Study: Zoloft And Cipralex Better Than Other Drugs
But in a paper published online Thursday in the Lancet medical journal, two antidepressants came out on top, though only marginally.
International doctors examined more than 100 previous studies on a dozen antidepressants, which included nearly 26,000 patients from 1991 to 2007.
They found that Zoloft, developed by Pfizer Inc., and Cipralex, developed by Forest Laboratories in the U.S. and Danish drugmaker H. Lundbeck A/S in Europe, were the best options when considering benefits, side effects, and cost. In contrast, Pfizers Edronax was the least effective.
All three drugs are now available generically.
The other drugs tested were Celexa, Cymbalta, Efexor, Ixel, Luvox, Prozac, Seroxat, Remeron, and Zyban.
“The bottom line is that there is a rational hierarchy when prescribing antidepressants,” said Dr. Andrea Cipriani, the studys lead author, of the University of Verona in Italy.
The experts judged a drug to be successful if it reduced patients baseline depression scores on two standardized tests by at least half and if patients had not stopped taking it within two months.
Side effects for the various drugs include nausea, sleeplessness, and sexual dysfunction.
Cipriani said all the antidepressants were effective, and that the differences between them were not huge. “If a patient is taking a drug and doing well, he should not stop and switch drugs,” he said.
Irving Kirsch, a professor of psychology at Britains University of Hull, predicted the study would affect doctors more than patients.
“Doctors will probably prescribe (Zoloft and Cipralex) more often, but patients may not see a big difference between one drug versus another,” he said. Psychiatrists should consider other ways to help patients, like behavioral therapy, Kirsch said.
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On the Net:
http://www.lancet.com
Source: caacs
Novartis Drops as Profit Disappoints, Vaccine Delayed
Novartis dropped 2.83 francs, or 5.5 percent, to 48.62 francs in Zurich trading, the lowest value since Oct. 10. The decline is the stocks biggest since Nov. 21.
Europes fourth-largest drugmaker earned $1.5 billion last quarter, below the $1.78 billion analysts had estimated, hurt by restructuring costs at the Sandoz generics unit and the dollars gain, which damped drug sales. Novartis, in need of new products before the patent expires on its best-selling hypertension pill Diovan, also said its Menveo vaccine will be delayed until 2011 because a clinical test needs more patients.
“Pharma is supposed to be a safe haven in the current environment,” said Joerg De Vries-Hippen, chief investment officer in European equities at Allianz Global Investors in Frankfurt. “The pharma unit didnt deliver.”
Sales were little changed overall, while drug revenue increased 5 percent last quarter, the Basel, Switzerland-based company said. The currency impact shaved $91 million from operating profit while costs for restructuring Sandoz and recalling products added up to $50 million, according to a presentation on the Novartis Web site.
Menveo, the experimental meningitis vaccine, will be delayed until 2011 because U.S. regulators asked the company to expand a clinical trial to add 1,500 infants and children up to 10 years old. Development is still on target for patients aged 11 to 55. The product could have brought in as much as $1 billion in sales in its indication for children, Merrill Lynch said in a note to clients today.
Drug Mergers
A year ago, Novartiss earnings were held back by generic- drug competition and product withdrawals. Sales of five products, including the Famvir herpes medicine and the irritable bowel treatment Zelnorm had fallen by almost half to $1.7 billion from 2006 after the medicines either faced generic competition or were pulled from the market.
Chief Executive Officer Daniel Vasella has cut jobs and reined in spending as Novartis prepares for the Diovan patent expiration. The company reduced its dependence on prescription medicines by developing its own generic treatments and vaccines and acquiring a stake in eye-care company Alcon Inc. last year.
Vasella said Novartis will continue to make small acquisitions but probably wont take part in a bigger wave of industry mergers.
“The most important thing is to grow organically,” he said in a televised interview. “But you have to act with your eyes wide open” after Pfizer Inc.s $68 billion bid for Wyeth earlier this week. He said he doesnt view the enlarged Pfizer as a competitive threat.
