OTC Thyroid ‘Boosters’ May Harm

From the Dietary Supplement Reporter this post:

Over-the-counter thyroid supplements are not supposed to contain any thyroid hormone,” Lee told MedPage Today. “But there’s no truth-in-labeling in these supplements.”

“People who are unsuspecting, or who are already on thyroid medications … can become significantly and severely hyperthyroid,” Lee said.

Lee said thyroid supplements have gained popularity because the symptoms of hypothyroidism — especially fatigue and weight gain — are so common in normal aging. Women looking for a quick fix to those problems may be attracted to supplements that promise to boost thyroid function.

More here: http://www.medpagetoday.com/Endocrinology/Thyroid/43501

http://dietarysupplementreporter.wordpress.com/2013/12/28/otc-thyroid-boosters-may-harm/

FDA warns consumers not to use muscle growth product Bluntforce-Mass Destruction

The U.S. Food and Drug Administration is advising consumers to immediately stop using a product called Mass Destruction, marketed as a dietary supplement for muscle growth. The product is labeled to contain at least one synthetic anabolic steroid and has been linked to at least one reported serious illness.

View a larger version of this image on Flickr.

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View a larger version of this image on Flickr.

The FDA was alerted by the North Carolina Department of Health and Human Services of a serious injury associated with use of Mass Destruction. The report described a previously healthy 28-year-old male with liver failure requiring transplant after several weeks of product use. Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances. The product’s ingredients are undergoing further analysis by the FDA.

Mass Destruction is manufactured for Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on the Internet. An investigation is underway to identify the product’s manufacturer. Consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional, especially if they have experienced unexplained fatigue, abdominal or back pain, discolored urine, or any other unexplained changes in their health.

“Products marketed as supplements that contain anabolic steroids pose a real danger to consumers,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as dietary supplements and vitamins do not pose harm to consumers.”  

In general, anabolic steroids may cause other serious long-term consequences in women, men and children. These include adverse effects on blood lipid levels; increased risk of heart attack and stroke; masculinization of women; shrinkage of the testicles; breast enlargement; infertility in males; and short stature in children.  

Health care professionals and consumers are encouraged to report adverse events that may be related to this or similar products to FDA’s MedWatch Adverse Event Reporting program by:

• completing and submitting the report online atwww.fda.gov/medwatch/report.htm; or
• downloading and completing the form, then submitting it via fax at 800-FDA-0178.

FDA: Recall of all non-expired sterile drugs from Abrams Royal Compounding Pharmacy

The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, Texas. The recalled products include injectable medications, intravenous (IV) injections, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments that were distributed between June 17, 2013 and Dec. 17, 2013.  

Contaminated sterile drugs put patients at risk of serious infection. Health care professionals who have received the affected products should stop using them and follow Abrams’ recall instructions.

The FDA is aware of one adverse event associated with mineral IV injection produced by Abrams’ lot number 11142013@74. A patient who received this product was admitted to a hospital in California and had blood cultures that tested positive forStenotrophomonas maltophilia, a gram-negative bacterium that can cause many types of infections. These include respiratory infections such as pneumonia, bloodstream infections and meningitis. In addition, Abrams identified a similar gram-negative bacterium in the same lot of mineral IV injection. 

“Patient safety is our top priority, and giving a patient a contaminated drug could result in a serious infection,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Using these products puts patients at an unacceptable risk, and we urge health care professionals to follow recall instructions issued by the firm.”

Patients who were administered any sterile drug products produced and distributed by Abrams and have concerns should contact their health care professional.

Adverse reactions experienced with the use of any Abrams products should be reported to FDA’s MedWatch Adverse Event Reporting program by:
• completing and submitting the report online at www.fda.gov/medwatch/report.htm; or 
• downloading and completing the form, then submitting it via fax to 800-FDA-0178.

Preliminary Settlement Agreements Exceeding $100M in NECC Deadly Meningitis Outbreak Litigation Announced By Plaintiffs' Steering Committee

I'm one of the seven lawyers appointed by Judge Saylor in the tainted epidural steroid litigation, currently before the Court in Boston, Massachusetts.

There is news today that gives the victims of this tragedy some small measure of good news:

The Court-appointed Plaintiffs' Steering Committee (PSC), charged with speaking for hundreds of victims of tainted steroids produced by the New England Compounding Pharmacy, Inc. (NECC), today announced a preliminary settlement with the owners, operators and insurers of the bankrupt NECC.

