Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

Taro Pharmaceuticals U.S.A., Inc. Issues Voluntary Nationwide Recall of Lamotrigine Tablets USP, 100 mg, 100 Count Bottles

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-lamotrigine-tablets-usp-100-mg-100

Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Cross contamination with another drug substance, Enalapril Maleate
Company Name:
Taro Pharmaceuticals U.S.A., Inc.
Brand Name:
Taro Pharmaceuticals
Product Description:
Lamotrigine Tablets, USP 100mg

Company Announcement

Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling one (1) lot of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021) in 100 count bottles, NDC 51672-4131-1 to the consumer level. This single lot of Lamotrigine 100 mg Tablets Lot #331771 (expiration date June 2021) was found to have been cross-contaminated with a small amount of another drug substance (Enalapril Maleate) used to manufacture another product at the same facility.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200110005522/en/External Link Disclaimer

Risk Statement: Use of Lamotrigine 100 mg Tablets could potentially result in exposure to a small amount of Enalapril Maleate, if present in the product in question. Enalapril Maleate is a drug substance indicated for hypertension and congestive heart failure. There is potential with chronic exposure to Enalapril Maleate to impact users particularly if they are small children or pregnant women. Enalapril Maleate is also associated with risk of birth defects in a developing fetus. Therefore, there is risk associated with the continued, long-term use of Lamotrigine 100 mg Tablets, Lot # 331771 (expiration date June 2021).

Taro has not received any product complaints or adverse events related to contamination of this product with Enalapril, or any complaints or adverse events that are associated specifically with this recall. Taro will continue to actively monitor for any and all adverse event reports that may be received, in compliance with FDA regulatory requirements.

Lamotrigine 100 mg Tablets are indicated for Epilepsy and Bipolar disorder. This product is packaged in white plastic bottles with screw cap closure, and each bottle contains 100 tablets. Each bottle is labeled to indicate the name of the product, Lamotrigine Tablets USP, 100 mg, the NDC #51672-4131-1 (see image of container label below), the lot number 331771 and expiration date of June 2021.

Lamotrigine 100 mg Tablets, Lot # 331771 were distributed to wholesale distributors in the US market between August 23 and August 30, 2019. These wholesale customers may have further distributed Lot # 331771 to retail pharmacies for prescription dispensing to patients who were prescribed 100 mg Lamotrigine Tablets.

Taro is notifying its distributors and customers by Phone, E-mail, and Letters via US Mail and is arranging for return of any containers or quantities of Lamotrigine 100 mg Tablets, Lot # 331771 (exp. June 2021). Consumers that have any quantities of Lamotrigine 100 mg Tablets, Lot # 331771 being recalled should stop using this product and return it to the pharmacy that dispensed it. Retailers, pharmacies and distributors should stop distributing or dispensing this product and return it to Taro.

Consumers with questions regarding this recall can contact Taro by calling 1-866-923-4914 or by e-mail at TaroPVUS@taro.com, Monday through Friday between 7:00 AM and 7:00 PM US Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

  • Complete and submit the report Online
  • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


Company Contact Information

Consumers:
1-866-923-4914
TaroPVUS@taro.com

Chronic pain patients concerned about proposed federal law

https://www.fox4now.com/news/local-news/chronic-pain-patients-concerned-about-proposed-federal-law

PUNTA GORDA, FLA. — For Debra Alleig, this is the best way she can describe the chronic pain she’s lived with for 17 years.

“It’s like for me a huge toothache. Like a dull, burning, constant, gnawing, nerve-ending root pain kind of,” said Alleig, “If I want to make soup, let’s say I’ll come out, cut an onion. If it’s real bad, I will go back to bed and lay down for half an hour.”

It started with back pain and then hip pain.

One spinal fusion and a hip replacement later and the aching is still there.

Over the years she been prescribed different treatments and has found that opioids work best to give her some quality of life.

But she says recent crackdowns on opioids have left chronic pain sufferers like her dealing with random drug tests, decreasing doses and sometimes being mislabeled as addicted.

