New Drugs: Should I wait to take?

On Sunday, February 23, 2013, Affymax and Takeda Pharmaceuticals recalled all lots of Omontys, a drug they developed to treat anemia in patients undergoing kidney dialysis.

Omontys, an injection given intravenously once monthly to treat anemia in adult dialysis patients suffering from chronic kidney disease, was pulled off the market via a voluntary recall on February 23, 2013.  There have been reported of it causing anaphylaxis, and even death in some cases, upon first use to patients who were hypersensitive.

As noted by the Wall Street Journal:

The deaths highlight a long-standing concern about the safety of newly approved drugs. During studies testing the compounds, a relatively small number of patients take the medicines—so few that some side effects can go undetected. Yet once a drug goes on sale, far more patients can take it, and rare but serious side effects can start surfacing. For this reason, many doctors wait to prescribe newly approved drugs.

There have been at least 5 deaths associated with Omontys.  The company’s CEO told analysts that it is too soon to determine how these patients developed the fatal reactions.

If you or someone you love suffered a serious adverse effect after taking Omontys, you should contact Slater Slater Schulman LLP for a free consultation by filling out the form on this page or by calling us at (800) 251-6990.


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