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Ortho-McNeil knew Ortho Evra Patch was Lethal

Evelyn Pringle April 19, 2006

Documents have surfaced in litigation that show Ortho-McNeil has been analyzing the FDA’s death and injury reports on women using the Ortho Evra birth-control patch, and has charts that show a higher rate of blood clots and deaths in women on the patch when compared to women who take birth-control pills.

In addition, according to a November 11, 2005, article by the Associated Press, an internal company memo shows that in 2003, the company refused to fund a study comparing the Ortho patch to the company’s Ortho-Cyclen pill because there was “too high a chance that study may not produce a positive result for Evra” and a “risk that Ortho Evra may be the same or worse than Ortho-Cyclen.”

A number of doctors and health-care providers no longer prescribe the patch, saying they do not want to take any chances. In Memphis, TN, obstetrician and gynecologist, Henry Sullivant, told the Wall Street Journal, that he has stopped writing new prescriptions and suggests that his roughly 2 dozen users try other forms of birth control, such as the pill or vaginal ring.

Pennsylvania State University, which provides health services for 42,000 students, is also no longer issuing prescriptions, and according to the Journal, is considering contacting all students who have been given prescriptions, even if they are no longer at the university.

Since obtaining FDA approval in 2002, the Ortho patch has become a very popular product. In 2004, according to the industry monitoring firm, IMS Health, doctors wrote more than 9.4 million prescriptions for the patch and sales topping $411 million. That is 21% more than the top-selling brand of birth-control pill, IMS Health says.

The patch is about the size of a matchbook and the biggest draw is that it eliminates the need to remember to take a pill every day. The patch is applied to the lower abdomen, buttocks, upper arm or upper body and worn for 7 days, and then replaced with another patch, for 3 consecutive weeks, followed by a week without a patch.

The system delivers hormones through the skin into the bloodstream and contains progestin and estrogen, the same hormones found in birth-control pills. Although the estrogen levels are similar in the pill and the patch, before entering the blood stream the hormones in the pill are processed through the digestive tract, while hormones in the patch go straight to the bloodstream.

Both products work the same by: (1) preventing ovulation; an egg is not released by the ovaries for fertilization; (2) thickening cervical mucus so sperm are less likely to enter the uterus; and (3) causing changes in the endometrium to reduce egg implantation.

In the case of adverse reactions, blood clots usually form in the legs, and become serious problems if they travel to the heart, lungs or brain. Symptoms include pain in the calf, shortness of breath, chest pain, or coughing up blood.

When the patch was up for approval in 2000, it is now known that doctors warned the FDA that clots could be a problem if the patch was approved.

When conducting the review of more than 3000 women, doctors discovered that two women had been treated for clots in the lungs. Ortho argued that one case should not be counted as an adverse event because the woman had undergone surgery. However, in report, a reviewing doctor argued against that claim in capital letters.

“THE REVIEWER DOES NOT AGREE WITH THE SPONSOR’S ABOVE CONCLUSIONS,” he wrote.

“The two cases of pulmonary embolus, a serious and potentially fatal condition, must be counted as two cases …,” the report said. “The incidence rates quoted by the sponsor may be misleading.”

The doctor also said, “the label should clearly reflect this reviewer’s safety concern about a potential increased risk.”

In addition, the reviewer expressed concern that 211 women had gained 10 or more pounds during the trial and said the effectiveness of the patch was reduced in women weighing over 198 pounds.

And although the report said it would be important to continue to study problems with the patch once it was approved, there were no requirements for follow-up studies other than the routine review of reports filed by consumers, doctors and manufacturers.

In July 2005, the Associated Press conducted an investigation that tracked adverse reactions in women using the patch since it came on the market. In response to a FOIA request, the FDA provided the AP with a database that contained roughly 16,000 adverse reaction reports.

The FDA’s Adverse Event Reporting System (AERS) is a computerized database designed to handle the agency’s post-marketing safety surveillance program for approved drugs. AERS receives reports from manufacturers as required by law, and health care providers and consumers send reports voluntarily through the MedWatch program. The reports then become part of the AERS database.

