Category X drugs cause fetal abnormalities: Not for OTC

Statins are categorized by the FDA use-in pregnancy ratings under category X. Category X is defined as "adequate well-controlled or observational studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities or risks." (from a Canadian pharmacist.)

Category X drugs should not be over-the-counter.

If you think statins sold as OTC will be dangerous, this is where you have to write, fax and call. These

and tv interviews you will be seeing pushing this topic in the coming days,weeks and months.

This is a public relations campaign orchestrated by the National Lipid Association to drum up public support, and then take it to the FDA saying
"see Americans want this."

Do you?

Do you want a young woman, perhaps slightly over-weight and thinking of her "heart-health" picking up these drugs with her shampoo, then finding out at two or three months gestation she is not only pregnant, but has been taking the 21st century's version of
Thalidomide?

Who are these "lipid professionals?" How many are on the take, being paid by pharma as "consultants" to this effort? Here is a link explaining how "consultancy" works in the pharma business:
http://groups.google.ca/groups?q=uffe+ravnskov&hl=en&lr=& ie=UTF-8&scoring=d& selm=e5f4a9c2.0404101939.31115f5a%40posting.google.com& amp;rnum=4

The story:

The organization: www.lipids.org

This organization of "lipid professionals" want to
"explore the benefits and challenges" of over-the-counter statins in the United States. As you may or may not know, Merck has been given the green light for OTC Zocor (simvastatin) in the United
Kingdom. The thin edge of the wedge...

Please, let these people knowwhat you think about the "challenges" of statin use. Dangerous. Impossible to control as over the counter.

You have a right to use a statin if that is your choice but do you not also have a responsibility to speak out about how this category of drug is marketed and sold?

There is an on-site e-mail, at www.lipid.org/contact.php but on-site e-mail responses are often junked.

Let them know the slow mail way. Send your political representatives a copy of whatever you send. And your state physician's regulatory body, and the state cardiology association. If everyone gets a copy, it's not so easy for them to say "we have not received any negative comment."
National Lipid Association
8833 Perimeter Park Blvd., Suite 301
Jacksonville, FL 32216

The National Lipid Association (NLA), a 501(c)6 not-for-profit organization, was created in 2002 to serve the community of lipid professionals who manage patients with lipid disorders and increased cardiovascular risk.

(1) American Heart Association, 2002 Heart and Stroke
Statistical Update, Dallas, Texas: American Heart
As.sociation, 2001.

You may contact us by telephone or fax: (904) 998-0854
Fax: 998-0855

Southeast Lipid As.sociation Staff
Christopher Seymour - Executive Director
Eileen Karregeannes - Director of Meetings
Lori Clawges - Director of Communications and
Jennifer DiPietro - Associate Director of Programs
Nicola Sirdevan - CME Director
Cynthia Moore - Administrative As.sistant
Chris Nuland, Esq. - General Counsel

That you may.

You remain in my prayers, neighbor.

Servant to the humblest person in the universe,

I beg to disagree: everyone in medicine does not know statins potential for disabling side effects. Hundreds of statin users are still told by physicians who get their drugs information from pharma reps (hardly unbiased) that the disabling symptoms they are experiencing could not possibly be caused by statins. They are told they must continue to take them or they will almost certainly get heart attack and stroke, and die.
http://www.rxlist.com/rxboard/lipitor.pl
Statin users experiencing side effects come here with their queries.
Many say their doctors told them statins can't do that when they complain of muscle pain, atrophy, and weakness etc.

Also, the liver function tests you mention may detect rhabdomyolysis, but there is mitochondrial myopathy and myositis which are *not* detectible by this test.
http://www.impostertrial.com/physician.htm
What is known about statin-associated myopathy with normal CK. Also note the histopathology link.

As far as I know, and in my personal experience, there is no *must* about the liver panel test. It certainly didn't protect me or predict anything for me.

However to return to the subject of my post; there may yet be a fail safe for our fictional young woman and her fictional baby threatened by an over the counter category X drug:

If she has been taking statins for a couple years, she may already have mitochondrial damage caused by cholesterol depletion, which then effects dolichols (precursor to coenzyme q10); peripheral neuropathy, polyneuropathy, pancreatitis, gall bladder disease, cognitive adverse effect, including transient global amnesia, short term memory loss, aphasia including language loss, vocabulary loss, thinking and learning difficulties. She will also have mitochondrial myopathy including muscle pain, weakness and atrophy. She may have ocular myasthenia, chronic sinus condition, chronic plantar fasciaitis and gout.

A real hottie.

Then, if her partner is also using statins...

"Life is our Life's Work" says the altruistic and misleading slogan on
Pfizer's Canadian website.

...and liver failure, heart failure and brain damage.


Servant to the humblest person in the universe,

Truth be told, a liver panel should probably be done every few months for those who imbibe significant amounts of ethanol especially in conjunction with acetaminophen ingestion.


Servant to the humblest person in the universe,

I agree that there should be physician supervision. But then again there are many things that should be physician supervised and often are not. Weight loss would be a good example.

Nonetheless, the consequences of unsupervised alcohol use appear to be acceptable to society. The consequences of unsupervised statin use will be far less in comparison.

May God bless you for contributing in a civil manner to this discussion, in Christ's name.

Servant to the humblest person in the universe,

Any examples? It seem that recent medications that have become OTC have had little in the way of increased adverse effects.

There is also a significant population that will become alcoholic with one drink and yet our society allows this to be OTC.

I do not have a problem with folks being careful.

Servant to the humblest person in the universe,

Can we add, while we are reacting, the same cautions about the supplement biz, most of whose products are drugs which action during pregnancy is not known and have not a category by which to make informed consumption decisions.