Drug Safety Developments

Diabetes drug class action launches

Quoted from http://www.cbc.ca/news/health/story/2011/12/22/daibetes-actos-class-action.html

Diabetes drug class action launches

Suit alleges manufacturer should have disclosed increased bladder cancer risk

CBC News

Posted: Dec 22, 2011 11:44 AM ET

DOCUMENT | FDA - Actos (pioglitazone): Ongoing Safety Review

A class action has been launched on behalf of people who took the diabetes drug Actos against the manufacturers of the medication.

The class action alleges that Takeda Pharmaceutical Company, the manufacturer and distributor of Actos (pioglitazone hydrochloride) and Eli Lilly, who used to sell and distribute the drug, failed to disclose that taking it for longer than one year led to an increased risk of bladder cancer.

The suit has been filed with the Ontario Superior Court of Justice.

The lead plaintiff in the class action is a now-deceased Toronto woman who was prescribed Actos in 2002. She died in April after battling bladder cancer for over two years.

[Article continues at original source]

Bone drugs linked to rare thigh fractures: Health Canada

Quoted from http://www.ctv.ca/CTVNews/Health/20111220/osteoporosis-thigh-bone-femur-fracture-111220/

Bone drugs linked to rare thigh fractures: Health Canada

The Canadian Press

Date: Tuesday Dec. 20, 2011 8:51 AM ET

TORONTO — Health Canada is alerting Canadians that a class of drugs used for osteoporosis is linked to a slightly higher risk of a rare but serious thigh bone fracture known as an atypical femur fracture.

The advice is the result of Health Canada's review of bisphosphonate drugs, which has led to new warnings and precautions for patients and doctors and will lead to new labels for the drugs.

The department says the risk is higher for those taking the drugs, but the benefits of using the medications to avoid other osteoporosis-related fractures outweighs that risk.

Atypical femur fractures are rare, accounting for less than one per cent of all hip and femur fractures.

They can occur with minimal or no impact to the thigh area, and can occur in both legs in the same person.

Health Canada says patients who are currently taking or who took bisphosphonate drugs previously and who notice new or unusual pain in the hip, groin or thigh should talk to their doctor as this may be a sign of an atypical femur fracture.

The U.S. Food and Drug Administration announced similar findings and warnings in a statement issued in October 2010.

[Article continues at original source]

Gilenya trial could ease safety worries

Quoted from http://www.reuters.com/article/2011/12/15/us-novartis-idUSTRE7BE0GM20111215

Gilenya trial could ease safety worries

ZURICH | Thu Dec 15, 2011 2:25am EST

ZURICH (Reuters) - A third late-stage trial of Novartis' multiple sclerosis drug Gilenya did not throw up any new safety issues with the pill, going some way to alleviating concerns about possible risks linked to the potential blockbuster.

The study results come just days after Novartis said it was looking into whether the pill had caused the death of a 59-year-old patient who had just started therapy.

But Novartis said there had been no deaths in patients treated with Gilenya on the trial and that safety and tolerability were broadly consistent with the safety profile of the medicine in previous Phase III trials.

This study, known as Study 2309, was mainly carried out to give specific safety data for the Gilenya New Drug Application that was submitted to the U.S. Food and Drug Administration at the end of 2009. Gilenya has since won approval there.

[Article continues at original source]

Grieving mother's warning about popular birth control pill

Quoted from http://www.wcax.com/story/16334249/grieving-mothers-warning-about-popular-pill

Grieving mother's warning about popular birth control pill

By Jennifer Reading

Brownington, Vermont - December 15, 2011

April Bapp said of her daughter, "She was valedictorian of her class in high school; she got the state scholarship that paid tuition to college."

But Rebecca Bapp of Brownington will never graduate. She died last month. At first doctors were puzzled. What killed this 21-year-old just hours after her parents brought her to the ER for shortness of breath?

April Bapp: They said her reaction should not have been that bad from high sugar.

Reporter Jennifer Reading: So at that point, they didn't know what was wrong?

Bapp: They had no idea.

An autopsy revealed it was blood clot in her lungs. Rebecca's death certificate also listed obesity and her birth control pill as contributing conditions. She was taking Ocella, a generic version of Yasmin. It is similar to the popular pill Yaz which claims to treat premenstrual dysphoric disorder and acne in addition to preventing unwanted pregnancy.

"It seems like this is the brand they're pushing to young girls," April Bapp said.

But the safety of Yaz, Yasmin and their generic formulations have come under fire.

"This has been a very controversial topic," said Dr. Mary Cushman, the director of thrombosis and hemostasis at Fletcher Allen Health Care.

Cushman is a blot clot specialist. She says it's the combination of estrodyl and drospirenone in these pills that make it a higher risk.