Since the FDA estimates that it only receives reports on between 1% and 10% of the adverse events that actually occur, the death and injury rate for products is known to be significantly higher that indicated in the database.

Within the group of 16,000 adverse reaction reports, the AP determined that there were 23 deaths. Doctors who reviewed the 23 deaths said about 17 appeared to be clot-related.

According to the AP, about a dozen women, mostly in their late teens and early 20s, died from clots in 2004, and dozens more experienced strokes and other clot-related problems.

In November 2005, the FDA warned that women using the patch were found to have as much as 60% more estrogen in their blood steam than women on the pill, putting them at a higher risk for potentially fatal side effects.

Greater exposure to estrogen, the FDA said, may increase the risk of blood clots. Experts say that clots are a known risk with hormonal birth control because estrogen promotes blood coagulation.

On November 10, 2005, the FDA revised the labeling for the Ortho patch to include a new, bolded warning to alert health care providers that the amount of estrogen delivered through the patch produces a higher level of estrogen exposure than birth control pills.

Johnson and Johnson has consistently denied knowledge of any problems with the patch. However, according to a story by CBS News, documents have surfaced in a lawsuit that show the company’s own records reveal that it received some 500 reports of serious problems associated with the patch between April 2002 and December 2004.

Apparently, Johnson and Johnson has decided it’s time to spring into damage control. On April 9, 2006, the New York Post reported that women “who suffered life-threatening blood clots and strokes on the Ortho-Evra birth-control patch are receiving cash settlements from the manufacturer, which allegedly failed to warn customers about the known risks.”

“Ortho-McNeil Pharmaceutical of Raritan, N.J., a subsidiary of Johnson & Johnson,” the Post said, “has settled a dozen lawsuits for millions of dollars in the last few months, and more than 100 other suits are pending.”

The settled cases include a lawsuit filed by Philomena Ugochukwa, a 37-year-old woman, who remains totally paralyzed after suffering a massive stroke and brain damage while wearing the patch for less than 2 weeks.

The other 11 plaintiffs who settled out of court include women between the ages 18 to 47, who suffered blood clots in the lung, leg, and brain.

One case involved 18-year-old Zakiya Kennedy, who died after collapsing in a subway station, in which the medical examiner determined the death was caused by a clot brought on by use of the Evra patch

More lawsuits are being filed all across the country.

In November 2005, a federal lawsuit was filed in Madison, Wisconsin, by the parents of the youngest patch victim, Alycia Brown, a 14-year-old eighth-grader, who died on May 7, 2004, after using the patch for 8 weeks, when blood clots developed in her lower pelvis. The medical examiner listed the patch as a likely contributing factor in her death.

In another case, twenty-five-year-old, Sasha Webber, a Baychester, NY mother of two, died of a heart attack in March 2004, after 6 weeks on the patch.

In many instances it is difficult to determine with any degree of certainty that a specific product did in fact cause a death or an injury. Such is not the case with the Ortho patch, experts say, because the injuries and deaths are occurring in young women of child-bearing age, who in most cases have no prior history of health problems.

Filed under: 2006, birth control patch, Johnson and Johnson, Ortho, patch, stoke

Oops – Bayer Forgot to Tell FDA About Lethal Side Effects of Trasylol

Evelyn Pringle October 26, 2006

On September 29, 2006, the New York Times reported that Bayer “failed to reveal to federal drug officials the results of a large study suggesting that a widely used heart-surgery medicine might increase the risks of death and stroke,” citing an FDA announcement. That drug is aprotinin, marketed as Trasylol.

Bayer’s memory lapse would be bad enough in itself, but it seems the FDA is particularly annoyed because Bayer scientists appeared at a public meeting with an FDA advisory committee on September 21, 2006, specifically set up to discuss the risks associated with Trasylol, and did not mention a word about the study or its negative findings.

The lethal side effects of Trasylol became public on February 8, 2006, when the FDA issued an advisory to healthcare professionals requesting that they limit the use of the drug based on research in the New England Journal of Medicine that found its use to be associated with a 2-fold increase in renal failure, a 48% increase in myocardial infarction, a 109% increase in heart failure, and a 181% increase in strokes.

