Friday, May 31, 2013

FDA Issues Class I Recall of Zilver® PTX® Drug-Eluting Stent

The Zilver PTX Drug-Eluting Peripheral Stent was manufactured from Dec. 1, 2012 through April 16, 2013 and distributed from Dec. 13, 2012 through April 16, 2013.
Use: The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The Paclitaxel coating helps prevents the artery from narrowing again. The Zilver PTX Drug-Eluting Peripheral Stent acts as a scaffold to hold open a narrowed artery caused by Peripheral Artery Disease in the legs and to improve blood flow.
Recalling Firm:
Cook Medical, Inc.
750 N Daniels Way
Bloomington, Indiana  47404-9102
Reason for Recall: Cook Medical received a small number of complaints that the delivery system of the device had separated at the tip of the inner catheter. Potential adverse events that may occur in cases where the inner deliver catheter breakage occurs include possible surgery to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death.

FDA Recalls GemStar Infusion Machine After Battery Problems

The FDA has issued a Class 1 Recall for a wide range of GemStar Infusion intravenous machine models, as reported by

The recalled models, according to the American Society of Anesthesiologists, suffered issues wherein a drop in the battery voltage rendered the device unusable; the malfunction can also erase the history logs of the device’s on-board computer. The devices, which were manufactured between 1999 and 2013, are critical to patient care; an interruption in the service the machines provide can result in serious injury and death.

More info at

Januvia News

English: Logo of the .
English: Logo of the . (Photo credit: Wikipedia)
An interesting read in the NYT on this diabetes drug:

Based on the  latest study, both the Food and Drug Administration and the European Medicines Agency have begun investigations that could lead to new warnings on the drugs, or even to their removal from the market.  Or they could result in no action at all.
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Thursday, May 30, 2013

Relapse of Fungal Meningitis Seen Months Later

Reports today about ongoing medical issues with recalled steroid injections and fungal meningitis:
From medpage:
An 80-year-old Virginia man, discharged after more than 4 months of therapy, relapsed and needed additional treatment less than a month after discharge, according to Rachel Smith, MD, of the CDC, and colleagues at the agency and in Virginia.
The case illustrates the possibility of relapse despite lengthy therapy and resolution of signs and symptoms, Smith and colleagues reported online in the New England Journal of Medicine.
On the other hand, they noted, the CDC knows of similar patients who have not relapsed after stopping antifungal therapy but "the risk of relapse should be considered" when doctors decide to discontinue treatment.
The outbreak started in late September, 2012, when Tennessee doctors began treating a man for an unusual form of meningitis that did not seem to have a bacterial or viral cause.
Eventually, they found evidence of a fungal infection -- with the mold Aspergillus fumigatus -- and notified the state's public health authorities.

5/30/13 Florida Illnesses from Main Street Family Pharmacy -13 new illnesses linked to TN drug compounder

In a statement released Wednesday, Florida officials said adverse reactions were limited to skin abscesses and did not involve any life-threatening conditions. The disclosure boosts the total number of cases in the growing cluster to 20, including five in Illinois and two in North Carolina.
According to Florida health officials, the victims were all given intramuscular injections of methylprednisolone acetate shipped from the Main Street Family Pharmacy in Newbern, Tenn. Four Florida facilities received the suspect drugs.

Wednesday, May 29, 2013

5/29/13: FDA Report on Steroid Injections in TN

Health officials are investigating cases involving patients who suffered complications after being injected with potentially contaminated medications made by a Tennessee specialty pharmacy.

The Food and Drug Administration said Friday the problems involve seven patients who received steroid injections from Main Street Family Pharmacy, a compounding pharmacy in Newbern, Tenn.

Tennessee health officials said the pharmacy has agreed to recall all of its sterile products, which are generally injectable prescription drugs. Officials from the FDA and the Tennessee Department of 

Health have been inspecting the Newbern pharmacy since Wednesday.
Officials have not confirmed that the products are contaminated, but they are being treated as though they are, Tennessee Health Commissioner John Dreyzehner said in a Friday conference call.

Saturday, May 25, 2013

Steroid recall affects Southern Illinois

Thousands of patients in Southern Illinois are being notified of problems from a steroid injection after a federal announcement Friday the drug might be contaminated.
Some 2,000 Logan Primary Care patients who received injections of preservative-free methylprednisolone acetate (MPA) in Herrin and West Frankfort between Dec. 6 and April 24 are being notified, clinic officials said at a Friday afternoon news conference.
Logan Primary Care is part of Southern Illinois Medical Services, a wholly owned subsidiary of Southern Illinois Healthcare.
All patients received injections of MPA from a shipment that originated from Main Street Family Pharmacy LLC in Newbern, Tenn.

