Drug Safety Developments

J&J strengthens warning on HIV drug

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSN2628355520090826

J&J strengthens warning on HIV drug

WASHINGTON, Aug 26 (Reuters) - Johnson & Johnson has strengthened a warning about serious skin reactions in patients treated with the company's HIV drug Intelence, U.S. regulators and the company said on Wednesday.

J&J's Tibotec Therapeutics unit updated the warning after reports of one death from a skin reaction known as toxic epidermal necrolysis, and another case of liver failure from a severe reaction, said Tibotec spokeswoman Pam Van Houten. The patient with liver failure recovered.

Intelence has included a warning about the risk of severe skin reactions since it was launched in January 2008, Van Houten said. In clinical trials, the rate of serious skin or allergic reactions was less than 0.1 percent, she said.

Intelence should be immediately discontinued if signs of severe skin or allergic reactions, Tibotec said in a letter to doctors.

The Tibotec letter was posted here

Glaxo, Roche Weight-Loss Drugs Linked to Liver Injury

Quoted from http://www.bloomberg.com/apps/news?pid=newsarchive&sid=aoU_G62.eaZ0

Glaxo, Roche Weight-Loss Drugs Linked to Liver Injury

By Catherine Larkin

Aug. 24 (Bloomberg) -- Weight-loss drugs made by GlaxoSmithKline Plc and Roche Holding AG were linked to at least 32 reports of serious liver injury from 1999 to October 2008, U.S. regulators said.

Consumers taking Glaxo’s over-the-counter drug Alli or Roche’s prescription Xenical should consult a doctor if they experience weakness, fever, jaundice or other symptoms of liver injury, the Food and Drug Administration said today in a notice posted on its Web site. The agency doesn’t recommend that patients or doctors stop using these medicines.

Both medicines contain orlistat, a chemical that blocks the intestines from absorbing fat when taken as many as three times a day with meals. The FDA approved Xenical in 1999 for weight loss and weight management in conjunction with a reduced-calorie diet. Alli, half the dose of Xenical, was cleared for non- prescription use in 2007.

“FDA is reviewing other data on suspected cases of liver injury submitted by the manufacturers of orlistat,” the agency said in its Early Communication about an Ongoing Safety Review. “FDA’s analysis of these data is ongoing and no definite association between liver injury and orlistat has been established at this time.”

Thirty of the 32 reports reviewed by FDA occurred outside the U.S., according to the notice. Six of the cases involved liver failure.

Merck's Gardasil Has Higher Rates of Fainting, Clots

Quoted from http://online.wsj.com/article/SB125062519949640947.html

Merck's Gardasil Has Higher Rates of Fainting, Clots

AUGUST 18, 2009, 4:15 P.M. ET

By PETER LOFTUS

Recipients of Merck & Co.'s Gardasil cervical-cancer vaccine had higher rates of fainting and blood clots than those receiving other vaccines, but it doesn't appear to raise the risk of certain severe adverse events, according to a new safety analysis.

A separate article accompanying the safety study, published Tuesday in the Journal of the American Medical Association, criticized Merck's marketing of Gardasil, including the company's funding of education campaigns by professional medical associations, which the authors said didn't provide a balanced view of the vaccine.

The two articles add to questions about the safety, effectiveness and marketing of Gardasil, which have dogged the vaccine since its 2006 introduction.

[Article continues at original source]

Digitek MDL judges deny request to transfer cases to Texas judge

Quoted from http://www.wvrecord.com/news/220677-digitek-mdl-judges-deny-request-to-transfer-cases-to-texas-judge

Digitek MDL judges deny request to transfer cases to Texas judge

8/20/2009 8:58 AM By Steve Korris -From LegalNewsline.com

AUSTIN, Texas -- Manufacturers and distributors of heart medicine Digitek succeeded in consolidating 19 personal injury suits from 12 counties, but were taught a lesson in judge shopping.

On Aug. 5, multi district judges in Austin transferred suits against drug maker Actavis Totowa and distributor Mylan Pharmaceuticals to a pretrial judge, but denied a motion to put Jefferson County District Judge Milton Shuffield in charge of the cases.

