News Blog

FDA Sends Warning Letter to California Orthopedic & Spine Device Company

Wednesday, April 11th, 2012

The FDA recently conducted an inspection of a company in California, Orthopedic Alliance, and the inspection results are posted on the FDA

site. The company was found to not be in conformity with the “current good manufacturing practice requirements of the Quality System regulation.” The violations included failure to establish and maintain procedures for implementing corrective and preventative actions and failure to establish and maintain procedures for control and distribution of the finished devices.

Here’s an excerpt of the letter:

During an inspection of your firm located in Murrieta, California, on July 20, 2011, through September 23, 2011, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures various orthopedic implant devices, including the SC Total Hip System and the SC Ceramic Ball Heads. Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or they are intended to affect the structure or function of the body.
This inspection revealed that these devices are adulterated within the meaning of Section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from Mr. Arnold Neves, Jr., dated September 30, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).

For example, your firm’s General Counsel Representative stated that there was no corrective and preventive action procedure.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that two of its employees will be attending a CAPA workshop in early October, 2011, and that the CAPA procedure will be implemented in sixty days. However, neither procedures nor additional procedural details have been submitted for our review. In addition, your firm did not provide a rationale for requiring up to sixty days to complete this corrective action.
2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally-designated unit, as required by 21 CFR 820.198(a).

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm297260.htm

Qnexa- Not Yet

Wednesday, April 11th, 2012

FDA regulators will take another three months to make a decision on Qnexa, which could become the first new prescription weight loss pill to reach the market in more than a decade.

The Food and Drug Administration pushed back its target date t

o July 17, 2012 to consider a new drug safety plan submitted by the company. Previously the agency was scheduled to make a decision by April 17. Vivus said the three-month extension is standard when companies submit additional risk management information for a drug.

http://finance.yahoo.com/news/fda-3-more-months-review-221936151.html

Dietary supplements not without risks

Friday, March 30th, 2012

From the Mayo Clinic’s site, a timeless article:

Before you try any dietary supplements, take a close look at the bottle and the science behind the claims. Then proceed with caution. Here’s why:

  • Just because you can purchase a supp

    lement, that doesn’t mean it’s safe. Dietary supplements don’t undergo the same scrutiny that’s required of prescription medications.

  • Dietary supplements, including herbal supplements, aren’t benign. Whether they’re in the form of pills, drinks, powders or foods, supplements can have strong effects in the body. Supplements can also interact with prescription medicines, leading to potentially dangerous reactions.
  • “All natural” on the bottle is no guarantee that a supplement is in fact all natural. In recent years, the Food and Drug Administration has discovered chemicals, prescription drugs and steroids in some supplements.
  • Few supplements have rigorous science to support their claims. In all fairness, it’s possible the science just isn’t there yet. Whatever the reason, you’re in uncharted waters when it comes to most supplements.

If you’re currently taking or considering taking dietary supplements, keep a few key points in mind:

  • Be skeptical. If a claim seems too good to be true, it probably is. When in doubt, ask your doctor or pharmacist.
  • Talk to your doctor. Tell your docto.
  • If you’re taking a supplement and if you experience any problems with it.

Read more here: http://www.mayoclinic.com/health/dietary-supplements/MY01408

Format

From the Mayo Clinic’s site, a timeless article:
Before you try any dietary supplements, take a close look at the bottle and the science behind the claims. Then proceed with caution. Here’s why:
Just because you can purchase a supplement, that doesn’t mean it’s safe. Dietary supplements don’t undergo the same scrutiny that’s required of prescription medications.
Dietary supplements, including herbal supplements, aren’t benign. Whether they’re in the form of pills, drinks, powders or foods, supplements can have strong effects in the body. Supplements can also interact with prescription medicines, leading to potentially dangerous reactions.
“All natural” on the bottle is no guarantee that a supplement is in fact all natural. In recent years, the Food and Drug Administration has discovered chemicals, prescription drugs and steroids in some supplements.
Few supplements have rigorous science to support their claims. In all fairness, it’s possible the science just isn’t there yet. Whatever the reason, you’re in uncharted waters when it comes to most supplements.
If you’re currently taking or considering taking dietary supplements, keep a few key points in mind:
Be skeptical. If a claim seems too good to be true, it probably is. When in doubt, ask your doctor or pharmacist.
Talk to your doctor. Tell your docto.
If you’re taking a supplement and if you experience any problems with it.
Read more here: http://www.mayoclinic.com/health/dietary-supplements/MY01408
Path:

Hydroxycitric Acid Dietary Supplement-Related Herbal Nephropathy

Friday, March 30th, 2012

We see hydroxycitric acid as an ingredient in may products sold over the counter. Here is a recent study regarding it:

Herbal preparations are unregulated and widely used because of public perception of being “harmless” and “natural.” Hy

droxycitric acid, an extract from the herb garcinia cambogia, is a popular weight-loss supplement used for centuries in Asia. Its effect on weight loss, although being demonstrated in animal studies, may be effective on humans, but with harmful consequences. This is the first report of acute kidney injury caused by an herbal product containing hydroxycitric acid.

Case Presentation
A 38-year-old obese woman presented to the emergency department for treatment of abdominal pain, nausea, and vomiting of 3 days duration. Her medical history was significant for gastroesophageal reflux. The patient said she generally took no medication, but she had begun taking ranitidine 150 mg/d a few days previously and used an “occasional” hydrocodone/acetaminophen 5/500 tablet to ameliorate her abdominal pain. She denied use of nonsteroidal anti-inflammatory drugs and did not initially disclose her hydroxycitric acid herbal supplement use (500 mg/d 5 days per week for 1 year) until directly questioned by the admitting physician.

The patient’s positive findings were a hypertensive state of 145/76 mm Hg, an elevated creatinine level of 5.8 mg/dL (compared with a baseline of 0.79 mg/dL), and a fractional excretion of sodium greater than 4. Negative laboratory results were anti-nuclear and anti-neutrophil cell antibodies, C3, C4, and serum protein electrophoresis. Renal artery ultrasound was normal.

After the supplement was discontinued, her creatinine increased to 6.2 mg/dL (glomerular filtration rate of 8 mL/min) over the next day, necessitating nephrology to institute hemodialysis. Consequently, her renal function sufficiently improved, so no renal biopsy was performed. She was discharged on day 7 with a creatinine level of 1.6 mg/dL and glomerular filtration rate of 38 mL/min.

The temporal relationship of her symptoms, the prolonged use of hydroxycitric acid, the absence of other nephrotoxic agents except ranitidine, and the improvement of renal function after cessation of hydroxycitric acid support the impression of acute renal failure secondary to herbal nephropathy.

If you or anyone you know has been hurt by hydroxycitric acid dietary supplements, call us at: 877 882 0095

For original article see:
http://amjmed.blogspot.com/2011/09/hydroxycitric-acid-dietary-supplement.html

Vaginal Mesh Helpline Helping women Nationwide

Monday, March 26th, 2012

The Vaginal Mesh Helpline is seeing an alarming increase in women and family members calling for both medical and legal help. The reported complications range from mild to very severe and some even life threatening. “They are all very similar”

says Lisa Spitzer MSW who speaks to most of the callers personally “The mesh was usually implanted to help strengthen a weakened pelvic floor” Says Spitzer ” In a women the pelvic floor consists of the bladder, bowel and Uterus, The vaginal wall is an intricate system of muscle and ligaments that can weaken from age, child birth or hysterectomy. Sometimes it is just poor genetics. Many women went in for a hysterectomy and came out with a mesh”” Doctors were lead to believe the mesh was the miracle answer”” very often the mesh was used for very mild SUI”” Women began having complications and infections when the mesh began to fail” The symptoms of a failed mesh which are reported to us include severe razor blade pain or pain that feels like child birth, pain on one side of the body, lower back pain, Spot bleeding, inability to have sexual intercourse, Increased incontinence or problems voiding, Bowel related symptoms or abdominal pain, difficulty sitting and infections.” ” It is important women understand they are not alone”” It is reported over 300,000 women have been implanted with mesh devices”We asked what is the mesh made of ” The mesh is made of a synthetic propylene fiber, a stretchy synthetic material.””When it falls apart and erodes it is very painful” She continues ” Women are angry at their Doctors”” many women are going back to the Doctors that put the Mesh in with no help”” They are being told it is all in their mind, just get used to it, We can try to trim it, It cannot be removed, we do not have your records any longer, try physical therapy, It is your fault for coughing, It is because you smoke and cough, get a colonoscopy, it is a tumor, and everything imaginable other then it could be the mesh failing. In October 2008 the FDA issued a warning regarding the vaginal mesh implants to Healthcare practitioners.