Multiple Sclerosis
This year, sales from continuing operations will probably rise at a mid-single-digit rate. Drug sales will likely grow at a mid-to-high-single-digit rate in local currencies, Novartis said.
The companys experimental drug for multiple sclerosis fingolimod, a pill aimed at making treatment less painful for patients, is expected for submission to regulators at the end of 2009, according to the earnings report.
The drugmakers shares fell 10 percent last year, making it the eighth-worst-performing stock on the Bloomberg Europe Pharmaceutical Index.
To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net.
Home-birth Advocates Press Pro-midwife Campaign
Nationally, a group called the Big Push for Midwives marked President Barack Obamas inauguration with an e-mail campaign urging him to ensure that midwives who specialize in home births are included in deliberations on federal health care reform.
“Were at a tipping point now,” said Katherine Prown, the Big Push campaign manager. “Home births are still only a small part of the total, but its poised for growth.”
The campaign seeks to emphasize that in this time of economic crisis, home births can be a safe, satisfying and moneysaving option for many women. But it runs into adamant opposition from the American Medical Association and the American College of Obstetricians and Gynecologists.
“Childbirth decisions should not be dictated or influenced by whats fashionable, trendy, or the latest cause celebre,” the obstetricians policy statement says. “Despite the rosy picture painted by home birth advocates, a seemingly normal labor and delivery can quickly become life-threatening for both the mother and baby.”
According to the latest federal data, there were only about 25,000 home births nationally in 2006 – most of them assisted by midwives – out of nearly 4.3 million total births.
Midwife-attended home births increased by 27 percent between 1996 and 2006. Home-birth advocates believe the numbers will rise as more states amend their laws to accommodate the practice, which they contend is at least as safe as hospital births for healthy women with low-risk pregnancies.
One of the strengths of the state-by-state campaign is its diversity, Prown said.
“Were one of the few movements thats succeeded in bringing together pro-life and pro-choice activists, liberal feminists and Christian conservatives,” she said. “In every state we manage to recruit Republican and Democratic co-sponsors who normally would never be on the same bill together.”
The states are now evenly split on legal recognition of certified professional midwives (CPMs) – those who lack nursing degrees and who account for most midwife-assisted home births.
Half the states have procedures allowing CPMs to practice legally – including five which have taken such steps since 2005. The other 25 states lack such procedures and CPMs are subject to prosecution for practicing medicine without a license.
Depending on legislative decisions, the balance could shift this year. Among the battlegrounds:
-In Idaho, advocates who failed previously to get a voluntary licensing bill through the legislature are back with a mandatory licensing bill. State Rep. Janice McGeachin, R-Idaho Falls, says the changes helped persuade the state boards of nursing and pharmacy to drop their opposition. The Idaho Medical Association, which fought the earlier version, has expressed respect for the changes in the bill and is deliberating on whether further changes might produce a version it could accept.
-In Illinois, advocates also are back with a new version of a licensing bill that failed in 2007. Rep. Julie Hamos, D-Evanston, says it toughens qualification standards for CPMs – changes that prompted the Illinois Nurses Association to drop its opposition. The Illinois State Medical Society remains opposed.
“There are many in the legislature who feel a need to have this option – they need to be educated,” said Dr. Shastri Swaminathan, the societys president. “Were in strong opposition to licensing midwives who dont have the medical training to provide safe home births.”
Cost is a major element in the debate. A routine hospital birth often can cost $8,000 to $10,000, with higher bills for cesarean section deliveries that now account for 31 percent of U.S. births.
Midwives fees for home births are often less than a third of the hospital cost, in part because the mothers generally dont receive epidural anesthesia or various other medical interventions at home.