A conditional agreement has been reached between bankruptcy trustee Paul D. Moore, the PSC and the Unsecured Creditors Committee under which the Cadden and Conigliaro families, the insurers of NECC and related company Ameridose, have promised to pay to a compensation fund an amount that may exceed $100 million. This fund will allow victims who received injections of tainted steroids made by NECC to seek a measure of justice against those wrongdoers.

The agreements are not final, require due diligence on the part of the PSC to ensure the rights to victims are protected under these agreements, and will be conditional upon approval by creditors and a federal court for fairness and adequacy.

Thomas M. Sobol, lead counsel for the PSC in the national litigation pending before a federal court in Boston, said, "The PSC has worked hard over the last several months to evaluate the liability of everyone involved in this tragedy and the tentative agreements are a big step forward in getting justice for victims. However, we must all be mindful that the agreements still require much work in order to protect the rights of victims. We also recognize that any amount of money would be grossly inadequate to compensate the families of those persons killed and others grievously injured by the callous conduct of those in charge of NECC."

Sobol said, "This is but one chapter in this saga; litigation will continue against medical clinics, doctors, hospitals and other companies who were hired by NECC that bear responsibility to those who were badly injured or who died horrible and painful deaths as a result of having the injection of the tainted product into their bodies. This case is not over until all the wrongdoers have been brought to justice."

"The proposed settlement does not resolve families' claims against the corporate-owned clinics that sold and injected these contaminated medications, such as St. Thomas Outpatient Neurosurgery Clinic in Nashville, Tenn., and other related St. Thomas companies. Numerous St. Thomas patients died or suffered serious illnesses as a result of receiving contaminated medications sold and administered at St. Thomas' Nashville facility," said PSC Member Gerard Stranch.

"These corporate-owned companies chose to put profits over patient safety, as detailed in the hundreds of lawsuits filed against these companies, including St. Thomas, by families whose loved ones died or suffered serious injuries," said PSC Member Mark Chalos, who also represents a number of affected families. "Any corporation that endangers our families by breaking patient safety rules should be held accountable for their conduct - no matter how rich or powerful those corporations are," said Chalos.

There is no deadline set for when details of the proposal will be made public.

The next court hearing in connection with this case is scheduled for January 10, 2014, at which point further due diligence will have been undertaken and additional details can likely be released. Full and complete information will be released to the public in due course and all victims who file a proof of claim in the Bankruptcy Court will have the opportunity to support or oppose the settlement.

Stay tuned

Red Bull Litigation

Quick reads this week: Lawyers on both sides of Red Bull Litigation:

http://www.foodproductdesign.com/news/2013/12/lawyers-divided-on-strength-of-red-bull-lawsuit.aspx

FDA Scientists Find Amphetamine-Like Ingredient In 9 Diet Supplements… So Where’s The Warning?

An interesting read here:  http://consumerist.com/2013/11/19/fda-scientists-find-amphetamine-like-ingredient-in-9-diet-supplements-so-wheres-the-warning/


Extracts of Acacia rigidula leaves are used in weight-loss products sold in vitamin shops and over the internet with little or no published data about their potential biological effects. In our chemical investigations on authenticated A. rigidula plant material, we established a rapid and sensitive LC–MS/MS method for the quantitative determination of several phenethylamine, tyramine and tryptamine derivatives. Stable isotopically labeled compounds were used as internal standards for quantitative analysis. We found total calculated contents of 6 biogenic amines in A. rigidula leaf of 18.6 and 32.9 μg/g. The content of selected amines in 21 dietary supplements labeled as containing A. rigidula was determined by a second LC–MS/MS method. Our study revealed significant differences in the amine profiles of authenticated plant materials and dietary supplements. β-Methylphenethylamine, a non-natural compound, was found in 9 of the 21 dietary supplement products. β-Methylphenethylamine was found at levels of 960–60,500 μg/g while phenethylamine was found at levels of 710–171,620 μg/g. β-Methylphenethylamine is a positional isomer of amphetamine and our results showed that it can be misidentified as amphetamine during LC–MS analysis. An independent GC–MS analysis was used to confirm the presence of β-methylphenethylamine and the absence of amphetamine in dietary supplements labeled as containing A. rigidula. This study demonstrates that confirmations by independent analytical methods are essential to verify findings of unusual or unexpected compounds in dietary supplements.