If you or anyone you know has been hurt by any Vaginal Mesh, Call us at: 877 882 0095

For full article see: http://world.einnews.com/pr_news/86730936/vaginal-mesh-helpline-helping-women-nationwide

Recall of Brilliant Blue G Urgent Product Recall – Immediate Action Required

Sunday, March 25th, 2012

Contact:
Consumer:
Pharmacist-in-Charge
352-622-2913 ext. 209

Media:
Jim Kilbride, RPH
352-622-2913
Fax: 352-690-6770

March 9, 2012

Dear Physician:
Our records indicate that your office received Brilliant

Blue G compounded at Franck’s Lab. We have recently received reports that some patients treated with Brilliant Blue G have experienced fungal infections in the eye. The origin and cause of these eye infections has not yet been determined. The following lots of Brilliant Blue G are suspected of fungal contamination:

Lot Number:

  • 08232011@80
  • 10132011@6
  • 10112011@82
  • 10192011@125

As a precautionary measure and to prevent any additional risk of eye infections in patients, we are recalling all Brilliant Blue G compounded by Franck’s Lab. You are requested to immediately quarantine and return to us any remaining Brilliant Blue G product you may still have. This includes ALL LOTS of Brilliant Blue G that you have received from Franck’s Pharmacy. Our accounting department will issue credit on receipt of product.

Please complete the recall response form and return the product to the address below with the postage provided. If you would like to report any adverse events, or if you would like to receive additional information regarding this product recall, please contact us Monday through Friday, 8 a.m. to 5 p.m., at 352-622-2913 ext. 209 and request the Pharmacist-in-Charge.

Regards,
Jim Kilbride, RPh
Pharmacist-in-Charge
Franck’s Compounding disclaimer icon Lab
1210 SW 33rd Ave. Ocala, FL 34474
352-622-2913
Fax: 352-690-6770

GA March 23, 2012 Mesh News: Prolift Pelvic Mesh Product Sold For Over 3 Years Without Necessary FDA Clearance

Sunday, March 25th, 2012

Read more: http://www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5Io0Rjv

The FDA confirmed in a March 16, 2012 communication released to Bloomberg News that the vaginally pl

aced pelvic mesh product known as the Prolift, sold by Johnson & Johnson subsidiary Ethicon, Inc. since March, 2005, was initially marketed without any clearance or approval from the FDA. Ethicon attempted to justify this decision, claiming the Prolift, a vaginal mesh medical device for treatment of pelvic organ prolapse, was legally marketed pursuant to the 510K for a significantly different product.In the March 16, 2012 communication, FDA spokesperson Morgan Liscinsky stated that the: “FDA disagreed with this assertion.” The FDA statement unequivocally rejects Ethicon’s contention that the Prolift was legally marketed under the 2002 clearance provided to the other device known as Gynemesh PS.

If you or anyone you know has been hurt by any pelvic mesh, call us at: 877 882 0095

Read more: http://www.timesunion.com/business/press-releases/article/FDA-Confirms-Johnson-Johnson-Prolift-Pelvic-3426909.php#ixzz1q5J7lsqi

FDA Cautions On Memory, Diabetes Side Effects In Cholesterol-Lowering Drugs

Saturday, March 17th, 2012

The Food and Drug Administration just add

ed new language telling consumers about potential memory problems and an increased risk of high blood sugar for patients on statin cholesterol-lowering medicines. These medicines, including Lipitor, Zocor, and Crestor, are the most-prescribed class of drug in the country. According to drug data firm IMS Health, 255 million prescriptions for cholesterol-lowering drugs were written in 2010.

According to the FDA, the changes to the statin labels are:

* The drug labels have been revised to remove the need for routine periodic monitoring of liver enzymes in patients taking statins. FDA now recommends that liver enzyme tests should be performed before starting statin therapy, and as clinically indicated thereafter. FDA has concluded that serious liver injury with statins is rare and unpredictable in individual patients, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing this rare side effect. Patients should notify their health care professional immediately if they have the following symptoms of liver problems: unusual fatigue or weakness; loss of appetite; upper belly pain; dark-colored urine; yellowing of the skin or the whites of the eyes.

