Wednesday, September 28, 2011

The Pill is Dangerous; Feds Say Keep Taking it

Even though the federal Food and Drug Administration say some new birth-control pills could cause blood clots, the agency “advises women taking birth control pills with drospirenone not to stop the product before talking to their doctors first.”

The FDA reasoning is that these types of birth control pills perhaps are no worse than any other.

For background, read Contraceptive Pill 'Yaz' Causes Disease, Death

UPDATE 12/6/11: Birth Control Studies Needed to Assess Clot Risk, FDA Says

UPDATE 12/6/11 video:
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UPDATE 10/27/11: Risks greater for several types of the pill

-- From "FDA Flags Concern on Birth-Control Pill" by Jennifer Corbett Dooren, Wall Street Journal 9/27/11

In a drug safety communication posted on the agency's website Monday, the FDA said preliminary results of an agency-funded study involving 800,000 women suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth-control pills, compared to users of other hormonal contraceptives.

Drospirenone is used in pills including Yaz and Yasmin, which are marketed by Bayer AG. Drospirenone is a type of female sex hormone called a progestin. Some drospirenone pills are also available in generic versions.

But the FDA said it hasn't reached a final conclusion that the products raise the risk of blood clots beyond that of other pills, and the agency will convene an outside panel of medical experts on Dec. 8 to discuss the matter.

Most birth-control pills contain two types of hormones, estrogen and progestin. All types of pills increase the risk of blood clots, and product labels warn of such risk.

To read the entire article above, CLICK HERE.

From "Yaz and newer birth control pills could raise risk of blood clots, FDA says" by Susan Todd, The Star-Ledger 9/26/11

The agency also noted that it plans to meet with two advisory panels in December — the Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee — to sort through through some of the conflicting safety data generated by a half dozen different studies of the contraceptives.

Bayer Healthcare . . . faces thousands of lawsuits over health problems and, in some cases, deaths that are blamed on the [Yaz and Yasmin] drugs, which lawyers have said are often prescribed to teen-age girls for treating acne and premenstrual moodiness.

While the FDA study is new, warnings about the risks of the birth control pills are not. A year after Yasmin’s approval, Public Citizen, a non-profit consumer advocacy group, began warning of the drug’s dangers and placed Yasmin on its list of "Do Not Use Pills."

To read the entire article above, CLICK HERE.

From "FDA concerned about certain birth-control pills" posted at News 9/28/11

Patients should talk to their healthcare professional about their risk for blood clots before deciding which birth control pill to use. Known risk factors that increase the risk of a blood clot include smoking, obesity and family history of blood clots, in addition to other factors that contraindicate use of birth control pills.

Women currently taking a drospirenone-containing birth control pill should be informed of the potential risk for blood clots. The FDA previously communicated preliminary information about these concerns to the public on May 31.

To read the entire article above, CLICK HERE.

Also read 'The Pill' Reaches Age 50, but Do the Women Who Use It?