FDA ties newer birth control drugs to blood clots
(AP) -- Safety concerns with the popular birth control pill Yaz increased Thursday as federal health scientists reported that the Bayer drug and other newer birth control treatments appear to increase the risk of dangerous blood clots more than older medications.
A new study released by the Food and Drug Administration reviewed the medical history of more than 800,000 U.S. women taking different forms of birth control between 2001 and 2007. On average, woman taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking older birth control drugs.
Yaz contains estrogen along with a next-generation synthetic hormone called drospirenone, which is known to increase potassium levels in the blood. FDA compared medical records of women taking the drug with those taking the older drug levonorgestrel.
Yaz, Yasmin and related drospirenone-containing pills were Bayer's second-best-selling franchise last year at $1.6 billion in global sales.
In 2009, the FDA took the unusual step of ordering Bayer to run corrective TV advertisements on Yaz, saying the drugmaker's marketing campaign overstated the drugs' ability to prevent acne and premenstrual syndrome.
Bayer Healthcare, a division of the German conglomerate, said it "is currently evaluating this publication and cannot comment at this point in time."
The agency also reported higher complications in women using the Ortho Evra patch from Johnson & Johnson and the Nuvaring vaginal ring from Merck & Co. Inc. Those drugs combine estrogen, which is present in all birth control pills, with two other synthetic hormones launched in the last decade.
The FDA said it hasn't reached a final conclusion on the drugs' safety but will hold a meeting with scientific advisers Dec. 8.
Consumer safety advocates have criticized the agency for approving newer, more expensive birth control drugs when cheaper, generic drugs with established safety records are widely available.
"At a certain point we have to ask why the FDA continues to approve drugs that are less safe and have no benefit compared to drugs already on the market," said Dr. Diana Zuckerman, president of the National Center for Women and Families, a consumer group for women's health issues. "With all these different birth control options, why take the most expensive one that can also kill you?"
Recent studies have reached differing conclusions on the risks of newer birth control pills.
A study published earlier this week involving more than 1 million Danish women found that women taking Yaz and other newer medications had twice the risk of blood clots as women taking the older hormone levonorgestrel. The findings appeared Tuesday in the British Medical Journal.
However, two studies published in 2007, conducted as part of the postmarketing requirements of the FDA or European regulators, did not find any difference in blood clotting between the two comparable groups.
Birth-control pills that contain drospirenone include Bayer's Yaz, Yasmin, Beyaz, Safyral; Sandoz's Syeda and Loryna; as well as Barr Laboratories' Ocella, Watson Pharmaceuticals' Zarah and Teva Pharmaceuticals' Loryna.
©2011 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- New warning OK'd for birth control patch Jan 21, 2008 | not rated yet | 0
- US reviews birth control pill safety over clot risk May 31, 2011 | not rated yet | 0
- Newer oral contraceptive as safe for gall bladder as older birth-control pills: research Apr 18, 2011 | not rated yet | 0
- Increased stroke risk from birth control pills Oct 26, 2009 | not rated yet | 0
- FDA warns of birth defects with Topamax Mar 04, 2011 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
How can there be villous adenoma in colon, if there are no villi there
12 hours ago As title suggest. Thanks :smile:
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013 Hello everyone, Ok Stomach's normal epithelium is simple columnar, now in intestinal type of adenocarcinoma of stomach it undergoes "intestinal...
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
- More from Physics Forums - Medical Sciences
More news stories
An independent panel of experts on Wednesday recommended US approval of a new Merck sleeping pill called suvorexant, but expressed concerns over the highest dosage and risks of drowsy daytime driving.
Medications 1 hour ago | not rated yet | 0
GlaxoSmithKline PLC says it's starting an unusual collaboration with the U.S. government to develop several antibiotics for both bioterrorism threats and bacterial infections resistant to current medicines.
Medications 3 hours ago | not rated yet | 0
The new 13-valent pneumococcal conjugate vaccine (PCV13) appears to be as safe as the previous version used prior to 2010, the 7-valent pneumococcal conjugate vaccine (PCV7), according to a Kaiser Permanente study published ...
Medications 8 hours ago | not rated yet | 0
The University of Gothenburg Vaccine Research Institute (GUVAX) announces successful results in a placebo controlled phase I study of an oral, inactivated Escherichia coli diarrhea vaccine.
Medications 11 hours ago | not rated yet | 0
(HealthDay)—For HIV-infected individuals with recurrent Clostridium difficile infection, fecal microbiota therapy is feasible, according to a letter published in the May 21 issue of the Annals of Intern ...
1 hour ago | not rated yet | 0
Calorie information in fast food restaurants used by 40 percent of 9-18 year olds when making food choices
A new study published online today (Thursday) in the Journal of Public Health has found that of young people who visited fast food or chain restaurants in the U.S. in 2010, girls and youth who were obese were more likely ...
10 minutes ago | not rated yet | 0
(HealthDay)—Migraines and depression can each cause a great deal of suffering, but new research indicates the combination of the two may be linked to something else entirely—a smaller brain.
3 hours ago | 5 / 5 (1) | 0 |
Until now, little was scientifically known about the human potential to cultivate compassion—the emotional state of caring for people who are suffering in a way that motivates altruistic behavior.
3 hours ago | not rated yet | 2 |
Swiss scientists reveal the mechanism responsible for aging hidden deep within mitochondria—and dramatically slow it down in worms by administering antibiotics to the young.
6 hours ago | 4.5 / 5 (2) | 0 |
(HealthDay)—Implementation of systematic monitoring for medication adherence will allow for identification of barriers to adherence and tailoring of interventions, according to a viewpoint piece published ...
1 hour ago | not rated yet | 0