Drug & Device News

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Potasium-Lowering Medication May Blunt Power of Other Medications

On Oct.22, the U.S. Food and Drug Administration (FDA) issued a recommendation to prescribers and their patients that they separate the taking of the drug Kayexalate by six hours from the time that they ingest other drugs. Kayexalate is a sodium polystyrene sulfonate product used to reduce high potasium levels in the blood. The new recommendation comes following results of studies that show Veltassa, a similar potasium-lowering drug to Kayexalate, binds to many other drugs, reducing their effectiveness. This problem showed up with about half of the secondary drugs tested with Veltassa. The FDA's Oct. 22 announcement states that if tests currently being conducted on Kayexalate eventually do indicate it has the same efficacy-lowering effect on other drugs as Valtessa has, then the agency will require all manufacturers of sodium polystyrene sulfonate products to update their drug labels to include information about these types of drug interactions. Until that time, the FDA recommends that patients taking Kayexalate along with other medications by mouth do so at least six hours before or after taking the Kayexalate. This recommendation applies to both prescription and over-the-counter medications. Health care providers should also monitor blood levels or clinical response to the other medications, according to the FDA.

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Judge Says NJ's Law Applies to Risperdal Claims

Determining that the state of New Jersey had the greater interest in applying its law to a mass tort litigation concerning the drug Risperdal, Judge Arnold L. New, coordinating judge of the Complex Litigation Center, recently dashed the hopes of nearly 1,500 plaintiffs, most of whom were likely to have sought punitive damages against the manufacturer, Janssen Pharmaceuticals. The plaintiffs, all of whom claim they were not adequately warned of the risks of gynocomastia with use of the anti-psychotic drug, had argued that the law of Pennsylvania should apply. (Gynocomastia is a condition characterized by the development of enlarged breasts in young males.) In his opinion, released Oct. 23, Judge New explained that the “evidence, when read together, shows the decisions concerning the development and marketing of Risperdal were made in New Jersey, where the various directors and supervisors worked,” and this apparently held more sway with the judge than the fact that these decisions “were communicated to staff members at meetings and presentations at various locations, including restaurants and venues in Pennsylvania.”

The Risperdal plaintiffs are not likely to leave the issue alone, however. As explained by Thomas R. Kline of Kline & Specter, who is also representing a number of Risperdal plaintiffs, his clients and others “have been waiting for some time in this long continuum of Risperdal litigation to get the [choice of law] issue moved forward for appellate review with the hope and expectation that we'll try future cases with punitive damages in them, and the opportunity to add punitive damages in cases in which it has not been allowed.”

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Potasium-Lowering Medication May Blunt Power of Other Medications

On Oct.22, the U.S. Food and Drug Administration (FDA) issued a recommendation to prescribers and their patients that they separate the taking of the drug Kayexalate by six hours from the time that they ingest other drugs. Kayexalate is a sodium polystyrene sulfonate product used to reduce high potasium levels in the blood. The new recommendation comes following results of studies that show Veltassa, a similar potasium-lowering drug to Kayexalate, binds to many other drugs, reducing their effectiveness. This problem showed up with about half of the secondary drugs tested with Veltassa. The FDA's Oct. 22 announcement states that if tests currently being conducted on Kayexalate eventually do indicate it has the same efficacy-lowering effect on other drugs as Valtessa has, then the agency will require all manufacturers of sodium polystyrene sulfonate products to update their drug labels to include information about these types of drug interactions. Until that time, the FDA recommends that patients taking Kayexalate along with other medications by mouth do so at least six hours before or after taking the Kayexalate. This recommendation applies to both prescription and over-the-counter medications. Health care providers should also monitor blood levels or clinical response to the other medications, according to the FDA.

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