Source: nymid
Novartis Profit Misses Analyst Estimates, Shares Drop
Net income rose to $1.5 billion, or 68 cents a share, from $904 million, or 40 cents, a year earlier, the Basel, Switzerland-based company said. Product withdrawals and generic-drug competition had depressed earnings a year ago. Sales were little changed overall, while drug revenue increased 5 percent. Novartis shares fell as much as 4.3 percent.
“The pharma unit didnt deliver,” said Joerg De Vries- Hippen, chief investment officer in European equities at Allianz Global Investors in Frankfurt. “Pharma is supposed to be a safe haven in the current environment.”
Chief Executive Officer Daniel Vasella has cut jobs and reined in spending as Novartis prepares for the patent expiration on its hypertension drug Diovan. Europes fourth- largest drugmaker reduced its dependence on prescription medicines by developing its own generic treatments and vaccines and acquiring a stake in eye-care company Alcon Inc. last year.
Profit from continuing operations last quarter was $1.51 billion, falling short of the $1.78 billion median estimate of seven analysts surveyed by Bloomberg News.
Drug Mergers
Novartis fell 1.97 francs, or 3.8 percent, to 49.48 Swiss francs at 9:31 a.m. in Zurich trading. The drugmakers shares fell 10 percent in 2008, making it the eighth-worst-performing stock on the Bloomberg Europe Pharmaceutical Index.
A year ago, earnings were held back by generic competition and product withdrawals. Sales of five products, including the Famvir herpes medicine and the irritable bowel treatment Zelnorm had fallen by almost half to $1.7 billion from 2006 after the medicines either faced generic competition or were pulled from the market.
Vasella said Novartis will continue to make small acquisitions but probably wont take part in a bigger wave of industry mergers.
“The most important thing is to grow organically,” he said in a televised interview. “But you have to act with your eyes wide open” after Pfizer Inc.s $68 billion bid for Wyeth earlier this week. He said he doesnt view the enlarged Pfizer as a competitive threat.
This year at Novartis, sales from continuing operations will probably rise at a mid-single-digit rate this year. Drug sales will likely grow at a mid-to-high-single-digit rate in local currencies, Novartis said.
The companys experimental drug for multiple sclerosis fingolimod, a pill aimed at making treatment less painful for patients, is still expected for submission to regulators at the end of 2009, Novartis said.
Daiichi Sankyo May Forecast Biggest Loss By Japanese Drugmaker
Daiichi Sankyo has fallen 32 percent, the most among Japans largest drug stocks, since Chief Executive Officer Takashi Shoda bid for Ranbaxy in June to enter the market for lower-priced generic medicines. He paid 488.7 billion yen and has written down almost three-fourths of that since the acquisition.
“I fear the loss is only the beginning,” said Yuichi Chiguchi, who helps manage about $8.6 billion in assets, including pharmaceutical stocks, at DIAM Co. in Tokyo. “I dont see growth yet.”
Maho Tanabe, a spokeswoman for Daiichi Sankyo, declined to comment on earnings or forecasts for the year ending March 31 before their release set for 12:30 p.m. on Jan. 30 in Tokyo. It will be the first of Japans top-four drugmakers to report results for October to December.
The market for the lower-priced copies made by the likes of Ranbaxy is expanding at almost twice the pace as for branded originals. New York-based Pfizer Inc., the worlds largest drugmaker, offered to buy Wyeth this week for $68 billion to get access to new medications and offset intensifying generic competition.
Domestic Dependence
Daiichi Sankyo generated 22 percent of sales in the latest business year from Benicar, a pill against hypertension. Takeda Pharmaceutical Co. and Astellas Pharma Inc., Japans two largest drugmakers, also made purchases in the past two years to counter an expected sales decline when medicines lose patent protection.
Shoda, who led Sankyo Co. from 2003 and remained CEO after it bought Daiichi Pharmaceutical Co. in 2005, aimed to boost profits at the new company. Net income represented 11.1 percent of sales last year, the narrowest margin among Japans top-three drugmakers.
