FDA warns Pfizer's drug Tygacil raises risk of death

n">(Reuters) - Pfizer Inc's antibacterial drug Tygacil increases the risk of death whether used as authorized by the U.S. Food and Drug Administration or for unapproved conditions, the agency warned on Friday.

Pfizer must place a warning inside a black box on the drug's label, indicating the risk is of the most serious nature. The FDA said the drug, which is usually given intravenously, should only be used when alternative treatments are not suitable.

The drug is approved to treat complicated skin and abdominal infections and community-acquired bacterial pneumonia. It is not approved to treat diabetic foot infection or hospital-acquired pneumonia.

In September 2010, the FDA issued a reminder to physicians that Tygacil carried a higher risk of death than other drugs used to treat infection. The agency said at the time it had analyzed pooled clinical trial data and determined that most deaths were related to progression of the infection.

The agency said the increased risk of death was mostly seen in patients with hospital-acquired pneumonia though it was also seen in patients with other types of infection. The agency updated the "Warnings and Precautions" section of the label to reflect risks.

Since issuing that 2010 notice, the FDA said it has analyzed data from 10 trials of patients who took the drug only for FDA-approved uses. This analysis also showed a higher risk of death compared to other antibacterial drugs.

In general, the deaths resulted from worsening infections, complications from infection or another underlying medical condition, the agency said.

Tygacil was approved in the United States in 2005. It generated sales in 2012 of $335 million.

Pfizer did not immediately respond to a request for comment.

The drugmaker's shares were up 42 cents, or 1.5 percent, to $28.94 in midday trade on the New York Stock Exchange.

(Reporting by Toni Clarke in Washington; Editing by Leslie Gevirtz)

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Kenyan Panel Warns Against Nullifying Election

Kenya’s Supreme Court, which was recently overhauled through the passage of a new Constitution, has been asked to play referee in the disputed election, in which Uhuru Kenyatta, son of Kenya’s first president, was declared the winner this month. Mr. Kenyatta beat Prime Minister Raila Odinga in the first round of voting and averted a runoff, clearing the majority threshold by a wafer-thin margin of less than one-tenth of a percent.

On Thursday, Ahmednasir Abdullahi, a lawyer for Kenya’s election chairman, told the court that “in every election, votes get stolen.”

He then played down video images that appeared to show vote rigging, saying they were fraudulent, produced in a notorious, crime-ridden neighborhood of Nairobi. And he warned the Supreme Court that “there would be an enormous constitutional crisis” if the justices deemed the election invalid and called for a new one.

All eyes in Kenya are on the five men and one woman who sit on the Supreme Court, which is now widely considered one of the most professional and trusted public institutions in a country with a long history of corruption.

But that did not stop Mr. Kenyatta, the president-elect, from making a disparaging remark about the justices. On Wednesday, he was filmed at a meeting with political allies, offhandedly saying he was ready to start his job “once some six people decide something or other.”

On Thursday, he apologized via a Facebook message, saying, “My informality may be interpreted as disrespect for the court, and that is not the case.”

Kenyan voters streamed to the polls on March 4 in the first presidential election since 2007. In that contest, Mr. Odinga asserted that the presidency had been stolen from him through electoral fraud, stirring longstanding ethnic grievances and leading to clashes that killed more than 1,000 people.

Since then, Kenya has overhauled some of its public institutions — including the Supreme Court and the election commission — but ethnic identity remains a stubborn undercurrent of political life. Ethnicity has even come up in the choice of lawyers in this landmark election case, as lamented by letters to the editor on Thursday in the newspaper Daily Nation.

Mr. Odinga, the second-place finisher in the election, chose a lawyer from his Luo ethnic group; Mr. Kenyatta put his case in the hands of a lawyer from his Kikuyu ethnic group; William Ruto, Mr. Kenyatta’s running mate, picked a Kalenjin lawyer from his ethnic group; and even the election chairman, Isaack Hassan, selected a fellow Somali-Kenyan to represent him.

“We may need the intervention of psychologists,” said the first letter to the editor.

“It’s a big shame and a pity,” said another.

Mr. Odinga’s lawyers and several nonprofit groups have claimed that there was a conspiracy to pad the vote for Mr. Kenyatta, whose ethnic group has dominated much of politics and economics since Kenya’s independence in 1963. On Wednesday, they presented videotaped evidence that appeared to show that election results certified by the election commission differed from those announced at local tallying centers, giving Mr. Kenyatta an extra edge of several thousand votes, just enough to clear the 50 percent bar and be declared the winner.

