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Use tied to maternal high blood pressure, study finds, but benefits may still outweigh risks

www.medtipster.com Source: Healthday.com 3.22.12 – Steven Reinberg

Pregnant women taking the antidepressants known as selective serotonin reuptake inhibitors (SSRIs) face a slightly increased risk of developing dangerously high blood pressure, Canadian researchers report.

This condition, known as preeclampsia, can harm both mothers and their unborn infants, the researchers noted. However, this association may not be cause-and-effect, so women should not just stop taking these medications but should consult with their doctor if they are concerned, they stressed. Two of the most commonly prescribed SSRIs are Paxil (paroxetine) and Prozac (fluoxetine).

“We know that antidepressants should be used during pregnancy, but they should be used with caution,” said lead researcher Anick Berard, director of the research unit of medications and pregnancy at CHU Ste-Justine’s Research Center and a professor with the Faculty of Pharmacy at the University of Montreal.

The association between SSRIs and hypertension is a new finding, she added.

The report was published in the March 22 issue of the British Journal of Clinical Pharmacology.

For the study, Berard and her colleague, Mary De Vera, collected data on women in the Quebec Pregnancy Registry. They looked at more than 1,200 women who had high blood pressure during pregnancy that did or did not result in preeclampsia and who had no history of high blood pressure before pregnancy, and compared them with more than 12,000 healthy women.

They found women taking SSRIs had a 60 percent higher risk of developing high blood pressure. In absolute terms, the risk went up from 2 percent to 3.2 percent.

It appears that all SSRIs are not equal when it comes to risk, however. For instance, for women taking Paxil the risk was increased 81 percent, or to 3.6 percent in absolute terms.

“It’s a big relative increase, but if you look at absolute risk it is 1 percent,” Berard said.

These findings are important because SSRIs are the most common drugs used to treat depression, and of the estimated 20 percent of women who suffer from depression during pregnancy, between 4 percent and 14 percent take antidepressants, the researchers said.

Commenting on the study, Dr. Gene Burkett, a professor of obstetrics and gynecology at the University of Miami Miller School of Medicine, said that “this study has severe limitations. There are a lot of factors in preeclampsia they do not account for, so they don’t show a cause-and-effect relationship.”

However, pregnant women should be concerned about SSRIs for a lot of other reasons, he said. The medications have been linked to lower birth weights, he noted.

“Every physician has to measure the risk of taking an SSRI vs. the risk of not taking it in patients who really need it,” Burkett said.

“If the patient is really in need of it, then you have to give it to them, because the consequences, especially after delivery, of those patients who are depressed can be anything up to suicide or killing their infant; these are the extremes,” he said.

“We do see cases of women whose depression gets worse after delivery and wind up killing their babies,” he said. “Those patients benefit from SSRIs, and the benefits may be greater than the risks of not taking them.”

However, many women with mild depression may be able to cope without SSRIs, Burkett said. “But if you do take a woman off an SSRI during pregnancy, they need to be followed closely,” he noted.

“In some cases you cannot take women off SSRIs; in other cases you can; you have to evaluate each woman individually,” Burkett said.

Research published earlier this month also found risks associated with SSRI use during pregnancy. Dutch doctors reported that the medications were associated with delayed head growth of the fetus.

“Fetal body growth is a marker of fetal health, and fetal head growth is a marker for brain development,” said lead researcher Hanan El Marroun, a postdoctorate fellow in the department of child and adolescent psychiatry at Sophia Children’s Hospital and Erasmus Medical Center in Rotterdam. “We found prenatal exposure to SSRIs was associated with decreased growth of the head, but not decreased growth of the body.”

www.Medtipster.com Source: US Government Accountability Office, January 31 2012

What GAO Found

Our review identified articles that used varying approaches to estimate the savings associated with generic drug use in the United States. One group of studies estimated the savings in reduced drug costs that have accrued from the use of generics. For example, a series of studies estimated the total savings that have accrued to the U.S. health care system from substituting generic drugs for their brand-name counterparts, and found that from 1999 through 2010 doing so saved more than $1 trillion. A second group of studies estimated the potential to save more on drugs through greater use of generics. For example, one study assessed the potential for additional savings within the Medicare Part D program—which provides outpatient prescription drug coverage for Medicare—and found that if generic drugs had always been substituted for the brand-name drugs studied, about $900 million would have been saved in 2007. A third group of studies estimated the effect on health care costs of using generic versions of certain types of drugs where questions had generally been raised about whether substituting generic drugs for brand-name drugs was medically appropriate. Unlike the other two groups which focused on savings on drugs only, these studies compared savings from the lower cost of generic drugs to other health care costs that could accrue from their use, such as increased hospitalizations. The studies had mixed results regarding the effect of using these generics in that some found they raised health care costs, while others found they led to cost savings.

Why GAO Did This Study

Prescription drug spending in the United States reached $307 billion in 2010—an increase of $135 billion since 2001—and comprised approximately 12 percent of all health care spending in the country. Until the early 2000s, drug spending was one of the fastest growing components of health care spending. However, since that time, the rate of increase has generally declined each year, attributable in part to the greater use of generic drugs, which are copies of approved brand-name drugs. Generic versions of brand-name drugs become available to consumers when brand-name drugs’ patents and periods of market exclusivity expire and generic manufacturers obtain approval to market their drug. The competition that brand-name drugs face from generic equivalents is associated with lower overall drug prices, particularly as the number of generic manufacturers grows and price competition among them increases. On average, the retail price of a generic drug is 75 percent lower than the retail price of a brand-name drug.

Increased use of generic drugs can partly be attributed to the regulatory framework that was established in the Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act. The Hatch-Waxman Act facilitated earlier, and less costly, market entry of generic drugs, while protecting the patent rights of brand-name drug manufacturers, to encourage continued investment in research and development. When the act was enacted in 1984, the generic utilization rate—which is the share of all drugs dispensed that are generic—was about 19 percent. Today it is about 78 percent for drugs dispensed in retail settings, such as independent, chain, and mail-order pharmacies, as well as in long-term care facilitates. The generic utilization rate is expected to continue to grow over the next few years as a number of blockbuster drugs come off patent through 2015.

For a complete copy of the GAO report, visit: www.gao.gov/assets/590/588064.pdf