The possible loss for this year would be the companys first deficit since the Sankyo-Daiichi combination in September 2005. It would dwarf Eisai Co.s loss of 17 billion yen last year, the largest deficit on record for a Japanese drugmaker.
Ranbaxy was the largest acquisition by Daiichi Sankyo, and the priciest Indian takeover by a Japanese company. Shoda bought Ranbaxy to reduce Daiichi Sankyos dependence on its domestic market, which generated 68 percent of sales last year, making it vulnerable to government-imposed price cuts on prescription drugs.
Daiichi Sankyo rose 4.7 percent to 2,025 yen as of the 11 a.m. break today on the Tokyo Stock Exchange. Of 17 analysts tracked by Bloomberg who cover Daiichi Sankyo, 11 recommend buying the stock and 6 say “hold.”
Not Bullish
He cut his rating on Daiichi Sankyo to “equal weight” from “overweight” that day, after Ranbaxy posted a loss of 6.8 billion rupees ($139 million) for October to December, hurt by foreign-exchange moves and declining U.S. sales following an import ban. Daiichi Sankyo this month booked 354 billion yen in writedowns for the period related to Ranbaxy.
The Japanese companys stock slumped 35 percent since the takeover was announced on June 11 to yesterdays close. The U.S. Food and Drug Administration banned imports of more than 30 of Ranbaxys drugs in September on concern about manufacturing deficiencies, exacerbating the companys stock slump as equity markets worldwide declined amid a worsening credit crisis.
While Daiichi Sankyo paid 737 rupees a share for its 64 percent stake in Indias largest drug company, Ranbaxys stock had lost 66 percent of its value by the Dec. 31 close in Mumbai trading. It has fallen a further 21 percent this year.
For Related News and Information: Top Health-Care News: HTOP <GO> News on Daiichi Sankyo: 4568 JP <Equity> CN <GO> For most read Asian stories: MNI ASIA <GO> Stories on Asian companies earnings: TNI ERN ASIA <GO>
Abbott Fires Sales Force Ready to Market Long-acting Vicodin
The drugmaker said in October that the drug, an extended release form of Vicodin, failed to gain U.S. Food and Drug Administration approval. The company hasnt released details of the so-called complete response letter from the FDA.
Vicodin is in a class of powerful pain medications under scrutiny by U.S. regulators and doctors because of increasing abuse rates and a fear the drugs may lose their effectiveness when given over a long period of time. Abbott said its extended release form, Vicodin CR, would be the first in the hydrocodone class of narcotics to provide relief for 12 hours. Other hydrocodone drugs sell for less than $1 a dose and must be taken every four to six hours.
“Were looking at a path to bring Vicodin CR to market but do not anticipate a launch in 2009,” said Laureen Cassidy, a spokeswoman for Abbott. “Based on the delay in the market availability of Vicodin CR, Abbott is reducing the number of staff supporting our pain-care business.”
If approved, the drug may face skepticism from insurers, who would be reluctant to pay for a more expensive version of a drug that has had generic competition for years, said Tony Butler, an analyst with Barclays Capital in New York.
Modest Sales
“They dont care how many pills you take,” Butler said in an interview yesterday. “We projected modest numbers even at peak sales. We wouldnt have thought sales would be much more than a couple hundred million dollars a year,” he said.
The move may benefit King Pharmaceuticals Inc., which bought Alpharma Inc. for $1.3 billion in December, gaining one of a half-dozen companies racing to sell the first long-acting painkillers modified to deter potentially fatal misuse. By buying Alpharma and investing in its own pain drugs, King has positioned itself to lead a market that Ian Sanderson, an analyst at Cowen & Co., has predicted may reach $3 billion by 2015.
Purdue Pharma LP, maker of OxyContin, also is working to develop painkillers that are resistant to abuse.
Abbott rose 34 cents to $54.39 in New York Stock Exchange composite trading yesterday. The company has declined 2 percent in the last 12 months, outperforming the Standard & Poors 500 Health Care Index, which fell 19 percent.
