Schering-Plough Drug Linked to 8 Deaths in Japan (Update12)
Bloomberg News
August 7, 1998, 12:06 p.m. ET
Schering-Plough Drug Linked to 8 Deaths in Japan (Update12)
(Adds Schering-Plough comment in 6th paragraph; updates
share price.)
Tokyo, Aug. 7 (Bloomberg) -- Japan's Health Ministry warned
doctors not to prescribe a prostate cancer drug developed by
Schering-Plough Corp. to people with liver problems, after eight
patients in Japan died.
The patients, aged between 50 and 89, died of liver
complications after taking flutamide, an established drug sold in
70 countries, including in the U.S. as Eulexin and in Japan as
Odyne. Five of the deaths occurred this year, said Shoichi
Matsunuma, a spokesman for Nippon Kayaku Co., which has exclusive
rights to the drug in Japan.
Madison, New Jersey-based Schering-Plough couldn't comment
immediately. Eulexin sales fell 21 percent in 1997 to $214
million, or about 3 percent of Schering-Plough's sales.
''If sales of Odyne are terminated, it'll be really tough
for Nippon Kayaku,'' said Osamu Matsumaru, a chemicals analyst at
Kokusai Securities Co. Odyne is Nippon Kayaku's fastest-growing
product, Matsumaru said. It generated sales of more than 7
billion yen ($48.3 million) in Japan in the year to May 31, or 6
percent of Nippon Kayaku's sales.
Shares in Nippon Kayaku fell 55 yen, or 9.6 percent, to 520.
Some 817,000 shares changed hands, 3.6 times the daily average
for the past three months.
Schering-Plough spokesman Stephen Galpin said flutamide is
safe and effective when taken as indicated. The company has no
plans to change its marketing of the drug, he said.
Schering-Plough rose 1 5/16 to 93 3/16 in midday trading as
U.S. stocks rose after a report on the labor market pointed to
steady growth with low inflation.
Cancer Drugs
Schering-Plough already warns patients in the U.S. that the
drug can harm the liver, said Michael Krensavage, an analyst with
Brown Brothers Harriman. These kinds of side effects are more
accepted in a drug such as Eulexin, used to treat cancer, than
they would be in a medicine for a less serious condition, such as
ones given for weight loss, he said.
''Cancer drugs typically are loaded with side effects,''
said Krensavage, who has a ''neutral'' rating on Schering-Plough.
''It's such a terrible disease that patients and doctors are
willing to accept risks.''
Schering-Plough's Galpin said the drug's label also carries
warning about the potential for liver damage in Europe and Japan.
The U.S. Food and Drug Administration couldn't immediately
be reached for comment.
Previously, Japan's Health Ministry advised doctors not to
prescribe flutamide to patients with serious liver disease. Today
it stepped up the warning, cautioning patients with even minor
liver problems against taking the drug. The ministry also said
patients taking the drug should receive a liver check-up at least
once a month.
Prescription Drugs
Deaths linked to properly used prescription drugs that, like
Eulexin, have been on the market for years are relatively rare.
Toxic effects are more common for drugs that are in clinical
development or have recently been introduced.
Some drugs linked to patient deaths include Pfizer Inc.'s
impotency drug Viagra. As of June 8, the U.S. Food and Drug
Administration said it had received reports of 16 deaths from
people using Viagra, which was introduced this year. Some of the
fatalities were among patients who defied advice and took the
drug while also using heart medicines, the agency said,
maintaining that the drug is safe when used properly.
The FDA also said 14 people have died after using Warner-
Lambert Co.'s new diabetes drug Rezulin. The company agreed last
month to strengthen the warning on Rezulin's label to alert users
to the possibility of liver problems.
''If enough people take a drug, you will get
complications,'' said Matthew Northover, an analyst at J.P.
Morgan Securities in London. ''It could be one of a whole host of
things,'' including negative drug interactions, improper
prescribing, bad medicine batches or statistical variations, he
said.
Side Effects
Flutamide belongs to a class of drugs called anti-androgens,
which work by directly blocking the cancer-promoting activities
of male sex hormones, the main one being testosterone. The drug
is known for ''its strong side effects,'' said Kazuhisa Sugita, a
pharmaceuticals analyst at ABN Amro Securities (Japan) Ltd.
The most commonly prescribed drug in Japan for prostate
cancer is Takeda Chemical Industries' Leuplin (leuprorein), said
Sugita. The drug, which is also sold overseas, had sales in Japan
of 31.6 billion yen in the year to March 31.
Nippon Kayaku, which started business as a gunpowder maker
and diversified into chemicals, reported group net profit of 5.88
billion yen in the year ended May 31, on sales of 126.445 billion
yen. Last year, 44.3 percent of the company's sales came from
medicines, Kokusai Securities' Matsumaru said.
The company has forecast profit of 5.78 billion yen on sales
of 118.084 billion yen.
--Jackie Andrews in the Tokyo newsroom, with reporting by Tak |
