When was the last time you read the fine print on a prescription drug, much less the two pages of boring clinical data that follows each drug advertisement in magazines? If you’re like most people, you skip right past.
The FDA knows this, and they’re now changing their tune to get manufacturers to focus on less, but more important data information in their drug ads.
A new study out this month suggests that a popular class of drugs known as proton pump inhibitors used by millions of people daily may contribute to heart attacks and cardiovascular death.
The results were released this week in the online journal Public Library of Science, or PLOS One. Researchers based at Stanford University tracked more than 16 million medical records from 2.9 million patients.
A class of antibiotics relied on for years for serious infections are being overused, says a consumer group advocating for tougher warnings from the FDA. And now, with numerous cases surfacing of patients suffering nerve damage, some are filing lawsuits against the drug makers.
Fluoroquinolones are synthetic antibiotics designed to be used in cases of serious infection. The precursor to these, quinolones, have been in use since the late 1970s. Since then, they have undergone at least four generational evolutions to maintain effectiveness and name brand protection against generics.
When the dust settled last May on years of litigation over bleeding risks from the blockbuster anticoagulant Pradaxa, German manufacturer Boehringer Ingelheim had agreed to pay $650 million to compensate around 4,000 patients and surviving family members.
The problem with the settlement, legal experts pointed out, was that Pradaxa was still being prescribed to millions of new patients with little warning of the potential for internal bleeding. And, those hospitalized after May 2014 would not receive compensation.
Not fair, said a group of leading drug injury law firms, who have commenced plans to start new Pradaxa litigation in a different court this year.
Last year, news broke that power morcellator surgical devices used in hundreds of thousands of hysterectomies could cause the spread of deadly uterine cancer, and that 1 in 350 women could be affected.
Most of the involved parties acted swiftly to limit the risk to future patients: major surgical centers announced they were halting use of the devices; the FDA recommended limiting their use; and the largest manufacturer of the machines stopped selling them.
A Pennsylvania jury this week ruled that a retired teacher’s bladder cancer was caused in large part by the diabetes medication Actos, and that the maker of the drug had not properly warned he or his doctor of the dangers.
The decision is the latest warning to consumers over the safety of Actos, which was once the most popular drug in the world for treating type-2 diabetes. Japanese drug maker Takeda continues to claim it is safe, although they now face over 7,500 patient lawsuits for bladder cancer.
In May of 2010, 28-year-old Petra Zele was a young, vibrant woman living out her dreams in Australia. Like many her age, she was taking Yasmin, one of the most popular birth control pills at the time.
However, less than a week later, she would be dead from a massive pulmonary embolism blood clot in her lungs.
A fresh report from a leading prescription medication watchdog suggests drug companies aren’t holding up their end of the bargain of letting consumers know all the details of their product side effects.
The report, out last week from the Institute for Safe Medication Practices, shows pharmaceutical companies don’t turn in complete reports for over half of the instances of drug side effects that take place.
It’s no surprise that with pressure from shareholders, drug companies must find new ways to continue increasing profits. However, recent double-digit increases in the cost of medications is putting many dependent Americans in a tough position.
On one side, the cost of brand name drugs continues to rise, forcing many to consider cheaper generics or causing most insurance companies to push generic alternatives on patients whenever possible.
A study released this week by the Journal of the American Medical Association shows patients over age 65 who take popular sleep aid medications may face higher chances of developing dementia.
It’s not the first study to produce such results, however, it is the first to isolate the risk to the drugs themselves, instead of underlying risk factors in patients taking them. Also, what were initially thought to be temporary cognitive side effects may now actually be permanent.
DrugNews reported last year on the wave of male breast growth side effects sweeping minors who were prescribed the antipsychotic drug Risperdal for autism, depression or anxiety.
Now, with the latest trial underway for a boy allegedly affected by Risperdal, the former head of the Food and Drug Administration has been called on to testify about Johnson & Johnson’s marketing of the medication for unapproved purposes.
With cases in a newly-created Louisiana federal court moving full steam ahead over injuries from the blood thinner Xarelto, a Pennsylvania state court recently announced it too would enter the fray and hear claims over patient internal bleeding.
DrugNews reported last month that the Judicial Panel on Multidistrict Litigation had transferred more than 50 cases from around the country alleging internal bleeding from Xarelto to the Eastern District of Louisiana for handling by U.S. District Judge Fallon. That MDL system is designed to provide an expedited legal process for patients with similar cases.