Gilead Fourth-quarter Profit Gains On Aids Medicines
Fourth-quarter net income increased to $568.2 million, or 60 cents a share, from $401.6 million, or 41 cents, a year earlier, the Foster City, California-based company said today in a statement. Excluding costs, earnings were 63 cents a share, beating the 56-cent average estimate of 25 analysts surveyed by Bloomberg.
Revenue rose 30 percent to $1.43 billion. Gilead derives 84 percent of its sales from its AIDS drugs, which are taken by more than two-thirds of U.S. patients on treatment and 1 million people worldwide. A push to test more people for HIV, the virus that causes AIDS, and treat them earlier has helped fuel increased use of the medicines, said William Tanner, an analyst with Leerink Swann & Co. in New York in an interview on Jan. 21.
“Its fair to say theres been some good tailwind for the HIV franchise in 2008,” said Tanner.
Gilead sales also are benefiting from studies last year that showed rival drugs Epzicom and Ziagen by GlaxoSmithKline Plc may be linked to treatment failure or heart attack risk, Tanner said.
Sales of the companys top-selling drug Truvada rose 25 percent to $562.1 million. Gileads three-drug combination AIDS pill Atripla had sales of $465.5 million, a 79 percent increase.
2009 Outlook
Gilead expects 2009 sales to increase 16 percent to $5.9 billion to $6 billion, said Robin Washington, Gileads chief financial officer, today in a call with analysts. That is less than the $6.4 billion average estimate of 25 analysts surveyed by Bloomberg. Low estimates are consistent with past company guidance, Tanner said.
“They have a history of being conservative,” Tanner said in an interview after the conference call. “For 2008, what they put out, they beat.”
Norbert Bischofberger, executive vice president and chief scientific officer, said during the call that Gilead received “positive feedback” from the U.S. Food and Drug Administration about the companys plans for a trio of studies of its new antiviral drug elvitegravir, a booster compound, and its new Quad-combination pill for HIV.
Flattened Sales
A draw down of inventory in the fourth quarter flattened sales, said Kevin Young, executive vice president commercial operations, during the conference call.
Reauthorization of the Ryan White Care Act by Congress may broaden access to AIDS drugs, Gilead President John Milligan said in an interview. It will also provide more funding for HIV testing and identify more people with the virus, many of whom will enter treatment, he said.
Gilead is trying to broaden its revenue base by diversifying its product lines around hepatitis, hypertension and respiratory diseases. In the second quarter, the company is expected to release study results on darusentan, a new treatment for drug- resistant high blood pressure. The study is part of the final phase of testing generally required for U.S. approval. Tanner said he envisions a market of about 2 million people for darusentan, with multibillion dollar sales potential.
New Studies
Gilead expects to begin efficacy studies of its new four- drug Quad combo pill in the second quarter of this year. The medicine is built around Gileads new medicine, elvitegravir, which is designed to block an enzyme the AIDS virus needs to integrate itself into its victims genes.
Gilead shares fell $1.18 to $47.05 at 4:24 p.m. in extended trading on the Nasdaq Stock Market. The shares fell 16 cents, or less than 1 percent, in regular trading.
Peanut Corp. Shipped Product After Finding Salmonella
After getting the results, the closely held company based in Lynchburg, Virginia, contracted with other laboratories to conduct new tests and continued sending products to customers, said Michael Rogers, director of the division of field investigations of the U.S. Food and Drug Administration.
“There were no steps taken” by the firm to reduce contamination at the time, Rogers said today in a telephone briefing for reporters conducted by officials of the FDA and the Centers for Disease Control and Prevention in Atlanta.
The Georgia plant has been identified as the source of an outbreak of Salmonella typhimurium that began in September and as of Jan. 25 had sickened 502 people in the U.S. and Canada, leading to the deaths of eight people, CDC officials said today.
