Drug Safety Developments

Study: Yaz Has Higher Risks of Blood Clots

Quoted from http://prescriptions.blogs.nytimes.com/2011/10/26/study-yaz-has-higher-risks-of-blood-clots/

 

Study: Yaz Has Higher Risks of Blood Clots

By DUFF WILSON

October 26, 2011, 12:53 pm

A new study of 1.3 million Danish women over nine years adds to the evidence that some newer birth-control pills, including the best-seller Yaz, have a higher risk of causing potentially dangerous blood clots.

Newer pills containing drospirenone, a synthetic hormone, were linked to a six-fold increase in the risk of venous thromboembolism, which is the formation of clots in the lower leg or thigh that can break loose and travel to the lungs.

That risk was compared with a three-fold increase in women using older contraceptives containing the synthetic hormone levonorgestrel. The study was published Tuesday on the Web site of BMJ, formerly known as the British Medical Journal.

A BMJ editorial added, “It is crucial, however, not to exaggerate the risk — oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality.”

The Food and Drug Administration is already studying the possible increased risk of blood clots with pills containing the drospirenone. The F.D.A. says its preliminary results suggest a 1.5-fold increased risk compared with other hormonal contraceptives, to about 10 women in 10,000 from 6 women in 10,000.

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J&J Unit Cleared of Liability for Alleged Levaquin Injuries

Quoted from http://www.businessweek.com/news/2011-10-14/j-j-unit-cleared-of-liability-for-alleged-levaquin-injuries.html

J&J Unit Cleared of Liability for Alleged Levaquin Injuries

October 14, 2011, 12:18 PM EDT

By Jef Feeley

Oct. 14 (Bloomberg) -- A unit of Johnson & Johnson isn’t responsible for tendon damage suffered by two New Jersey men who took the drugmaker’s Levaquin antibiotic, a jury found.

The state court jury in Atlantic City, New Jersey, deliberated about eight hours over two days before clearing J&J’s Ortho-McNeil-Janssen Pharmaceutical unit of liability for Paul Gaffney’s and Robert Beare’s injuries. The two men contend their Achilles tendon snapped after they took Levaquin to treat respiratory infections.

It’s the company’s second win in a Levaquin case. In June, a Minnesota jury rejected a man’s claim that the antibiotic caused his Achilles injury. Another Minnesota jury in December 2010 awarded another former Levaquin user a total of $1.8 million in damages over his tendon injury.

“The evidence showed Ortho-McNeil-Janssen Pharmaceuticals properly informed of the benefits and risks associated with the use of Levaquin and that the company acted responsibly by providing appropriate and timely information about” the drug, William Foster, a spokesman for the J&J unit, said in an e- mailed statement.

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J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues

Quoted from http://www.businessweek.com/news/2011-10-12/j-j-didn-t-warn-levaquin-riskier-than-rivals-lawyer-argues.html

J&J Didn’t Warn Levaquin Riskier Than Rivals, Lawyer Argues

October 12, 2011, 4:30 PM EDT

By Jef Feeley

 

Oct. 12 (Bloomberg) -- A Johnson & Johnson unit never warned users of the Levaquin antibiotic that it posed a greater risk of tendon damage than rival medications, a lawyer for two men suing the company said today.

Executives of J&J’s Ortho-McNeil-Janssen Pharmaceutical unit sought to protect sales by omitting information about Levaquin’s “comparative risk” from its warning label, Andy Alonso, a lawyer for Paul Gaffney and Robert Beare, said in closing arguments in the trial of their lawsuits against the drugmaker.

“They should be held to account for not fully disclosing” that they knew Levaquin generated a higher number of reports of Achilles tendon injuries than competing antibiotics, Alonso told a state court jury in Atlantic City, New Jersey, today.

The case is the third over Levaquin tendon injuries to go to trial since November and the first to be tried in New Jersey state courts. J&J faces more than 2,600 claims in U.S. courts over the drug, court dockets show.

A lawyer for the J&J unit countered today that for more than a decade starting in 1996, Levaquin’s labels contained repeated warnings about the risk of tendon injuries associated with the drug.

 

Gaffney’s and Beare’s own doctors said “they were aware” of the tendon risk posed by the drug, Christy Jones, one of the drugmaker’s lawyers, told jurors in her closing argument today.

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Australian court backs Merck's Vioxx case on appeal

Quoted from http://www.reuters.com/article/2011/10/12/merck-vioxx-idUSL3E7LC0GD20111012

Australian court backs Merck's Vioxx case on appeal

MELBOURNE | Wed Oct 12, 2011 12:16am EDT

MELBOURNE Oct 12 (Reuters) - The Australian arm of Merck & Co won its appeal against compensation awarded to a user of its recalled drug Vioxx, though lawyers for the plaintiff said the ruling did not shut the door on action by other class members.

