Lupron was injected in thousands of women in an effort to inhibit puberty or increase height.
More than 10,000 adverse event reports have been filed with the FDA based on the experiences of women who’ve taken Lupron. The reports describe a variety of symptoms experienced by those who took the drug to grow taller or delay puberty.
Lupron, currently manufactured by AbbVie, is an injection designed to reduce testosterone in men or estrogen in women. The drug is also approved for use by men with prostate cancer.
The experiences of the women that used the drugs are varied but complex. Many women reported experiencing symptoms and conditions linked to older, even elderly people. According to the FDA reports:
A 20-year-old was diagnosed with osteopenia, a thinning of the bones. A 26-year-old in Massachusetts needed a total hip replacement. One 25-year-old woman from Pennsylvania has osteoporosis and a cracked spine. In Wisconsin, another woman in her 20’s has chronic pain and degenerative disc disease.
Other women described depression and anxiety.
Additionally, the FDA is reviewing deadly seizures caused by the use of Lupron and similar drugs.
The drug has had success in the marketplace. In 2015, the drug-maker reportedly brought in $826 million in sales.
The Tecfidera label now reflects a possible side effect of liver injury.
Tecfidera, Biogen Inc’s multiple sclerosis (MS) drug, has received label updates to disclose a potential liver injury that could require hospitalization.
The world’s best selling oral MS drug experienced sales of $1.03 billion in the third quarter and accounts for about a third of the pharmaceutical company’s revenue.
Biogen reports that only 14 instances of liver injury have occurred around the 230,000 patients who have taken Tecfidera.
This isn’t the first time Tecfidera has had the spotlight. Just last week, Biogen Inc. announced a settlement of a patient infringement lawsuit for $1.25 billion concerning the multiple sclerosis drug.
The label updates mention that abnormalities are resolved after use of Tecfidera ends. A few cases required that the user be hospitalized. None of the cases have led to serious conditions including liver failure, liver transplant, or death.
The city of Everett, Washington has filed a “first-of-its-kind lawsuit” against Perdue Pharma, the manufacturer of OxyContin.
Everett, Washington is a place where addiction to heroin and other opioids is officially considered an epidemic. Now, the city has filed a “first-of-its-kind lawsuit” against the manufacturer of OxyContin. Citing gross negligence, the city claims that when Perdue Pharma marketed OxyContin as a less-addictive alternative to other pain medication, they did the public a disservice.
The city wants the manufacturer to start paying to repair damagesdone to the community harmed by the epidemic. Everett Mayor Ray Stephanson said “we are going to go at them, and we are going to go at them hard.”
Officials claim that at the height of the epidemic, OxyContin was a factor in more than half of the crimes committed in Snohomish County.
In an LA Times article it was noted that “those drawn to the pills included young people and professionals who saw the painkiller as more fashionable and less dangerous than street drugs.
Many became addicted and lost their homes, jobs and families. After Purdue reformulated OxyContin in 2010 to make it harder to abuse, addicts moved en masse to heroin, which has a similar effect.”
Experts have mixed opinions about Everett’s chances of recovering money.
The company has agreed to pay a $150 million fine after they allegedly failed to detect and report suspicious orders of prescription pain pills, according to federal prosecutors. This has arguably led to the growing heroin crisis.
For example, more than 1.6 million orders for controlled substances were filled by McKesson in Colorado between June 2008 through May 2013. However, just 16 of them from a single customer as suspicious, the Justice Department said.
In a statement from the White House last summer, federal fears related to pain killer and opioid addictions were made clear:
“President [Obama] has made [it] clear that addressing this epidemic is a priority for his Administration. While Federal agencies have been using their authority to take every available action they can, Congress needs to take action on what is most urgently needed now – additional funding to make lifesaving treatment available to everyone who seeks it. The President has called for $1.1 billion in new funding to help Americans who want treatment get it wherever they live.”
McKesson, the nation’s largest drug distributor, was accused of failing to create an effective system to detect suspicious pharmacy orders. This was argued to be a violation of the Controlled Substances Act.