Kellogg Co., Trader Joes Co. and Jenny Craig Inc. are among dozens of companies that have recalled more than 350 products because they contain ingredients from Peanut Corp.
“PCA has cooperated fully with FDA from Day 1 during the course of this investigation,” said George Clarke, a Peanut Corp. spokesman, in an e-mailed statement. “We have shared with them every record that they have asked for that is in our possession and we will continue to do so.”
Tracking Products
The FDA has visited 1,000 companies that purchased products from Peanut Corp., is tracking shipments, and reviewing records, said Stephen Sundlof, director of the FDAs Center for Food Safety and Applied Nutrition.
“We expect the list of recalled products to expand,” Sundlof said during the telephone briefing.
Many of the people sickened in the outbreak have been children, said Robert Tauxe, deputy director, Division of Foodborne, Bacterial and Mycotic Diseases at the CDC. Half have been younger than 16 and 21 percent have been younger than 5.
So far, 108, or 22 percent, of the people who have become ill have been hospitalized. Many of the people affected have told health investigators they ate peanut butter crackers before becoming ill, Tauxe said.
Theres a “strong association” with peanut butter crackers, he said. “Not every one recalls eating these. We dont think its the whole cause.”
Violations Notice
The FDA has issued a violation notice against the company based on inspection of the Blakely plant that began on Jan. 9, Rogers said.
The FDA didnt inspect the Georgia plant during 2007 and 2008, Rogers said. Instead, inspections were carried out by Georgia state officials under contract with the FDA, he said.
Four strains of salmonella have now been linked to the Blakely plant, FDA officials said. Only one of these is believed to be responsible for the illnesses reported so far. Like other forms of salmonella, the strain found in the peanut butter is spread through human or animal droppings.
Lawmaker Critical
The salmonella outbreak and whether the FDA had a role in it are being investigated by the House Energy and Commerce Subcommittee on Oversight and Investigations.
Representative Bart Stupak, the committees chairman, criticized the FDA in a statement today.
Novartis Quarterly Profit Rose 70%, Missed Estimates
Net income rose to $1.5 billion, or 68 cents a share, from $904 million, or 40 cents, in the year-earlier period, the Basel, Switzerland-based company said in an e-mailed statement today. Sales grew to $10.1 billion. Profit from continuing operations fell short of analyst estimates.
Chief Executive Officer Daniel Vasella has cut jobs and reined in spending as Novartis prepares for the patent expiration on its hypertension drug Diovan. Europes fourth- largest drugmaker reduced its dependence on prescription medicines by developing its own generic treatments and vaccines and acquiring a stake in eye-care company Alcon Inc. last year.
“Weve seen a steady improvement in the growth of the pharma unit,” Andrew Weiss, an analyst at Bank Vontobel in Zurich, said in a telephone interview before the release. “The transition is over, and 2009 should be an interesting year.”
A year ago, earnings were held back by generic competition and product withdrawals. Sales of five products, including the Famvir herpes medicine and the irritable bowel treatment Zelnorm had fallen by almost half to $1.7 billion from 2006 after the medicines either faced generic competition or were pulled from the market.
Heart, Cancer Drugs
“Novartis anticipates another year of record results in 2009,” Vasella said in an e-mailed statement. Sales from continuing operations will probably rise at a mid-single-digit rate this year. Drug sales will likely grow at a mid-to-high- single-digit rate in local currencies, Novartis said today.
The companys experimental drug for multiple sclerosis fingolimod, a pill aimed at making treatment less painful for patients, is on track for submission to regulators at the end of 2009, Novartis said.
The Swiss drugmaker is preparing for generic competition in 2012 with a clutch of new drugs including several combination heart pills and the Afinitor cancer drug.
Rival Pfizer Inc.s $68 billion bid for Wyeth and its future plans of gaining market share overseas may cramp Novartiss plans to grow in countries such as Russia, China and Turkey, a market that may be worth $80 billion by 2012, according to Vontobels Weiss.
