Washington, DCHeavy menstrual bleeding is a sufficient-enough issue for some women to consider surgery, such as a hysterectomy, to stem the flow and related health issues once and for all. That said, the pharmaceutical industry could always be counted on to propose and provide medicinal options to such challenges, in spite of the potential for drug side effects. A little over two years ago, Lysteda was approved by the US Food and Drug Administration (FDA) for the treatment of menorrhagia (heavy periods).
However, the non-hormonal product is not without risks. The manufacturer, in fact, quietly updated safety warnings on its prescribing information last April to include the possibility for visual or ocular problems while taking Lysteda (tranexamic acid). The latter warning is also duly reflected on the Lysteda website, together with other serious adverse reactions that—while not the norm—are possible while taking Lysteda.
The drug, marketed by Ferring Pharmaceuticals, is a non-hormonal treatment for heavy menstrual bleeding. The website is quick to point out that Lysteda is not meant to take the place of birth control and does not act as such. Lysteda use is also restricted to a woman's period, and should not be taken outside of that window.
Such precaution is necessary to minimize the drug side effects associated with Lysteda.
And there ARE side effects. The most common, according to both the Lysteda website and the prescribing information, are headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, and anemia and fatigue.
However, other more serious adverse reactions are possible with a drug first approved in 1986 as an injection to ward against excessive bleeding in hemophiliacs following tooth extraction. Drug companies will often develop a drug for one indication, only to discover the possibility for others and the chance to open a drug up to a wider market.
In the process, drugs that are considered as an acceptable risk suddenly morph into dangerous drugs once the wider population is factored in.
The more serious concerns inherent with Lysteda include a risk for the development of blood clots—a risk that is heightened if Lysteda is taken with contraceptives containing hormones. Risks for blood clot (thrombosis) may also be increased when and if Lysteda is used in concert with other drugs needed to control blood clots, as well as drugs associated with the treatment of leukemia.
The manufacturer notes that women prone to blood clots or having experienced a blood clot, should not take Lysteda under any circumstances.
Risks for blood clot also rise for women who are prone to excessive weight gain or women who smoke.
The concern for ocular issues is a more recent addition to the list of safety issues associated with Lysteda. The Lysteda website urges patients to stop taking the drug if there are any changes or problems with eyesight.
Shortness of breath and a tightening in the throat is yet another issue prompting the manufacturer to recommend stopping Lysteda and seeking immediate medical help. Such an allergic reaction, while rare, is nonetheless possible. One participant in the initial clinical trials experienced such a reaction.
Lysteda safety information also includes reference to cerebral edema and cerebral infarction that may be caused by use of Lysteda in women with subarachnoid hemorrhage or bleeding in the area between the brain and tissues that surround the brain.
Ligneous conjunctivitis, an ocular condition, has been reported in patients taking tranexamic acid.
It should be noted that Lysteda has not been researched for patients younger than 18 years of age, and thus should not be prescribed to them.
Patients who are taken aback by the potential for drug side effects—in any drug—should not be. All drugs, no matter how mild, carry some risk for adverse reaction. The mandate of the FDA, together with the medical device companies that manufacture products some describe as a dangerous medical device, is to provide and regulate pharmaceuticals and medical devices whose benefits outweigh the risks. Apart from any attempt on the part of any pharmaceutical manufacturer or regulator to prove that harmful drugs are safe, health advocates have suggested that a more correct burden of proof is whether or not a drug is unsafe.
Same holds true for medical device companies. There is always the risk for a defective medical device, as there is for a defective drug. It falls to the surgeon and the prescribing physician—together with the consumer—to weigh the risks accordingly.
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