News Briefs: Week of May 24-28

This roundup includes the following news briefs:

On May 25, Ortho-McNeil-Janssen Pharmaceuticals Inc. and the FDA announced changes to the Warnings section of the prescribing information for the opioid analgesic tramadol, which is marketed by Ortho-McNeil-Janssen as Ultram.

The strengthened Warnings language emphasizes the risk of suicide in patients using the drug who are prone to addictions and advises health care professionals to not prescribe the drug for patients who are suicidal or addiction-prone. The new wording also urges prescribers to use caution when considering the drug for patients who are taking tranquilizers or antidepressants and those who use alcohol excessively and are depressed or otherwise emotionally disturbed.

In addition, the updated information warns of the risk of overdose associated with tramadol use, particularly when the medication is used in conjunction with alcohol, other opioids or illicit drugs that cause central nervous system depression.

According to a letter to health care professionals (3-page PDF; About PDFs) from the drug's manufacturer, tramadol-related deaths have occurred in individuals with a history of emotional disturbances; suicidal ideation or attempts; or misuse of tranquilizers, alcohol or other substances that act on the central nervous system.

Finally, the drug maker notes, tramadol has mu-opioid agonist activity, can be abused and may be subject to criminal diversion.

FDA officials said May 24 that the agency has cleared Simplexa Influenza A (H1N1) 2009, a test used to detect the H1N1 virus in patients with signs and symptoms of respiratory infection.

The Simplexa test, along with other 2009 H1N1 influenza tests, previously had been available only under an Emergency Use Authorization, or EUA, which permits the FDA to authorize use of unapproved or uncleared medical products -- or unapproved or uncleared uses of approved and cleared products -- during a national emergency.

President Obama officially declared a state of emergency due to spread of the virus on Oct. 23, 2009. That declaration cleared the way for HHS Secretary Kathleen Sebelius to temporarily waive or modify certain requirements, including allowing specific products to be distributed under EUAs.

The FDA's action means that the availability of the Simplexa test will not be affected when the emergency ends.

The policy and research arm of America's Health Insurance Plans, or AHIP, has released a new report (16-page PDF; About PDFs) that shows continuing growth in the health savings account, or HSA, market. According to AHIP's report, the number of Americans covered by HSAs increased to 10 million in January 2010, up from 8 million in January 2009 and 6.1 million in January 2008.

States with the highest levels of HSA enrollment were California (1,018,000); Ohio (651,000); Florida (639,000); Texas (637,000); Illinois (575,000); and Minnesota (361,000).

HSAs offer a tax-exempt savings account that is used by consumers to pay their medical expenses. The accounts usually are coupled with a high-deductible health plan.

Physicians have identified HSAs as an area of difficulty in patient collections because often, no copay is owed at the time of the visit. Physicians bill the patient for a lesser amount depending on the physician's contract with the patient's health insurance plan.