Propecia – Increased Concern Over Permanent Sexual Side Effects

Propecia is one of several prescription drugs called “5-alpha reductase inhibitors (5-ARI)” used to treat hair loss and pattern baldness in men. Pending lawsuits allege that Merck, the drug company that makes Propecia, failed to warn consumers of permanent sexual side effects. The cases claim that the drug was not thoroughly researched and Merck withheld information from health care providers and consumers. Although Merck acknowledged potential sexual side effects, they maintained these problems would go away when the drug was discontinued. However, in April 2011 Merck changed the label to include information about “reports of erectile dysfunction that continued after discontinuation of Propecia.” The label also includes a warning that in “rare cases” users of propecia have developed breast cancer.

In June 2011 the FDA required the warning labels on Propencia and several other 5-ARI drugs to include information on the increased risk of high-grade prostate cancer. The FDA has yet to take action in response to rising concerns over reports linking Propecia to permanent sexual side effects. Information about these potential side effects have been well publicized in Europe for several years. As far back as 2008 Sweden demanded that Merck add reports of “persistent erectile dysfunction” to the label.

The recent removal of the Merck-sponsored website, Propecia.com, has sparked speculation about a possible recall. The promotional website has been replaced with prescription information, refund request procedures related to the Propecia Promise Program, and information on how to report adverse side effects to the FDA.

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Anticoagulant Pradaxa – FDA Safety Announcement

photo of PradaxaIntroduced in October 2010, the purpose of the blood thinner Pradaxa is to reduce the risk of blood clots and stroke in patients with atrial fibrillation. According to a recent article by the Institute for Safe Medication Practices (ISMP0), the Food and Drug Administration has been notified of over 900 reports that link Pradaxa to serious medical complications. These “adverse events” include 120 deaths, 25 cases of permanent disability, and 505 cases of hemorrhage. The events involving hemorrhage predominantly occurred among patients with a median age of 80 years. These reports raise questions concerning safe doses and monitoring standards when Pradaxa is prescribed for elderly patients. Although bleeding has long been recognized as a possible complication of anticoagulant medications, the FDA is re-evaluating Pradaxa in light of the number of adverse events to determine whether occurrences of bleeding are excessive.
“At this time, FDA continues to believe that Pradaxa provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Pradaxa follow the recommendations in the approved drug label… Patients with AF should not stop taking Pradaxa without talking to their healthcare professional. Stopping use of blood thinning medications can increase their risk of stroke.” Click here to read the full text of the FDA Safety Announcement.

Liberty Jeep Airbags

NHTSA logoThe National Highway Traffic Safety Administration is investigating 2002 and 2003 Liberty Jeep SUVs in response to complaints from jeep owners that the airbags go off unexpectedly. Although no deaths have been reported, drivers have suffered cuts, burns and bruises. 42 incidents involved the driver side front air bags and in 45 cases both driver and passenger front bags inflated. Chrysler believes the problem is related to an electrical voltage spike.

To date, the problem appears to be limited to vehicles made prior to March of 2003. However, Chrysler has no explanation why more recent models are not affected. An engineering analysis is ongoing and might ultimately lead to a recall. To monitor the investigation and learn of a recall visit the NHTSA’s website, or call NHTSA’s auto safety hotline at: 1-888-327-4236.

Birth Control Pill Recall

birth control pillsThe pharmaceutical company Pfizer has recalled one million packages of birth control pills due to errors in packaging. Some of the packages have too many active tablets while other packages have too few active tablets. Although the recalled pills are not a safety risk, they may not prevent pregnancy. Pfizer is advising women who have used the pill to also use a “non-hormonal” form of contraception. According to the statement released from Pfizer, “…the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

The recall includes 14 lots of Lol Ovral-28, and 14 lots of Norgestrel and Ethinyl Estradol. Full text of the Pfizer Press Release announcing the voluntary recall is available on the Pfizer website.

Silicosis: Delay in Adopting Rules to Limit Exposure to Silica

construction workerSilicosis is an incurable lung disease caused by breathing in particles of silica dust. Silica is also linked to other diseases like lung cancer and chronic renal disease. The types of employment where silica dust exposure is most prevalent include mining, construction and manufacturing. According to health professionals, thousands of patients are diagnosed with silicosis each year and hundreds die from the disease.

Almost a year ago the Occupational Safety and Health Administration proposed new regulations intended to combat this work place hazard. However, worker safety advocates maintain that industry stakeholders are interfering with the passage of the regulations. The existing rules limiting worker exposure to silica were adopted in the 1960s and occupational health experts insist that the safe limit is half of what is permitted by the current standard. Members of a coalition representing several industries claim that the current levels are adequate to protect workers and the changes proposed by the new regulations would cost billions of dollars. Jackson Morrill, the head of the coalition, asserts that the real problem is a failure on the part of employers to comply with the current rules.

Union groups and safety advocates are frustrated with the delay in passing the proposed regulations and are pushing for the Department of Labor to initiate a public debate and put an end to behind the scenes negotiations. According to a statement issued by The National Advisory Committee on Occupational Safety and Health “the current standard is many decades old and is insufficient to protect workers from this serious occupational health hazard… The silica rule delay is extraordinary and without explanation…”

Click here to read a letter written to President Obama, signed by 300 public health scientists, doctors, and occupational safety experts, asking him to direct the White House Office of Management and Budget to complete its review of the proposed regulations.

Sources: New Silica Rules Languish In Regulatory Black Hole, by Nell Greenfield Boyce, NPR Morning Edition, February 2, 2012.
SafetyNewsAlert.com, January 26, 2012.