Pharmco Laboratories received a warning letter from the FDA citing 4 violations.
Pharmco Laboratories received a warning letter from the Food and Drug Administration. The letter to the Florida-based skincare manufacturer “summarized significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
In the letter posted to the agencywebsite, four specific violation were referenced.
Pharmco Laboratories was accused of presenting an allergy risk to consumers. The FDA states that there has been insufficient evidence of the proper cleaning of equipment that came in contact with major allergens. Dietary supplements, for example, containing soybeans used the same dryer as the ingreditents in skincare items.
The FDA warning letter stated that “repeated lapses demonstrate a failure of your executive management to exercise proper oversight and control over the manufacture of drugs.”
The company has agreed to pay a $150 million fine after they allegedly failed to detect and report suspicious orders of prescription pain pills, according to federal prosecutors. This has arguably led to the growing heroin crisis.
For example, more than 1.6 million orders for controlled substances were filled by McKesson in Colorado between June 2008 through May 2013. However, just 16 of them from a single customer as suspicious, the Justice Department said.
In a statement from the White House last summer, federal fears related to pain killer and opioid addictions were made clear:
“President [Obama] has made [it] clear that addressing this epidemic is a priority for his Administration. While Federal agencies have been using their authority to take every available action they can, Congress needs to take action on what is most urgently needed now – additional funding to make lifesaving treatment available to everyone who seeks it. The President has called for $1.1 billion in new funding to help Americans who want treatment get it wherever they live.”
McKesson, the nation’s largest drug distributor, was accused of failing to create an effective system to detect suspicious pharmacy orders. This was argued to be a violation of the Controlled Substances Act.
In 2008, McKesson agreed to a $13.25 million civil penalty for actions including failing to report suspicious sales of their drugs on “internet pharmacies.”
In a statement, McKesson said it settled “in the interest of moving beyond disagreements about whether McKesson was complying with the controlled substance regulations … and to instead focus on the company’s partnership with regulators and others to help stem the opioid epidemic in this country.”
The Food and Drug Administration (FDA) has found that powdered medical gloves (powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove) “present an unreasonable and substantial risk of illness or injury.” This has led to a new rule banning these products from use, effective January 18, 2017.
One group has called the ban “18 years too late.” Nearly 20 years ago, in 1998, the advocacy group Public Citizen, filed the first of several citizen’s petition calling on FDA to ban powdered gloves.
After the ban was proposed by the FDA,Public Citizen responded saying that “when a medical product, drug or, in this case device, has unique serious risks but no unique benefit, it should be banned. The FDA’s statement that “we … only take this action when we feel it’s necessary to protect the public health” ignores overwhelming evidence going back almost two decades about the necessity to do so.”
Back in March of 2016, theFDA had prosedthe powdered medical gloves citing evidence that they were a danger to patients, risks included airway and wound inflammation, post-surgical adhesions and allergic reactions.
The rules not that powder is fine when used in the manufacturing process, but should not be a part of the finished product. The rule from the FDA “encourages manufacturers to ensure finished non-powdered gloves have as little powder as possible.”
If you believe that you or a loved one might have suffered from the medical use of powdered gloves, let the Medical Claim Legal Team help.
Reports have been released showing legendary pop star Prince, died of an overdose of the painkiller Fentanyl. The drug, which can be found on the black market, is more than 100 times more potent than morphine, making it the strongest opioid available.
“Fentanyl is a very dangerous opioid, whether you’re taking it as a prescription or you’re mixing it with black-market heroin,” said addiction specialist Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, in a USA Today article.
“Celebrity overdoses are just the tip of the iceberg of an epidemic,” Kolodny said. “Many of these deaths are occurring in people who are not your typical drug abuser. They are suffering from chronic pain and they are becoming addicted to legitimately prescribed medication.”
Prince’s death is just one in an increasing trend of opioid-related fatalities in America. According to a CDC report, Since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids. The alarming growth of opioid addictions and deaths has even been a topic in the presidential race, and continues to be a major topic in politics as a whole.
One startling point made in a Washington Post article is that so many people are dying of drug overdoses that it’s easing the shortage of donated organs. While there are many factors, whether accidental or intentional, that contribute to the number of overdoses in this country, there must be more effort put in to stop this growing epidemic.
In the past year, google searches containing the word “opioid” have increased continuously, and they grew even more when Prince’s death was linked to the painkillers. The awareness of the problem has grown across the country, however a solution has not been found. Hopefully there can be a solution to rehabilitate addicts, and prevent future overdoses from occurring.
Addiction to painkillers, and other opioid drugs, is a serious problem in the state of West Virginia. According to a CBS News report, West Virginia has the highest rate of overdose deaths in the nation. Each year doctors write the equivalent of one painkiller prescription for every man, woman and child in this state of 1.8 million people. The painkiller problem has become so severe that state legislature has stepped in to make changes, and has led to the addicts suing doctors.
More than 30 addicts have sued their doctors for enabling their addiction. Many of these patients suffered from work related injuries and had to rely on painkillers in order to continue working.
Patients are not the only ones filing lawsuits regarding this subject. West Virginia Attorney General Patrick Morrisey has filed a lawsuit against McKesson Corporation, a prescription drug distributor, for allegedly failing to identify, detect, report and help stop the flood of suspicious drug orders into the state.
According to a CBS San Francisco article, The DEA, along with six states, sued McKesson (a San Francisco based company) in 2008 for supplying hundreds of suspicious hydrocodone orders to rogue pharmacies. McKesson settled, paying more than $13 million in fines and agreeing to closely monitor their pill supply.
In research of McKesson’s involvement in West Virginia, it shows that more than 100 million doses of opioids to a state where the population is 1.8 million. This egregious amount of drugs being sent to a state that has the most overdose related deaths in the country is what has put the company in hot water. McKesson could face tens of millions in legal fees, but for a company that makes over a billion dollars that is simply pocket change.
Hopefully the changes made by the legislation in West Virginia can help the addicts recover and find the treatment they need.
Invokana is a drug used for treatment of type-2 diabetes that has recently become the topic of many lawsuits in North America. The purpose of the drug is to maintain blood sugar levels in the patient by forcing the kidneys to release excess sugar through urination. This causes more stress on the kidneys than what is typically put on them without the drug. The Invokana lawsuit is growing everyday as more patients have been affected by the drug.
What is the reason for the lawsuits?
According to the FDA there have been 19 filed claims of people who developed blood and kidney infections as a result of Invokana. According to Digital Journal, all of the patients filing the Invokana lawsuit alleged to have required hospitalization and kidney failure treatment with dialysis. The first side effect that can cause serious health issues is an increase in the amount of acid in the blood, as well as Urinary Tract Infections (UTI). These harmful side effects have led to the hospitalization of many Invokana users. Another serious side effect of the drug is Ketoacidosis. In another post by Digital Journal, many patients have filed lawsuits against manufacturers claiming that the drug causes severe side effects and that the companies were negligent in communicating the risks associated with the drugs.
What is Ketoacidosis?
Ketoacidosis is defined by the FDA as “a serious condition in which the body produces high levels of blood acids called ketones. Symptoms of ketoacidosis include nausea, vomiting, abdominal pain, tiredness, and trouble breathing. Patients should also be alert for signs and symptoms of a urinary tract infection, such as a feeling of burning when urinating or the need to urinate often or right away; pain in the lower part of the stomach area or pelvis; fever; or blood in the urine.” If you have experienced symptoms of Ketoacidosis, you should contact a doctor immediately.