Articles Posted in Drug and Pharmacy Errors

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The costs of using unsafe pharmaceuticals can be life altering. These dangerous drugs can cause serious injury or even wrongful death. The federal agency tasked with making sure our drugs are safe is the United States Food and Drug Administration (FDA). This agency is responsible for approving safe drugs and removing the dangerous ones from the market. The FDA has now announced that certain drugs used as soft tissue dermal fillers, usually for cosmetic purposes, are riskier than many initially thought. Any patient considering these products needs to fully understand the risks.

What Are Cosmetic Soft Tissue Dermal Fillers?

Soft tissue dermal fillers are injectable products that have been approved to treat wrinkles or to ënhance”a person’s cheeks or lips. These products are injected directly into the area to be treated, According to the FDA they should only be injected by health care providers who have appropriate training and experience and who have an in-depth understanding of the anatomy around the treatment area.

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Prescription drug safety is already a complex issue. There are legitimate questions about the Food and Drug Administration’s (FDA) reliance on manufacturer funded studies in making approval. There is a serious real world problem of prescription and pharmacy error, particularly as large scale pharmacies pressure pharmacists to work faster and faster. In this complex framework the FDA sometimes takes steps that actually help consumers, like approving substantially cheaper generic counterparts to extremely expensive prescription drugs. However, name-brand drug manufacturers are now fighting back, and they are going to court to do it over a generic version of Abilify.

What is Abilify?

Abilify is an antipsychotic medication that changes the actions of chemicals in the brain. It is used to treat mental health conditions like schizophrenia and bipolar disorder. It is also used in children who are often too young to be accurately diagnosed with specific mental health conditions for symptoms like aggression and self-injury associated with autism spectrum disorder.
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The United States Food and Drug Administration (FDA) is the agency responsible for determining whether drugs are safe enough to be used in the United States. On one hand, a speedy approval process is good in that it can provide people who may otherwise die or suffer with life-changing treatments. On the other hand, speedy approval can mean approval for medications that are not actually safe which can cause serious injuries or even deaths. This dichotomy is extremely important to consider in light of the news that FDA drug approvals are at an 18-year high.

FDA Drug Approvals Reach 18-Year High
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Most people who either take prescription drugs or care for someone who does are familiar with generic drugs. These medications are supposed to be the same as the name brand medications but they are made by a different manufacturer who did not have to front all of the costs for marketing and research and development, so they are substantially cheaper. Most drugs eventually wind up with a generic equivalent when the name brand drug maker’s patent expires. But one class of drugs has, up until now, been isolated from the generic market. That era, however, appears to be at an end.

FDA Panel Approves Generic Version of Biologic Drug

The Food and Drug Administration (FDA) is the agency responsible for approving generic drugs. CNBC reports that a panel of the agency has unanimously voted to support the approval of Novartis AG’s copy of Amgen’s cancer drug Neupogen. Neupogen is an injectable biologic that prevents infections in breast cancer patients who are undergoing chemotherapy. Biologics are drugs made from living cells rather than being made from chemicals. A biosimilar is a biopharmaceutical drug designed to have active properties similar to one that has previously been licensed. While the panel’s recommendation is not binding on the ultimate agency decision, it is rare for the agency to not follow the panel’s recommendations.
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When we are sick or injured we go to the doctor in hopes of getting better. Unfortunately sometimes the treatment winds up being worse than the original problem. Particularly dangerous treatments can result in personal injury or even wrongful death. It appears this may be the case with a drug called Victoza. This means that if you are taking or have taken Victoza and the medicine caused serious side effects, you should contact us as soon as possible.

What is Victoza?

According to the Food and Drug Administration (FDA), Victoza is an injectable prescription drug that might improve blood sugar in adults with type 2 diabetes. It is manufactured by Novo Nordisk and was approved back in 2010. When the FDA approved the drug, it claimed that “the benefits of this drug to patients with [type 2 diabetes] outweigh potential risks associated with its use.” As it turns out, this decision may have been wrong.

What are the Problems with Victoza?
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When we are sick we find ourselves in a position where we are completely dependent on medical professionals. When those healthcare providers make errors the results can be catastrophic. Pharmacy errors are particularly problematic because, when the wrong drug or dose is administered the cure becomes the cause of a new host of problems in an already ill person. Unfortunately, that is exactly what happened to one cancer patient in Oregon.

