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Opioids: FDA Warnings and News

• March 12, 2018
many prescription drug containers

Big Pharma: Recall Of The Anti-Inflammatory Medication Methylprednisolone Sodium Succinate Over Impurity Concerns

On March 6, the United States Food and Drug Administration (FDA) announced a voluntary recall being conducted by Sagent Pharmaceuticals, Inc. over ten lots of its anti-inflammatory medication Methylprednisolone Sodium Succinate for Injection. The recall involves the risk of elevated impurity levels, which may make the medication less effective in patients.

Methylprednisolone Sodium Succinate for Injection is an anti-inflammatory glucocorticoid used in the treatment of a number of serious conditions including:

• Allergic reactions
• Skin conditions
• Endocrine disorders
• Gastrointestinal diseases
• Hermatologic disorders
• Trichinosis with neurological or myocardial involvement
• Tuberculosis meningitis (when used in conjunction with antituberculosis chemotherapy)
• Neoplastic diseases
• Nervous system disorders
• Renal diseases
• Respiratory diseases
• Ophthalmic disease
• Rheumatic disorders

If you recently have received an anti-inflammatory injection related to the treatment of any of the above conditions, check with your healthcare provider to see if you received a dose of an affected lot of Methylprednisolone Sodium Succinate for Injection. If you did receive a dose of the recalled drug, the FDA urges you to monitor your health for any adverse events or side effects and to report any such incidents to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.

Methylprednisolone Sodium Succinate for Injection is supplied in tubular glass vials of 5 ml, 10, ml, and 30 ml. The recalled lots were supplied to distributors, wholesalers, and hospitals between April 2017 and February 2018.

Sagent Pharmaceuticals reports that it has taken steps to notify customers by fax, email, FedEx, and/or certified mail, but the company still is urging its customers to report any additional individuals or entities to whom the impacted product may have distributed.

As TheLawFirm.com readers know, a disturbing number of drug recalls have taken place recently involving substandard manufacturing practices that have created risks of contamination and impurity. If you or a loved one has been harmed by taking a medication, the expert attorneys at TheLawFirm.com stand by ready to help you defend your rights.

Sources:
United States Food and Drug Administration (FDA)

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• March 12, 2018
many prescription drug containers

Big Pharma: Recall of Hospira Opioid Hydromorphone HCL

The United States Food and Drug Administration (FDA) announced March 5 that pharmaceutical company Hospira is conducting a voluntary recall of three lots of its opioid agonist Hydromorphone HCL Injection. The recall involves concerns that certain of the glass vials in which the drug is distributed may be cracked on the bottom and/or may be empty. The FDA urges “wholesalers/distributors/retailers/hospitals” receiving affected lots to contact Hospira to arrange for the return of any affected products.

Hydromorphone HCL Injection is a powerful opioid reserved for use in situations where alternative pain-relief treatments have proven inadequate or where the patient has developed a high tolerance to other opioid medications. The affected lots were distributed in cartons containing ten single-dose 1 mL glass vials that were sold throughout the United States and Puerto Rico between October 2016 to July 2017.

Cracked vials can pose a greater problem than just leaked drugs. According to the FDA, cracked vials can compromise sterility. When non-sterile solutions are injected intravenously into patients, it can result in bloodstream infections, which in turn can cause more serious conditions such as bacteremia and sepsis. The risk of infection from non-sterile injections is particularly acute for patients suffering from compromised immune systems. Further, the FDA warns that the “[u]se of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.”

Hospira reports that it has sent a recall notice notifying impacted customers and telling them to inform the healthcare professionals within their organizations of the situation. As always, patients who may have received affected supplies are encouraged to contact their healthcare provider and to monitor their health for any adverse events or side effects. If any such situation should arise, it should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report.

Stay tuned to TheLawFirm.com for the latest FDA drug recall information. If you or a loved one has been harmed by a prescription medication, our team of experienced attorneys is standing by now for a free consultation. The law places strict deadlines on your ability to file a claim, so contact us today!

Sources:
United States Food and Drug Administration (FDA)

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• February 11, 2018

FDA Says Elevated Concerns About Opioid Kratom

On February 6, the United States Food and Drug Administration (FDA) released a statement from the Commissioner pertaining to the botanical substance known as kratom. While the FDA concedes in the statement that there is much still to be learned about kratom, the agency warns that new information further elevates concerns about the opioid properties of compounds contained in the substance.

