US warns two drugs may have sexual side effects

Two Merck drugs for treating male baldness and enlarged prostate will now carry extended labels to add more possible sexual side effects, US regulators said.

The changes involve Propecia and Proscar, both of which contain the active ingredient finasteride, after patients reported additional adverse effects that were not apparent at the time of the drugs' approval, the US Food and Drug Administration said Friday.

The new Propecia label will include "libido disorders, ejaculation disorders, and orgasm disorders that continued after discontinuation of the drug," the FDA said. Propecia is a drug to treat male baldness.

Proscar, which treats symptoms of enlarged prostate, will now have a label that adds "decreased libido that continued after discontinuation of the drug."

In addition, both labels are being revised to "include a description of reports of male infertility and/or poor semen quality that normalized or improved after drug discontinuation," the FDA said.

FDA spokeswoman Stephanie Yao said the drugs were previously known to cause adverse sexual events in a small number of patients, and that information was included on labels at the time of approval.

The latest labeling change "expands the list of sexual adverse events reported to the FDA postmarketing," she told AFP, adding that "no new clinical studies were reviewed to evaluate these adverse events."

Proscar was approved for the US market in 1992 and Propecia in 1997. In 2011, both drugs' labels were "revised to include erectile dysfunction that continued after drug discontinuation," the FDA said.

Last year, labels for Proscar and Propecia were also changed to advise of the possibility of an increased risk of high-grade prostate cancer.

The agency noted that even though "clear causal links between finasteride (Propecia and Proscar) and sexual adverse events have NOT been established, the cases suggest a broader range of adverse effects than previously reported in patients taking these drugs."

Since these side effects may be important to some patients, doctors were urged to discuss them with patients when deciding on treatment options.

In the case of Propecia, clinical trials showed 3.8 percent of men had reported one or more adverse sexual experiences, compared to 2.1 percent who were taking a placebo.

"Propecia and Proscar are generally well tolerated and effective for their respective intended uses in accordance with their approved product labeling," Merck said in a statement.

The company added that "a causal relationship between the use of Propecia or Proscar and continued sexual dysfunction after discontinuation of treatment has not been established," and expressed support for ongoing monitoring of adverse event reports.

Loading...

Editor’s note:Yahoo Philippines encourages responsible comments that add dimension to the discussion. No bashing or hate speech, please. You can express your opinion without slamming others or making derogatory remarks.

  • Filipina maid photographs "modern slavery" in Hong Kong

    By Emma Batha LONDON, May 26 (Thomson Reuters Foundation) - A Filipina maid in Hong Kong has published stark photographs of burned and beaten domestic workers to highlight the "modern slavery" she says has long been the city's shameful secret. "Hong Kong is a very modern, successful city but people treat their helpers like slaves," said Xyza Cruz Bacani, whose black and white portraits won her a scholarship from the Magnum Foundation to start studying at New York University this month. It's …

  • Philippines to fly over disputed South China Sea: Aquino
    Philippines to fly over disputed South China Sea: Aquino

    Philippine military and commercial aircraft will keep flying over disputed areas in the South China Sea despite Chinese warnings over the airspace, President Benigno Aquino said on Monday. "We will still fly the routes that we fly based on the international law from the various conventions we entered into," Aquino told reporters when asked whether the Philippines accepted China's position. The Chinese military last week ordered a US Navy P-8 Poseidon surveillance plane away from airspace …

  • ‘Kentex owners still in Phl’
    ‘Kentex owners still in Phl’

    The daughter of one of the Kentex Manufacturing Corp. owners has assured the government that the businessmen are still in the Philippines, contrary to some reports that they have fled the country. Barbara Ang, daughter of Kentex shareholder Veato Ang, said her father and his business partners have no plans of leaving the country despite the razing of the Valenzuela slipper factory, which killed 72 workers on May 13. Valenzuela Mayor Rex Gatchalian also stood by his promise to punish any local …

  • Gasoline prices up, diesel down
    Gasoline prices up, diesel down

    Oil companies announced yesterday a price hike of 50 centavos per liter for gasoline and a rollback of 50 centavos per liter for diesel effective at 6 a.m. today. Independent oil firms were among the first to announce the price adjustment. In an advisory, PTT Philippines, the local subsidiary of Thailand’s biggest oil firm said it cut diesel prices by 50 centavos per liter and increased gasoline prices by 50 centavos per liter. …

  • Lawmakers to review building code provisions
    Lawmakers to review building code provisions

    Lawmakers are set to review provisions of the National Building Code and Republic Act 10121, or the Philippine Disaster Risk Reduction and Management Act, to strengthen contingencies and policies to prepare the country for possible major earthquakes. The move came following proposals from Reps. Winston Castelo of Quezon City and Lito Atienza of the Buhay party-list to review the two laws and other regulations during a hearing of the House committee on Metro Manila development on the …

  • Noy: Phl may attain first world status with continued reforms
    Noy: Phl may attain first world status with continued reforms

    The Philippines’ attaining first world status may soon be imminent if significant reforms initiated by the current administration would be consistently pursued, President Aquino suggested yesterday. “Kung madidiligan ang ating mga pinunla, at makaka-graduate ang mga pinag-aaral natin upang makapasok sa maaayos na trabaho, baka po tuluyan nang nasa first world status tayo sa panahong iyon (If we water the seeds sown and those we sent to school will find better jobs, then time will come that …

  • Phl won’t recognize China air restrictions
    Phl won’t recognize China air restrictions

    The Philippines will not recognize restrictions on air and sea travel set by China in the West Philippine Sea, President Aquino said yesterday. “We will still fly the routes that we fly based on international law and the various conventions, agreements that have been entered into through various decades,” Aquino told reporters in an ambush interview after inspecting the Marikina Elementary School in preparation for the opening of classes in June. “Maybe we should not think about getting …

  • Rainy season likely in 2nd week of June
    Rainy season likely in 2nd week of June

    Filipinos may have to wait until the second or third week of June for rain, the Philippine Atmospheric, Geophysical and Astronomical Services Administration (PAGASA) said yesterday. Rene Paciente, chief of PAGASA’s marine meteorological services section, said they expect the rainy season to start in the second or third week of June. The criteria for declaring the onset of the rainy season include the prevalence of the southwest monsoon and the 25-millimeter rainfall recorded in at least five …

POLL

Should Aquino be held accountable over the Mamasapano operations?

Loading...
Poll Choice Options