L-citrulline Not First Time Medisca Has Been in Trouble With FDA; In 2012, the company was sentenced in U.S. district court for unlawfully selling human growth hormone drugs from China.

Recalled Supplement L-citrulline May Endanger Kids, FDA Warns

Posted February 24th, 2014 by Michelle Llamas & filed under FDA.

            

The U.S. Food and Drug Administration (FDA) is warning doctors and consumers that a supplement used to treat genetic disorders in children can cause serious harm and in some cases could lead to death.
New York-based compounding firm Medisca recently issued a voluntary recall of certain lot numbers of its L-citrulline products and warned consumers to be on alert for potential problems.
Children are primary users of L-citrulline, an amino acid used to treat genetic disorders found primarily in kids. It is also being studied for use in mild to moderate erectile dysfunction in men.
The FDA reported that several recalled lots of the medication actually contained no L-citrulline. Instead of L-citrulline, the lots contained another drug, N- acetyl-leucine, which is prescribed to treat vertigo.
Eight of the recalled lot numbers were sent to hospitals and pharmacies across the country. The FDA did not identify specifically who received the bad lots.
After receiving reports of several adverse events linked to the faulty drug, the FDA recently released a warning.
“Subpotent L-citrulline in patients with certain urea cycle defects can lead to high ammonia levels, which is serious and potentially life-threatening,” the FDA said.

Several Children Already Affected by Faulty Supplements

At least half a dozen children have already reported health problems from taking what they thought was L-citralline.
This amino acid clears excess ammonia from the blood. Too much ammonia in the blood can lead to brain damage and in serious cases, even death.
Cynthia LeMons, the executive director of the National Urea Cycle Disorders Foundation told NBC News that one girl sustained a significant loss of her hair, which came out in clumps, and suffered stomach pains because of excessive ammonia in her blood. The girl had to be hospitalized.
Medisca ships L-citrulline in powder form. From that, the drug can be sold as a power or be compounded into tablets, capsules or liquids.
Most at risk from the faulty supplements are children who take them because of rare urea cycle disorders, which effects 2,000 to 2,500 U.S. kids. While other companies also supply the drug, Medisca is the main supplier.
Parents, caregivers and doctors of patients who take L-citrulline are urged to call their healthcare providers immediately if they have concerns about the product.
The FDA is also asking healthcare professionals to be aware of these recalled lots numbers and not administer them to patients. It also instructs them to return all unused products to Medisca.

The FDA and Troubled Compounding Pharmacies

This is not the first time Medisca has had trouble with its products. In 2012, the company was sentenced in U.S. district court for unlawfully selling human growth hormone drugs from China.
The compounding firm was ordered to pay a $15,000 fine and lost $1.7 million.
Other compounding companies have also come under fire for putting the public at risk. In 2012, a contaminated steroid distributed by the New England Compounding Center used to treat back pain resulted in almost 1,000 cases of fungal meningitis which resulted in 64 deaths.
This incident prompted the FDA to pass stricter regulations on compounding pharmacies. In January of 2014, these companies began registering with the FDA – including Medisca.
Medisca released a statement saying the faulty L-citrulline products “represent a potential health hazard. These lots should not be used for any pourpose.”
The FDA said that all adverse reactions should be reported to the agency at MedWatch.

Last modified: February 24, 2014

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Medisca, Inc. and Signature Compounding Pharmacy: Overview of Criminal Case

Here is another example of a compounding pharmacy, Signature Compounding Pharmacy, charged in a criminal case.  Signature was located in Orlando, Florida but the criminal case was brought in Albany, New York.  The Florida Department of Health filed administrative complaints against the pharmacy for improper distribution of human growth hormone but never pursued the charges.  Signature closed down after the indictment.  A Plattsburgh pharmaceutical company, Medisca Inc., and its president, a Canadian citizen, both pleaded guilty to misdemeanor federal drug charges for mislabeling more than $1 million worth of human growth hormone that was imported from China and distributed to pharmacies around the country.  Signature Compounding Pharmacy was among the customers of  Medisca, Inc, which had corporate offices in St. Laurent, Quebec.  This case has led to 17 convictions. The remaining case is against Naomi Loomis; her husband, Robert "Stan" Loomis; his brother, Kenneth Michael Loomis; Kirk Calvert; and Anthony Palladino.

Soares defends steroids case
Albany prosecutor cites factual errors in federal ruling; rejects bias claim
By BRENDAN J. LYONS Senior writer
Published 05:00 a.m., Monday, September 13, 2010

ALBANY -- Prosecutors have asked an Albany judge to forge ahead with a criminal trial for five Florida pharmacy operators accused of being at the center of an alleged illegal steroids business. It's a part of a case that drew national interest in 2007, but that has since brought attacks on the Albany County district attorney's office.
The remaining criminal case, which targets the pharmacist-owners of Orlando's former Signature Compounding Pharmacy, has languished for three years following an interstate law enforcement raid in February 2007 -- spearheaded by Albany County prosecutors -- that exposed illicit steroid use by professional athletes and others.

