Some birth control shows higher clot risk: US

October 28, 2011 in Medications

Some birth control products, including contraceptive pills, rings and patches for women, carry a significantly higher risk of blood clot than low-dose medications, US regulators said Thursday.

The US said in its review of studies that have included more than 800,000 women that the higher risks are posed by products such as the pill Yaz, the transdermal Ortho Evra patch, and the NuvaRing vaginal insert.

All three methods are "associated with an increased risk of VTE () relative to the standard low-dose" pills, the FDA said.

Featured in the study were pills that contain drospirenone, as opposed to another type of progestin known as levonorgestrel. Some brand names include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.

Yaz is the second biggest selling product made by the German pharmaceutical giant Bayer, with 1.56 billion in global sales.

NuvaRing is a once-a-month vaginal insert made by Merck pharmaceuticals, and the weekly Ortho Evra patch is made by Janssen Pharmaceuticals.

The finding about clot risk associated with patches and rings are new and need to be replicated, the FDA said. A full discussion on the matter is scheduled for December.

These "continuous exposure" methods "potentially result in higher sustained exposure to estrogen and hence, increased thromboembolic risk," the FDA warned.

The European Medicines Agency concluded on May 27 that such carry a higher risk of venous thromboembolism and that should be updated accordingly.

However it noted the overall risk of blood clot from any birth control method remains small and stopped short of advising women to stop taking pills containing drospirenone.

The pills have been the focus of numerous lawsuits, including one lodged earlier this year on behalf of a teenager who died from a blood clot allegedly linked to the German chemical and pharmaceutical company Bayer's Yaz contraceptive.

Michelle Pfleger, an 18-year-old college student in North Carolina, died of cardiac arrest last September after taking Yaz, also known as Yasmin or Ocella, to treat acne, according to the complaint.

Two studies out this year in the British Medical Journal found that drugs like Yaz and Yasmin increase the risk of serious blood clots three-fold or two-fold compared to earlier-generation oral contraceptives.

The official Yaz website says the drug is associated with "increased risks of several serious side effects, including , stroke, and heart attack."

According to Glenn Jacobowitz, vice-chair of the division of vascular surgery at New York University, doctors have been aware of the risks of Yaz and similar for some time.

"The information on NuvaRing and Ortho Evra would be a new, but similar finding. This is certainly worrisome, particularly for women over age 35 and for smokers," he said.

(c) 2011 AFP

not rated yet  

Rank not rated yet
Relevant PhysicsForums posts

More news stories

Acne pill benefits outweigh blood clot risk: EU agency

Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.

Medications created May 17, 2013 | popularity not rated yet | comments 0

First influenza vaccine brought to clinical testing

Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...

Medications created May 17, 2013 | popularity not rated yet | comments 0

Aspirin not always best treatment for many individuals

(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...

Medications created May 16, 2013 | popularity 3.5 / 5 (2) | comments 0 | with audio podcast

FDA: lower ambien's dose to prevent drowsy driving

(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...

Medications created May 15, 2013 | popularity not rated yet | comments 0

Simponi approved for ulcerative colitis

(HealthDay)—Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

Medications created May 15, 2013 | popularity not rated yet | comments 0


New research identifies risks, interventions for children's GI health

An increasing number of U.S. children are experiencing gastrointestinal issues that require interventions to resolve, according to research presented at Digestive Disease Week (DDW).

US psychiatry gets makeover in new manual

The latest makeover to a massive psychiatric tome honored by some, reviled by others and even called the "Bible" of mental disorders is being released Saturday with a host of new changes.

New case of SARS-like virus in Saudi: ministry

A new case of the deadly coronavirus has been detected in Saudi Arabia where 15 people have already died after contracting it, the health ministry announced on Saturday on its Internet website.

AIDS science at 30: 'Cure' now part of lexicon

Big names in medicine are set to give an upbeat assessment of the war on AIDS on Tuesday, 30 years after French researchers identified the virus that causes the disease.

For combat veterans suffering from post-traumatic stress disorder, 'fear circuitry' in the brain never rests

Chronic trauma can inflict lasting damage to brain regions associated with fear and anxiety. Previous imaging studies of people with post-traumatic stress disorder, or PTSD, have shown that these brain regions can over-or ...

New colonoscope provides ground-breaking view of colon

A ground-breaking advance in colonoscopy technology signals the future of colorectal care, according to research presented today at Digestive Disease Week(DDW). Additional research focuses on optimizing the minimal withdrawal ...