Merck recently agreed to revise the labels of the patented anti-baldness drug, Propecia, after the Post-Finasteride Syndrome Foundation petitioned the FDA. In response, the FDA agreed to include a warning about the potential dangers of persistent sexual depression as a side effect of finasteride. The change comes after Public Citizen filed a lawsuit on behalf of the foundation.
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Suicides linked to Merck anti-baldness drug Propecia
According to the latest data from the World Health Organization, there have been over 100 suicides and depression cases related to Merck’s anti-baldness drug. The FDA declined to include a suicide warning on its label, citing insufficient scientific evidence. The company maintains that it is not at fault for the rising number of suicides. Still, the company is working with the US health regulator to add the warning.
The US Food and Drug Administration recently rejected a patient advocacy group’s request to remove the infamous anti-baldness drug Propecia from the market. The group based its claim on scientific studies that Merck had knowingly concealed information that could have led to a decrease in patient safety. Meanwhile, the drug’s label was expanded in 2011 to include warnings about depression and persistent sexual dysfunction, but it did not mention suicide as a possible side effect.
New warnings on drug packaging
If you’re a consumer, you’ve probably noticed new warnings on your prescription drug’s packaging. These warnings, called “boxed warnings” by the FDA, are meant to inform patients and health care professionals about the potential side effects of their medication. However, these warnings do not mean that you shouldn’t take your medicine. It’s important to discuss the risks of any medication with your healthcare provider before you take it. The FDA identifies potential safety concerns involving a particular medication through adverse event reports and clinical trial data.
In 2004, all antidepressants received a black box warning stating the risk of suicide and severe psychiatric events. However, the anti-anxiety drug Xanax does not carry a black box warning. There are several petitions calling for the removal of the warnings on benzodiazepines. The FDA, in response to these petitions, has not yet made any final decisions.
Merck’s redesigned drug labels intended to reduce medication errors
A recent study concluded that the redesigned labels for Merck’s prescription medicines are effective in reducing medication errors. According to the study, the redesigned labels were approved by the FDA after the company sought to optimize the U.S. label for six of its products. Merck conducted human factors testing and failure modes and effects analysis to test the effectiveness of the new labels. During a validation study of the final Merck drug labels, there were no errors in any of the 425 prescriptions filled.
The new labels were approved by the US Food and Drug Administration in June 2011. They have several features that help users understand the dosage of a medication. These features include a nonbranded logo, high-contrast color bands to indicate dosage strength, and an enhanced three-dimensional tablet image. The new labels have already received positive reviews from consumers. The lawsuits filed by Merck and the US government are the latest in a long-running battle between the government and drug manufacturers.
Merck’s redesigned drug labels expected to improve readability
Three victims of the sexual side effects of Propecia are suing Merck Sharp & Dohme, the company that makes the hair growth product. They say the manufacturer failed to disclose the serious risks associated with Propecia’s labeling and the lack of transparency surrounding the drug’s development. A court document filed elsewhere by Merck cites a study that found that forty percent of men who were aware of the product’s sexual side effects would not take it.
A lawsuit over the drug’s inability to be read by patients has been filed against Merck, but the company believes that the evidence will support its position that it acted responsibly. The company has asked Health Canada to conduct an independent review of the drug’s labels, which it believes will prove that the labeling was more clearly communicated. Health Canada is the regulatory body for pharmaceutical monographs, and it also performs reviews when new safety issues arise.
Merck’s redesigned drug labels
A recent Merck lawsuit alleges that the company redesigned the drug label for Propecia to hide certain side effects. The warning was added because Merck’s research indicated that 40% of men who heard about Propecia would not take the drug because of the potential side effects. Merck’s internal study was filed elsewhere, and it’s unclear whether this information was included on the revised drug label.
Merck says the evidence supports its claims that it did act responsibly in designing the drug label. But the company’s global communications director, Lainie Keller, claims the company has acted responsibly. Despite this, Merck is still facing a Propecia lawsuit alleging the drug caused permanent sexual dysfunction in men. A Merck representative declined to comment on the lawsuit. The FDA wants to monitor the drug label and grade it to prevent future errors. If you believe you were given the wrong drug, please report it to the agency’s MedWatch adverse event reporting program.
Merck’s redesigned drug labels expected to reduce medication errors
The FDA recently approved redesigned labels for 16 drug products by Merck, including the new bundled supplement regulatory approach. These changes will help consumers and healthcare providers pick the correct medication. Drug container labels should be easy to understand. Labels may be different colors or use bold letters to identify the strength. Labels should also include patient and prescribing information. They should be easy to read to ensure the right medication is being prescribed.
The FDA’s recent report highlights several steps it has taken to improve drug labels. For example, the agency has issued voluntary guidelines for drug label reform. However, most drug labels do not have to be updated; many are not regulated. Despite this, the new drug labels are expected to improve patient safety. Some states have begun this process. In addition, the new labels will make electronic prescribing easier.