The finding on Wednesday overturns a March 2010 decision by Federal Court judge Christopher Jessup who awarded A$287,912 ($259,400) plus interest to grandfather Graeme Peterson, who claimed the drug caused him to have a heart attack in 2003.

Peterson's lawyers, Slater & Gordon , said at the time that the move paved the way for similar claims from hundreds of other Australians who had suffered heart attacks after using the medicine.

"The court's decision (on Wednesday) does not foreclose all rights available to class members other than Mr Peterson," Slater & Gordon said in a statement to the Australian stock market. The firm represents Petersen on a no-win, no-fee basis.

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Bristol’s Sprycel May Increase Hypertension Risk, FDA Says

Quoted from http://www.bloomberg.com/news/2011-10-11/bristol-s-sprycel-may-increase-hypertension-risk-fda-says.html

Bristol’s Sprycel May Increase Hypertension Risk, FDA Says

By Anna Edney - Oct 11, 2011 10:01 AM ET

Bristol-Myers Squibb Co. (BMY)’s leukemia drug Sprycel may increase the risk of a rare condition that causes high blood pressure in the lungs’ arteries, U.S. regulators said today.

Health-care providers should evaluate patients for signs of underlying cardiopulmonary disease before starting Sprycel, chemically known as dasatinib, and during treatment. If abnormally high blood pressure known as pulmonary arterial hypertension is confirmed, patients should discontinue the medicine, according to the safety announcement from the Food and Drug Administration.

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Blood clots warning for women on the pill

Quoted from http://www.theaustralian.com.au/national-affairs/health/blood-clots-warning-for-women-on-the-pill/story-fn59nokw-1226160647368

Blood clots warning for women on the pill

• by: Adam Cresswell
• From: The Australian
• October 07, 2011 12:00AM

 

AUSTRALIA'S drug watchdog has issued a safety alert over two contraceptive pills taken by nearly 200,000 Australian women, warning they may carry a two- to three-fold increased risk of potentially dangerous blood clots.

The two drugs, Yaz and Yasmin, both contain the synthetic hormone drospirenone, and have come under increasing scrutiny amid concerns they could cause more clots known as deep-vein thromboses compared with older contraceptives.

Although not listed on the Pharmaceutical Benefits Scheme and thus not the most commonly prescribed contraceptives, both Yaz and Yasmin have won a large clientele of women prepared to pay their $25 to $30 a month private cost because of the lower rate of side-effects such as weight gain and pre-menstrual tension.

In its latest safety update issued yesterday, the Therapeutic Goods Administration told doctors that recent studies had found "drospirenone-containing oral contraceptives may be associated with an increased risk" of blockages in veins caused by clots.

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Doctors Grow Wary of Avastin for Eye Treatment

Quoted from http://prescriptions.blogs.nytimes.com/2011/10/04/doctors-grow-wary-of-avastin-for-eye-treatment/

Doctors Grow Wary of Avastin for Eye Treatment

By ANDREW POLLACK

October 4, 2011, 9:51 am

Dr. Robert Feig, a retina specialist in Brooklyn and the Bronx, says he wants to save patients and Medicare money by treating eye diseases with a drug that costs $50 a dose, rather than one that costs $2,000 a dose.

But three recent incidents around the country in which a total of 21 patients lost some or all vision in the affected eye after injections of the less expensive drug have made him fearful of a malpractice lawsuit, should something similar happen at his practice.

“Why would I want to risk my family to save America $1,950 a dose?” asked Dr. Feig. So even though he laments it, he is starting to use more of the expensive product, Lucentis, instead of the cheaper one, Avastin.

Similar trade-offs of cost versus perceived risk are being weighed across the country.

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N.J. manufacturers cannot be sued for claim that their drugs caused breast cancer, panel says

Quoted from http://www.nj.com/news/index.ssf/2011/09/nj_manufacturers_cannot_be_sue.html

N.J. manufacturers cannot be sued for claim that their drugs caused breast cancer, panel says

Published: Thursday, September 29, 2011, 8:39 PM Updated: Thursday, September 29, 2011, 8:39 PM

By MaryAnn Spoto/The Star-Ledger The Star-Ledger

TRENTON — Putting more than 150 lawsuits over hormone replacement therapy into question, a state appellate panel today said two New Jersey manufacturers cannot be sued by two women who claim the synthetic drugs they took for years caused their breast cancer.

The decision — 3½ years in the making — was a victory for Pfizer Inc., whose subsidiaries, Wyeth Pharmaceuticals Inc. and Upjohn Co., have been accused of failing to provide adequate warning of the risk of breast cancer from their drugs used to treat the symptoms of menopause.

The dismissals do not set precedent for courts outside of New Jersey — there are lawsuits based on the same evidence proceeding in other states — but the decision calls into question the future of more than 150 lawsuits put on hold in New Jersey while this appeal was pending.

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