Drug Safety Developments

FDA asks for wider warning on testosterone products

Quoted from http://www.reuters.com/article/2014/06/20/fda-warning-idUSL4N0P12UR20140620

FDA asks for wider warning on testosterone products

June 20 Fri Jun 20, 2014

June 20 (Reuters) - The U.S. Food and Drug Administration said all testosterone products on the market should include in their labels a general warning about the risk of blood clots in veins.

The regulator cited post-market reports of such clots for the warning.

The FDA said that while testosterone products already carry a warning about the risk of clots related to a condition that sometimes occurs with testosterone treatment, the latest reports of clots were unrelated to that condition, called polycythemia. (1.usa.gov/1laK0ai)

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Bayer faces law suits in United States over Xarelto

Quoted from http://in.reuters.com/article/2014/06/14/bayer-suit-idINL5N0OV0G020140614

Bayer faces law suits in United States over Xarelto -paper

FRANKFURT, June 14 Sat Jun 14, 2014

FRANKFURT, June 14 (Reuters) - Germany's Bayer AG faces its first law suits in the United States over anti-clotting drug Xarelto, one of its top five medicines, the Frankfurter Allgemeine Zeitung newspaper reported on Saturday, citing company sources.

There are fewer than ten suits so far, the paper cited one company insider as saying. It gave no details of the suits.

A Bayer spokesman declined to comment on the newspaper's report but said the drug's safety profile since its launch is consistent with the results of clinical studies that involved more than 75,000 patients.

[Article continues at original source]

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$100 million NuvaRing settlement finalized

Quoted from http://www.washingtonpost.com/business/technology/100-million-nuvaring-settlement-finalized/2014/06/05/849a7666-ece1-11e3-b10e-5090cf3b5958_story.html

$100 million NuvaRing settlement finalized

By Associated Press, June 5, 2014

ST. LOUIS — A $100 million settlement involving NuvaRing, a birth-control device linked to sometimes-fatal side effects, will stand now that the vast majority of claimants have chosen to opt into the agreement, those involved in the lawsuits said Thursday.

U.S. District Judge Rodney W. Sippel of St. Louis approved the settlement in February, but NuvaRing maker Merck & Co. had the right to abandon the deal if less than 95 percent of eligible claimants opted in.

The lead attorney for the claimants, St. Louis lawyer Roger Denton, said the 95 percent threshold has been reached, and the deal is now final. Merck, in a statement, confirmed that the agreement is final.

Denton said about 3,800 claimants will share in the settlement.

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