* Certain cognitive (brain-related) effects have been reported with statin use. Statin labels will now include information about some patients experiencing memory loss and confusion. These reports generally have not been serious and the patients’ symptoms were reversed by stopping the statin. However, patients should still alert their health care professional if these symptoms occur.

* Increases in blood sugar levels (hyperglycemia) have been reported with statin use. The FDA is also aware of studies showing that patients being treated with statins may have a small increased risk of increased blood sugar levels and of being diagnosed with type 2 diabetes mellitus. The labels will now warn healthcare professionals and patients of this potential risk.

* Health care professionals should take note of the new recommendations in the lovastatin label. Some medicines may interact with lovastatin, increasing the risk for muscle injury (myopathy/rhabdomyolysis). For example, certain medicines should never be taken (are contraindicated) with Mevacor (lovastatin) including drugs used to treat HIV (protease inhibitors) and drugs used to treat certain bacterial and fungal infections.

If you or anyone you know has been hurt by Lipitor, Zocor or Crestor; call us at 877 882 0095

For original article see: http://www.forbes.com/sites/matthewherper/2012/02/28/fda-cautions-on-memory-diabetes-in-statin-drugs/

DMAA will be banned in NZ?

Wednesday, March 14th, 2012

A common ingredient in weight-loss and sports-performance supplements is to be banned in New Zealand after at least one user suffered a stroke.

Associate Health Minister Peter Dunne this week used legislation brought in to combat synthetic c

annabis products to ban the substance, commonly known as DMAA.

It acts as a stimulant and is also used in a variety of party pills.

DMAA-containing sports-nutrition products such as Jack3d – a “pre-workout booster” – sell well because they increase energy, concentration and metabolism.

Also known as geranium extract, DMAA is already banned by many sports federations and its use has shown up in tests on athletes including Springboks Bjorn Basson and Chiliboy Ralepele.

Its use in New Zealand has led to health concerns including increased blood pressure, headaches and vomiting.

If you or anyone you know has been hurt by DMAA, call us at: 877 882 0095

For more information see:

http://www.odt.co.nz/lifestyle/health/200837/dmaa-will-be-banned

Feds Slap New Warnings on Cholesterol-Lowering Statins, Including Diabetes Risk

Friday, March 9th, 2012

U.S. health officials will be adding new safety warnings of memory loss, confusion, high blood sugar, and type II diabetes as possible side effects to popular cholesterol-lowering drugs called statins, the U.S. Food and Drug Administratio

n anno

unced on Tuesday.

The FDA on Tuesday also removed the requirement that health care providers must monitor patients’ livers because serious liver injury is “rare” with statins, the agency said in a statement.

The new safety labels of statins like Pfizer’s Lipitor, AstraZeneca’s Crestor and Merck & Co. Inc.’s Zocor, must now contain information that warns patients of the risk of cognitive impairment, mental confusion, risk of high blood sugar and risk of being diagnosed with type II diabetes.

The health agency also singled out lovastatin, sold under the brand name Mevacor, with an additional warning for risk of muscle damage. All statin medications have a small risk for muscle injury, but the FDA said that this risk is especially high for patients taking lovastatin along with certain other drugs for HIV and some antibiotics.

“We want health care professionals and patients to have the most current information on the risks of statins, but also to assure them that these medications continue to provide an important health benefit of lowering cholesterol,” Mary Parks, MD, director of the FDA’s Division of Metabolism and Endocrinology Products, said in a news release.

The products subject to FDA’s new labeling requirements include: Lipitor (atorvastatin), Lescol (fluvastatin), Mevacor (lovastatin), Altoprev (lovastatin extended-release), Livalo (pitavastatin), Pravachol (pravastatin), Crestor (rosuvastatin), and Zocor (simvastatin). Combination products include: Advicor (lovastatin/niacin extended-release), Simcor (simvastatin/niacin extended-release), and Vytorin (simvastatin/ezetimibe).

However, the FDA stresses that the new information should not “scare people off” statins.

Statins have been shown to significantly reduce the risk of heart attack and heart disease, said the deputy director for safety in FDA’s Division of Metabolism and Endocrinology Products, Amy Egan, and that “their benefit is indisputable” but patients need to know about the drugs side effects and that statins “need to be taken with care”.

If you or anyone you know has been hurt by Statin, call us at: 877 882 0095

Article from: http://www.medicaldaily.com/news/20120228/9195/fda-statins-drugs-lipitor-cholesterol-warning.htm

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