"It affects clotting function in a more adverse way compared to those other kinds of pills," Cushman explained.

Often these clots occur in the leg veins and can become fatal when they break apart and travel to the lungs, like in Rebecca's case. It's a condition called pulmonary embolism. Cushman says clots are rare, but the risk triples for women on birth control and for Yaz users, it can be 10 times as high. Age, obesity and smoking can also increase the risk. A woman should contact her doctor immediately if she experiences leg swelling, aches and pains in the legs, red streaking, chest pain or shortness of breath while on the pill.

"I just can't believe this would happen," April Bapp said. "People need to be aware how dangerous it is."

Rebecca's mom hopes by talking about her daughter's death it might spare another family the heartache of losing a child.

"We didn't really know how serious the side effects can be from this particular brand and we just don't want it to happen to someone else," she said.

Yaz and Yasmin are manufactured by Bayer Pharmaceuticals. Rebecca Bapp was prescribed the generic Ocella which is made by Barr Laboratories, a division of the generic drug giant Teva Pharmaceuticals. Teva would not comment on the safety of Ocella, even telling us it's manufactured for Teva by Bayer. Bayer denied that.

The Bapps plan to pursue legal action for their daughter's death.

Novartis: Patient Died After Starting Gilenya

Quoted from http://www.bloomberg.com/news/2011-12-12/novartis-patient-died-after-starting-gilenya.html

Novartis: Patient Died After Starting Gilenya

By Naomi Kresge - Dec 12, 2011 12:32 PM ET

Novartis AG (NOVN) said a multiple sclerosis patient died on Nov. 23 after starting treatment with Gilenya, the first pill approved to treat the debilitating neurological disease.

Whether Gilenya played a role in the patient’s death can’t be excluded or confirmed, Eric Althoff, a spokesman for the Basel, Switzerland-based drugmaker, said today in an e-mailed statement. The death is the first reported within 24 hours of the first Gilenya dose in more than 28,000 patients who have taken the drug, Althoff said.

Gilenya was approved in the U.S. last year and cleared for sale in Europe in March. It’s among the products Novartis is depending on to boost sales as patents start to expire on the company’s best-selling drugs, including the hypertension pill Diovan. It’s not clear yet how a single death might affect doctors’ cost-benefit analysis of the drug, Jack Scannell, a London-based analyst for Sanford C. Bernstein Ltd., wrote in a note to investors today.

[Article continues at original source]

Pfizer Has Settled About Half of Prempro Cases, Adds to Reserve

Quoted from http://www.bloomberg.com/news/2011-12-15/pfizer-has-settled-about-half-of-prempro-cases-adds-to-reserve.html

Pfizer Has Settled About Half of Prempro Cases, Adds to Reserve

By Jef Feeley - Dec 15, 2011 8:38 AM ET

Pfizer Inc. (PFE), the world’s largest drugmaker, has settled almost half of the lawsuits over its menopause drugs and increased the funds set aside to resolve the cases, the company said in a regulatory filing.

Pfizer and its Wyeth and Pharmacia & Upjohn units have resolved about 46 percent of suits that claimed the companies’ hormone-replacement medicines, including Prempro and Premarin, caused breast cancer, according to the Securities and Exchange Commission filing. Pfizer said it added $68 million to the $772 million it already reserved for the cases.

“We have recorded a charge of $260 million in the first nine months of 2011 that provides for the minimum expected costs to resolve all the remaining hormone-replacement actions,” Pfizer officials said in the Nov. 10 filing.

More than 6 million women took Prempro and related menopause drugs to treat symptoms including hot flashes and mood swings before a 2002 study highlighted their links to cancer. Wyeth’s sales of the medicines, which are still on the market, exceeded $2 billion before the release of the Women’s Health Initiative study sponsored by the National Institutes of Health.

Until 1995, many menopausal women combined Wyeth’s Premarin, an estrogen-based drug, with progestin-laden Provera, made by Pfizer’s Upjohn unit, to relieve their symptoms. Wyeth combined the two hormones in its Prempro pill. Pfizer, based in New York, acquired Wyeth in 2009.

[Article continues at original source]

Bayer Birth Control Pill Benefits Outweigh Risks, Panel Says

Quoted from http://www.businessweek.com/news/2011-12-12/bayer-birth-control-pill-benefits-outweigh-risks-panel-says.html

Bayer Birth Control Pill Benefits Outweigh Risks, Panel Says

December 12, 2011, 2:07 PM EST

By Anna Edney

Dec. 8 (Bloomberg) -- Bayer AG’s Yaz and other birth control pills containing the hormone drospirenone won the backing in a close vote of advisers to the U.S. Food and Drug Administration examining whether the products increase the danger of blood clots.

