Increased risk of muscle injury with high doses of Zocor (simvastatin).

Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.

Audience: Primary care providers, patients
[Posted 03/19/2010] FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury.
Recommendations for healthcare professionals, recommendations for patients and a data summary of information used in this ongoing review are provided in the Drug Safety Communication.
[03/19/2010 - Drug Safety Communication¹ - FDA]
[03/2010 - Prescribing Information: Zocor² - Merck]

Drug Safety Labeling Changes February 2010

 Drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections during February 2010.

Key to Label Section Acronyms:

BW=BOXED WARNING, C=CONTRAINDICATIONS, W=WARNINGS, P=PRECAUTIONS
AR=ADVERSE REACTIONS, PPI/MG=PATIENT PACKAGE INSERT/MEDICATION GUIDE

DRUG NAME	SECTIONS MODIFIED
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Caduet (amlodipine besylate/atorvastatin calcium) tablets1		X	X	X	X
Cialis (tadalafil) tablets2		X	X	X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Accutane (isotretinoin) capsules3			X
Bystolic (nebivolol) tablets4			X	X
Carbocaine (mepivacaine HCl) injection5 *risk of chondrolysis			X
Didrex (benzphetamine hydrochloride) tablets6			X	X	X
Excedrin Migraine (250 mg acetaminophen/ 250 mg aspirin/ 65 mg caffeine) tablets7			X
Genotropin (somatropin [rDNA origin] for injection8			X	X
Lanoxin (digoxin) pediatric injection and tablets9			X
Marcaine (bupivacaine HCl) injection10 Marcaine with Epinephrine 1:200,000 (as bitartrate)(bupivacaine HCl and epinephrine) injection11 Marcaine Spinal (bupivacaine HCl) dextrose injection12 *risk of chondrolysis			X
Naropin (ropivacaine HCl) injection13 *risk of chondrolysis			X
Nesacaine (chloroprocaine HCl) injection14 Nesacaine-MPF (chloroprocaine HCl) injection15 *risk of chondrolysis			X
Norvasc (amlodipine besylate) tablets16			X	X	X
Prepidil (dinoprostone) cervical gel17			X
Rocephin (ceftriaxone sodium) IV and IM18			X
Savella (milnacipran HCl) tablets19			X
Treanda (bendamustine hydrochloride) for injection, for intravenous infusion20			X	X
Xylocaine (lidocaine HCl) injection21 Xylocaine (lidocaine HCl and epinephrine) injection22 Xylocaine (lidocaine HCl) 4% solution23 *risk of chondrolysis			X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Cefoxitin for injection and Dextrose injection in the Duplex container24				X
Intelence (etravirine) 100 mg tablets25				X
(Click on drug name to go to detailed view)	BW	C	W	P	AR	PPI/MG
Dyazide (hydrochlorothiazide/triamterene) capsules26					X
Forane (isoflurane) liquid for inhalation27					X
Niaspan (niacin) extended release tablets28					X
Pristiq (desvenlafaxine) extended-release tablets29					X

Medical Device Recalls For 2010

Following medical devices have been recalled in 2010, and we will continue to report the same in the future.
Baylis Medical Company Inc., Torflex Transseptal Guiding Sheath7	02/08/10
Thomas Medical Products Inc., Transseptal Sheath Introducer Kits8	02/01/10
StatSpin, Inc., doing business as IRIS Sample Processing, StatSpin Express 4 Centrifuges, Model #5109	01/27/10
Gyrus ACMI, Inc. Micron Bobbin Vent Tube T, 1.27 mm10	01/08/10
Baxter HomeChoice and HomeChoice PRO11	01/08/10
Beckman Coulter Inc., UniCel DxC Synchron Clinical System - Ion Selective Electrode (ISE) Flow Cell12	01/04/10

Novartis Vaccines and Diagnostics Withdraws Chiron RIBA HCV 3.0 SIA From Market

DATE NOTIFICATON INITIATED:
February 26, 2010
PRODUCT / LOT NUMBER / EXPIRATION DATE:
Chiron RIBA HCV 3.0 SIA 
Product Code:  930600

Lot Numbers	Expiration Date
YA1209	June 22, 2009
YA1691	August 31, 2009
YA1758	September 22, 2009
YA1804	September 29, 2009
98290	May 17, 2010
98743	May 31, 2010

MANUFACTURER:
Novartis Vaccines and Diagnostics
Emeryville, CA
REASON:
Novartis Vaccines and Diagnostics, Inc. (Novartis Diagnostics) received complaints from customers reporting false positive assay results when using the Chiron RIBA HCV 3.0 SIA (Strip Immunoblot Assay).

