Articles Posted in Dangerous Drugs/Medications

Opioids were responsible for over 47,000 overdose deaths in 2017, according to the Center for Disease Control and Prevention (CDC). Over one-third of those deaths involved medications obtained with a prescription. Doctors often prescribe opioids for pain management, but the use of opioids for long-term management has reportedly never received adequate scientific review. In February 2019, the U.S. Food and Drug Administration (FDA) directed drug companies that manufacture approved opioid pain medications to conduct further research on their long-term use. This directive came after widespread criticism of the agency regarding its handling of the opioid epidemic. Manufacturers of well-known prescription opioids have also faced extensive criticism for allegedly pressuring the FDA to modify drug labels and inserts to allow expanded marketing and prescribing.

The term “opioid” refers to a class of drugs used in pain management. It includes illegal drugs like heroin, as well as controlled substances that are available for medical use like morphine, codeine, oxycodone, and hydrocodone. Opioids are different from opiates, in the sense that while opiates are derived from naturally-occurring chemicals in the opium poppy, “opioid” describes any substance that binds with opioid receptors in the human body. It therefore includes synthetic compounds like fentanyl.

Heroin is classified as a Schedule I controlled substance under federal law, meaning that the federal government has determined that it has “a high potential for abuse,” “no currently accepted medical use,” and “a lack of accepted safety for use…under medical supervision.” Numerous other opiates and opium derivatives, including certain forms of codeine and morphine, are also listed in Schedule I. Other opiates and opioids are listed in Schedule II, which allows for medical use. These include fentanyl and substances that are “chemically equivalent or identical with” substances listed in Schedule I, such as oxycodone.
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A recent report in the New York Times focuses on the increasing problem of women dying from an overdose of prescription painkillers such as OxyContin, Percocet and Vicodin. The report highlighted a study that was conducted by the Centers for Disease Control (CDC) and concluded with data from 2010.

The article examined the painkiller abuse in the city of Portsmouth, Ohio, which is located on the edge of Appalachia in Scioto County. Prescription painkiller addiction was originally more of a problem with men, who would be given opoids such as Vicodin for back pain from working in the coal mines and factories. However, the CDC notes that since 1999, the death rate among women from prescription painkiller overdoses has quintupled.

Women are now more likely to dies from overdoses of OxyContin than from homicide or cervical cancer. The study reveals that white women are much more likely to suffer a fatal overdose than African American women, and older women (defined by the CDC as the age group of 45-51) are dying in greater numbers than younger women, even though abuse of these opoids is seen more frequently in younger women.

The CDC analysis noted that Asians and Hispanics had the lowest fatality rates from prescription painkiller overdose. In 2010, 6631 women died from painkiller overdoses. One of the major contributing factors in the increase in female deaths appears to be that women are more likely to also be on anti-depressants and anti-anxiety medications, which can be a lethal combination in conjunction with opoids. Another contributing factor according to the CDC is that chronic pain syndromes such as fibromyalgia are more commonly seen in women than men. Further, the CDC indicates that statistics show that women are more likely to obtain prescriptions of OxyContin, Vicodin and Percocet, to get higher doses, and to use these drugs more frequently.

The article also discusses other factors contributing to the problem, such as financial distress, single mothers with little support from the fathers of their children, and a family history of child abuse and alcohol abuse.

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Pain Management has become a major growth industry in this country, with wide spread addiction to Oxycodone and Hydrocodone a large part of the problem. For many of our clients who are injured in automobile accidents, construction accidents or trip and fall accidents, when the pain becomes intractable and surgery is not necessarily an option, it is now a common practice for the clients to undergo lumbar or cervical epidural steroid injections. For example, in 2011, approximately 2.5 million Medicare recipients and a similar amount of younger patients received the injections.

Spinal injections for back or neck pain is now under significant scrutiny as the result of a meningitis outbreak which has spread across the United States. The drug which is responsible for the meningitis outbreak is known as mehtylprednisolone acetate, which was apparently made by a company called New England Compounding Center (NECC) in Framingham, Massachusetts. According to an article by Denise Grady, Andrew Pollack and Sabrina Tavernise in the New York Times on October 9, 2012, the company sold 17,676 vials of the mehtylprednisolone acetate to 75 pain clinics in 23 states across the United States. The New York Times has reported that compounding centers are used by doctors and hospitals to obtain certain medications for two major reasons. First, when medications are in short supply, compounding centers such as NECC are a potential alternative, and second, the prices for the drugs from the compounding centers are often much lower than if the hospitals had to purchase the medications from a pharmaceutical company.