Ingredient spurs firm to recall two sports supplements

Physique Enhancing Science, also called PES, this week launched a recall of certain lots of Enhanced, a pre-workout supplement, and Alphamine, which is sold as a fat burner.

Both products contain aegeline, an ingredient flagged by the U.S. Food and Drug Administration during its investigation of an outbreak of dozens of liver injuries linked to a weight-loss supplement made by a different company: USPlabs' OxyElite Pro. 

Return of Alphamine and Enhanced products

     From PES: 

     If customers have unused or opened containers of these products, we request that you to return them to where it was purchased. A full refund will be provided for all returned product.

     These products contain “aegeline”, an unapproved New Dietary Ingredient according to the FDA. PES has received no serious adverse events from either of these products, but out of an abundance of caution we are requesting their return.

Alphamine Lot #’s (Distributed between 09/09/2013 – 11/12/2013)	Enhanced Lot #’s (Distributed between 2/4/13 – 11/5/13)
• N09474   EXP: 08/2015   • N08447-B   EXP: 08/2015   • N08448   EXP: 08/2015   • N08447-A   EXP: 08/2015   • N07398   EXP: 07/2015   • N07397   EXP: 07/2015	• N04238   EXP: 04/2015   • N01047   EXP: 03/2015   • N01046   EXP: 03/2015   • M11589   EXP: 02/2015   • M11588   EXP: 02/2015

- See more at: http://pescience.com/recall#sthash.GquJVjL6.dpuf

FDA Issues Warning on Recalled Medtronic Device

Regulators have determined that defects in some medical devices made by Medtronic Inc.have the potential to cause serious harm or death, according to statements issued by the company and the U.S. Food and Drug Administration Friday night.

The FDA's determination relates to a recall initiated by Medtronic last month of nearly 15,000 guidewires manufactured since April that are used in heart procedures. The FDA has now designated the action as a Class I recall, the most serious classification given to product recalls.

http://online.wsj.com/news/articles/SB10001424052702303789604579202070968854270

FDA: Idaho knew about mold in yogurt at Chobani factory before recall

From http://www.nydailynews.com/life-style/eats/idaho-knew-chobani-yogurt-mold-recall-fda-article-1.1539860

A report by the FDA says the Idaho State Department of Agriculture detected abnormalities in yogurt at a Chobani facility two months before the company issued a recall, but state officials say that’s not true.

This stems from an issue earlier this year:

The company has ceased the distribution of the product due to reports of product bloating and swelling and some claims of illness as the company continues its investigation to identify the root cause.

The potentially affected product was distributed nationwide from its Twin Falls, Idaho facility and was delivered to consumers through retail and club stores.

The products subject to recall are identified as follows:

Best By Date Codes	IMS Number	Chobani Branded Products	UPC Codes
Sep 11 –13 (four digit time stamp) to Oct 07-13 (four digit time stamp)	16-012 (three digit line number)	Chobani 6 oz. cups – all flavors Chobani 16 oz. tubs – all flavors Chobani 32 oz. tubs – all flavors Chobani 3.5 oz. cups – all flavors Chobani Bite™ 3.5 oz. cups – all flavors Chobani Flip™ 5.3 oz. containers – all flavors Chobani Champions® cups 3.5 oz. – all flavors Chobani Champions® tubes 2.25 oz., 8, 16 and 36 count – all flavors	See attached list.

Consumers who have purchased the product should discard the product and may contact the company's Customer Loyalty Team at chobani.com/care or call us at 877-847-6181 between the hours of 9am and 5pm ET. Our team is diligently working to coordinate replacements or refunds and will be in touch as soon as possible during this time of very high contact volumes.

The quality of Chobani products and the trust of its consumers are the company's primary concern, and it sincerely apologizes to its consumers impacted by this issue. Chobani holds itself to the highest standards and is committed to fully transparent and decisive action to rectify any identified issues.

Proposed FDA Regulation Reopens Courthouse Doors to Consumers After the Mensing Decision

This post from my friend Rick Schulte, from the TrialLawyerCenter.com:

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.

FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011).  

The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.

In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.

FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.

The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.

Stay tuned for news on the official ruling in weeks to come.