The FDA panel today also recommended the pills’ labels be changed to better reflect the risk of potential blood clots from the oral contraceptives. Labels now inform women of conflicting studies on the hazards. The FDA isn’t required to follow the panels’ advice.

Studies have shown conflicting evidence about whether women who take the pills have a higher risk of blood clots than if they take older birth control pills that don’t contain drospirenone. Those ambiguous results prompted the FDA to ask for the review at the panel meeting today in Adelphi, Maryland.

“All of these studies have significant strengths and weaknesses,” said Julia Johnson, acting chairwoman of the panel and chair of the University of Massachusetts Medical School Department of Obstetrics and Gynecology.

Panel members were concerned that the results may have been affected by factors that weren’t studied such as women’s body mass index, smoking habits, family history and ethnicity, Johnson said.

[Article continues at original source]

FDA advisers: Ortho Evra patch needs clearer label

Quoted from http://www.reuters.com/article/2011/12/09/us-fda-birthcontrol-patch-idUSTRE7B827N20111209

FDA advisers: Ortho Evra patch needs clearer label

By Alina Selyukh

ADELPHI, Maryland | Fri Dec 9, 2011 6:13pm EST

ADELPHI, Maryland (Reuters) - U.S. drug advisers recommended that the label for Johnson and Johnson's Ortho Evra birth control patch be simplified to better explain the risk of blood clots.

In a 20 to 3 vote with one abstention, advisers to the Food and Drug Administration found that the current label for Ortho Evra inadequately reflects the risks women face by using it. It is the only contraceptive patch sold in the United States.

The panel voted 19 to 5 that the patch's risks were outweighed by its benefits, such as pregnancy prevention through a once-weekly application.

"I'm satisfied generally with what the content is for this label, it's the understandability and presentation that needs some work," said Jacqueline Gardner, panel member and a University of Washington professor.

All commonly used birth control pills increase women's chances of getting blood clots. The patch, approved in 2001, has been linked to an even higher risk as it contains a much greater amount of the hormone estrogen than a pill.

The current label, which has undergone numerous revisions over the past decade, has a boxed warning of a higher risk compared to older birth control pills. But a new FDA study earlier this year again showed that women using the patch were about 60 percent more likely to experience venous thrombotic events (VTEs).

[Article continues at original source]

Sanofi rebuffs renewed Lantus cancer worries

Quoted from http://www.reuters.com/article/2011/12/07/us-sanofi-lantus-idUSTRE7B60NA20111207

Sanofi rebuffs renewed Lantus cancer worries

By Ben Hirschler

LONDON | Wed Dec 7, 2011 6:27am EST

LONDON (Reuters) - A Swedish study has rekindled concerns about a possible link between Sanofi's top-selling insulin drug Lantus and cancer, but the French drugmaker said on Wednesday the observational research was seriously flawed.

It said separate data would be presented on December 8 showing no increased risk of cancer among patients taking its $4.7 billion-a-year product.

The Swedish research, which looked at the medical records of 23,000 people in the southwest of the country in an attempt to find common links to cancer, found an apparent doubling of cancer risk in those taking Sanofi's long-acting insulin.

[Article continues at original source]

J&J’s Birth-Control Patch Needs More Research on Blood-Clot Risk

Quoted from http://www.bloomberg.com/news/2011-12-06/j-j-s-birth-control-patch-needs-more-study-on-blood-clot-risk-fda-says.html

J&J’s Birth-Control Patch Needs More Research on Blood-Clot Risk

By Anna Edney - Dec 7, 2011 12:01 AM ET

More research is needed to determine whether Johnson & Johnson (JNJ)’s Ortho Evra birth-control patch is linked to an increased risk of blood clots, U.S. regulators said.

The Food and Drug Administration asked outside advisers to assess at a Dec. 9 meeting the risks and benefits of the patch and review studies showing an association between the contraceptive and a higher risk of blood clots, according to an agency staff report released yesterday. The agency isn’t required to follow the advisers’ recommendations.

In October, the FDA found the product from New Brunswick, New Jersey-based J&J was associated with “a significantly high risk” of blood clots compared with standard low-dose birth control pills.

“Based on the current studies, it is unclear whether the increased risk seen for thrombotic and thromboembolic events in some of the epidemiologic studies is actually due to use of Ortho Evra,” according to the FDA’s report.

The patch is the object of hundreds of lawsuits filed by women, most of whom allege Ortho Evra caused blood clots in the legs or lungs. J&J has voluntarily strengthened the product’s warning label three times since 2005 with the FDA’s agreement and paid at least $68.7 million to settle the claims, according to court records. J&J hasn’t disclosed revenue from Ortho Evra.

[Article continues original source]