Sunday, March 31, 2013

Brilliant Blue G Eye Infection Lawsuits Filed Over Recalled Surgical Dye


By: Irvin Jackson | Published: March 29th, 2013

At least four lawsuits have been filed this month against Franck’s Compounding Lab, alleging that individuals suffered severe eye infections that were caused by contaminated doses of Brilliant Blue G, an eye surgery dye.
The product liability lawsuits accuse the compounding pharmacy of distributing contaminated and unsafe drugs, which led to their eye infections.
As a result of problems from Brilliant Blue G surgical dye, plaintiffs allege that they suffered debilitating eye injuries and permanent blindness in some cases.
The complaints were filed by Howard McMaster (PDF) and Brenda Hess (PDF) in the U.S. District Court for the District of Nevada, and by Eldon McKinley (PDF) and Bernice Tharp (PDF) in the U.S. District Court for the Northern District of Indiana.
Each of the lawsuits indicate that the plaintiffs received Brilliant Blue G during an eye procedure in November 2011, including cataract surgery and vitrectomy procedures.

Brilliant Blue G Recall Issued Due to Contamination

Brilliant Blue G is a compounded medication that was sold by Frank’s Compounding Lab to opthalmologists, who were told the product was safe to inject into the patient’s eyeball during surgery to help the doctor achieve desired results during the procedure.
In March 2012, Franck’s Compounding Pharmacy issued a Brilliant Blue G recall, following multiple reports of eye infections.
About two months later, the FDA issued a safety alert announcing the recall for all sterile human and veterinary prescriptions distributed by the pharmacy after investigators discovered microorganisms and fungal growth in areas of the facility that were supposed to be sterile.
According to a report by the U.S. Centers for Disease Control and Prevention (CDC) in May 2012, more than 30 confirmed or probable cases of fungal endophthalmitis were identified among patients who underwent eye surgery that involved products distributed by the pharmacy. Brilliant Blue G was linked to 20 of those cases.
Endophthalmitis is an eye infection that results in inflammation of the eye and can lead to vision loss and the loss of the entire eye in some cases. Antibiotics are usually applied via intravitreal injection (an injection into the eye itself), but in some cases eye removal is required.
The recently filed complaint alleges that the compounding pharmacy knew or should have known that the batches of Brilliant Blue G were unsafe for use, pursuing claims under theories of negligence, strict liability, failure to warn and breach of warranty.
The cases come as compounding pharmacies nationwide are undergoing intense scrutiny following a nationwide fungal meningitis outbreak that killed nearly 50 people and sickened more than 700. That outbreak was linked to epidural steroid injections distributed nationwide by the New England Compounding Center (NECC). Later investigations by the FDA discovered fungal contamination of drugs at that facility as well.
NECC also faces a growing number of fungal meningitis outbreak lawsuits, which drove the company into bankruptcy.
Source found here

N. Ind. woman's diagnosis took 5 painful months ANGELLE BARBAZO, Associated Press

Veterinary compounders and veterinarians are trying to block a push by drugmakers to require patient-specific prescriptions before a medication can be made--Lobbyists weigh in on pharmacy oversight