Call us if you may have been exposed to this steroid. Our law firm serves as leaders in similar lawsuits against NECP - the Framingham, Mass company. 

Main Street Pharmacy Steroid Recall update 5/26/13

Federal authorities have identified five cases in Illinois and two more in North Carolina. The Illinois patients received injections at the Logan Primary Care clinic in the town of Herrin between Jan. 3 and Feb. 21, according to Illinois health officials.
All five patients from Illinois had skin infections in the hips and buttocks while at least one patient in North Carolina appears to have a fungal infection, according to the Centers for Disease Control and Prevention.

May 25, 2013: Another steroid injection recall, made by Main Street Family Pharmacy, TN

Several government agencies are investigating the production of an injectable steroid that was shipped to clinics in parts of North Carolina, including a medical center in Brunswick County. This comes after the FDA learned of two people who developed complications after taking the product.
The injectable steroid product, called methylprednisolone acetate, was prepared by the Main Street Family Pharmacy of Newbern, Tennessee.  It was shipped to three clinics in North Carolina -- Carolina Arthritis Center in Pitt County, Bailey Family Practice Center in Nash County, and Shallotte Medical Center in Brunswick County.
Main Street has issued a voluntary recall for all sterile products.
According to a news release, state and local public health officials are working with those clinics to notify patients who may have taken the product and alert them to any complications. The NC Board of Pharmacy asked that the steroid be quarantined and each pharmacy has agreed to voluntarily surrender their state pharmacy licenses.
The complications that have been identified at this point are for skin abscesses. There have been no reports of meningitis, stroke or death, according to the notification.
The complications were noted by people who administered the product at a clinic in Greenville, NC, according to a news release.

Tuesday, May 14, 2013

Lightning Rod capsules recalled

Chang Kwung is recalling a dietary supplements sold under the brand name Lightning Rod 500 mg per capsule packaged in 3-count, UPC 6 89076 20257 2 and 12-count bottles, UPC 6 89076 20297 8.
The company was notified that the product contains an analogue of Sildenafil, the active ingredient in an FDA-approved drug used for the treatment of male erectile dysfunction (ED), making it an unapproved new drug. The active drug ingredient is not listed on the label for this product.
Use of this product may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
The firm says it has not received any reports of adverse events related to this recall or is aware of any illnesses associated with this product.
Lightning Rod capsules are sold nationwide via internet in 3 capsule count and 12 capsule count bottles between August 2012, and May 3, 2013.

Nexium MDL Established

As a result of the ongoing lawsuits over Nexium bone fracture side effects and the fact that the number of the lawsuits keeps increasing, 39 of the filed cases were consolidated by the U.S. Judicial Panel as of December 2012. 

The lawsuits in the Nexium MDL claim that Nexium, created by manufacturer, AstraZeneca LP, causes side effects such as bone loss, which subsequently has resulted in fractures and similar symptoms. To counter the multidistrict litigation, AstraZeneca argued that there are still lingering questions -- namely product identification and distinct causation questions -- that justify their argument to keep the lawsuits separate.

California's Central District will be the court. 

Court data updated on March 5th, 2013, by the US Judicial Panel on Multi-District Litigation (MDL), indicate that there are 42 actions currently pending in the Nexium MDL (U.S. District Court, Central District of California, MDL 2404). Nexium, manufactured by AstraZeneca, is a proton pump inhibitor (PPI) prescribed for the treatment of heartburn, acid-reflux, and inflammation of the esophagus. Plaintiffs allege that Nexium may cause a variety of bone ailments —in particular, osteoporosis, loss of bone density, and bone fractures— and that AstraZeneca failed to adequately warn of these potential adverse side effects.

XYMOGEN issues recall of Artriphen

From the FDA:

Nutraceutical company XYMOGEN in Orlando, Fla., is recalling artriphen, a product recommended for the support of healthy joint function, because it contains traces of the undeclared allergens soy and milk.

People who have an allergy or severe sensitivity to either allergen run the risk of serious or life-threatening allergic reaction if they consume this product. Although there have been no reported allergic reactions or any adverse events in connection with the product to date, consumers are urged to return this product for a full refund.

XYMOGEN learned that artriphen might contain the two allergens and immediately discontinued sale of the product. XYMOGEN then had a third-party laboratory test the product to confirm the presence of the allergens.