In 2008, McKesson agreed to a $13.25 million civil penalty for actions including failing to report suspicious sales of their drugs on “internet pharmacies.”
In a statement, McKesson said it settled “in the interest of moving beyond disagreements about whether McKesson was complying with the controlled substance regulations … and to instead focus on the company’s partnership with regulators and others to help stem the opioid epidemic in this country.”
Data from the Center for Safety and Applied Nutrition’s Adverse Event Reporting System can be useful in litigation and beyond.
Thanks to a new service, consumers might be little bit safer. The Food and Drug Administration (FDA) recently announced that the Center for Safety and Applied Nutrition’s Adverse Event Reporting System (CAERS) database will be made public. The CAERS is a database that includes reports about harm and product complaints submitted to the FDA.
The new database can be accessed by consumers, researchers, industry pros and attorneys. The boon helps individuals learn more about products and their potential or previous harm to individuals.
Perhaps more importantly, industry professionals now have access to data with transparency. The co-founder of Center for Science in the Public Interest in Washington, a group that monitors concerns about food safety, Michael Jacobson sees this as a victory.
“If somebody, like a poison-control center, has concerns, they can go and see if there happen to be some reports,” Jacobson said told Bloomberg.
Lawyers and companies, will find this information particularly useful. Some of the information can help with litigation. The information will certainly be mined by parties who could use reports to file lawsuits against manufacturers or retailers.
The CAERS data will help the FDA and other experts monitor and study trends in “adverse event reports” that could signal a genuine safety issue with a product.
Popular over-the-counter heartburn drug Nexium, has made news recently over possible harmful side-effects. Multiple lab tests have revealed that the drug can lead to damage of arteries as well as an increased risk of heart attack or heart disease.
According to a CBS news report, AstraZeneca, the maker of Nexium, responded with a statement noting that the study was conducted in a laboratory setting, “not in humans within a controlled clinical trial. Therefore, conclusions around cause and effect cannot be made.
In a CNN report it was stated that patients who took PPIs (like Nexium) had a 96% increased risk of developing kidney failure and a 28% increased risk of chronic kidney disease compared to the patients who took the histamine H2 receptor blockers (another form of heartburn medication.)
AstraZeneca also stated that the drug is typically safe to use when taken in the prescribed doses, however many people do not follow the recommended doses as printed on the label. Roughly 1 in every 14 Americans use some form of heartburn medication, and many people end up overusing the drugs over a long period of time.
This continues to be a somewhat confusing topic due to the fact that it has not been proven that Nexium is the cause of the damaged arteries, but with all of the speculation there is cause for concern. The FDA has called for increased testing on all heartburn medications to ensure the products are safe, and the side-effects are properly labeled on the packaging.
There have not been any lawsuits filed over this issue, but if it is revealed that Nexium is linked to heart problems, there could be cases to come.
Reports have been released showing legendary pop star Prince, died of an overdose of the painkiller Fentanyl. The drug, which can be found on the black market, is more than 100 times more potent than morphine, making it the strongest opioid available.
“Fentanyl is a very dangerous opioid, whether you’re taking it as a prescription or you’re mixing it with black-market heroin,” said addiction specialist Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, in a USA Today article.
“Celebrity overdoses are just the tip of the iceberg of an epidemic,” Kolodny said. “Many of these deaths are occurring in people who are not your typical drug abuser. They are suffering from chronic pain and they are becoming addicted to legitimately prescribed medication.”
Prince’s death is just one in an increasing trend of opioid-related fatalities in America. According to a CDC report, Since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids. The alarming growth of opioid addictions and deaths has even been a topic in the presidential race, and continues to be a major topic in politics as a whole.
One startling point made in a Washington Post article is that so many people are dying of drug overdoses that it’s easing the shortage of donated organs. While there are many factors, whether accidental or intentional, that contribute to the number of overdoses in this country, there must be more effort put in to stop this growing epidemic.
In the past year, google searches containing the word “opioid” have increased continuously, and they grew even more when Prince’s death was linked to the painkillers. The awareness of the problem has grown across the country, however a solution has not been found. Hopefully there can be a solution to rehabilitate addicts, and prevent future overdoses from occurring.