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf

This week the FDA made game changing moves dealing with American health and drug manufacturer liability. Their hope, is that fair game will be established between brand name and generic manufacturers—and that means equal liability.
FDA’s movement for parity stems from the contentious ruling of Pliva v Mensing, 131 2 Ch 2357 (2011). The Mensing ruling was a big win for generic drug makers, who make up about 80% of the pharmaceutical market. It states that generic drug manufacturers cannot be sued for failing to warn consumers of dangerous side effects, as long as their labels mirror brand labels. Two years later, the ruling has evolved to be called the “Mensing preemption” because, as a federal law, it overrides state personal injury laws.
In turn, brand name labels are held more severely for liability, while generic labels are essentially granted immunity. A growing post-Mensing trend is that courts will dismiss cases with allegations of design defect, fraud, negligence, and breach or implied or expressed warranty, as essentially failure to warn claims. Ironically, while generic drug makers are actually liable for negligent manufacturing processes and monitoring their mirrored-labels in a timely manner, the over-arching “failure to warn” statute has stonewalled such cases from being heard or ruled fairly. See the cases here.
FDA’s new proposal is to allow generic drug companies to initiate CBE changes (“Changes Being Effected”). This would essentially overrule Mensing, by permitting generic drug companies add or strengthen a warning label without prior FDA approval. The proposal also sates that once approved, drug companies must conform their labels within 30 days (it used to be an ambiguous “as soon as possible”). And finally, both brand and generic labels may use the CBE process to add new warnings to the “Highlights” section of new drug labels (which was previously restricted). With such changes, generic and brand name companies will have no excuse for inappropriate labeling or have immunity from harm caused to American consumers.
The proposed action is a positive step toward protecting the checks and balances of the civil justice system and the pharmaceutical market. Above all, it is a prospective change on behalf of the rights and wellbeing of American consumers.
Stay tuned for news on the official ruling in weeks to come.
- See more at: http://triallawyercenter.com/2013/11/15/proposed-fda-regulation-will-give-consumers-rights-back-after-the-mensing-decision/#sthash.6INlQYqW.dpuf

USPlabs LLC recalls OxyElite Pro dietary supplements; products linked to liver illnesses

From the FDA this weekend:

The U.S. Food and Drug Administration announced today that USPlabs LLC, of Dallas, Texas, is recalling certain OxyElite Pro dietary supplement products that the company markets. The company took this action after receiving a letter from the FDA stating that the products have been linked to liver illnesses and that there is a reasonable probability that the products are adulterated. 

The letter also notified USPlabs that if the company did not initiate a voluntary recall, the FDA could by law order the company to immediately stop distributing the dietary supplements and immediately notify other parties to stop distributing the dietary supplements. The action marks the second time the FDA has exercised its recall authority under the FDA Food Safety Modernization Act (FSMA) by sending such a letter.

“We took this step to ensure that adulterated and harmful products do not reach the American public,” said Deputy Commissioner for Foods and Veterinary Medicine Michael R. Taylor. “We will continue to work with our state, industry and regulatory partners to prevent such products from reaching the public.”

The products involved in the recall include:

• OxyElite Pro Super Thermo capsules
  --two count capsules UPC #094922417275
  --10 count capsules UPC #094922417251
  --10 count capsules UPC #094922417268
  --21 count capsules UPC #094922426604
  --90 count capsules UPC #094922395573
  --90 count capsules “Pink label” UPC #094922447906
  --180 count capsules UPC #094922447852
   
• OxyElite Pro Ultra-Intense Thermo capsules
  --three count capsules UPC #094922447883
  --three count capsules UPC #094922447876
  --90 count capsules UPC #094922395627
  --180 count capsules UPC #094922447869
   
• OxyElite Pro Super Thermo Powder
  --Fruit Punch 0.15 oz UPC #094922417237
  --Fruit Punch 0.15 oz UPC #094922447517
  --Fruit Punch 4.6 oz UPC #094922426369
  --Fruit Punch 5 oz. UPC #094922447487
  --Blue Raspberry 4.6 oz UPC #094922426376
  --Grape Bubblegum 4.6 oz UPC #094922447500
  --Green Apple 4.6 oz. UPC #094922426499

By letter dated Nov. 6, 2013, the FDA notified USPlabs about findings indicating a link between the use of the above listed OxyElite Pro products and a number of liver illnesses reported in Hawaii. The FDA also noted that cases of liver damage after use of these OxyElite Pro products had been found in a number of other states.

In a review of 46 medical records submitted to the FDA by the Hawaii Department of Health, the records indicated that 27 patients, or 58 percent, had taken a dietary supplement labeled as OxyElite Pro prior to becoming ill. Seventeen of the 27 patients (or 63 percent) reported that OxyElite Pro was the only dietary supplement they were taking. One death has occurred among these patients, another patient has required a liver transplant, and others await liver transplants.

