Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist
Showing posts with label Black Box Warning. Show all posts
Showing posts with label Black Box Warning. Show all posts

Wednesday, December 04, 2019

Turning Something Bad Into Good (Spin)



Jacob Polete (16)

Sean Polete shared his concerns about antidepressants and whether a prescription contributed to the suicide death of his 16-year-old son, Jacob Polete, on Nov. 30, 2018.

Jacob's Dr didn't inform him about the black box warning. He didn't inform him that he was prescribing it off-label' and that it wasn’t approved to treat depression in teens.

Jacob's father told the Dayton Daily News:

“I didn’t do the research because I felt like, well, I’m just happy to have somebody giving us some advice. These antidepressants and things have significantly different effects on a child’s brain and it’s much different than the adult brain.”

Step forward the spin doctors.


V. Grace Matheson, MD, PhD


In the same article, Dr. Virginia Grace Matheson, a child psychiatrist at Dayton Children’s Hospital, said:

“For most children, the drugs work. We don’t want them to be afraid of the medicine. The vast majority of cases, the medication will really help the child feel better and if they are having suicidal thoughts as part of their depression, it will relieve those in most cases. But there are those kids who have the adverse effects.”

Matheson added:

“Most of them [antidepressants] work in a very similar way, so we can sort of extrapolate from the adult data. It doesn’t mean that it’s not safe or it doesn’t work. Sometimes a child prescribed antidepressants actually has a form of bipolar disorder that wasn’t detected.”

T.J. Grimm, retail and ambulatory director for University Hospitals in Cleveland, and president-elect of the Ohio Pharmacists Association, added:

“There are people who, because they’ve heard about increased suicides, they’ve heard these medicines don’t work, (they’ve been) scared off. ”

Jacob Polete was just 16-years-old. Part of his online obit reads:

He attended Fairhaven church where he volunteered at Celebration Place, a program serving children 5 to 13 years old coping with life’s tough issues. Jacob was an avid naturalist, a fan of bushcraft, and wilderness survival. He enjoyed hiking in the woods, biking riding, and exploring large cities like New York and rural areas like the Metro Parks. He was not a fan of suburbs. He had recently started working as a bagger at Dorothy Lane Market, and was very proud of himself for saving his earnings to buy himself a new bicycle. Jacob loved food challenges, cooking, and pushing the limits of his taste buds with strong flavors and strange foods. He was fearless and impulsive, and never backed away from a challenge. He had great compassion and love for his furry friend Athena and an intimate circle of friends. His loving yet mischievous personality, combined with his intelligence and innate wisdom, gave the sense of being in the presence of an old soul. He was captivated by Lord of the Rings, both the books and the movies, and the band Pink Floyd. He was a curious experimenter and delved deeply into chemistry and botany. Since early childhood, Jacob was a skilled “deconstructive engineer,” and took apart every object he could get his hands on.

Read the full vomit-inducing spin by the 'experts' here.

In the meantime, this is for Dr Virgina Grace Matheson.


Bob Fiddaman

Monday, November 04, 2013

FDA Lose Sight With Glaxo's Potiga




The Food and Drug Administration (FDA), the US drugs regulator, have slammed a black box warning on another of Glaxo's drugs, this time it warns that their anti-seizure medication, Potiga (ezogabine), is linked to eye damage and skin problem side effects. [1]

A Black Box Warning, is the strongest warning that can be placed on a prescription medication. The warning will alert patients and doctors to the risk of severe retinal pigment changes that can lead to blindness. The label will also warn about a risk of skin discoloration, particularly of hands, toes and lips, among users of Potiga.

Potiga was approved by the European Medicines Agency under the trade name Trobalt on March 28, 2011, and by the FDA, under the trade name Potiga, on June 10, 2010.

Earlier this year the British drugs regulator, the MHRA, issued a warning to healthcare professionals in the UK. They wrote:

Pigment changes (ie, discolouration) of ocular tissue, including the retina, have been reported in two long-term clinical studies of retigabine and a compassionate use programme. These studies also observed blue-grey discolouration of the nails, lips, or skin. These reports are considered to be very common (ie, occurring in ≥1/10 patients) after prolonged retigabine treatment.

From these studies, 55 patients had eye examination up to May 2, 2013; baseline eye assessments were not done. 21 patients had pigment changes in ocular tissue—15 of which involved the retina. Five patients had visual acuity worse than 20/20. 


GlaxoSmithKline, who developed Potiga with Valeant Pharmaceuticals, proudly boast on their website that they are "a global healthcare company that is committed to helping people to do more, feel better and live longer."


Bob Fiddaman


[1] Glaxo’s Anti-Seizure Drug Gets Black-Box Warning on Eye Risks





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