Purdue Pharma, makers of OxyContin, are facing some increased scrutiny from the FDA over their marketing of the popular painkiller. Since the release of OxyContin, the packaging has always said “12-hour relief” however in some patients the effects of the drug begin to wear off after about eight hours. This leads to many patients having to take more pills each day than what they were originally prescribed. Opioid addiction is increasing across the country and Purdue is being blamed as one of the leading causes.
In a large-scale investigation of the pharmaceutical company by the LA Times, it was revealed that they knew the effects of OxyContin did not always last 12 hours. The main reasoning for the company’s false advertising was because the 12-hour relief claim gave the drug a large competitive advantage over other, less expensive drugs. In the late 1990’s, doctors began prescribing OxyContin at shorter intervals so Purdue sent a team of sales executives all across the country to convince doctors to stick with the 12-hour doses. According to the LA Times report, More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.
In a statement released by Purdue the company had this to say, “Nearly a decade ago, the FDA cited a lack of clinical evidence when it formally rejected the ‘fundamental premise’ that patients receiving OxyContin at intervals more frequent than twice-daily are at increased risk of ‘side effects and serious adverse reactions.’ In doing so, the agency reinforced the twice-daily labeling for OxyContin. The LAT omitted the findings of this report from its story.”
This story will be one that continues to develop and as news comes out, lawsuits may follow. The entire medical world will be following these developments as it could change the market for painkillers in the United States and other countries as well.
Addiction to painkillers, and other opioid drugs, is a serious problem in the state of West Virginia. According to a CBS News report, West Virginia has the highest rate of overdose deaths in the nation. Each year doctors write the equivalent of one painkiller prescription for every man, woman and child in this state of 1.8 million people. The painkiller problem has become so severe that state legislature has stepped in to make changes, and has led to the addicts suing doctors.
More than 30 addicts have sued their doctors for enabling their addiction. Many of these patients suffered from work related injuries and had to rely on painkillers in order to continue working.
Patients are not the only ones filing lawsuits regarding this subject. West Virginia Attorney General Patrick Morrisey has filed a lawsuit against McKesson Corporation, a prescription drug distributor, for allegedly failing to identify, detect, report and help stop the flood of suspicious drug orders into the state.
According to a CBS San Francisco article, The DEA, along with six states, sued McKesson (a San Francisco based company) in 2008 for supplying hundreds of suspicious hydrocodone orders to rogue pharmacies. McKesson settled, paying more than $13 million in fines and agreeing to closely monitor their pill supply.
In research of McKesson’s involvement in West Virginia, it shows that more than 100 million doses of opioids to a state where the population is 1.8 million. This egregious amount of drugs being sent to a state that has the most overdose related deaths in the country is what has put the company in hot water. McKesson could face tens of millions in legal fees, but for a company that makes over a billion dollars that is simply pocket change.
Hopefully the changes made by the legislation in West Virginia can help the addicts recover and find the treatment they need.
Johnson & Johnson is back in the news, although it is not they type of news they would like to hear. The company is entrenched in a pelvic mesh lawsuit that has already seen over 100 cases settled in the past year, and faces over 30,000 more cases that have yet to be heard. While the exact settlement numbers have not been released by Johnson & Johnson, it is speculated that the company could lose millions.
What is the Reason for the Lawsuits?
The pelvic mesh lawsuits are flooding in from patients all over the country who have experienced severe side effects from the mesh. The claims are being made that Johnson & Johnson did not properly market the products, failing to cite the side effects that were caused by the product.
In a report by the Associated Press, Attorneys General Bob Ferguson of Washington and Kamala Harris of California accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain. These side effects can make everyday activities such as walking up and down stairs, laying down, or exercising extremely painful.
In a Reuters article, it is stated that Johnson & Johnson sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California. Also in that article, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse trans-vaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices’ safety. Hopefully this increased scrutiny by the FDA will prevent something like this from happening again in the future.