Oregon Cancer Patient Given Wrong Drug to Treat Anxiety

Central Oregon’s KTVZ reports that sixty-five year old Loretta Macpherson died as a result of being given the wrong medication. Ms. Macpherson went to the hospital to be treated for anxiety. One month before she went to the hospital she had undergone surgery to remove a cancerous brain tumor. She had been making a speedy recovery, and before her trip to the hospital was expected to recover fully. Then tragedy struck.
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Time and time again we see the same thing-a complete lack of information regarding prescription drug safety for pregnant women and their fetuses. And when this information is not provided, women find themselves either harmed themselves or dealing with harm done to their children that sometimes is not recognized until birth or even after. Fortunately, it appears that the Food and Drug Administration (FDA) is finally taking steps to provide expectant mothers with more desperately needed information so they can make the right choices for their family regarding their health care. The changes will also help breastfeeding mothers.

FDA Changed How Pharmaceutical Companies Present Medication Risks During Pregnancy The New York Times reports that the FDA changed how pharmaceutical companies will present the risks of taking medications during pregnancy and breast-feeding. The system up to now was created in the 1970s and is vague and ultimately not terribly useful. A key problem is that most drugs were classified in the category that meant “animal studies have shown potential risks to the fetus, but … no adequate studies exist for humans.” In other words, most drugs were categorized as “we don’t know the risk” and the guess work was completely pushed off onto the expectant mother.
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America is a melting pot, and it always has been. Throughout our nation’s entire history there have been members of our community who have spoken languages other than English as their primary language. As medical science advanced and our medical system became more complicated, we have had to take steps to ensure that both international guests and new immigrant residents can obtain medical care when necessary. Some doctors have taken it upon themselves to learn second or even third languages, and hospitals work to bring in translators when necessary. However, a big hole in this system exists on the pharmacy side of things. When the instructions that come with prescription drugs are either not translated or are improperly translated for a non-English speaking patient, the result can be injury or even wrongful death.

California Delayed Action on Translating Prescription Drug Labels

The Sacramento Bee reported earlier this year that the California State Board of Pharmacy opted not to decide yet whether pharmacies should be required to translate prescription drug labels for patients with limited or no English-language skills. Most people at a meeting of the Board agreed that change is necessary in part because of the relatively high rate of adverse medical reactions amongst patients with limited English. However, a host of complicating issues also arose at the meeting relating to how many different translations would be necessary, how accuracy would be insured, and who would be held responsible for inaccurate translations and their consequences.
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The United States Food and Drug Administration (FDA) is responsible for determining what warnings drug manufacturers are required to put on the drugs they produce. After the serious pharmaceutical error involving the meningitis outbreak caused by contaminated steroid injections, the FDA is considering requiring more stringent warning labels for the drugs. Such warnings could possibly prevent future injuries and deaths. However, it looks like the FDA will probably not opt for harsher labels, leaving essentially what was the status quo at the time of the meningitis outbreak in place for the foreseeable future.

Panel Rejects Strict Warnings

The New York Times reports that an FDA advisory panel decided Tuesday not to recommend using the sternest federal warning label on steroid injections intended to treat neck and back pain. These panels are typically made up of groups of medical experts. The group makes recommendations to the FDA about what actions it should or should not take on issues like labeling. The recommendations are in no way binding. However, the agency usually follows these recommendations.
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Another patient has lost her life to a tragic pharmacy error. A new report out of Texas shows what may be the cause of some of these totally preventable wrongful deaths: corporate greed.

Pharmacy Accused of Causing Deadly Drug Overdose

Katheryn Barton, a California woman, claims that her mother Ruth Eller died because of a pharmacy error, reports CBS Los Angeles. Ms. Eller was in generally good health, but she experienced an arrhythmia of the heart. Her doctor prescribed a generic version of the drug diltiazem to treat the condition. She had that prescription filled by the Kenneth Road Pharmacy in Glendale, California. That is where the problem occurred.

The instructions on the bottle said to take one tablet four times daily, instructions which Ms. Eller followed. After three days, she was unresponsive to her daughter. So her daughter started to dig into the more detailed instructions provided by the drug’s manufacturer. And those instructions indicated that the drug Ms. Eller was actually provided with was an extended release drug, and that it should only be administered once a day. Ultimately Ms. Barton discovered that the dosage the pharmacist had instructed Ms. Eller to take was ten times the amount of the medication that Ms. Eller’s doctor had prescribed. Ultimately, as a result, Ms. Eller died and the coroner listed the cause of death as diltiazem intoxication due to pharmacy error. Ms. Barton immediately reported the incident to the California Board of Pharmacy, but that agency only fined the pharmacy’s owner $1000 for the error. So Ms. Eller will have to file a civil action against the pharmacy to see any justice done for her mother.
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