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Nov. 19, 2004, 9:37 a.m. EST

FDA official comments impact drugs

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By Kabir Chibber, CBS MarketWatch

Updates to clarify that FDA official spoke to Finance Committee

HONG KONG (CBS.MW) -- Shares of leading U.K. pharmaceutical makers stumbled Friday after comments from U.S. and European regulators flagged safety concerns.

AstraZeneca /zigman2/quotes/203048482/delayed UK:AZN -0.49% /zigman2/quotes/200304487/composite AZN -1.02% shares were holding down over 7 percent in the afternoon after a Food and Drug Administration official told a Senate Finance Committee that AstraZeneca's anti-cholesterol drug Crestor was one of five drugs which could raise safety concerns. The official was speaking on issues raised by Merck's withdrawal of its drug Vioxx. See full story

David Graham, associate director for science and medicine in the FDA Office of Drug Safety, warned about the possible risk of renal failure associated with Crestor. AstraZeneca's shares ended down 8.6 percent to $40.34 in U.S.

The European Medicines Agency put further pressure on AstraZeneca when it also said Thursday it will investigate whether patients taking Crestor should be started on the lowest 5 milligram dose of the drug.

AstraZeneca issued a statement defending the safety of the drug. "To date more than 45,000 patients have received Crestor in clinical trials, more than 12 million prescriptions have been written worldwide, and more than 3.5 million patients have been prescribed the drug," the company said. "Based on these data, we are fully confident in the safety profile of Crestor, which has now been approved in more than 65 countries worldwide.

The FDA defended its approval of five currently-marketed drugs that Graham warned may be unsafe. Graham's testimony "does not reflect the views of the Agency," FDA official Steven Galson said late Thursday in a statement.

Grahman told lawmakers that AstraZeneca's cholesterol drug Crestor, GlaxoSmithKline's asthma therapy Serevent, Pfizer's arthritis drug Bextra and Abbott Lab's weight loss drug Meridian have been linked to serious side effects.

Crestor was developed by AstraZeneca based on a compound discovered by Japanese pharmaceutical company Shionogi /zigman2/quotes/202489631/delayed JP:4507 -0.78% /zigman2/quotes/204528875/delayed SGIOF -1.46% . Shionogi, which gets royalties from sales of Crestor, ended trading 10 percent lower in Japan Friday. See full story

Graham also mentioned GlaxoSmithKline's /zigman2/quotes/209463850/composite GSK -0.53% asthma treatment Serevent as one of the five drugs that bear further investigation in his testimony at the House. GlaxoSmithKline shares /zigman2/quotes/200381158/delayed UK:GSK +0.04% fell 3.3 percent in London trade.

Graham said the FDA approved the Serevent despite a U.K. study pointing to a possible increased risk of respiratory failure as a result of taking the drug. He explained that the FDA had asked the pharmaceutical giant for a more in-depth study to better understand that risk, but the firm cancelled that study and the drug remains on the market.

GlaxoSmithKline shares lost 3.4 percent in the U.S. Thursday to close at $43.50.

/zigman2/quotes/203048482/delayed
UK : U.K.: London
8,191.00 p
-40.00 -0.49%
Volume: 1.58M
Dec. 3, 2021 4:35p
P/E Ratio
87.24
Dividend Yield
2.47%
Market Cap
£126.89 billion
Rev. per Employee
£282,763
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/zigman2/quotes/200304487/composite
US : U.S.: Nasdaq
$ 54.23
-0.56 -1.02%
Volume: 0.00
Dec. 3, 2021 4:00p
P/E Ratio
85.59
Dividend Yield
2.53%
Market Cap
$167.75 billion
Rev. per Employee
$362,602
loading...
/zigman2/quotes/202489631/delayed
JP : Japan: Tokyo
¥ 7,599.00
-60.00 -0.78%
Volume: 1.60M
Dec. 3, 2021 3:00p
P/E Ratio
19.96
Dividend Yield
1.45%
Market Cap
¥2290.98 billion
Rev. per Employee
¥54.18M
loading...
/zigman2/quotes/204528875/delayed
US : U.S.: OTC
$ 67.50
-1.00 -1.46%
Volume: 3,038
Dec. 3, 2021 3:51p
P/E Ratio
19.01
Dividend Yield
N/A
Market Cap
$20.23 billion
Rev. per Employee
$510,855
loading...
/zigman2/quotes/209463850/composite
US : U.S.: NYSE
$ 41.25
-0.22 -0.53%
Volume: 4.09M
Dec. 3, 2021 4:00p
P/E Ratio
17.56
Dividend Yield
4.85%
Market Cap
$101.60 billion
Rev. per Employee
$464,855
loading...
/zigman2/quotes/200381158/delayed
UK : U.K.: London
1,534.60 p
+0.60 +0.04%
Volume: 4.44M
Dec. 3, 2021 4:35p
P/E Ratio
17.97
Dividend Yield
5.21%
Market Cap
£76.85 billion
Rev. per Employee
£362,501
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Kabir Chibber is a reporter for CBS MarketWatch in London.

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