Should a Birth Control Label Carry an HIV Risk Warning?
June 4, 2015
The U.S. Food and Drug Administration (FDA) has received a petition urging the federal agency to add a warning to Pfizer Inc.'s Depo-Provera birth control shot. The warning would note that women using Depo-Provera should also use a method of HIV prevention, as the petitioners believe the shot could possibly increase a woman's risk of acquiring HIV. Nearly two dozen doctors and scientists signed the petition, reports Law360.
Depo-Provera's label currently warns that the progestin injection does not prevent HIV acquisition. The U.S. Centers for Disease Control and Prevention (CDC) finds the current warning sufficient, though the agency did acknowledge in 2012 that some studies showed results that, while inconclusive, were suggestive of a relationship between progestin-only shots (like Depo-Provera) and increased HIV acquisition risk.
Heidi Jones, M.P.H., Ph.D., assistant professor at CUNY's School of Public Health, led efforts to file the petition. In the letter to FDA Acting Commissioner, Stephen Ostroff, M.D., the petitioners state that the CDC must reconsider its position in light of two recently released meta-analyses, one in The Lancet and one in PLOS Medicine, which collected data indicating strong ties between Depo-Provera and HIV acquisition.
The petition also highlighted a study conducted on monkeys that linked Depo-Provera to increased vaginal inflammation and suppressed T-cell activation. Several studies, including a recent African study, have shown that vaginal inflammation is a biological risk factor for HIV acquisition. Inflammation can leave bodily tissue open to HIV exposure and infection.
The petition also cited a study backed by the Microbicide Trials Network that showed that women using a norethisterone enanthate injectable for birth control did not see the same increase in HIV acquisition. The petitioners claim that this rules out the possibility that HIV acquisition risk may be associated with women abandoning HIV prevention methods once they begin injectable birth control.
"We recognize that the clinical evidence for a causal link is inconclusive as the findings are based on observational studies which are subject to residual confounding and selection bias," the petitioners wrote. "Nevertheless, we posit that the ... data to date suggest a reasonably plausible association."
The petitioners are requesting that Depo-Provera's label be amended so that women and doctors are able to make "informed decisions" regarding birth control.
A representative for Pfizer told Law360 that the observational nature of the analysis does not fully represent the variety of factors that may explain HIV acquisition.
"We are not aware of any scientific evidence demonstrating a causal relationship between use of hormonal contraceptives and an increase in HIV transmission rates," MacKay Jimeson told Law360.
The petitioners also indicated to the FDA that a randomized controlled trial is being planned to study the possible effect of Depo-Provera on HIV acquisition risk.
You can read the petition in full, as well as comment further on it before it is considered by the FDA.
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