“Am I dependent on my medication? Yes. Because otherwise, I would be in bed crying,” said Alleig.

She says that’s why proposed federal laws, like the NOPAIN Act gives her pause.

Those who back the bill say if passed, it would make it easier for doctors to prescribe non-opioid pain management to patients dealing with acute pain.

“This legislation is in now way shape or form intended to impact those patients ability to get access to these needed medications. The only thing that this legislation does is that it says that we think providers and patients deserve choices like they do in many other healthcare decisions and we think that pain should be no different,” said Chris Fox, the Executive Director of Voices for Non-Opioid Choices.

Still, some living with chronic pain say they’d rather keep the government out of their medical decisions.

“You go back to regular doctors treating patients. They diagnose and treat. Not our legislators. Not the government. But our doctors,” said Alleig.

Prescription-Drug Policing: The Right To Health Information Privacy Pre- and Post-Carpenter

Prescription-Drug Policing: The Right To Health Information Privacy Pre- and Post-Carpenter

This Article operates at the intersection of privacy law, Fourth Amendment doctrine, and prescription-drug surveillance instigated by the U.S. drug-overdose crisis. Reputable reporting sources frequently frame that ongoing crisis as a prescription-drug-overdose “epidemic.” Current epidemiological data, however, indicate that the majority of American overdose deaths are now a result of illicit and polysubstance drug use and not prescription-opioid misuse. The prescription-opioid-centric frame has nonetheless sparked the rapid rise of surveillance of prescribers and patients in the form of state prescription-drug monitoring program (“PDMP”) databases. State PDMPs, which maintain and analyze significant data concerning every dispensed controlled substance, surreptitiously collect a stunning amount of sensitive health information.

PDMPs are predominantly law enforcement investigative tools dressed up in public-health-promoting rhetoric. Under the guise of rogue prescriber, pill mill, and doctor–shopper crackdowns,

the Drug Enforcement Administration (“DEA”) routinely self-issues subpoenas that permit the agency to conduct warrantless sweeps of the voluminous data stored in state PDMP databases.

These rampant law enforcement sweeps procure highly sensitive health information and raise serious constitutional privacy concerns. The Supreme Court’s recent Fourth Amendment decision in Carpenter v. United States , however, may limit the DEA’s otherwise unfettered access to state PDMP databases.

Carpenter and the Fourth Amendment doctrines central to its holding motivate this Article and animate its two core contentions. First, pertinent pre-Carpenter precedent requires the DEA to obtain a warrant in order to conduct sweeps of state PDMP databases. Second,

courts are even more likely to rule that warrantless DEA searches of highly sensitive health-care data run afoul of the Fourth Amendment in the post-Carpenter world. Simply stated, patient prescribing records stored in state PDMP databases are entitled to Fourth Amendment protection.

IF you wish to read all 79 pages, click on the link above.  Carpenter vs United states     was about the government going thru a person’s cell phone history without a properly signed warrant.

There is growing list of letters from various large healthcare corporations and/or office practices owned by a large healthcare corporation.. that state that they are going to limit or stop prescribing opiates and/or controlled substances.

They are making a PUBLIC STATEMENT that they are going to start discriminating against pts who have a valid medical necessity for controlled substances and most/all of those pts are considered a COVERED ENTITY under the Americans with Disability Act and Civil Rights Act  and it is a civil rights violation.

Most/all of these healthcare corporations have NO FEAR of pts… they fear the DEA because NO PT has sued them for civil rights discrimination.

If you are a pt being discriminated against and you have one of these “denial of care letters” or know someone who has and is being discriminated against you should be contacting law firms that deal with civil rights violation… in talking to these law firms there needs to be two things you need to make clear… you are NOT TALKING ABOUT MALPRACTICE… you are talking about civil rights violation and that there is probably HUNDREDS OR THOUSANDS OF OTHER PTS being discriminated against.  All are being DENIED APPROPRIATE CARE because of the medication that you have a valid medical necessity to help optimize your quality of life and you are being ABUSED by this healthcare corporation and its employees.

