The Clot Thickens: FDA Delays Lilly Blood Thinner
1 CommentBy Ed Silverman // June 23rd, 2008 // 9:59 pm
Although the drug was placed on fast-track status, the agency has postponed a final decision on prasugrel for another three months - until September 26 - in order to complete its review, according to a statement from Lilly and its partner, Daiichi Sankyo.
The move was largely expected on Wall Street, where investors were betting the FDA would opt for additional time to decide the drug’s fate due to uncertainty over the increased risk of major bleeding associated with the blood thinner.
Last winter, Lilly released a study showing prasugrel lowered the risk of cardiovascular death, non-fatal heart attacks or non-fatal strokes when compared with Plavix, the leading blood thinner. But the med caused some patients to experience a statistically significant increase in major bleeding compared to those treated with Plavix, which is marketed by Bristol-Myers Squibb and Sanofi-Aventis.
In an investor note tonight, Tim Anderson, a pharma analyst at Sanford Bernstein, writes: Lilly “continues to decline answering whether they expect an advisory committee to be held prior to final FDA action. There is currently scheduled a tentative meeting date in August, but it is unclear at present what the agenda for this meeting could be. We believe prasugrel will indeed be put before an expert panel prior to final FDA action.”
Lilly, meanwhile, confirmed the start of a head-to-head trial involving prasugrel and Plavix.
Maureen
I am exhausted, frusterated, heart sick.
At less than two years of age my parents took me to the doctors office for vaccine..either the 15, 0r 18 month shot. Within a week I had congunctivitis, seizures, hypotonia. Parents advised I had menningitis. Do not leave hospital she’s going to die. I obviously survived. At the age of 5 my little brother had the “second cousin” to polio, post polio vaccine was paralized for several weeks and recovered. My first born child (first marriage)is currently 16 and has no known health problems. My second born child(second marriage) died at 21 minutes old “potters sequence” his sister died in utero at 34 weeks, still birth. Third child currently four, no known health concerns. Fourth born, had sereal ultrasounds..born 3 weeks premature. Developed sepsis, pnumothorax, hyperbilirubinemia at 6 hours old. He spent the first weeks in neo intensive care. He died at home in his sleep at seven weeks old. We were suspects in his death. Our living children were removed from our care for more than a year and a half. I was pregnant at the time of the accusations. They took my newborn infant five weeks premature. He developed the exact same complications within the exact same time frame. At 6.5 hours old he developed sepsis, pnumothorax, hyperbilirubinemia. He spent the first three weeks of life in neo intensive care.
As suspects in his brothers death we were not allowed near him. He seized for the first 6 months of life, A relative took him to hospital time and time again. They looked at us with “concern” while his seizures were discounted as “normal” myoclonic jerks seen on EEG..I was being accused/investigated for a mental condition that does not exist. For hurting a child I could not even touch. After fighting the Ontario Coroners office, the police, the CAS..despite no charges ever being laid, my husband and I have been financially destroyed.
In an effort to pay the mounting legal bills I took a second job in a nursing home. I was required to get a T.B. shot. I had had this two step manatoux before..no reaction. This time within days of getting the shot, pressure built up in my head, blood poured out of my nose, my eyes started twitching uncontrolably. I have constant presure in my head, neck and spine. It is like I have sand in my spinal fluid. I now have fibromyalsia in addition to gullian barre that has not gotten any better or worse in a the year since its onset. I have been told that there is no cure, no treatment. I have had no follow up. The hair on my head is falling out, my chin hair has never been healthier. I have bizare pain that comes and goes. I have a muscular mass in my gutts, that tapers in at my waist line. I have constant pain above my kidney area. I am now incontenant in my bowels. I am a thirty four year old woman. I have been thru hell.
The son I so desperately wanted is finally home. He has reactive airway disease, asthma, allergies to cladisporium mold..and is undergoing testing for cystic fibrosis. Guess I was right, he has some health challenges..what came first the chicken or the egg. Does it really matter? I cant afford either.
The real kicker..If I dont immunize my kids..they will be taken into PROTECTIVE CUSTODY where they will be given the shots anyway. Rights exist for those that can afford to protect them. I chose my kids over my rights. My children and I have ten foot pole disease and we have done nothing wrong.
I am now truly immunized.