Kratom is a relatively obscure substance the popularity of which recently has been on the rise in the US, a spread that has been strongly associated with the opioid epidemic presently sweeping the nation. According to a recent report in The Washington Post, “kratom is hailed as a readily available pain remedy that is safer than traditional opioids (such as oxycodone), an effective addiction withdrawal aid and a pleasurable tonic.”

However, these alleged benefits do not come without a significant risk, according to the FDA, which has associated 44 deaths with kratom use dating back to 2011. Further, the FDA notes in the Commissioner’s statement, “there is no reliable evidence to support the use of kratom as a treatment for opioid use disorder and significant safety issues exist.”

Advanced computer modeling performed by the FDA suggests that, on a molecular level, many of the compounds contained in kratom target the body’s mu-opioid receptors. The FDA’s model “predicted that 22 (including mitragynine) of the 25 compounds in kratom bind to mu-opioid receptors,” and confirmed that “two of the top five most prevalent compounds (including mitragynine) are known to activate opioid receptors (‘opioid agonists’).”

This means that, in practice, kratom compounds would be expected to impact the human body in much the same manner as opioids, leading the FDA to the conclusion that “we feel confident in calling compounds found in kratom, opioids.”

Kratom is derived from a tree found in Southeast Asia. The United States Drug Enforcement Administration (DEA) presently is considering categorizing kratom as a Schedule I substance, which the DEA defines as “drugs with no currently accepted medical use and a high potential for abuse.” Examples of drugs currently listed as Schedule I include heroin, LSD, marijuana, ecstasy, and peyote. The statement from the FDA Commissioner, which warns of the dangers of kratom while declaring no medicinal benefits to its use, is expected to aid the DEA in its effort to criminalize the substance.

Advocates for kratom use say that it is an effective treatment for the symptoms of opioid withdrawal and that it provides a safe recreational high.

Sources:
United States Food and Drug Administration Website
The Washington Post
United States Drug Enforcement Administration (DEA) Website

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• February 6, 2018

FDA Reiterates Commitment To Fighting The Opiod Epidemic

In a statement issued January 30, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D., reiterated the FDA’s commitment to addressing the ongoing, nationwide opioid epidemic, announcing a gathering of stakeholders to include representatives on all sides of the issue, from provider groups and organizations of healthcare professionals to patient advocates, pharmaceutical companies, and academics. The statement also included an announcement that the FDA had issued to the makers of over-the-counter (OTC) loperamide, a widely available anti-diarrhea drug associated with the opioid epidemic, a voluntary request for label and packaging changes.

In his statement, Commissioner Gottlieb outlined what he sees as the numerous proactive steps the FDA is taking to treat existing opioid addictions while preventing new ones. In addition to the aforementioned gathering of stakeholders and the voluntary request made to the makers of loperamide, the Commissioner’s statement cites as examples of these steps the formation of the Opioid Policy Steering Committee in May 2017; a plan to contact in the future the online sellers of loperamide with a voluntary request similar to that made to the drug’s manufacturers; and an updated version of the FDA’s educational guide for health care providers dealing with patients in pain.

According to the FDA, the use of loperamide has been on the rise as a perceived means for those suffering from opioid addiction to lessen the effects of opioid withdrawal. Loperamide is sold under popular brand names such as Imodium A-D. The FDA has requested that manufacturers sell loperamide only in the small doses suitable for short-term use at safe levels, for example “a retail package containing 8 2-milligram capsules in blister packaging.” At high dosages, says the FDA, loperamide has been associated with serious heart conditions and even death.

TheLawFirm.com finds these measures by the FDA to be half-hearted attempts to do too little too late in the face of a serious opioid epidemic that continues to ravage the nation, resulting in—by the FDA’s own figures—more than 11.5 million Americans misusing prescription opioids in the past 12 months and on average more than 40 Americans dying every day from prescription opioid overdoses alone (And this figure does not include the many more who, unable to obtain prescription drugs to satiate their addiction, have turned to street drugs like heroin or black-market fentanyl).

If you or a loved one has suffered the harms of opioid addiction, including overdose, and want to explore your legal rights, the expert attorneys at TheLawFirm.com stand by ready to provide a free consultation.

Source: US FDA Website

• January 28, 2018

12 Opioid Manufacturers recieve FDA and FTC Warning Letters

In a sign of increased attention being addressed to supplement makers who promote unsubstantiated claims about their products’ efficacy in treating symptoms of opioid withdrawal, on January 24, the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC) announced that they had jointly sent warning letters to the marketers and distributors of 12 such products, advising the companies that they were in violation of multiple federal statutes.