In a warning letter issued to USPlabs LLC on Oct. 11, 2013, the FDA informed the company that OxyElite Pro and another dietary supplement called VERSA-1 were deemed to be adulterated. The products contained aegeline, a new dietary ingredient (i.e., an ingredient not marketed in the United States before Oct. 15, 1994) that lacks a history of use or other evidence of safety. The letter stated that failure to immediately cease distribution of all dietary supplements containing aegeline may result in enforcement action.

In addition to the products being recalled, the FDA continues to advise consumers not to use any dietary supplements labeled OxyElite Pro or VERSA-1.

Consumers who believe they have been harmed by using a dietary supplement should contact their health care practitioner.

If consumers think they have suffered a serious harmful effect or illness from a dietary supplement, their health care provider can submit a report by calling the FDA’s MedWatch hotline at 1-800-FDA-1088 or by reporting it online. The MedWatch program allows health care providers to report problems possibly caused by FDA-regulated products such as drugs, medical devices, medical foods and dietary supplements. The identity of the patient is kept confidential.

Consumers can contact USPlabs at 1(800) 890-3067 (Monday-Friday, 9 a.m. - 5 p.m. EST) or info@usplabsdirect.com.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

OxyElite Pro and a CDC update

An interesting read from the CDC:

Notes from the Field: Acute Hepatitis and Liver Failure Following the Use of a Dietary Supplement Intended for Weight Loss or Muscle Building — May–October 2013

On September 9, 2013, the Hawaii Department of Health (HDOH) was notified of seven patients with severe acute hepatitis and fulminant liver failure of unknown etiology. Patients were previously healthy and sought medical care during May-September 2013. Clinicians reported that the seven patients had all used OxyELITE Pro, a dietary supplement marketed for weight loss and muscle gain, before illness onset.

The HDOH, with the CDC and the Food and Drug Administration (FDA), initiated a public health investigation including patient interviews, medical chart reviews, and collection of supplement samples for analysis. Subsequently, a case was defined as acute hepatitis of unknown etiology occurring on or after April 1, 2013 in a person who had consumed a weight loss or muscle-building dietary supplement within the previous 60 days and had a serum alanine aminotransferase level greater than or equal to four times the upper limit of normal (>160 IU/L) and a total bilirubin level greater than or equal to two times the upper limit of normal (>2.5 mg/dL) and a negative evaluation for infections including viral hepatitis. Excluded were other etiologies such as pre-existing autoimmune hepatitis, chronic alcohol use, and chronic liver diseases such as primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, and hemochromatosis.

Clinicians reported 45 possible cases to the Hawaii DOH in response to a public health alert. Of those, 29 have been identified as cases. The patients have a median age of 33 years (range: 16–66); 14 (48%) were male. The date of first reported laboratory test was used as a proxy for illness onset and ranged from May 10 through October 3, 2013 (Figure). The most commonly reported symptoms included loss of appetite, light-colored stools, dark urine, and jaundice. Median laboratory values reported at the peak of illness were: aspartate aminotransferase 1,128 IU/L (range: 104–2,184, upper limit of normal ~40); alanine transaminase 1,793 IU/L (range: 347–3,091, upper limit of normal ~40); alkaline phosphatase 150 IU/L (range: 68–251, upper limit of normal ~120); and total bilirubin 12.6 mg/dL (range: 2.8–39.6, upper limit of normal ~1.2). Ten patients had liver biopsy data available at the time of this report; seven had histology consistent with hepatitis from drug/toxic injury, with findings including hepatocellular necrosis and cholestasis. Eleven (38%) patients were hospitalized, with a median duration of 7 days (range: 1–45). One patient died, two patients received liver transplants, and two remain hospitalized; all other hospitalized patients have been discharged.

Of the 29 identified patients, 24 (83%) reported using OxyELITE Pro during the 60 days before illness onset. Twelve (41%) reported use of OxyELITE Pro and no other dietary supplement, and 12 (41%) reported use of both OxyELITE Pro and at least one additional dietary supplement. Three (10%) reported using other dietary supplements for weight loss or muscle building, but not OxyELITE Pro. Information about use of OxyELITE Pro is not yet known for two (7%) patients. For twelve patients with specified dates of use, the median duration from starting OxyELITE Pro to the onset of symptoms was 60 days (range: 7–130). There was no other dietary supplement or medication use reported in common by more than two patients.