So far, there are 7 reported fatalities, 57 people who have become ill from the tainted medications, and potentially thousands more who could be endangered. It appears that the medication was contaminated with a fungus, which is the worst of three possible ways to contract meningitis, the others being through a virus or bacteria. Doctors note that the fungal meningitis is hardest to treat and leads to strokes. The only means to determine if the person is suffering from meningitis is to perform a spinal tap. If the spinal fluid is cloudy, it is likely that the person has the fungal infection.

The New York Times article discussed the tragic case of Eddie C. Lovelace, a judge in Kentucky who was still on the bench in his late seventies. Judge Lovelace was suffering from severe neck pain from a car crash. He underwent spinal injections for pain relief, and within several months, he was dead at the age of 78. Doctors and hospitals frequently do not have any idea where the medication they are prescribing and requesting comes from. Dr. Anders Cohen, the chief of neurosurgery at Brooklyn Hospital Center, notes: “We ask for the medication, it’s in stock, we use it. I don’t know if it’s coming from A, B or C. This is a wakeup call about where your stuff is coming from.”

Compounding centers are able to provide the medications less expensively since they are not subject to the federal oversight of the Food and Drug Administration, (FDA), which requires stringent testing before a drug offered by a pharmaceutical company can be approved for public use. The approval process takes several years and costs the drug companies several million dollars. New England Compounding charged $25.00 for a vial of five 80 milligram doses, whereas a similar vial of Depo-Medrol, manufactured by Pfizer, costs in the range of $40-$46.00. Compounders are able to register as pharmacies, placing them under the review of state agencies and regulations, not the federal government. The F.D.A. reports that problems with products be reported to the agency, whereas there is no equivalent procedure under state laws, allowing compounding centers like NECC to flourish.

Ironically, The New England Compounding Center had significant problems in the past, with several complaints lodged against the company over the past decade. The Massachusetts State Health Dept. inspected the company in 2006, and as a result, the letter sent a letter to the company accusing them of among other things, illegal production of an anesthetic topical cream and allowing a doctor’s office to order products without prescriptions for patients. It is also tragic to note that there is a significant question as to whether the injections are even effective, so that many patients risked their health or their lives for a questionable treatment to alleviate their suffering.

As a precaution, the F.D.A. is advising health care professionals and consumers not to use any product manufactured by the NECC until further notice.

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The controversial drug propoxyphene, sold under the brand names Darvocet and Darvon, will be withdrawn from the market after 53 years due to serious heart risks, according to an announcement by the Food and Drug Administration (FDA) on November 19, 2010. The studies reviewed by the FDA determined that the drug caused dangerous heart electrical changes in otherwise healthy people. The removal of propoxyphene ends a 32 year crusade by the Health Research Group of Public Citizen, a consumer advocacy group out of Washington, to stop manufacture of the drug.

An FDA advisory committee voted 14-12 to remove the dangerous drug from the market in January of 2009, and it unclear why it took almost 2 additional years before the removal was finally effectuated. Great Britain banned the drug in 2005 and the European Union followed in 2009 after reports of an unusual number of deaths in Florida, where medical examiners do more toxicology studies.

There was some opinion that patients with severe pain might be switched to other medications which could cause more sedation, dizziness and falling. Medications that will most likely be used instead of Darvocet include Extra Strength Tylenol, Tramadol and low doses of hydrocodone or oxycodone. Propoxyphene was the 38th most prescribed drug in 2009 according to SDI/Verispan, a medicine information company, with 17.5 million prescriptions in the United States.

According to John J. Jenkins, director of the Office of New Drugs at the Food & Drug Administration, “the benefits of [propoxyphene] no longer outweigh its serious heart risks.” The drug had been on the market since 1957, when it was manufactured by Eli Lilly, which profited in the billions from the drug until it sold the rights to Xanodyne Pharmaceuticals in 2005. Xanodyne voluntarily agreed to withdraw the drug after hearing last week from the FDA.

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