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Despite looking, it is rare for us to find that drugs differ based on sex alone.Many drug labels already comment on dose considerations or side effect profiles related to age, health problems, or sex. For example, Lotronex (alosetron), a drug used to treat irritable bowel syndrome (IBS), is only approved for women because clinical trial data showed the drug is not effective in men.

There’s a lot happening these days with regard to the personalization of medicine and how drugs work differently in people, particularly in men versus women.

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Some differences in how drugs affect men versus women can relate to variations in metabolism and rates of absorption, and sometimes even because a particular illness has different characteristics in men and women.

So we expect our reviewers and pharmaceutical companies to routinely look for sex differences in their new drug applications.

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