With more than 2 million Americans suffering from opioid addiction, the market for treatments—legitimate and not—has exploded in recent years. The joint move by the FDA and FTC demonstrates an increased willingness to crack down on the marketing and sale of such products and services.

“People who are addicted to opioids should have access to safe and effective treatments and not be victimized by unscrupulous vendors who are trying to capitalize on the opioid epidemic by taking advantage of consumers and selling products with baseless claims,” said FDA Commissioner Scott Gottlieb in a statement.

According to the agencies, all of the companies subject to the warning letters had been marketing their products online, using forums ranging from dedicated websites to Facebook pages. Examples of the allegedly illegal marketing claims include: “#1 Selling Opiate Withdrawal Brand”; “Relieve Your Symptoms…addiction, withdrawal, cravings”; and “Safe and effective natural supplements that work to ease many physical symptoms of opiate withdrawal.”

The FDA warns consumers that unapproved products such as these pose serious health risks, as they have not been demonstrated to be safe or effective. The FDA goes so far as to label the marketing and sale of these products “[h]ealth fraud scams”.

Stay tuned to TheLawFirm.com for updates on all aspects of the opioid epidemic, as it continues to impact millions of Americans.

• August 21, 2017
drug enforcement agency logo

DEA GIVEN GO-AHEAD TO PREVENT DRUG MAKER FROM SELLING OPIOIDS

The D.C. Circuit Court has lifted a stay that had prevented drugmaker Masters Pharmaceutical from selling controlled substances, including opioid medications. At the same time, the Drug Enforcement Administration (DEA) issued a challenge to Masters’ putative compliance with federal controlled-substance standards.

Masters’ drug-selling certificate was first revoked in 2008 on suspicion that the company was not acting to adequately prevent its drugs from being diverted into illegal channels. Masters was then ordered to spend $500,000 to establish a compliance program.

The company came under suspicion again in 2013, when the DEA alleged that Masters had provided millions of doses of the powerful opioid oxycodone to eight illegitimate pharmacies. Masters was found to be out of compliance, but was granted a stay. That stay has now been revoked, giving the DEA full authority to shut down Masters’ drug distribution operations.

The D.C. Circuit Court refused to hear Masters’ appeal.

• August 2, 2017
soldier who looks very sad

VA WATCHDOG URGES ACTION TO ADDRESS RISKS OF OPIOID MEDICATIONS TO VETERANS

The Office of the Inspector General (OIG), a watchdog agency for the Veterans Affairs Administration (VA), has urged the VA to take steps to monitor opioid prescriptions and abuse among veterans, stating that the powerful medications pose a particular risk to vets.

The OIG warned that veterans with chronic pain and mental illness are particularly vulnerable to the overeager prescription of opioid painkillers, and that the VA should use all available means to curtail the abuse of the drugs.

The agency pointed specifically to such programs as the Veterans Choice Program, which allows veterans to visit community health centers, as those centers may not be sufficiently informed of the risks that opioids pose to vets, who have experienced greater rates of opioid abuse and death than the general population.

The VA has in place an Opioid Safety Initiative, but the OIG found that community health centers are often unaware of its provisions, largely due to poor communication between the centers and VA hospitals.

The VA responded to the OIG report by stating that it will encourage veterans to fill their prescriptions at VA pharmacies whenever possible. The VA is reportedly looking into strengthening its guidelines that pertain to opioid prescriptions, as well.

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• July 31, 2017

FDA NIXES USE OF BLUE DYE IN OPIOID PAINKILLER

The U.S. Food and Drug Administration (FDA) voted overwhelmingly not to approve a version of Intellipharmaceutics International’s Rexista opioid that would attempt to discourage abuse by staining potential users with a blue dye that would be released upon a tamper attempt.

The FDA rejected the measure on the grounds that it would not mitigate the abuse of the drug via injection. The agency also scolded the drugmaker for not including enough information in its application about human studies that address the potential for the abuse of Rexista.

Rexista’s maker also included in the drug an irritant that would allegedly make it less attractive to those who wished to inhale it.

Rexista is a powerful opioid medication that is equivalent to OxyContin. It is intended for the treatment of severe, constant pain.

Intellipharmaceutics responded to the advisory panel’s decision by stating that it would commence further studies on the drug.

• July 20, 2017

DEA URGES COURT TO BLOCK OPIOID SUPPLIER’S SALES

The U.S. Drug Enforcement Administration has urged the D.C. Circuit Court to block Masters Pharmaceutical, a maker of opioids and other prescription painkillers, from selling controlled substances.