“It would be a sad day if these grave irregularities can be ignored,” said George Oraro, Mr. Odinga’s lawyer.

But the election commission then presented a multifanged defense, citing case law from Uganda to India — even mentioning Bush v. Gore from the 2000 election in the United States — and urging the Supreme Court to consider the consequences of nullifying the results.

“Don’t crucify our nascent institutions,” said Lucy Kambuni, a lawyer for the election commission. “I ask you to be consequentialists.”

The Supreme Court basically has three options: uphold Mr. Kenyatta’s win; call for a runoff between Mr. Kenyatta and Mr. Odinga; or call for a whole new election.

Chief Justice Willy Mutunga, a former human rights lawyer who presides from the bench with an iPad, has said that the court will decide by Saturday.

View the original article here

Kenyan Panel Warns Against Nullifying Election

Kenya’s Supreme Court, which was recently overhauled through the passage of a new Constitution, has been asked to play referee in the disputed election, in which Uhuru Kenyatta, son of Kenya’s first president, was declared the winner this month. Mr. Kenyatta beat Prime Minister Raila Odinga in the first round of voting and averted a runoff, clearing the majority threshold by a wafer-thin margin of less than one-tenth of a percent.

On Thursday, Ahmednasir Abdullahi, a lawyer for Kenya’s election chairman, told the court that “in every election, votes get stolen.”

He then played down video images that appeared to show vote rigging, saying they were fraudulent, produced in a notorious, crime-ridden neighborhood of Nairobi. And he warned the Supreme Court that “there would be an enormous constitutional crisis” if the justices deemed the election invalid and called for a new one.

All eyes in Kenya are on the five men and one woman who sit on the Supreme Court, which is now widely considered one of the most professional and trusted public institutions in a country with a long history of corruption.

But that did not stop Mr. Kenyatta, the president-elect, from making a disparaging remark about the justices. On Wednesday, he was filmed at a meeting with political allies, offhandedly saying he was ready to start his job “once some six people decide something or other.”

On Thursday, he apologized via a Facebook message, saying, “My informality may be interpreted as disrespect for the court, and that is not the case.”

Kenyan voters streamed to the polls on March 4 in the first presidential election since 2007. In that contest, Mr. Odinga asserted that the presidency had been stolen from him through electoral fraud, stirring longstanding ethnic grievances and leading to clashes that killed more than 1,000 people.

Since then, Kenya has overhauled some of its public institutions — including the Supreme Court and the election commission — but ethnic identity remains a stubborn undercurrent of political life. Ethnicity has even come up in the choice of lawyers in this landmark election case, as lamented by letters to the editor on Thursday in the newspaper Daily Nation.

Mr. Odinga, the second-place finisher in the election, chose a lawyer from his Luo ethnic group; Mr. Kenyatta put his case in the hands of a lawyer from his Kikuyu ethnic group; William Ruto, Mr. Kenyatta’s running mate, picked a Kalenjin lawyer from his ethnic group; and even the election chairman, Isaack Hassan, selected a fellow Somali-Kenyan to represent him.

“We may need the intervention of psychologists,” said the first letter to the editor.

“It’s a big shame and a pity,” said another.

Mr. Odinga’s lawyers and several nonprofit groups have claimed that there was a conspiracy to pad the vote for Mr. Kenyatta, whose ethnic group has dominated much of politics and economics since Kenya’s independence in 1963. On Wednesday, they presented videotaped evidence that appeared to show that election results certified by the election commission differed from those announced at local tallying centers, giving Mr. Kenyatta an extra edge of several thousand votes, just enough to clear the 50 percent bar and be declared the winner.

“It would be a sad day if these grave irregularities can be ignored,” said George Oraro, Mr. Odinga’s lawyer.

But the election commission then presented a multifanged defense, citing case law from Uganda to India — even mentioning Bush v. Gore from the 2000 election in the United States — and urging the Supreme Court to consider the consequences of nullifying the results.

“Don’t crucify our nascent institutions,” said Lucy Kambuni, a lawyer for the election commission. “I ask you to be consequentialists.”

The Supreme Court basically has three options: uphold Mr. Kenyatta’s win; call for a runoff between Mr. Kenyatta and Mr. Odinga; or call for a whole new election.

Chief Justice Willy Mutunga, a former human rights lawyer who presides from the bench with an iPad, has said that the court will decide by Saturday.

View the original article here