News Briefs: Week of Aug. 16-20

This roundup includes the following news briefs:

Illinois has enacted a truth in advertising measure that requires advertisements for health care services to indicate the type of license held by the individual who advertises the service. The law (5-page PDF; About PDFs), which went into effect on July 1, also says that advertisements must be free from any and all deceptive or misleading information.

Health care professionals violating any provision of the act are "guilty of unprofessional conduct and subject to disciplinary action under appropriate provisions of the act," according to a synopsis of the law.

Novartis Vaccines and Diagnostics Inc. and the FDA are informing health care professionals that the tip caps of Fluvirin and Agriflu prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals.

Novartis said in a letter to providers posted on the FDA website that procedures should be put in place for the emergency care of a person who experiences an anaphylactic reaction.

"Epinephrine and equipment for maintaining an airway should be available for immediate use," the letter says. "All vaccine providers should be familiar with the office emergency plan and should be certified in cardiopulmonary resuscitation."

Multidose vial presentations of Fluvirin are not affected, Novartis said.

The package inserts for Fluvirin and Agriflu are being updated to include this information, according to the manufacturer.

The Agency for Healthcare Research and Quality, or AHRQ, is inviting individuals and organizations to nominate primary and secondary prevention topics that they would like the United States Preventive Services Task Force, or USPSTF, to consider for review.

The USPSTF, an independent panel of experts, makes evidence-based recommendations regarding the provision of clinical preventive services, including screening, counseling and preventive medications associated with primary care.

AHRQ said Aug. 5 in the Federal Register that the USPSTF will consider topic nominations in two steps. The committee first will determine if the topic constitutes primary or secondary prevention applicable to healthy asymptomatic persons, is primary care-feasible or referable from primary care, and addresses a condition that poses a substantial health burden. The USPSTF then will prioritize topics based on importance to public health and potential for greatest impact.

Topic nominations should be submitted by August 27.

The FDA has proposed withdrawing approval of midodrine hydrochloride because manufacturers failed to verify the clinical benefit of the drug, which is used to treat orthostatic hypotension.

Midodrine hydrochloride, which is marketed as ProAmatine by Shire Development Inc., was approved in 1996 under the FDA's accelerated approval regulations for drugs that treat serious or life-threatening diseases. That approval process, however, requires that the manufacturer verify clinical benefit to patients through postapproval studies.

The FDA said in an Aug. 16 news release that neither Shire nor any generic manufacturer has demonstrated the drug's clinical benefit.

According to the FDA, about 100,000 U.S. patients filled prescriptions for either ProAmatine or generic versions of the drug last year.

The agency said patients who take the medication should not stop taking it, but they should consult their physician about other treatment options.

The FDA has approved ulipristal acetate, which is marketed as ella, for emergency contraception. The prescription drug prevents pregnancy when taken orally within five days after a contraceptive failure or unprotected intercourse, the agency said in an Aug. 13 news release.

The product is not intended for routine use as a contraceptive.

Ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation, the FDA said. The product has been available in Europe since May 2009.

According to the product's label (11-page PDF; About PDFs), women who are pregnant, suspect that they are pregnant or are breastfeeding should not use ella.

The Agency for Healthcare Research and Quality, or AHRQ, has launched a new website focused on men's health. Healthy Men offers information about tests recommended by the U.S. Preventive Services Task Force, tips on talking to physicians, basic health tips, and a 10-question preventive health quiz.

AHRQ data show that men are

AHRQ also offers a resources page for women.