In 2013, Masters allegedly failed to report to the DEA a number of “suspicious” orders from Florida for its opioid-based oxycodone medications, leading the DEA to revoke Masters’ registration in 2015. The company petitioned that revocation, and has been operating under the terms of a court-ordered stay. Now, the DEA has urged that the stay be rescinded, thus effectively prohibiting Masters from selling opioid medications.

Florida’s governor declared that the state was in a “state of emergency” with regard to the opioid problem. Opioid abuse has killed some 30,000 Americans over the last several years.

Masters is one of several pharmaceutical manufacturers that have come under fire for their roles in supplying the drugs that are being fatally abused.

The results of the DEA’s request are pending.

• July 20, 2017

DEA CLEARED TO BLOCK OPIOID SUPPLIER’S SALES

The U.S. Drug Enforcement Administration has urged the D.C. Circuit Court to block Masters Pharmaceutical, a maker of opioids and other prescription painkillers, from selling controlled substances.

In 2013, Masters allegedly failed to report to the DEA a number of “suspicious” orders from Florida for its opioid-based oxycodone medications, leading the DEA to revoke Masters’ registration in 2015. The company petitioned that revocation, and has been operating under the terms of a court-ordered stay. Now, the DEA has urged that the stay be rescinded, thus effectively prohibiting Masters from selling opioid medications.

Florida’s governor declared that the state was in a “state of emergency” with regard to the opioid problem. Opioid abuse has killed some 30,000 Americans over the last several years.

Masters is one of several pharmaceutical manufacturers that have come under fire for their roles in supplying the drugs that are being fatally abused.

The results of the DEA’s request are pending.

Opioid Fact:
Opioids killed more than 33,000 people in 2015
• June 12, 2017
food and drug administration logo

FDA URGES ENDO INTERNATION TO CEASE SALES OF OPANA

For the first time in history, the U.S. Food and Drug Administration has formally insisted that an opioid medication be removed by its manufacturer from the market. On June 8, the agency issued a statement urging Endo Pharmaceuticals to pull from circulation the powerful painkiller known as Opana.

In his remarks on Opana, FDA Commissioner Scott Gottlieb referred to the nation’s “opioid epidemic” as a “public health crisis.” Gottlieb said that the FDA was urging the removal of Opana from the healthcare marketplace because of the “public health consequences of abuse.”

According to the Centers for Disease Control and Prevention, opioid abuse killed more than 33,000 people in 2015.

Opana is even stronger that OxyContin, probably the best-known and most widely abused opioid painkiller. The drug is used to manage severe pain.

In recent years, Endo had taken some steps to reduce the potential for the abuse of Opana. Since crushing the pills release its active ingredients more rapidly (and at greater risk to the user), the company manufactured a version of the drug that had a hard-to-crush coating. Addicts circumvented this measure; some even took to injecting the medication. In a case in Indiana, needles shared by Opana addicts were linked to an HIV outbreak.

The FDA’s push for the recall of Opana was based on the agency’s finding that Endo had not taken sufficient steps to reformulate the drug or otherwise take steps that would decrease the likelihood of its abuse.

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• July 5, 2017

DRUG MANUFACTURERS ASK FDA TO REMOVE EASILY ABUSED OPIOIDS FROM MARKET

The Center for Lawful Access and Abuse Deterrence (CLAAD), a coalition funded largely by drag manufacturers, has urged the U.S. Food and Drug Administration (FDA) to remove from the market a class of prescription opioid painkillers that lack abuse-deterrent measures. The petition comes in advance of the FDA’s preparations to approve three opioids that contain the anti-abuse measures.

The FDA has approved 10 opioid painkillers that have been manufactured to include features that allegedly deter the drugs’ being abused. The drugs’ active ingredients are designed to be released at a slow trickle, thereby reducing the “high” that abusers seek.

Sales of abuse-deterring opioids have been hindered, CLAAD argues, by the fact that numerous opioid painkillers that lack the anti-abuse measures remain on the market. These older drugs tend to be less expensive than the newer, abuse-deterring drugs.

The abuse of opioid painkillers has been declared a nationwide epidemic, with more than 30,000 dying every year from the abuse of these prescription medications.

The FDA has said that it is considering the petition.

If you believe that the profit-hungry pharmaceutical industry is partly or fully to blame from any ill effects that you or loved one has suffered due to opioid painkillers, you may have a case. Contact TheLawFirm.com to learn how we can help you.

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