There was little fanfare in the business world earlier this year when Valeant Pharmaceuticals International acquired the rights to two drugs made by Marathon Pharmaceuticals. However what happened after that acquisition is raising serious concern.
With the deal, Valeant gained the rights to a pair of lifesaving heart drugs, Nitropress and Isuprel. The Wall Street Journal reported that on the same day bought the rights to these heart drugs, their list prices rose by 525% and 212% respectively. more
Serious concerns about the possible increased risk of heart attacks and strokes in patients using “low-T” products, have led the Food and Drug Administration to issue a new ruling requiring the makers of these dugs to alter labeling to reflect the dangers associated with them.
The FDA will now require the makers of “low-T” products, to make clear that using these products carries the possible increased risk of heart attacks and strokes. The new labeling will also state that these drugs are only approved to treat low testosterone levels caused by disease or injury, not normal aging. Continue reading
Last month, after little outside input, the Food and Drug Administration swiftly approved Vyvanse — originally marketed as an attention deficit hyperactivity disorder drug — to treat Binge Eating Disorder (BED), calling it “an effective option to help curb episodes of binge-eating.”
Days after Vyvense was approved, retired professional tennis player Monica Seles coincidentally began appearing on popular television talk shows and was featured in People magazine sharing her struggle with binge eating. The timing wasn’t coincidental; Seles is a paid spokesperson for Shire, the makers of Vyvanse, and the face of the BED drug’s marketing campaign. Along with Seles, Shire also launched a website to spur social media and began providing funding for patient groups. Continue reading
Johnson & Johnson has been ordered by a Philadelphia jury to pay $2.5 million to a 20-year-old autistic man from Alabama – who developed size 46 DD breasts as a young teenager – because the company failed to adequately warn of that potential side effect from his use of the antipsychotic drug Risperdal.
This was the first Risperdal case to go to jury that was related to the condition gynecomastia – which causes abnormal development of breasts in males. The lawsuit claimed that J&J had knowingly hid the risks of gynecomastia, and came after several other similar cases were settled in recent years. Continue reading
A civil trial in Las Vegas is pitting two cancer victims against Takeda Pharmaceuticals, the maker of the diabetes drug Actos. This comes only a month after a Louisiana jury ordered Takeda to pay $6 billion in punitive damages in another case involving Actos.
The trial in Las Vegas has been marked by the use of ultra-aggressive tactics by Takeda’s defense attorneys. Early in the trial Takeda’s counsel made antagonistic attempts to have District Judge Kerry Earley removed from the case, raising vague questions of impropriety.
It was announced last week that Stephen Nichols, of Fort Collins CO, is planning to sue Abbott Laboratories subsidiary AbbVie, the manufacturer of the popular testosterone treatment AndroGel. Nichols joins the growing number of suits being filed against the makers of AndroGel including ones already filed in Illinois and Lousiana.
Nichols suffered a heart attack after he was prescribed AndroGel to treat low testosterone. It was only after the heart attack that he learned the FDA is investigating the safety of testosterone treatments. Recent studies have also linked the treatments to an increased risk of strokes, heart attack and death.
The FDA has issued a warning concerning the use of methadone in light of the recent life-threatening side effects and deaths occurring as a result of the drug’s overuse. The dangerous side effects include slow or shallow breathing, fluctuations in heart rhythm. In 2003, methadone was listed as a cause of 2,452 unintentional poisoning deaths, up from 623 in 1999.
The manufacturer of the contraceptive Ortho Evra will have to change its warning label to include a warning against blood clots. One study showed women who used the patch were twice as likely to develop blood clots than others who took the pill.
It’s been a bad day for Merck, the maker of Vioxx. First, a New Orleans jury hit them with a $50,000,000 verdict for failure to warn doctors about the dangers of its drug, Vioxx. Then, a New Jersey state judge vacated a Merck victory, ordering a new trial for a postal worker who blamed his heart attack on taking the company’s Vioxx pain medicine for two months. Judge Carol Higbee ruled evidence uncovered since the November verdict showed that Merck withheld information showing heart attacks could come with use of Vioxx for less than 18 months.
Three weeks after a worldwide recall of its product, ReNu with MoistureLoc is still being sold in some places in the United Kingdom. Anecdotal evidence of people still using the multipurpose ‘no rub’ solution raised fears that the message regarding the potential dangers of using the product had not reached all patients.
Roger Oldham, a website director from south-east London, told Optician he was still using the ReNu with MoistureLoc solution earlier this week, having purchased his last batch of solutions in early May.
He was concerned that his optician had not contacted him to tell him of the product recall and warn him of the dangers. Few practices, however, monitor the solutions sold to or used by their patients