'Morning-after' pill reconsidered

[Mestemia]

After almost a year's delay, the Food and Drug Administration said Monday that it would reconsider a highly controversial proposal to make the "morning-after" pill available over the counter.

The agency said it would resume talks with the drug's manufacturer, Barr Pharmaceuticals Inc., in the next week and hoped to agree on an approval process "in a matter of weeks" if the talks went well.

"The acting commissioner, Dr. Andrew von Eschenbach, believes resolving this public health issue is an important step," the FDA said.

But the pills won't be available without prescriptions in drugstores anytime soon.

The government has asked Barr to file a revised application and meet unusually strict standards, including enforcing a provision that limits drugstore sales to women age 18 and up. Many experts question whether the company will be able to comply with the agency's demands.

"I hope the agency is sincere and genuinely plans to expand access to this medication," said Dr. Georges Benjamin, executive director of the American Public Health Association.

"If they really mean it, this is a positive step in the right direction," echoed Dr. Douglas Laube, president elect of the American College of Obstetricians and Gynecologists.


Source and rest of article:
Chicago Tribune

[teancum79]

are these the same pills that where getting blames for heart attacks and other untimely deaths a few months back?

[Mestemia]

From what I understand this is Plan B, not RU-486

[teancum79]

Oh okay, I don't track the subject all that closely and was hoping the FDA is not that stupid. Thanks.

[Mestemia]

teancum79 said:

Oh okay, I don't track the subject all that closely and was hoping the FDA is not that stupid. Thanks.

NEVER underestimate the stupidity of government.

[Tara]

teancum79 said:

are these the same pills that where getting blames for heart attacks and other untimely deaths a few months back?

Well from what I understand about modern medicine in general is that there is always some sort of side-effect associated with them. How would you expect this one to be any different? Or why would you make this statement only about this one in particular?

[teancum79]

Well a headache and upset stomach are about as common with meds as ants, but when the side effect is fatal it is a bigger concern. In some cases the FDA will bend the rules if the company who wants a rule bending has enough friends in office.

[Mestemia]

Mifepristone is safer than acetaminophen (Tylenol®), Aspirin®, and sildenafil (Viagra®). Adverse drug events are not uncommon, even with well-accepted and widely used medications. For example, accidental acetaminophen overdose is the single most common cause of catastrophic liver failure in the US, causing approximately 150 deaths annually.2 The American Association of Poison Control Centers reported 59 deaths from aspirin poisoning in 2003. Estimates of the number of excess deaths due to gastrointestinal bleeding from use of aspirin and other non-steroidal anti-inflammatory drugs (such as ibuprofen) range in the thousands.3 From 1993 to 2000, the US Food and Drug Administration received over 4,000 adverse event reports, including 55 reports of death, involving loratadine (Claritin®), a drug which recently gained over-the-counter status.4 Among users of sildenafil, there have been approximately five deaths for every 100,000 prescriptions provided.5 According to the manufacturer, Pfizer, more than 23 million men worldwide have been prescribed the erectile dysfunction medication Viagra and more than 1 billion prescriptions have been written.

Source:
www.arhp.org/factsheets/mifepristonesafetyoverview.cfm

The following is from this site:
www.ru486facts.org/index.cfm

Definition:
RU-486 is the name commonly used for an artificial steroid that blocks progesterone, a hormone needed to continue a pregnancy.2

Other names for RU-486:
Mifepristone is the generic name for RU-486. In the U.S., RU-486 is sold under the brand names Mifeprex® and Early Option®.

Note: An RU-486 abortion involves two drugs
When taken alone, RU-486 causes a complete abortion only about 60% of the time.3 A second drug, a prostaglandin, is given 48 hours later to increase its effectiveness. The prostaglandin causes uterine contractions to help expel the embryo.

Misoprostol (brand name Cytotec) is the prostaglandin used with RU-486 in the U.S.

[Mestemia]

What is Plan B?

Plan B is emergency contraception, a backup method to birth control. It is in the form of two levonorgestrel pills (0.75 mg in each pill) that are taken by mouth after unprotected sex. Levonorgestrel is a synthetic hormone used in birth control pills for over 35 years. Plan B can reduce a woman’s risk of pregnancy when taken as directed if she has had unprotected sex. Plan B contains only progestin, levonorgestrel, a synthetic hormone used in birth control pills for over 35 years. It is currently available only by prescription

How does Plan B work?

Plan B works like other birth control pills to prevent pregnancy. Plan B acts primarily by stopping the release of an egg from the ovary (ovulation). It may prevent the union of sperm and egg (fertilization). If fertilization does occur, Plan B may prevent a fertilized egg from attaching to the womb (implantation). If a fertilized egg is implanted prior to taking Plan B, Plan B will not work.

Source:
www.fda.gov/CDER/drug/infopage/planB/planBQandA.htm

[Tara]

teancum79 said:

In some cases the FDA will bend the rules if the company who wants a rule bending has enough friends in office.

Sadly, that is true.