potiga's Label, Citing Risks to Eyes, Skin

The U.S. Food and Drug Administration has approved changes to the label of the anti-seizure drug Potiga (ezogabine), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent.

The revised label includes a new boxed warning because of the risk of abnormalities to the retina, a part of the eye that is needed for vision. The FDA advises that Potiga use be limited to patients who have not responded adequately to several alternative therapies to decrease the frequency of seizures, or epilepsy, and for whom the benefits of treatment outweigh the risks.

The FDA recommends that patients have eye exams by an ophthalmic professional before starting Potiga and every six months during treatment. These exams should include visual acuity and dilated fundus photography, with additional vision testing as necessary. Patients whose vision cannot be monitored should generally not take Potiga.

Also included in the updated label are warnings regarding the risk for discoloration of the skin, nail, mucous membrane and white of the eye. The updated drug label states that if a patient develops skin discoloration, an alternate medication should be considered.

Learn more at this FDA Web page.

Changes Made to Incivek Labeling

The U.S. Food and Drug Administration has approved changes to labeling of the hepatitis drug Incivek (telaprevir) to include results from trial C211 (Optimize) to support a twice-daily dosing regimen. In addition, new contraindications were added for anticonvulsant medications (carbamazepine, phenobarbital and phenytoin). Below is a summary of the changes.

  • Dosage and administration of telaprevir were updated throughout the label: from 750 mg three times a day to 1125 mg twice daily.
  • The anticonvulsant medications carbamazepine, phenobarbital and phenytoin were moved from the drug interaction section (Section 7, Table 5) to the contraindications section (Section 4, Table 3).
  • The section on adverse reactions was updated.

Learn more at this FDA Web page.

FDA Removes Some Restrictions on Drugs Containing Rosiglitazone

The U.S. Food and Drug Administration has determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl and generics, do not show an increased risk of heart attack compared to the standard type 2 diabetes medicines metformin and sulfonylurea. As a result, FDA is requiring removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put in place in 2010.

This decision is based on FDA review of data from a large, long-term clinical trial and is supported by a comprehensive, expert re-evaluation of the data conducted by the Duke Clinical Research Institute.

Previous data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone had suggested an elevated risk of heart attack, so the FDA required a Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks.

Although some scientific uncertainty about the cardiovascular safety of rosiglitazone medicines remains, in light of the new re-evaluation, the FDA's concern is substantially reduced, and the rosiglitazone REMS program requirements will be modified.

Learn more at this FDA Web page.