FDA Issues New Warning for Popular Type 2 Diabetes Drug

2 Indest-2009-1By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
The Food and Drug Administration (FDA) recently warned that a new class of type 2 diabetes drugs may cause a serious condition and can lead to hospitalization. Included in that warning is Invokana, the first in a new class of frontline treatment for type 2 diabetes. It was approved in 2013 and quickly gained popularity among health care providers and patients. Other drugs in the class include Invokament, Jardiance, Xigduo XR, Farxinga and Glyxambi. These drugs, known as SGLT2 inhibitors, are intended to improve glycemic control in patients with type 2 diabetes by blocking the absorption of glucose in the kidneys.

The Problem.

According to the FDA’s warning, SGLT2 inhibitors can lead to the development of diabetic ketoacidosis, a serious condition that can result in cerebral edema, pulmonary edema, heart attacks, strokes, cardiac dysrhythmia, nonspecific myocardial injury, diabetic retinopathy, severe dehydration, coma and death. The FDA recently took notice of these significant health risks and issued a safety announcement that warned of the serious side effects potentially resulting from treatment with SGLT2 inhibitors. To read the FDA’s warning, click here. To read one of our blogs on a similar case, click here. Click here to find out how The Health Law Firm can help you with a situation such as this.

Comments?

Did you develop ketoacidosis after taking a SGLT2 drug such as Inkovana? If you or a loved one took Invokana or another type 2 diabetes drug that resulted in ketoacidosis, you may have legal options. Please leave any thoughtful comments below.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Food and Drug Administration, FDA, defense attoryney, defense lawyer, defense counsil, Inkovana, Type 2 Diabetes Drug, SGLT2 inhibitors, products liability attorney, products liability lawyer, ketoacidosis, safety announcement, recall, safety warning, drug side effects, plaintiff products liability attorney, health care attorney, health care lawyer, health law, The Health Law Firm

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2015 The Health Law Firm. All rights reserved.

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United Parcel Service (UPS) Agrees to Pay Settlement for Online Pharmacy Shipping

11 Indest-2008-8By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

United Parcel Service, Inc. (UPS) will pay $40 million to the Department of Justice (DOJ) to settle a probe related to its shipments on behalf of illicit online pharmacies. This announcement came on March 29, 2013.

Click here to read the press release from the DOJ.

UPS and FedEx Corp., have been the targets of a federal investigation to crackdown on illegal sales of prescription drugs.

UPS Had Previous Warning of Investigation.

From 2003 to 2010, the government warned UPS that internet pharmacies were using its services to distribute controlled substances and prescription drugs, according to the Orlando Sentinel. Federal law prohibits the purchase of controlled substances without a valid prescription from a physician. Even after being made aware, the government alleges UPS did not implement procedures to close these pharmacies’ accounts.

According to the Orlando Sentinel, because of the settlement agreement, the government agreed not to prosecute UPS. The company has also agreed to enhance its compliance policies with respect to shipments made from internet pharmacies. The company could have faced charges ranging from money laundering to distribution of controlled substances. Click here to read the entire article from the Orlando Sentinel.

FedEx Calls the Investigation a Threat to Privacy.

FedEx, has acknowledged it is under investigation, but called the probe a threat to customers’ privacy, and “absurd and deeply disturbing,” according to an article in the Wall Street Journal. FedEx has allegedly asked the Drug Enforcement Administration (DEA) to give the company a list of pharmacies it believes to be illegally operating so FedEx can shut down shipping services to those pharmacies. So far, FedEx is not facing any charges. To read the article from the Wall Street Journal, click here.

DEA Went After Doctors, Pharmacists and Pharmacies First.

Law enforcement including the DEA, the Federal Bureau of Investigation (FBI), and the Department of Health (DOH) all seem to be having a hard time keeping up with prescription drug abuse, especially in Florida. These agencies have increased their efforts on doctors, pharmacies and pharmacists to crackdown on violators.

Click here to read a blog on an Orlando physician accused of prescribing painkillers to undercover agents. Click here to read a blog DEA’s investigation of six Walgreens pharmacies in Florida. Click here to read a blog on a Florida pharmacy owner who allegedly committed a $23 million health care fraud scheme. Check our website for similar blogs.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.


The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Comments?

What do you think of the government’s investigation into UPS and FedEx? Do you think it could possibly be an invasion of privacy? Please leave any thoughtful comments below.

