The FDA is recommending that pregnant women avoid taking NSAIDs (nonsteroidal anti-inflammatory drugs) during pregnancy. The agency says taking NSAIDs after 20 weeks gestation could cause kidney problems for unborn babies. It can also cause low levels of amniotic fluid, and long-term use could hinder fetal development.
The FDA is advising consumers not to use Rompe Pecho EX and Rompe Pecho CF cough syrups distributed by Efficient Laboratories, Inc. The FDA warns of a potential microbial contamination risk.
The FDA is reminding consumers not to use products manufactured by Herbal Doctor Remedies. The FDA says the products were not manufactured under “good manufacturing practices.” The manufacturing environment is unsanitary and an inspection revealed numerous serious violations.
The FDA is warning consumers not to use products marketed by Kratom NC. Certain Kratom NC products have been found to be contaminated with miccroorganisms, including Enterobacter spp. and Klebsiella pneumoniae.
The FDA is warning that kratom-containing products marketed by Kratom NC are misbranded due to their unproven claims that the products can cure or treat opioid addiction and withdrawal.
The FDA is warning patients about adverse side effects associated with the use of certain biologic medications. According to the FDA, there have been more than 500,000 reports of adverse events, and an estimated 34,000 deaths.
The FDA has issued a warning about taking supplements during pregnancy. According to the safety alert, women taking Vinpocetine, an ingredient in many supplements, are at an increased risk of miscarriage.
The FDA has issued a black box warning for insomnia medications:
- Lunesta
- Sonata
- Ambien
More Information:
- https://www.fda.gov/safety/medical-product-safety-information/certain-prescription-insomnia-medicines-new-boxed-warning-due-risk-serious-injuries-caused?utm_campaign=FDA%20MedWatch%20Certain%20Prescription%20Insomnia%20Medicines&utm_medium=email&utm_s
- https://www.druganddevicewatch.com/2019/05/10/boxed-warning-insomnia-medications/
FDA issues safety labeling change orders for Addyi and Plavix tablets:
FDA alerts that sudden discontinuation or decrease in opioids results in extreme adverse side
effects in patients who are dependent:
FDA warns healthcare providers about risks associated with Venclexta in patients with multiple myeloma (Venclexta is not FDA-approved for treatment of multiple myeloma):
FDA warns consumers about BLUEFUSION Capsules containing undeclared active ingredients
for which side effects have not been established:
FDA warns that certain lots of DG/health NATURALS baby Cough Syrup + Mucus may be
contaminated with Bacillus cereus/Bacillus circulans:
FDA safety alert related to two lots of Levoleucovorin Injections that may be contaminated with particulate matter – copper salts:
FDA safety alert issued for Losartan Tablets that may contain N-Nitroso N-Methyl 4-Amino butyric acid (NMBA), which is a potential human carcinogen:
FDA reports certain lots of SOdium Bicarbonate Injections contain particulate matter, confirmed to be glass:
FDA warns consumers that four lots of Drospirenone and Ethinyl Estradiol Tablets may contain
defective blisters or tablet arrangement:
FDA announces plan to improve drug safety and effectiveness related to drug absorption and the effects of eating certain foods:
FDA alerts the public that clinical trials of Rheumatoid Arthritis (RA) drug tofactinib (Xeljanz
and Xeljanz XR) showed a potential increase in the risk of blood clots in the lungs:
FDA warns consumers that gout medication Uloric (febuxostat) may increase the risk of heart-
related death:
FDA continues to warn of mislabeled Levetiracetam in 0.54% Sodium Hydrochloride Injections:
FDA warns that certain lots of Smiths Medical Sterile Saline and Water used for respiratory
therapy may be contaminated with baccilus infantis and staphylococcus epidermidis:
FDA warns compounders not to use Letco Medical glutathione-L-reduced powder to compound
sterile injectable drugs due to potential contamination with endotoxins:
FDA warns consumers of dangers in certain lots of Nature’s Rx Silver Bullet 10x tablets, after
undeclared sildenafil and tadalafil were discovered in the tablets:
FDA reports an increase in the lots included in a recall of Losartan potassium tablets, after
impurities were detected in the drug:
FDA warns that Irbesartan HCTZ Tablets have been recalled due to containing N-nitrosodiethylamine (NDEA) above the FDA-approved level. Lots not included in the recall may contain NDEA in amounts at or below the FDA guideline:
FDA analysis finds Happy Together Rhino 5k capsules may contain sildenafil and Tadalafil,
drugs used to treat erectile dysfunction:
FDA warns hospitals that certain lots of Vecuronium Bromide injections may be contaminated
with particles of glass:
FDA warns hospitals and physicians about certain lots of Ceftriaxone for Injection containing particulate matter in reconstituted vials, identified as rubber particles:
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