Presiding Judge David Peeples wrote that "we consider it improper for a motion to seek transfer to a certain court or county."

Plaintiffs' lawyers suing Actavis Totowa and Mylan objected to Shuffield, claiming he was a former partner of two defense lawyers in the litigation.

[Article continues at original source]

Avandia Raises Heart Failure Risk More Than Actos

Quoted from http://news.yahoo.com/s/hsn/20090819/hl_hsn/avandiaraisesheartfailureriskmorethanactos

Avandia Raises Heart Failure Risk More Than Actos

By Steven Reinberg
HealthDay Reporter

Wed Aug 19, 7:03 pm ET

TUESDAY, Aug. 18 (HealthDay News) -- The type 2 diabetes drug Avandia (rosiglitazone) increases the risk of heart failure and death more than another drug in the same class, Actos (pioglitazone), new Canadian research contends.

Avandia has been the subject of controversy since 2007, when it was linked to an increased risk for heart attack and death, although those claims have become clouded as other studies have discounted that risk to some degree. But taken together, many believe that the drug should not be used, especially since there appears to be a safer choice.

"It is difficult for making a case for using rosiglitazone in anybody, because we have an alternative," said lead researcher Dr. David Juurlink, division head of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto.

In 2007, Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, published a study that found Avandia showed a 43 percent greater risk of heart attack among diabetes patients, and he remains convinced that the drug should not be used.

"I agree with the authors' conclusions," Nissen said. "Rosiglitazone should not be used in patients with diabetes. Pioglitazone is a safer alternative."

[Article continues at original source]

Glaxo Used Ghostwriting Program to Promote Paxil

Quoted from http://www.nytimes.com/aponline/2009/08/19/us/politics/AP-US-GlaxoSmithKline-Ghostwriting.html

Glaxo Used Ghostwriting Program to Promote Paxil

• By THE ASSOCIATED PRESS Published: August 19, 2009

WASHINGTON (AP) -- Drugmaker GlaxoSmithKline used a sophisticated ghostwriting program to promote its antidepressant Paxil, allowing doctors to take credit for medical journal articles mainly written by company consultants, according to court documents obtained by The Associated Press.

An internal company memo instructs salespeople to approach physicians and offer to help them write and publish articles about their positive experiences prescribing the drug.

Known as the CASPPER program, the paper explains how the company can help physicians with everything from ''developing a topic,'' to ''submitting the manuscript for publication.

[Article continues at original source]

Glaxo's Avandia riskier than Takeda drug -study

Quoted from http://www.reuters.com/article/rbssHealthcareNews/idUSLI16832820090818

Glaxo's Avandia riskier than Takeda drug -study

Tue Aug 18, 2009 7:01pm EDT

LONDON, Aug 19 (Reuters) - GlaxoSmithKline Plc's diabetes drug Avandia is associated with an increased risk of heart failure and death among older patients compared with Takeda's Actos, according to Canadian research.

David Juurlink and colleagues of Sunnybrook Health Sciences Centre in Toronto said their findings -- the latest in a string of studies questioning Avandia, or rosiglitazone -- made it hard to justify using the medicine for most patients.

"Given the accumulating evidence of harm with rosiglitazone treatment and the lack of a distinct clinical advantage for the drug over pioglitazone (Actos), it is reasonable to question whether ongoing use of rosiglitazone is justified," they wrote in the British Medical Journal.

Sales of Avandia, once Glaxo's second biggest-selling product, plummeted two years ago after a U.S. study linked it to an increased risk of heart attack in a conclusion disputed by Glaxo.

The Canadian study, however, found no significant difference in the risk of heart attack between Avandia and Actos.

[Article continues at original source]

Asthma drug probed for links to cardiac problems

Quoted from http://www.cbc.ca/health/story/2009/08/13/asthma-xolair-safety.html

Asthma drug probed for links to cardiac problems

Last Updated: Thursday, August 13, 2009 | 4:43 PM ET

CBC News

The safety of the asthma drug Xolair is under review to investigate a potential link to cardiovascular problems, Health Canada said Thursday.

