Recalls Black Box Warnings, et al

[Guest guest]

Last month the FDA recalled several products. One is non-acetone Personal Care

Nail Polish:

http://www.fda.gov/oc/po/firmrecalls/photos/personalcare04_09.html

FOR IMMEDIATE RELEASE -- April 20, 2009 -- Universal ABC Beauty Supply

International, Inc. of Brooklyn, NY, has been informed by the Food and Drug

Administration (FDA) that FDA lab analyses of the dietary supplements

distributed by the company were found to contain undeclared Sibutramine, an

FDA-approved drug used as an appetite suppressant for weight loss. These dietary

supplements are not supposed to contain Sibutramine. The FDA has not approved

these products, therefore the safety and effectiveness of these products is

unknown.

Also 34 dietery supplements are being recalled. These can be found at the line

above. There is a phone number to call to get a refund.

MedWatch - Tarceva (erlotinib):Dear HCP letter issued to warn about GI

perforation, exfoliative skin conditions and corneal perforation/ulceration

Study shows benefits of anti-clotting medications reduced by common heartburn

drugs LAS VEGAS, NV (May 6, 2009) - The anti-clotting action of the medication

clopidogrel (Plavix) can be compromised by common drugs for the treatment of

heartburn...

ROCKVILLE, Md., May 5, 2009--FDA notified healthcare professionals that it

approved updated labeling for antiepileptic drugs used to treat epilepsy,

psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain

syndromes). FDA also required development of a medication guide, to be issued to

patients each time the product is dispensed. Since issuing safety alerts on

December 16, 2008 and January 31, 2008, FDA has been working with the

manufacturers of drugs in this class to better understand the suicidality risk.

Eleven antiepileptic drugs were included in a pooled analysis of

placebo-controlled clinical studies in which these drugs were used to treat

epilepsy as well as psychiatric disorders and other conditions. The increased

risk of suicidal thoughts or behavior was generally consistent among the eleven

drugs, with varying mechanisms of action and across a range of indications. This

observation suggests that the risk applies to all antiepileptic drugs used for

any indication.

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A pill imprint code is used to uniquely identify all solid oral dosage forms

such as tablets, capsules and pills. An imprint code consists of alphanumeric

text which is embossed, debossed, engraved or printed onto solid oral dosage

forms although pills may also have other identifying markings, such as trademark

letters, marks, symbols, internal and external cut outs. Imprint codes are a

legal requirement of the United States Food and Drug Administration.

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Select Care Patient assistance:

To combat the problem of unaffordable medications, many Pharmaceutical Companies

have developed Patient Assistance Programs (PAP's). These programs help patients

maintain their health and well being by offering prescription drugs at either no

cost or a small co-payment for the patients who qualify. Unfortunately, though

these programs have been around for years, they are often unheard of by the

people who need them most because no one has a vested interest in promoting

them.

Also, most Patient Assistance Programs involve a large amount of red tape that

prohibits most people from utilizing them. Still, when used properly, many

Seniors and low-income families can get prescriptions for little or no cost.

Members of SelectCare Benefits Network will receive unlimited access to our

turnkey assistance with over 200 different Patient Assistance Programs covering

over 1400 medications.

http://www.myrxadvocate.com/freePrescriptions.php

FYI,

Lottie