You let them start talking about MALPRACTICE … it is a loser discussion… because the defendant will hire a “expert” that will testify that he/she was following standard of care and best practices and your legal team will hire a expert that will testify that the plaintiff was not… it comes a he said … she said… and many states have caps on awards for malpractice and many are so low that even if the law firm wins a malpractice case on ONE PT… they will probably not cover their expenses if they take the case on a contingency basis.

If any attorney doubts the detrimental effects of under/untreated pain.. the above chart should change their mind.

Imagine if the pts that successfully sues these healthcare corporation.. would agree to put part of their settlement into a non-profit whose sole purpose to hire PR, Lobby and Law firms to fight for the rights of the chronic pain community.  After all, isn’t getting pts  their medications and optimize their quality of life what it is all about ? While the legal profession is circling like vultures around major healthcare corporations – think hospitals, chain pharmacies, insurance/PBM industry… the non profit can start taking on Congress and challenging the unconstitutional laws that they have passed and hopefully prevent future laws that will harmful to the chronic pain community if allowed to get thru Congress.

 

Dr Ibsen and pt who doc wants to keep doing spinal procedures that could produce worse outcomes

“in constant pain and nothing else could be done”. Two gunshots were then heard in the background

https://local12.com/news/local/delhi-township-police-investigates-deaths-of-couple-cincinnati

DELHI TOWNSHIP, Ohio (WKRC) – Delhi Township Police are investigating the deaths of a man and a woman found inside a home Tuesday. The Hamilton County Coroner identified them Wednesday as Harvey and Patricia Sander.

Harvey Sander called 911 from the home on Pontius Road at about 7 a.m. He told the call-taker that his wife was “in constant pain and nothing else could be done”. Two gunshots were then heard in the background. Communication with the caller ended.

When police and a SWAT team got there, they found both dead in an upstairs bedroom.

According to the coroner, Harvey Sander killed Patricia and then killed himself.

CHRONIC ILLNESS & THE HOLIDAYS

what happened with Walgreens: “standing behind their pharmacists’ decision not to fill a controlled substance ?”

Pharmacist files whistleblower suit

www.ellsworthamerican.com/featured/pharmacist-files-whistleblower-suit/

BUCKSPORTA pharmacist is suing his former employer, Walgreens Boots Alliance Inc., alleging whistleblower retaliation, age discrimination and defamation after the company allegedly fired him when he wouldn’t fill a prescription for fentanyl patches for a customer who had been arrested on a drug trafficking charge.

A civil complaint was filed Dec. 16 on behalf of the former pharmacist, Jon Simms of Hampden, who had been working at the Bucksport Walgreens.

The complaint states that Simms refused to fill a prescription for fentanyl patches for a Verona Island man after seeing a 2018 news article that reported the man and his wife had been charged with drug trafficking.

Maine Drug Enforcement agents seized $11,000 worth of cocaine and heroin from the residence. Two Massachusetts residents also were arrested.

“Walgreens fired Simms in retaliation for blowing the whistle on Walgreens’ policy and practice of filling unsafe and illegal opioid prescriptions and deviating from the applicable standard of patient care,” stated Portland attorney Chad T. Hansen of the Maine Employee Rights Group.

Hansen represents Simms in the suit.

The American was unable to reach a Walgreens representative for comment before press time.

Simms had already had concerns about the prescription for several months before seeing the Feb. 14, 2018, Ellsworth American article about the customer’s arrest, according to a copy of the civil complaint. Simms had discussed his worries with his supervisor, another pharmacist, who did not share his concerns.

The attorney cited Maine law in the complaint, which states “a pharmacist may exercise discretion and refuse to fill any prescription if unsatisfied as to the legitimacy or appropriateness of any prescription presented or the intention of the customer to use the drug according to the instructions for use.”

Prior to seeing the news article, Simms had concerns about the strength of the patient’s prescription for fentanyl patches and how leftover portions of the patches were being disposed of, Hansen said.

