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The Food and Drug Administration (FDA) wants to withdraw its approval of midodrine hydrochloride, a medication used to treat the low blood pressure condition orthostatic hypotension, because post-approval studies that verify the clinical benefit of the drug have not been done. This is the first time the agency has issued a withdraw proposal for a drug approved under the FDA’s accelerated approval regulations.
The Food and Drug Administration (FDA) is alerting emergency medicine and surgery professionals of serious adverse events that may result from the long-term use of inferior vena cava (IVC) filters. IVC filters are a type of catheter that is implanted into the inferior vena cava, a large vein that carries de-oxygenated blood from the lower half of the body into the right atrium of the heart, to prevent fatal pulmonary emboli.
The Food and Drug Administration (FDA) is warning the public about Solo Slim and Solo Slim Extra Strength, more dietary supplements that contain the undeclared drug ingredient Didesmethyl Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss that can cause serious health complications in some people, including life-threatening cardiovascular events.
Consumers should not take the oral mineral supplement Miracle Mineral Solution because when used as directed, it produces an industrial bleach that can cause serious health problems. The Food and Drug Administration (FDA) issued the warning after receiving several reports of injuries from consumers who had used the product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration. Consumers are advised to shop using the solution immediately and throw it away.
Consumers and pharmacists who use Advair Diskus inhalers (fluticasone propionate and salmeterol inhalation powder) to treat pulmonary conditions such as asthma and chronic obstructive pulmonary disease (COPD) should check their inhalers because they may be part of stolen lots of inhalers at risk of compromised safety and efficiency. Certain Advair Diskus inhalers stolen from a distribution warehouse in 2009 have turned up recently in some pharmacies, the Food and Drug Administration (FDA) warns. These inhalers may have been stored at improper temperatures or humidity levels, been contaminated, or have lost potency and thus are not considered safe.
The Food and Drug Administration (FDA) has placed a new black box warning on Arava (leflunomide), a drug used to treat rheumatoid arthritis, because it can increase the risk of severe liver injury. The drug’s current Boxed Warning states that lefluonmide is contraindicated in pregnant women, or women of childbearing potential who were not using reliable contraception, because the drug could harm the fetus.
Consumers are being advised by the Food and Drug Administration (FDA) that there is the potential risk of overdosing infants with liquid vitamin D. An overdose of vitamin D can cause serious harm to infants. The liquid vitamin D supplements are sold with droppers that could allow parents to accidentally give harmful amounts of the vitamin to their infant.
Cervidil, a vaginal insert used to speed childbirth in women who are near term for labor, carries a new safety label warning stating an increased risk of life-threatening complications, according to a Food and Drug Administration (FDA) safety labeling update.
The safety label of the antidepressant Wellbutrin XL and Wellbutrin SR (bupropion HCL) has been updated to include a notice to consumers not to chew, divide or crush tablets as doing so may lead to an increased risk of adverse effects, including seizures, according to a Food and Drug Administration (FDA) safety labeling update.
The safety label of Asacol and Asacol HD, a prescription treatment for mildly to moderately active ulcerative colitis (UC), is being updated to include precautions that the medication should not be used during pregnancy because of birth defects in unborn children.
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