More than 15 people, including doctors and business owners, pleaded guilty to related drug charges in a case that exposed systemic abuse of prescription drug laws. But the case against the pharmacists and their managers, who were also targets of a related federal criminal investigation, has thrust a spotlight on District Attorney David Soares' decision to indict operators of a faraway company that did a small percentage of its multi-million-dollar business in New York state and Albany County.
Two years ago an Albany County judge threw out the first indictment against the pharmacy's operators, citing prosecutorial missteps in the grand jury proceedings. A month later, the pharmacists fought back with a federal civil rights lawsuit in Florida seeking millions of dollars in damages for false arrest and malicious prosecution. They sued Soares, an assistant district attorney, the Orlando Police Department and other law enforcement officials.
But their criminal case in New York was not over. Earlier this year a state appellate court reversed a portion of the county judge's dismissal order that barred prosecutors from bringing a new indictment, which they did in June.
Last month defense attorneys for the five Signature defendants asked the same judge who dismissed the first case, County Judge Stephen W. Herrick, to do it again. This time, they claimed similar grand jury problems and also pointed repeatedly to a scathing analysis of the investigation last June by a federal judge in Florida, whose ruling has the civil rights lawsuit on course for a jury trial in Florida
"Soares not only participated in, but directed (assistant District Attorney Christopher) Baynes and others to violate plaintiffs' Fourth Amendment right to be free from unlawful arrests," wrote the federal judge, Gregory A. Presnell. "Rather than wait for any documentary evidence that plaintiffs had committed a crime in New York and comply with the very limited requirements of federal and state extradition statutes, Soares decided to orchestrate Plaintiffs' arrests without valid New York warrants and, in the process, garner significant media attention."
Last week, Christopher D. Horn, special counsel to the Albany County district attorney, filed a 34-page motion that seeks to uphold the latest 33-count indictment. It also accuses the federal judge of making numerous factual errors. Horn's written statement marks the first detailed response to Presnell's searing criticism of the Albany district attorney's investigation.
Lawyers in the criminal case are subject to a gag order and were unable to comment for this report.

Prosecutors and investigators have previously characterized Signature pharmacy as a prescription mill that manufactured many of its own drugs, including steroids, that were marketed to people through "wellness clinics" that did a large volume of business through the Internet. Several people convicted in the case admitted they set up the wellness clinics that funneled prescriptions to Signature, which mailed drugs to people around the country. Some of the clinic operators said they paid doctors to write prescriptions for people who were never evaluated in person, and who had no legitimate medical need for the controlled substances, including steroids and human growth hormone.
The case, especially the fallout of its exposure of illicit drug use by athletes, shook up the pro sports world. It also was cited by former Sen. George L. Mitchell in his 2007 report on illegal steroid use in Major League Baseball.
While Signature's defense team has characterized their clients as law-abiding pharmacists who were victims of a zealous prosecutor, others convicted of dealing with them have cast doubt on that assertion.
Last year in Rhode Island, Orlando businessman Victor Martin Effron pleaded guilty to federal charges related to the illegal importation of human growth hormone from China. Federal authorities said the product was being sold to Signature pharmacy, which had contracted Effron to smuggle the drug into Florida, and marketed as approved for use by the Food and Drug Administration.
Orlando police, who were an integral part of the Signature case, asked Albany's prosecutors four years ago to join their investigation after building a criminal case from wiretaps, cooperating witnesses and evidence collected from trash bins outside Signature's pharmacy. They solicited the interest of Soares, according to court records, because the company dispensed prescriptions in New York, which has some of the strictest prescription drug laws in the nation.
Still, defense attorneys have countered that Soares, known from his position as district attorney for the state capital, only became involved in the case to thrust himself into a national spotlight. They said the new charges should be dismissed, or a special prosecutor appointed, because Soares' office has a conflict due to the related federal civil rights lawsuit that has gained traction in Orlando.
Horn, who also handles appeals for the office, countered last week that appointing a special prosecutor would set a precedent for criminal defendants to disqualify prosecutors from pursuing cases by suing them, then claiming there is a conflict.
"The defendants had been being prosecuted for the same criminal conduct for well over a year prior to the filing of their federal civil lawsuit," Horn wrote in the motion to Herrick. "Now the defendants argue that the filing of a fifth indictment is evidence of bias born of the 'conflict' which the defendants themselves manufactured. They are in no different position than they were before they filed their lawsuit. They were being prosecuted then and they are being prosecuted now."
The defendants, three of whom are licensed pharmacists in the state of Florida, are: Naomi Loomis, 37, her husband, Robert "Stan" Loomis, 59; Kenneth Michael Loomis, 62, who is Robert's brother; former business manager Kirk Calvert, 40; and former business manager Tony Palladino, 34.
Horn's motion also attacks key sections of the federal court order, and notes that days after Presnell ordered the civil case to proceed, the judge abruptly issued a corrective order dismissing the claim against a former state Health Department investigator, Mark Haskins, who had played a key role in the Signature investigation.

To read the remainder of this article, click here.
To read more about this case, click here, here, here, and here.