Because of the strength of the patches prescribed, the patient would have two-thirds of each patch “left over,” according to the complaint.

Fentanyl poses a significant health threat and public safety concerns for anyone who comes into contact with it.

In March 2015, the U.S. Drug Enforcement Administration issued a safety alert about the synthetic opioid.

“Fentanyl is extremely dangerous to law enforcement and anyone else who may come into contact with it,” the DEA stated. “Fentanyl is potentially lethal, even at very low levels. Ingestion of small doses as small as 0.25 mg can be fatal. Often laced in heroin, fentanyl and fentanyl analogues produced in illicit clandestine labs are up to 100 times more powerful than morphine and 30-50 times more powerful than heroin.”

A new Maine law took effect on July 1, 2017, reducing the limit for all opiates prescribed to a patient to 100 Morphine Milligram Equivalent (MME).

In Simm’s case, the patient in question was being prescribed patches for daily use containing 360 MME per day, Hansen stated in the complaint. That resulted in excess fentanyl of 240 MME accumulating each day.

Maine law provides exceptions for exceeding the dosage of opiates when a person has cancer pain or is undergoing palliative care, Hansen said.

However, the prescriber must provide an appropriate “exception code.” In the case of the patient, the physician cited “palliative care.”

Simms’ other concern was that the fentanyl was being prescribed by a primary care physician.

“This was a red flag for Simms because fentanyl patches for chronic pain are normally prescribed by a pain specialist,” Hansen stated.

The patient’s wife allegedly told the pharmacist when he questioned her that “we just throw them out with the trash. It’s fine.”

The patient’s health insurance would only pay for one patch every three days, so his doctor contacted the Johnson & Johnson Patient Assistance Foundation, which agreed to pay for the patches, the complaint stated.

The last time Simms issued patches to the patient’s wife before Feb. 14, 2018 — the date of the drug bust — Simms asked the woman if she and her husband would consider disposing of them at the Bucksport police station.

“Simms watched her reaction closely,” said Hansen. “She recoiled for an instant, then recovered.” The woman said “I suppose that could be an option.”

Then the article about the drug bust came out.

“Simms thought of all the times that he had dispensed fentanyl directly into this alleged dealer network,” Hansen said. “Simms felt nausea and guilt that he had not acted sooner on his suspicions and that he had not called the doctor to propose witnessed disposal of the leftover patches.”

Hansen said Simms’ supervisor at the pharmacy told Simms that what happened to the fentanyl waste was not their concern as pharmacists and that their role was limited to counseling the patient on the safe disposal of partially used patches.

As a pharmacist working for Walgreens, Simms was required to complete “Walgreens’ Good Faith Dispensing Checklist,” before electronically filling any Schedule II drug, such as fentanyl.

Question 1 is “Are there warning signs present with this patient or this prescription?” Hansen said. “Simms could no longer answer ‘no’ to Question 1, which meant he could no longer fill this prescription.”

Simms alerted the patient’s physician that the pharmacy was no longer going to be able to fill the prescription in light of the drug arrest. He also notified the Johnson & Johnson Foundation.

The pharmacy supervisor notified him several days later that he was going to report Simms’ actions with the physician and the foundation to Walgreens.

On April 4, 2018, a Walgreens representative called Simms and advised that he had been fired.

Hansen said the company’s initial position about firing Simms was that he had violated the company’s privacy policy by accessing the patient’s profile in order to determine the next date of distribution for the patches. Simms checked that date after seeing the report about the patient’s arrest.

“Subsequently, Walgreens has changed its explanation for Simms’ termination to allege that he was terminated, in part, for contacting the patient’s physician and Johnson & Johnson,” the attorney stated.

At the time Simms was terminated, he was 59 years old. He was replaced with a “substantially younger employee pharmacist,” Hansen said. “After Walgreens took control of the Rite Aid stores in Maine, it has systematically removed older employees and replaced them with younger employees.”

The company viewed Simms as an older employee who had more experience, confidence and willingness to speak out against Walgreens’ practices, the attorney said.