The probe was triggered by interim findings in an ongoing U.S. study into the long-term safety of Xolair, known generically as omalizumab.

The early data point to a disproportionate increase in cardiovascular problems among people treated with Xolair compared with those who did not take the drug. The reported problems include heart attacks, abnormal heart rhythms, heart failure, fainting, mini-strokes and blood clots.

"At this time, Health Canada recommends that patients should not stop taking Xolair without first speaking to their doctor," the department said in a statement. "Patients should contact their health care professional if they have any concerns about the medicines they are taking."

In Canada, the drug is indicated to treat asthma in those 12 and older who have moderate to severe persistent asthma, who react to airborne allergens and whose symptoms are not controlled well enough with inhaled corticosteroids.

Health Canada has not concluded there is a link between Xolair and cardiovascular problems, but is assessing the interim findings and working with Novartis Pharmaceuticals Canada to get more information.

If its review raises new safety information, the department said it will inform patients and health care professionals and act if necessary.

The U.S. study, called Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma, or EXCELS, followed about 5,000 patients who use Xolair and a control group of approximately 2,500 people who do not.

Final results of the five-year study are expected in 2012.

Women Should Take Safest Birth-Control Pill, Researchers Say

Quoted from http://www.bloomberg.com/apps/news?pid=20601102&sid=ar0imx52GAkE

Women Should Take Safest Birth-Control Pill, Researchers Say

By Andrea Gerlin

Aug. 14 (Bloomberg) -- Doctors should prescribe the birth- control pills that are the least likely to cause blood clots, according to a study of more than 3,000 women published today in the British Medical Journal.

Oral contraceptives containing levonorgestrel and a low dose of estrogen, such as Bayer AG’s Microgynon 30, were associated with the lowest risk of blood clots in the leg or lungs, researchers at Leiden University Medical Center in the Netherlands found. Birth-control pills containing desogestrel, cyproterone acetate or drospirenone carried about 1.5 to 2 times the risk of clots, they found....

Bayer’s Yasmin, Yaz and Yasminelle contain drospirenone. The three drugs brought in $1.86 billion for Bayer in the first quarter, and Yasmin and Yaz are the two biggest-selling contraceptives worldwide, according to IMS Health.

“We have not seen the data and can’t comment on it at this point in time and soon as we have seen it, we can evaluate it,” Bayer spokeswomen Friederike Lorenzen said in an interview yesterday. “Patient safety is of utmost importance for us.”

[Read full article at original source]

Thrombosis Risk with OCs Depends on Progestogen

Quoted from http://www.medpagetoday.com/OBGYN/GeneralOBGYN/15525

Thrombosis Risk with OCs Depends on Progestogen

By Kristina Fiore, Staff Writer, MedPage Today Published: August 13, 2009 ReviewedbyZalman S. Agus, MD; Emeritus Professor University of Pennsylvania School of Medicine.

The risk of venous thrombosis from oral contraceptives is associated with both the estrogen dose and the type of progestogen used, two new studies show. Both found that levonorgestrel carried the lowest risk of thrombosis among all the progestogens. "Our results clearly show that the safest option with regard to the risk of venous thrombosis is an oral contraceptive containing levonorgestrel combined with a low dose of estrogen," wrote Astrid van Hylckama Vlieg, MD, of Leiden University Medical Center, and colleagues on the Dutch study. The study was published online in BMJ along with another by Ojvind Lidegaard, MD, of the Gynecological Clinic in Rigshospitalet in Copenhagen, that produced similar findings. Action Points Explain that two studies in BMJ found that risk of venous thrombosis was associated with both estrogen dose and type of progestogen used in oral contraceptives. Note that levonorgestrel was associated with the lowest risk of venous thrombosis among all the progestogens in both studies. Several large studies have already confirmed a two- to six-fold increased risk of venous thrombosis associated with oral contraceptive use. Estrogen doses have since been lowered, but it is still unclear which oral contraceptive is safest in this regard. [Article continues at original source]