This observational study involved more than 4,300 patients at 69 medical institutions worldwide. “Our findings raise serious concerns regarding the safety of an approved drug intended to limit blood loss in at-risk patients undergoing surgery,” wrote Dr Dennis Mangano of the Ischemia Research and Education Foundation, who led the study.

The San Bruno, California foundation is a non-profit organization founded in 1987 that funds cardiovascular research. In other recent studies, the group has shown that giving inexpensive beta-blockers after major surgery could save 250,000 lives a year, that aspirin use after heart surgery reduces the risk of blood clots, and that Bextra is associated with stroke and impaired wound healing, according to the January 26, 2006 Baltimore Sun.

Another study in the January 20, 2006 online edition of Transfusion, Karkouti, et al, also found an association between Trasylol and renal toxicity among patients undergoing cardiac surgery with cardiopulmonary bypass.

Critics say the Trasylol matter is another example of how serious side effects often fail to become known until after a drug is widely used. Post-marketing studies by drug makers to assess side effects are seldom conducted according to Dr Mangano. “There’s an enormous disincentive to finding safety problems,” he told Reuters on January 25, 2006.

Trasylol is one of Bayer’s top selling drugs with worldwide sales of $210 million in 2005, according to Bayer in a January 26, 2006 article by Associated Press.

On December 9, 2005, the Associated Press reported that Bayer’s Chief Executive, Werner Wenning, predicted that sales for Trasylol in 2006 would reach $600 million. However, on January 26, 2006, Reuters reported that shares in Bayer fell more than 3% “after a study showed that its Trasylol drug doubled the risk of kidney failure.”

Analysts said the result of the NEJM study increased the risk for investors in Bayer’s pharmaceuticals business, which was already recovering from a $1 billion recall of cholesterol lowering medication Baycol. Bayer withdrew Baycol in August 2001 after a number of patients developed muscle weakening and kidney failure and the drug was linked to as many as 100 deaths.

The FDA approved Trasylol in 1993 to control bleeding in patients during heart surgery and minimize the need for blood transfusions. The drug works by blocking enzymes that dissolve blood clots. Trasylol is indicated for patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery.

According to Heart Disease and Stoke Statistics 2005 Update, CABG is the most commonly performed major surgery in the US, with approximately half a million patients undergoing the procedures each year.

Trasylol was approved for heart surgery only but doctors have been routinely using the drug off-label when performing other surgeries. Prior to the NEJM study, Bayer was seeking FDA approval of the drug for patients undergoing hip replacement surgery and spinal fusion surgery.

Trasylol is extremely expensive with a full dose costing about $1,300, while the two generic drugs used in the NEJM study, aminocaproic acid, known by the brand name Amicar, and tranexamic acid, known as Cyklokapron, which turned out to be safer and as effective as Trasylol, at a fraction of the cost of just $11 and $44 respectively.

The “associations between aprotinin and serious end-organ damage indicates that continued use is not prudent,” Dr Mangano wrote in the study. “In contrast,” he said, “the less expensive generic medications aminocaproic acid and tranexamic acid are safe alternatives.”

Because the two alternative drugs that do the same job carry no such risks and are far less expensive, “continued use (of Trasylol) is not prudent,” the NEJM study concluded.

The study authors predicted that halting the use of Trasylol could prevent as many as 11,000 cases of kidney failure a year and save more than $1 billion per year in dialysis costs, in addition to the nearly $250 million spent on the drug itself.

The FDA’s cardiovascular and renal advisory committee met on September 21, 2006, to discuss the risks associated with Trasylol found in the two observational studies, Mangano et al and Karkouti et al, published in January 2006.

In the end, the committee concluded that there was not enough evidence to support changing the cardiovascular safety labeling on Trasylol, reportedly in large part because Mangano et al was the only study to find an increased cardiovascular risk with the drug – that is until the results of the Bayer study leaked out 6 days after the meeting.