National case finding efforts have included surveillance of poison center data using the National Poison Data System. A call for cases was also disseminated through the United Network for Organ Sharing listserv to transplant programs across the country. These activities have identified four persons in states outside of Hawaii with reported OxyELITE Pro or other weight loss or muscle-building dietary supplement use prior to the development of acute hepatitis of unknown cause. One of these is a resident of Hawaii who obtained their product in Hawaii but was diagnosed in a different state. CDC, in collaboration with state health departments, is collecting additional clinical and epidemiologic information from these persons to determine if this outbreak is nationwide.

Results from FDA product testing are pending. While the investigation is ongoing and these data are preliminary, clinical data, laboratory tests, and histopathology of liver biopsy specimens collected thus far suggest drug- or herb-induced hepatotoxicity. Drug- and herb-induced hepatotoxicity have been reported in association with exposure to a variety of drugs and herbs used as dietary supplements and can lead to severe acute hepatitis and liver failure (1,2). Drug- and herb-induced hepatotoxicity often resolves following discontinuation of the product (3). Attributing liver injury to a specific ingredient can be challenging because of multiple ingredients, product variability, and lack of testing to confirm exposure to a product. Clinicians evaluating patients with acute hepatitis should ask about consumption of dietary supplements as part of a comprehensive evaluation. Clinicians should report patients meeting the case definition to the local or state health department, as well as the FDA's MedWatch program. Clinicians can discuss patient management options with a medical or clinical toxicologist by calling their local poison center at 1-800-222-1222. Persons who use dietary supplements for weight loss or muscle gain should do so with caution and under a medical provider's close supervision.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6240a1.htm

FDA Warning that Pfizer’s Tygacil Increases Risk of Death

News from the FDA on this product:

ISSUE: FDA notified health professionals and their medical care organizations of a new Boxed Warning describing an increased risk  of death when intravenous Tygacil is used for FDA-approved uses as well as for non-approved uses. These changes to the Tygacil Prescribing Information are based on an additional analysis that was conducted for FDA-approved uses after FDA issuing a Drug Safety Communication about this safety concern in September 2010.

This analysis showed a higher risk of death among patients receiving Tygacil compared to other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively. The adjusted risk difference for death was 0.6% with corresponding 95% confidence interval (0.0%, 1.2%). In general, the deaths resulted from worsening infections, complications of infection, or other underlying medical conditions.

BACKGROUND: Tygacil is FDA-approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP).

RECOMMENDATION: Health care professionals should reserve Tygacil for use in situations when alternative treatments are not suitable. 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370170.htm

FDA Asks Ariad to Halt Sale of Leukemia Drug Iclusig

The FDA has asked Ariad Pharmaceuticals to suspend marketing and sales of Iclusig (ponatinib), a chemotherapy agent used to treat leukemia, pending further investigation of reports of a link between the drug and increased risk of "life-threatening blood clots and severe narrowing of blood vessels".

• Patients currently taking Iclusig who are not responding to the drug should immediately discontinue treatment.
• Patients who are currently taking Iclusig, who are responding to the drug, and whose healthcare professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA's safety investigation continues.
• Healthcare professionals should not start treating new patients with Iclusig unless no other treatment options are available and all other available therapies have failed.

http://www.medpagetoday.com/HematologyOncology/Leukemia/42637

University Compounding Pharmacy Initiates a Nationwide Recall

University Compounding Pharmacy is voluntarily recalling the following preparations (see below) for injection, to the consumer level.  In a recent inspection, FDA investigators observed that methods used by the Independent Third Party laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results. FDA has concerns that results obtained from the laboratory are not reliable.

If there is microbial contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening. 

The prescription preparations were distributed nationwide from May 9th, 2013 to September 7th, 2013. The preparations would have been sold, directly to customers by pick up and by mail from;

University Compounding Pharmacy 1875 3rd Avenue San Diego CA. 92101. 619) 683-2005

Product Name	Lot Number	Expiry
Testosterone Cypionate (Sesame Oil) 200mg/mL Inj.	511017	11/30/2013
Testosterone Cypionate/Testosterone Proprionate 180-20mg/mL Inj	513593	11/30/2013
PGE-1 NS 20mcg/mL Inj.	497940	9/6/2013
PGE-1 NS 100mcg/mL Inj.	497930	11/5/2013
Testosterone CYP (Sesame Oil) 200mg/mL Inj.	498616	9/25/2013