Profit from continuing operations last quarter was $1.51 billion, falling short of the $1.78 billion median estimate of seven analysts surveyed by Bloomberg News.
Novartis fell 1.1 francs, or 2.1 percent, to 51.45 Swiss francs at the close of trading in Zurich yesterday. The drugmakers shares fell 10 percent in 2008, making it the eight-worst-performing stock on the Bloomberg Europe Pharmaceutical Index.
Astrazeneca Is Asked to Expand Warning, Lawyer Says
The U.S. Food and Drug Administration wants AstraZeneca, the U.K.s second-largest drugmaker, to highlight on Seroquels warning label that some users experienced “significant weight gain,” lawyers for consumers suing the company said in a court filing yesterday. The first trial over claims that Seroquel caused diabetes is set to begin Feb. 2 in Orlando, Florida.
Letters sent by regulators to the London-based company last month “reveal FDA directives to AstraZeneca” to expand Seroquels warning label, Richard Laminack, a lawyer for two former Seroquel users, said in the federal court filing.
AstraZeneca faces about 9,000 lawsuits with more than 15,000 plaintiffs in the U.S. over claims that Seroquel causes diabetes and other health problems. Seroquel, which generated sales of $4.03 billion in 2007, is the companys second-biggest seller after the ulcer treatment Nexium.
“This warning will reduce the attractiveness of using this drug, given the risk of developing a serious condition,” said Navid Malik, an analyst at London-based Matrix Corporate Capital LLP. He doesnt have a rating on the stock.
AstraZeneca Shares
AstraZeneca fell 115 pence, or 3.9 percent, to 2,832 pence in London trading, the biggest drop in two months. The companys American depositary receipts, each representing one ordinary share, declined 83 cents, or 2 percent, to $39.99 in New York Stock Exchange composite trading.
Johnson & Johnson, maker of the rival antipsychotic Risperdal, rose 99 cents, or 1.8 percent, to $57.54. Eli Lilly & Co., maker of the antipsychotic Zyprexa, rose $1.04, or 2.8 percent, to $38.61.
Seroquels label has “always provided accurate and appropriate information and warnings,” Tony Jewell, a spokesman for AstraZeneca in Wilmington, Delaware, said in an e-mailed statement. “We continue to work with the FDA to share accurate information with the public as more scientific data becomes available about the medicine.”
Jewell declined to comment on whether the FDA had requested stronger Seroquel warnings and said communications with the agency were confidential.
Weight Gain
Studies linking Seroquel, Zyprexa and similar antipsychotic treatments to weight gain and diabetes prompted the FDA to require that all makers of such medicines warn doctors about risks in 2003 and 2004.
Evidence uncovered in pre-trial exchanges of information shows that FDA officials advised AstraZeneca executives in letters of Dec. 18 and Dec. 22 that the “significant weight gain” reference should be added to the labels “warnings and precautions section,” according to Laminacks filing. It had been listed under “vital signs” on the label, the lawyer said.
The FDA also wants “data for Seroquel-induced weight change and glucose changes” moved up into the labels warning section, according to the filing.
Karen Riley, an FDA spokeswoman, said she couldnt immediately comment on whether the agency had asked AstraZeneca to toughen Seroquels warning.
Expert Witnesses
The FDAs calls for stronger warnings “mirror” the contentions of consumers expert witnesses, who are seeking to testify in Linda Guinns trial, Laminack said in the filing. U.S. District Judge Anne Conway hasnt ruled whether jurors will be allowed to hear those experts.
“Seroquel and Zyprexa are among the worst offenders affecting hazardous weight gain and glucose changes,” Laminack claimed in the filing.
Lilly agreed to pay at least $1.2 billion to settle lawsuits filed by about 31,000 patients who used Zyprexa. The Indianapolis-based company said this month it would pay an additional $1.42 billion to resolve claims by state and federal officials that it marketed the drug for unapproved uses. Lilly also agreed to plead guilty to a criminal charge.