Novartis Diagnostics initiated an investigation including a review of all batch records for the lots listed above and determined that all lots were manufactured according to established procedures and met all performance specifications.  In addition, the kits lots were retested as part of this investigation and confirmed all lot-release specifications continue to be met.  However, as part of the investigational testing performed to date, Novartis Diagnostics reproduced discordant results with specimens returned from customers on certain lots of Chiron RIBA HCV 3.0 SIA.  The etiology of these discordant results is undetermined, and testing evidence supports that an increase in false positive results is possible with the lots listed above.  Internal testing of known positive specimens on retained lots yielded accurate results; therefore, Novartis has no evidence that true positive specimen results are impacted.  Customers have been asked to contact the manufacturer to arrange for product return.

C. H. Guenther & Son, Inc. Recalls pepper products due to Possible salmonella contamination

C. H. Guenther & Son, Inc. Recalls


If you have pepper products on your shelves and if they are from C.H. Guenther & Son please verify the products at Recallr. The might be under different brand names.
Recallr: C. H. Guenther & Son, Inc. Recalls several products that contain pepper due to Possible salmonella contamination,

House Passes Health Care Reform Bill 219 to 212

The health care reform bill has passed the house and awaits the next hurdle in the senate. If the senete passes, the bill will be written in to law by the President Obama.
According to the polls, many Americans did not like the bill. I think it is because they did not understand much about the bill, I had to laugh when people told that they did not like to control their health. But they seem to have forgotten that Medicare takes care of the elderly all over and run by the goernment.
What really do not understand is why 56% of the country want to get ripped by insurance companies, no matter they are rich or poor. I love this country. One cannot be poor, unless one really try hard.

National Women and Girls HIV/AIDS Awareness Day, Free HIV Test For Women Offered Snohomish Health District

Snohomish Health District, is supporting  National Women and Girls HIV/AIDS Awareness Day, by offering free HIV tests today, Tuesday and Wednesday. It is your chance to get tested. Usually this will cost $89.
Following is the press release;
SNOHOMISH COUNTY, Wash. ---
Snohomish Health District will support National Women and Girls HIV/AIDS Awareness Day by offering prevention information and free anonymous or confidential HIV tests on three days in March to qualifying women and girls age 14 years and older who are at risk for HIV infection. The rapid HIV antibody test, adopted in 2004 by the Health District, requires only a drop of blood pricked from a finger. Test results are available within 20 minutes. No appointment necessary; no ID required.
Health educators will offer rapid HIV antibody testing at these sites and times:
�� March 8, 5 to 7 p.m. – Lynnwood: Snohomish Health District, 6101 200th SW, Ste 100
�� March 9, 11 a.m. to 7 p.m. – Everett: Snohomish Health District, 3020 Rucker Ave, Ste 106
�� March 10, 11 a.m. to 7 p.m. – Everett: Snohomish Health District, 3020 Rucker Ave, Ste 106
National Women and Girls HIV/AIDS Awareness Day (NWGHAAD) is a nationwide initiative celebrated on March 10 every year to raise awareness of the increasing impact of HIV/AIDS on women and girls. About one-third of all newly detected HIV cases progress to full-blown AIDS within 12 months of initial HIV diagnosis. This indicates that individuals are not getting tested regularly as a part of their normal health care. Instead they are waiting until they experience health problems, by which time the disease can be more difficult to treat. The awareness campaign is an effort to help women and girls know their HIV status.
The federal Centers for Disease Control and Prevention and the Washington State Department of Health report:
�� Every 35 minutes a woman tests positive for HIV in the United States.
�� About 40 people test positive for HIV/AIDS every year in Snohomish County.
�� More than 640 people are living with HIV/AIDS in Snohomish County.
�� Having unprotected sex is the main way HIV spreads. It also spreads through injection drug use or from mother to baby during pregnancy, childbirth, or breastfeeding.
�� Today, about one in four Americans living with HIV is a woman.
�� HIV/AIDS is the leading cause of death for African American women age 25 to 34.
During a standard week, the Health District offers rapid tests, oral swab, and standard blood draw tests by appointment Monday through Friday. Tests cost $89 for everyone except high-risk persons—they are tested for free. Appointments: 425.339.5298. High-risk individuals include men who have sex with men (MSM), IV drug users (IDU), and persons who have sex with MSM or IDU.
The Health District also offers walk-in (no appointment) rapid HIV antibody testing routinely at these sites:
• All Tuesdays, 11 a.m. to 7 p.m. – Everett: Snohomish Health District 3020 Rucker Ave, Ste 106
• 1st Tuesdays, 11 a.m. to 1 p.m. – Everett: First Congregational United Church of Christ, 2624 Rockefeller Ave
• 2nd and 4th Mondays, 5 to 7 p.m. – Lynnwood: Snohomish Health District, 6101 200th SW, Ste 100
Incorporated in 1959, the Snohomish Health District works for a safer and healthier community through disease prevention, health promotion, and protection from environmental threats. Find more information about the Health District at www.snohd.org.