Simms has been unable to find a full-time position as a pharmacist because of Walgreens’ actions, Hansen said.

Simms is seeking a jury trial as well as back pay, benefits, compensatory damages and attorneys’ fees and legal expenses. No date for trial has been set yet.

Alcohol-related deaths in US have more than doubled over past 20 years, study finds: yet no CRISIS

Alcohol-related deaths in US have more than doubled over past 20 years, study finds

https://www.foxnews.com/us/alcohol-related-deaths-us-more-than-doubled-20-years

The number of alcohol-related deaths in the U.S. has more than doubled since the turn of the century, according to a new government report.

“Alcoholism: Clinical and Experimental Research” found alcohol-related deaths per year shot up from 35,914 in 1999 to 72,558 in 2017. Given reports that death certificates often fail to indicate alcohol as a cause of death, the actual number is likely higher.

Researchers at the National Center for Health Statistics looked at death certificates from 1999 to 2017 and found the rate of alcohol-related death increased 50.9 percent, from 16.9 to 25.5 per 100,000. This equates to nearly 1 million lives lost over the 18-year span.

In 2017 alone, 2.6 percent of deaths in the United States were alcohol-related. Nearly half of the alcohol-related deaths were the result of liver disease or overdoses.

Rates were highest among males, those between the ages of 45 and 74 years and among non-Hispanic American Indians or Alaska natives. However, the largest annual increase occurred among non-Hispanic white females.

Unsurprisingly, Americans have been consuming more alcohol since the start of the new millennium. Per capita consumption of alcohol over the same time period by about 8 percent. An average of 2.34 gallons of ethanol were consumed per capita in 2017. Over 20 million gallons of beer were consumed that year, according to Statista.

As of 2017, health care costs from alcohol abuse alone in the U.S. were estimated to be $27 billion per year.

Myth 8: Over prescribing: Dr. Thomas Kline, MD, PhD: Medical Myths Revealed

Myth 8: Overprescribing

 Over prescribing: Dr. Thomas Kline, MD, PhD: Medical Myths Revealed

Are CHRONIC PAIN PTS the only group not involved in suing someone over the opiate crisis.

Major Pharmacy Chains Claim Doctors, Other Providers Are Responsible For Opioid Crisis In New Lawsuit

https://khn.org/morning-breakout/major-pharmacy-chains-claim-doctors-other-providers-are-responsible-for-opioid-crisis-in-new-lawsuit/

“The pharmacist is not supposed to be second guessing the medical necessity of the doctor’s prescription,” said Timothy Johnson, an attorney for

Discount Drug Mart. Walgreens, CVS, Rite Aid, Walmart and others who have found themselves in the cross hairs over who was responsible for curbing the opioid crisis filed their own suit against providers.

The Associated Press: Pharmacies Say Prescribers Bear Opioid Crisis Responsibility Doctors and other healthcare practitioners who write prescriptions bear ultimate responsibility for improper distribution of opioids to patients, not pharmacists who are obliged to fill those prescriptions, a series of pharmacy chains argued in federal court. The filings, which were submitted Monday to the federal judge in Cleveland who has been overseeing the national opioid lawsuits, asked the judge to rule in the pharmacies’ favor and reject claims brought by some Ohio counties. The judge has scheduled an October trial for claims against CVS, Rite Aid, Walgreens, HBC and Discount Drug Mart. (Welsh-Huggins, 1/7)

when “deep pockets” start suing each other… then perhaps we really have some sort of crisis.. how much long before the insurance/PBM industry gets sued… after all they did PAY FOR ALL THE OPIATES … so how much of a stretch is it that the law firms start suing them because after all they did pay for most/all of those opiates. ?

could all of these legal activity cause some/many healthcare corporations to “just say no ” when it comes to dealing (prescribing, filling, paying ) with opiates. The financial liabilities could prove to be just too costly.

Of course, throwing tens of millions of chronic pain pts into untreated/unrelenting pain… may end up being NOT THEIR PROBLEM

 

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