A September 29, 2006 letter from the FDA to the advisory committee members said the agency may call a second meeting of the advisory panel to review the new data.

After being tipped off about the undisclosed study, the FDA also issued another public health advisory saying that it had learned of the study and that the preliminary results demonstrate “that use of Trasylol may increase the chance for death, serious kidney damage, congestive heart failure and strokes.”

The FDA advisory noted that the Bayer study was conducted by a contract research organization, and hospital data from 67,000 CABG patients were examined. Of these, it said, 30,000 patients were treated with aprotinin and 37,000 were treated with other drugs. The FDA’s recommendations in the new advisory are similar to those in the February 8, 2006 advisory issued after the publication of the initial studies.

According to an October 6, 2006 report by Bloomberg News, Dr Alexander Walker, a Harvard professor and researcher who helped conduct the Bayer study for i3 Drug Safety, a private research company, told the FDA about the study’s existence after noticing that it was not mentioned at the committee meeting. He is quoted by Bloomberg as saying that notifying the FDA “seemed like the right thing to do.”

According to Bloomberg, Bayer has admitted to the FDA that the company commissioned its own observational study to investigate the cardiovascular risks of Trasylol in June 2006, and received a copy of a preliminary report on the study on September 14, 2006.

Members of the advisory committee are understandably ticked off that Bayer failed to reveal this information before or during the meeting and several said they were shocked.

“For them not to mention that it was under way, that it was being analyzed or that results were available is appalling and will do significant harm to their reputation for transparency,” said Dr John Teerlink, a professor at the University of California, San Francisco, to the New York Times.

Bloomberg quotes him as saying that Bayer’s failure to tell the FDA about the study before the meeting “calls into question the honesty of Bayer and the honesty of the pharmaceutical industry in general.”

“I think the public health has been harmed in two ways,” Dr Teerlink said. “One, we didn’t have complete information to make our decision,” he stated. “But second,” he told Bloomberg, “it calls into question a process that all of us depend on.”

Committee member, Steven Findlay, a health care analyst at Consumers Union, told the Times that the FDA needed to investigate whether Bayer knowingly withheld the information from the committee. “The safety of this drug is called into further question now,” Mr Findlay said.

Dr Robert Harrington, a committee member from Duke University, in Durham, NC, told Heartwire: “Bayer’s failure to even disclose that these data were available and under preliminary analysis is very disturbing to me.”

“The process of evaluation, comment, and advice on important drug efficacy and safety data,” he said, “only works when all of the involved parties are open and honest about their data.”

“It is ironic that we spent part of the panel meeting criticizing Dr Mangano for failing to allow the FDA to perform an independent review of his database,” he told Heartwire, “yet Bayer failed to even acknowledge the existence of these data.”

“It is especially troubling,” Dr Harrington said, “when several panel members, including me, commented that more data and more analyses were needed to fully understand the risks and benefits of the drug.”

“I’d like to know if the Bayer team present that day had knowledge of the existence of the data and why they chose not to even mention it,” he stated.

Another member of the panel, Dr Michael Lincoff, from the Cleveland Clinic, shared similar views with Heartwire. “It was astounding to me that they did not disclose the information that the study had been conducted,” he stated, “even if the findings were considered preliminary.”

“They were in the midst of an entire day’s discussions at the FDA on that precise topic,” he noted, “where there was substantial comment regarding the desirability of more contemporary data than their older trials.”

“It is inconceivable,” Dr Lincoff told Heartwire, “that the representatives from Bayer did not know about the existence of the study or its potential relevance to the committee.”

Legal experts say the main problem for patients who are injured by Trasylol is that the serious injuries and death are often not attributed to the drug because most patients and their families are not informed that the patient received Trasylol during surgery and therefore, do not realize that the drug is to blame.

To avoid serious injuries or death, experts are recommending that patients request that Trasylol not be used prior to undergoing surgery, and for patients and their families who suspect that injuries or death may have been caused by the drug, to ask the surgeon whether Trasylol was administered.

Filed under: 2006, Bayer, FDA, stoke, Trasylol

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