Drug companies are ramping up efforts on Capitol Hill to block specialty pharmacies from mass producing drugs in lightly regulated conditions, urging lawmakers to require that these enterprises return to their traditional roles or face stricter standards.
Commercial drug makers are also pressing a lobbying campaign aimed at stopping these specialty pharmacies, known as compounders, from making “knockoff” drugs for people and their pets that the companies say are costing them millions of dollars in annual profits, records and interviews show.
This rapidly escalating struggle reaches far beyond congressional efforts to rein in reckless compounding pharmacies that began in October after tainted steroids from the Massachusetts-based New England Compounding Center (NECC) were linked to a meningitis outbreak that has killed 48 people.
Amid a public outcry, lawmakers began considering draft legislation to address public safety concerns. With a bill in the works, a range of companies, business associations and health organizations have begun pressing their own interests along a wide front.
Veterinary groups, for instance, have launched their own lobbying campaign opposing the drugmakers. These groups warn that any legislation that required patient-specific prescriptions would deprive them of vital drug stockpiles and that pets would die at their clinics.
Hospitals want to ensure that any new oversight of compounders by the Food and Drug Administration does not cripple the firms’ operations, which could worsen drug shortages.
And the compounders, while agreeing that tighter federal enforcement of safety standards is needed for the large firms, are vigorously resisting the drug companies’ bid to limit competition.
The Senate Health, Education, Labor and Pensions Committee is working on draft legislation directed at compounders and is expected to begin circulating it to interested groups as soon as next month. The House Energy and Commerce Committee, meanwhile, is investigating whether lax oversight of NECC by the FDA contributed to illnesses and deaths.
Since Congress and other federal officials began investigating NECC this fall, the number of groups lobbying on issues related to compounding pharmacies has more than doubled, records show.
“Some are making blatant copies of FDA-approved products,” said Ron Phillips, who is lobbying for the Animal Health Institute, which represents drugmakers. “You can go to any trade show or to their Web sites and they are openly promoting this. A clear line needs to be drawn.”
Over the past two decades, many compounders — who custom-mix medications — have moved from a traditional practice of filling prescriptions for individual patients to mass producing drugs, often without a prescription. Sometimes the drugs are similar to those made by drug manufacturers. Today, compounding is about a $2 billion-a-year industry.
The specialty pharmacists supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. Veterinary groups estimate that 20 percent of the medications they prescribe are compounded products.
Compounders also make some of the highest-risk drugs available, sometimes using potent raw ingredients that must go through a critical sterilization process to ensure safety. Many of them are injected directly into patients, such as the steroids linked to the meningitis outbreak, which has sickened 666 people in addition to those who have died.
Yet compounding pharmacies are not required to follow federal safety laws — such as testing their medications for contamination and potency levels — that apply to commercial drugmakers.
As compounders have moved into bulk production, federal regulators have sent conflicting signals about when they will step in.
The drugmaker K-V Pharmaceutical, for instance, won FDA approval in February 2011 for its drug Makena, which is given to pregnant women to prevent premature births, and was given the exclusive right to sell it for seven years. But the following month, the FDA announced it would not take action against pharmacies compounding a similar product.
The day after that announcement, K-V’s stock dropped by more than 60 percent. Since then, the company has cut the per-dose price of Makena from $1,500 to $690.
That episode was widely noted across the drug industry, with compounding experts calling it a watershed moment.
Earlier this winter, officials from K-V Pharmaceuticals were on Capitol Hill for two days, lobbying on the issue and telling congressional staffers that compounded versions of Makena can be “unsafe or ineffective,” said Sarah Sellers, senior director of epidemiology and risk management for K-V’s marketing and distributing arm, Ther-RX.
“If an FDA-approved product is medically appropriate, it should be used preferentially,” Sellers said.
Manufacturers of animal drugs — such as Frontline for flea and tick prevention and Heartgard for heartworm prevention — have also been pushing Congress to stop compounders from making what drug companies consider copycat products.
Compounders say there are times they should be allowed to make products that are essentially copies — when manufactured products are unavailable because of drug shortages and when drugmakers have stopped producing a needed product.
Veterinary compounders and veterinarians are trying to block a push by drugmakers to require patient-specific prescriptions before a medication can be made. Matt Wilson, a partner at Animal Clinic Northview in Ohio, said this creates serious problems in emergency situations. For example, apomorphine is commonly used to induce vomiting in dogs when they have ingested a poison but it must be given within hours to save the pet.
“There are so many drugs that are back-ordered and unavailable. You can’t properly practice medicine if you don’t have these products in hand,” said Wilson, who uses Wedgewood Pharmacy, which is part of the lobbying effort.
Instead of measures that could limit mass production or bar compounds similar to commercial products, compounders are telling Congress they want more-rigorous safety standards for all compounding pharmacies.
The International Academy of Compounding Pharmacists, the industry’s largest trade group, is asking for federal and state legislation that would require compounders to adhere to guidelines that are currently voluntary. The guidelines run more than 400 pages long and were developed by pharmacists, doctors and nurses.
“We believe they need to be mandated by law,” said David G. Miller, IACP’s executive vice president.
Miller said he told congressional staffers that he still wants state inspectors to retain the authority to enforce the standards for most compounding pharmacists. Last month,Miller reversed course on his long-held position that all compounders should be regulated by state boards of pharmacy, saying manufacturing-style firms that market and sell products without patient-specific prescriptions should register with the FDA and be inspected by the agency.
The shift in IACP’s position followed a Washington Post investigation that showed 15 of the nation’s largest compounding pharmacies mass produce medications, often shipping them across state lines without patient prescriptions. The Post also reported that shoddy equipment and unsanitary conditions at some of these firms had caused patient illnesses and deaths long before this fall’s deadly outbreak but that the firms rarely were penalized.
IACP and other groups are squaring off over which pharmacies would fall into the new category and face stepped-up FDA enforcement.
Many compounding experts and drugmakers maintain that size is the key factor for defining this new category.Express Scripts, a company that has a compounding arm that makes fertility drugs, is telling Congress that even though it ships to all 50 states, it does not belong in this new group, since it makes medications for individual patients.
Among those most affected are large hospitals, which often compound medications in-house. They want to be excluded from increased federal scrutiny, arguing that they make drugs only for their individual patients.
Many smaller community hospitals do not have the resources to mix their own medications. If they cannot buy the medications from drug manufacturers, these hospitals often rely on large compounding pharmacies to supply pain medication, anesthetics, and drugs commonly used in labor and delivery. Lobbyists for smaller hospitals say they want more oversight of compounded products.
Source found here

Reforms slow in wake of meningitis outbreak


March 31, 2013
Legal action is proceeding in the nation's fungal meningitis outbreak, but regulatory reform has been slow.
Last week, Michigan At-torney General Bill Schuette requested a grand-jury in-vestigation into whether the New England Compounding Center violated state law in distributing tainted steroid solutions in Michigan.
Yet while Congress and state regulatory agencies are debating changes in the way compounding pharmacies are regulated, little action has been forthcoming six months into the outbreak. Nor is any expected soon.
That's a concern for men-ingitis patients such as Jona Angst.
"I would have thought they would have jumped on it," the Brighton resident said. "It seems they're trying to do something — but it has been six months."
The contaminated steroids had been used by health-care facilities, including Michi-gan Pain Specialists in Genoa Township, to treat back pain.
Angst developed an epi-dural abscess — an infection but not full-blown meningitis — after receiving shots last year and is in treatment.
"The medicine's been horrible, I've been losing my hair," she said. "But it's been horrible for all of us."
The outbreak was first reported in September and Congress first took up the issue in November.
U.S. Rep. Mike Rogers, R-Brighton said Congress needs to be thorough it its investigation into the outbreak and in drafting solutions to prevent it from happening again.
"We must first fully understand what went wrong and caused the tragic deaths of dozens of Americans to ensure that any legislative solution put forth actually solves the problem," said Rogers in a statement to the Press & Argus.
Rogers sits on the House Energy and Commerce Committee, which oversees the Food and Drug Administration. He said the committee is also investigating the "oversight of the NECC to understand its knowledge of the operations."
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