University Compounding Pharmacy 1765 4th Avenue San Diego CA. 92101. 619) 398-1800

Testosterone CYP (Sesame Oil) 200mg/mL Inj.	474323	9/13/2013
Testosterone CYP (Sesame Oil) 200mg/mL Inj.	475475	9/26/2013

Specialty Medicine Compounding Pharmacy: Recall of Compounded Sterile Products

Specialty Medicine Compounding Pharmacy is voluntarily recalling all lots of certain unexpired human and veterinary sterile products to the consumer level due to particulate matter found in vials of a compounded dextrose injection product dispensed to a local hospital. Further testing and analysis of the medication is being conducted.

Specialty Medicine Compounding Pharmacy has not received any reports of adverse events related to this recall. If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.

The recalled products were distributed to hospitals and consumers located only within Michigan from July 1, 2013, through October 19, 2013.  No products were distributed out of state.

All unexpired lots of the following compounded products are subject to the recall:

Human Products
Acetylcysteine, 5%	Acetylcysteine, 10%	Acetylcysteine, 20%
Aluminum Potassium Sulfate	Aminophylline PF, 25mg/ml	Bevacizumab, 0.06ml (repackaged)
Bevacizumab, 0.11ml (repackaged)	Bi-Mix, 15mg/0.5mg	Biotin IM, 1mg/ml
Calcium Chloride PF, 500mg/ml	Ceftazidime, 22.5mg/ml (ophthalmic)	Clorpactin, 0.1%
Combo Eye Gel	Cyanocobalamin, 1000mcg/ml	Cyclopentolate HCL, 2% (ophthalmic)
Dexamethasone NaPO4  ionto-pf, 4mg/ml	Dextrose Vial, 50%	DMSO/Glutath, 3.75%/1.75% (ophthalmic)
Edetate Disodium (0.05m), 1.7%	Epinephrine (PF/SF), 0.5ml in 3ml	Epinephrine PF SF (0.3ml), 1:1000
Epinephrine PF SF (1ml), 1:1000	Fentanyl PF, 50mcg/ml	Fluconazole/Gentamicin, 200mg/480mg/1L
Fluorouracil PF, 50mg/ml	Gatifloxacin, 0.2ml 0.5% (ophthalmic) (repackaged)	Glutathione PF, 60mg/ml inhalation
Glycerin-Chromated (w/v), 72%	Hyaluronidase, pf 100U/ml	Hyaluronidase, pf 150U/ml
Hydroxocobalamin, 10,000mcg/ml	Hydroxocobalamin/thiamine, 1mg/100mg/ml	Lidocaine/Sodium Chloride, 0.4%/18%
Magnesium Sulfate, 1gm/50ml	Magnesium Sulfate, 2gm/50ml	Methocarbamol, 100mg/ml (repackaged)
Methylcobalamin, 1000mcg/ml	Methylcobalamin, 10mg/ml	Methylcobalamin, 25mg/ml
Methylcobalamin, 5000mcg/ml	Methylcobalamin, PF 25mg/ml	Multitrace-4 Pediatric Injection
Naloxone HCL, 0.4mg/ml	Naltrexone MCV, 1mg/ml	Neomycin, 333mg/ml
Papav/Phentol/PG E1, 30mg/1mg/20mcg/ml	Papaverine HCL, (10ml) 30mg/ml	Papaverine HCL, (2ml) 30mg/ml
Papaverine HCL, 30mg/ml	Phenol, 6%	Phenylephrine/Tropicamide, 2.5%/1% (ophthalmic)
Polidocanol, 1%	Polidocanol, 3%	Potassium Phosphate, 4.4meq/3mmol/ml
Proparacaine HCL PF, 0.5% (ophthalmic)	Quad Mix, 0.05mg/25mg/2mg/25mcg/ml	Quad Mix, 0.1mg/30mg/2mg/20mcg/ml
Quad Mix, 0.1mg/30mg/2mg/50mcg/ml	Quad Mix, 0.1mg/9mg/1mg/10mcg/ml	Quad Mix, in NaCl (1.8/0.2/0.02)mg/18mcg/ml
Sodium Chloride, 0.9% (repackaged)	Sodium Chloride, PF 14.6%	Sodium Phosphate, PF 3mmol/ml
Sodium tetradecyl SO4, 3%	Sodium Thiosulfate PF, 10%	Super Quad Mix, 0.1mg/30mg/2mg/20mcg/ml
Testos Cypionate in Oil, 100mg/ml	Testos Cypionate in Oil, 200mg/ml	Testos Cypionate in Olive Oil, 200mg/ml
Tranexamic Acid, 2gm/100ml	Tranexamic Acid, 2gm/75ml	Triple Mix, 15mg/0.5mg/10mcg/ml
Triple Mix, 15mg/1mg/20mcg/ml	Triple Mix, 30mg/1mg/10mcg/ml	Triple Mix, 30mg/1mg/20mcg/ml
Triple Mix, 30mg/1mg/40mcg/ml	Tropicamide, 1%	Vancomycin HCL, 10mg/ml (ophthalmic)
Vigamox in BSS (0.15%), 0.75mg/0.5ml
Veterinary Products
Amikacin Sulfate, 250mg/ml	Buprenorphine HCL, 0.3mg/ml	Buprenorphine HCL, 0.6mg/ml
Ceftazidime in pluronic 250mg/ml gel	Cyclosporin A Oint, 0.2% (ophthalmic)	Cyclosporin MCT, 0.2% (ophthalmic)
Cyclosporin MCT, 1% (ophthalmic)	Desmopressin Acetate (0.01%), 0.1mg/ml	Desmopressin Acetate (0.0125%), 0.125mg/ml
Desmopressin Acetate (0.02%), 0.2mg/ml	Diclofenac Sodium Oint, 0.1% (ophthalmic)	Idoxuridine Ophthalmic, 0.1%
Phenobarbital Sodium, 65mg/ml	Prednisone, 10mg/ml	Tacrolimus, 0.02% (ophthalmic drops)
Tacrolimus, 0.03% (ophthalmic drops)	Tacrolimus Ointment, 0.03% (ophthalmic)	Ticarcillin in Pluronic, 250mg/ml gel
Xylazine 100mg/ml