Sources:

Barrett, Devlin. “UPS to Settle Web Pharmacy Case.” Wall Street Journal. (March 29, 2013). From: http://online.wsj.com/article/SB10001424127887323501004578390623687298836.html

Pavuk, Amy. “UPS Agrees to $40M Settlement in Online Pharmacy Shipping Probe.” Orlando Sentinel. (March 29, 2013). From: http://articles.orlandosentinel.com/2013-03-29/news/os-ups-dea-prescription-drugs-20130329_1_online-pharmacies-prescription-drugs-ups

Department of Justice. “UPS Agrees to Forfeit $40 Million in Payments from Illicit Online Pharmacies for Shipping Services.” Department of Justice. (March 29, 2013). From: http://www.justice.gov/usao/can/news/2013/2013_03_29_UPS.forfeit.press.html

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

 

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

California, Pennsylvania and Kentucky Move to Tighten Laws Related to Controlled Substance

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

In reports from both coasts, three states have recently made moves to tighten monitoring and prescribing of controlled substances. Legislators in California, Pennsylvania and Kentucky are contemplating new actions. Health professionals should take note, these prescription drug monitoring programs can, and will be, used as a prosecution tool.

Details of the Prescription Drug Monitoring Program Possibly Coming to Your State.

According to the Los Angeles Times, California is looking to utilize its prescription drug monitoring program CURES to find physicians who are a little too loose with the prescription pad. Lawmakers are contemplating mining the data compiled by CURES to find physicians who are overprescribing and take action against them. Click here to read the entire Los Angeles Times article.

The Pennsylvania house recently forwarded a bill from committee to the floor for a final vote. The bill would establish a monitoring program like those in California, Florida and Kentucky. This monitoring program would be used to combat abuse and doctor shopping by identifying patients that have already received an adequate supply of medications.

Kentucky, already the home of some tough prescription drug laws, is looking to fine tune its regulatory scheme. According to The Courier-Journal, the new bill would clarify existing regulations by providing medical exemptions for patients that would otherwise be wrapped up in the enforcement provisions. To learn more on the proposed changes to Kentucky’s prescription drug laws, click here.

Most States Looking into Prescription Drug Monitoring Programs.

Lawmakers in all three states cited laws and regulations from other states as inspiration for the moves to consider new laws to monitor prescriptions of controlled substances. What this means is that whatever state you may be in, you should be aware that lawmakers are looking around the country at what works and are implementing similar programs and laws in their governments.

Databases Can Be Used as a Prosecution Tool.

Enforcement of drug laws and prescribing regulations has been ever increasing in recent years. The implementation of these databases and corresponding regulations are going to provide more tools for law enforcement and state medical boards to crack down on physicians. In order to avoid trouble it is crucial that you take time to review your state’s prescribing and record keeping laws with an experienced health care attorney.

From experience, we have seen the database in Florida used mostly as a tool for prosecution of pain management physicians and pharmacists. Even in cases where the pharmacist has been the one to notify the authorities of suspected forged prescriptions and where the pharmacist has cooperated in prosecuting the criminals, I have seen this database cited as evidence against him or her. I do not believe this is what the legislation intended. Physicians and pharmacists should consider using whatever database is implemented in their respective states, or otherwise remaining vigilant to avoid being labeled an overprescriber.

To read legal tips to manage pain patients, click here.

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

Opinions?

Does the state where you are located have a prescription drug monitoring program? Is it similar to any of programs we mentioned in this blog? What do you think of these programs? Are they necessary? Please leave any thoughtful comments below.

Sources:

Girion, Lisa and Glover, Scott. “Atty. Gen. Kamala Harris Urges Funding for Prescription Tracking.” Los Angeles Times. (March 3, 2013). From: http://latimesblogs.latimes.com/lanow/2013/03/attorney-general-kamala-harris-funding-prescription-database-.html

Wynn, Mike. “Kentucky Legislature Overhauls Prescription Drug Law.” The Courier-Journal. (March 4, 2013). From: http://www.courier-journal.com/apps/pbcs.dll/article?AID=2013303040093&nclick_check=1

Associated Press. “Lawmakers Mull Prescription Drug Monitoring.” Associated Press. (March 4, 2013). From: http://meadvilletribune.com/local/x986702017/Lawmakers-mull-prescription-drug-monitoring

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.