“In the past, our contract manufacturing partners applied labels to our products, thus the weight of responsibility on what allergens were or were not declared rested with them as the party handling the raw materials,” said Brian Blackburn, XYMOGEN’S president and CEO. “Making the big leap of taking on your own manufacturing dramatically shifts the weight. As a result, we have been, since day one, stringently verifying the presence or absence of allergens in raw materials we purchase, along with bulk items or finished products received from third-party manufacturers, as part of our due diligence to ensure product safety and compliance with U.S. Food and Drug Administration regulations.”

XYMOGEN discovered the allergens were not included in the product’s labeling while preparing to buy artriphen in bulk and then label and package it for the first time at its new 136,000-square-foot manufacturing facility and headquarters in Orlando.
“We were afraid the manufacturer had been fraudulently labeling the product after we received from them our mandatory allergen checklist, indicating both allergens as present in the formula,” Blackburn said. “After questioning them on this discovery, we were able to confirm this was the case and that we had been dealing with a company that was clearly incompetent of segregating allergenic raw materials and communicating their presence in customer’s formulas. If it were not for
XYMOGEN’s experienced and diligent team members that handle these processes, and our overall team’s commitment to the utmost quality, this serious error may have remained undiscovered.”

The U.S. Food and Drug Administration’s (FDA) regulations on dietary manufacturing, packaging and distribution require manufactures to disclose any of eight identified allergens in the labeling and marketing of products.

In addition to discontinuing the sale of artriphen, XYMOGEN is phasing out two other products, coolsens™ and dolorox™, provided by the same company, neither of which has any known safety concerns.
artriphen was available in quantities of either 90 or 180 capsules.

FDA Recalls Ready-to-Eat Classic Kettle Korn

A release by the FDA says certain popcorn is being recalled due to an undeclared allergen in the product.  The release reads as follows:

ConAgra Foods, Inc., (NYSE: CAG) in cooperation with the U.S. Food and Drug Administration (FDA) is voluntarily recalling packages of its Orville Redenbacher’s Classic Kettle Korn flavor ready-to-eat popcorn that may contain an undeclared allergen, milk. Certain bags of the Kettle Korn flavored ready-to-eat popcorn may have inadvertently been filled with white cheddar flavored popcorn, which contains an allergen, milk. The milk allergen is not declared on the Kettle Korn product label.

People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no illnesses reported to date in connection with this product. This product was shipped to food stores and distributors nationwide.

Sex supplements often contain Viagra ingredients

Herbal supplements aimed at improving men's sexual abilities often contain the active ingredients in erectile dysfunction pills such as Viagra, according to a new study.
Additionally, researchers found that some of these over-the-counter herbal remedies contained more of the ingredient than is allowed in prescription-only pharmaceuticals.

 Although 57 of the products claimed to be "all natural," 81 percent of them contained the tadalafil or sildenafil (marketed as Cialis and Viagra, respectively) or similar ingredients that are not approved by the FDA.

Pfizer Has Second Recall of Thyroid-Disorder Drug Levoxyl

Pfizer Inc. (PFE) issued its second recall of thyroid-disease treatment Levoxyl in recent weeks, this time because some tablets didn't meet potency standards.
Pfizer said Friday that Levoxyl is no longer available, and may not return to the market until mid-2014. Levoxyl is approved to treat hypothyroidism, a condition in which the thyroid gland doesn't produce enough hormones, and to prevent certain types of goite

Read more:

Friday, May 10, 2013

FDA Proposes New Tanning-Bed Warnings

“Using indoor tanning beds can damage your skin and increase your risk of developing skin cancer,” said FDA commissioner Dr. Margaret A. Hamburg in the FDA’s statement. “The FDA’s proposed changes will help address some of the risks associated with sunlamp products and provide consumers with clear and consistent information.”

Read more:

FDA warns pregnant women to not use certain migraine prevention medicines

The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Valproate products have several FDA-approved uses including: prevention of migraine headaches; treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder).
Medicines that contain valproate already have a boxed warning for fetal risk, including birth defects. The recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study found further evidence of the IQ risk, leading to today’s strengthened warnings.
“Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use,” said Russell Katz, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research.
For its other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but it should only be taken if other medications have not controlled the symptoms or are otherwise unacceptable. Women who can become pregnant should not use valproate unless it is essential to managing their medical condition. 
Women who are pregnant, or who become pregnant while taking one of these medications, should talk to their health care professional immediately. Women should not stop taking their medication without talking to their health care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the developing fetus. Women of childbearing age taking valproate products should use effective birth control.
It is not known if there is a certain time period during pregnancy when valproate exposure can result in decreased IQ. The women in the NEAD study were exposed to antiepileptic drugs throughout their pregnancies.
The FDA’s strengthened recommendations are based on the final results of the NEAD study, which showed that children exposed to valproate products in utero had decreased IQ at age 6 when compared to children who were exposed to other antiepileptic drugs. The difference in average IQ between the children who had been exposed to valproate and the children who had been exposed to other antiepileptic drugs varied between 8 and 11 points depending on the antiepileptic drug.
In a June 2011 alert, the FDA released interim results from the NEAD study that showed reduced cognitive test scores in these valproate-exposed children at age 3, and at that time the drug labels were updated.

Monday, May 06, 2013

FDA issues warning over stimulant found in dietary supplements

DMAA news hits Birmingham, AL

The FDA is issuing a warning over an ingredient commonly found in dietary supplements.
The stimulant is known as DMAA and is promoted as a natural way to enhance athletic performance and speed up weight loss.
According to the FDA, DMAA can cause increased blood pressure, shortness of breath, chest tightening, cardiovascular problems and even heart attacks.
The FDA has received a total of 86 illnesses and deaths associated with products containing DMAA.

FDA announces nationwide recall by Balanced Solutions Compounding Pharmacy

Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is recalling all lots of its sterile non-expireddrug products due to a lack of sterility assurance and concerns with product quality controls.
Health care facilities and health care providers that have received sterile products from Balanced Solutions should immediately check their medical supplies, quarantine the products, and follow the recall instructions from Balanced Solutions. Patients who were administered any sterile drug products produced and distributed by Balanced Solutions and who have concerns should contact their health care providers.
During an FDA inspection of Balanced Solutions, investigators observed poor practices and conditions, which may have exposed the company’s sterile products to microbial contamination. The FDA’s preliminary findings of sterile production practices and conditions at the site raise concerns about a lack of sterility assurance. This lack of sterility assurance has been confirmed by further FDA analysis. The FDA sampled chromium chloride injection from Balanced Solutions and identified gram-negative bacteria, a type of contaminant, in the product. Gram-negative bacteria can cause disease and many types of infection, but the Sphingobacterium thalpophilum bacteria found in the solution does not usually cause infection in humans.

Friday, May 03, 2013

FDA: Samsca May Cause Liver Damage

English: Logo of the U.S. Food and Drug Admini...
English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

After reviewing data from recent large clinical trials, the U.S. Food and Drug Administration has determined that Samsca (tolvaptan) should not be used for longer than 30 days and should not be used at all by patients with underlying liver disease.

Samsca, a selective vasopression V2-receptor antagonist indicated for the treatment of patients with hypervolemic and euvolemic hyponatremia, was shown to increase the risk of liver injury in trials evaluating the drug in patients with autosomal dominant polycystic kidney disease.

Samsca's recognized limitations will be reflected in its drug label, created in tandem by the FDA and Otsuka, the drug's manufacturer.

According to the FDA, "Samsca treatment should be stopped if the patient develops signs of liver disease. Treatment duration should be limited to 30 days or less, and use should be avoided in patients with underlying liver disease, including cirrhosis. Patients should be aware that Samsca may cause liver problems, including life-threatening liver failure, and should contact their health care professional to discuss any questions or concerns about Samsca."

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Cancer drug Avastin tied to cases of flesh-eating disease in Canada

The cancer-treatment drug Avastin has been linked to 52 cases of flesh-eating disease worldwide, including one that resulted in death in Canada.
Health Canada issued a warning in conjunction with the drug's manufacturer, Hoffmann-La Roche Ltd., echoing an earlier one from the U.S. Food and Drug Administration. It offered no specific details on two Canadian cases.
People who have diabetes or cancer have a greater risk of developing necrotizing fasciitis because their immune system responses are lowered.
The FDA issued a similar warning in mid-March, indicating that cases have mainly been seen in people who had wound-healing complications, gastrointestinal perforations or fistulas.
Health Canada and Roche.

Emergency visits related to sleep drug zolpidem - More and more of them reported

Zolpidem (Photo credit: Wikipedia)

The number of emergency room visits involving adverse reactions to the sleep drug zolpidem -- the active ingredient in Ambien and other sleep medications -- jumped nearly 220% from 2005 to 2010, according to a report out today.
The report, by the Substance Abuse and Mental Health Services Administration (SAMHSA), says 19,487 emergency visits were related to zolpidem in 2010, up from 6,111 in 2005.

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