Specialty Medicine Compounding Pharmacy has begun notifying its customers by mail and is arranging for the return of all recalled medication. Customers with questions regarding this recall may contact the pharmacy at 248-446-2643, Monday through Friday, between 8:00 a.m. and 5:00 p.m. EDT.

Customers that have product which is being recalled should stop using it and contact the pharmacy to arrange for return of unused product. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using these products. Adverse reactions may be reported to the FDA’s MedWatch program via:

FDA takes enforcement action against Oregon dietary supplement manufacturer

The U.S. Food and Drug Administration, in a complaint filed by the U.S. Department of Justice, is seeking a permanent injunction against the dietary supplement manufacturer James G. Cole, Inc., its president, James G. Cole, and its general manager, Julie D. Graves, following the company’s repeated distribution of unapproved drugs and adulterated dietary supplements in violation of the Federal Food, Drug, and Cosmetic Act.

 

If granted, the injunction would stop the company, based in Hood River, Ore., from promoting and distributing its products until it complies with current good manufacturing practice (cGMP) requirements for dietary supplements and all disease claims are removed from its websites, product labels, and all other products and websites under Cole’s custody and control.

 

“This company has ignored the multiple warnings they have been issued by the FDA by continuing to make unsubstantiated drug claims about the products it sells and by failing to conform to the cGMP requirements for dietary supplements,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “We are taking this action to protect the public health.”

 

James G. Cole, Inc. has marketed products online, with some sites linking to the company’s Facebook page. Cole has claimed that the dietary supplement products treat serious medical conditions, such as cancer, heart disease, rheumatoid arthritis, autism, Alzheimer’s, fibromyalgia, and high cholesterol. Under federal law, products offered for such uses are considered to be drugs, in that they are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.

 

The company’s dietary supplement products have been unlawfully marketed as drugs that have not been approved by the FDA for their claimed uses. The products include PCA, PCA-Rx, C-60, ACAI Resveratrol, Cytomune, Anavone, Liver Rescue, Probiotics, and several other products, which are marketed under the brand names Maxam Labs, Advanced Sports Nutrition, and Maxam Nutraceutics.

 

Additionally, during inspections of James G. Cole’s facility in 2012 and 2013, the FDA found that the company distributed dietary supplements that were not manufactured in accordance with the cGMP requirements for dietary supplements. For example, the company did not establish an identity specification for each component and did not conduct at least one appropriate test to verify the identity of a dietary ingredient.

 

The complaint was filed in the U.S. District Court for the District of Oregon, Portland Division.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm371516.htm