New drugs, old drugs, tainted drugs, approved and disapprove drugs. Check out drug news round up this weekend.
FDA approves combination contraceptive containing a folate
A new contraceptive has been approved by the FDA in the American market. Beyaz, in tablet form, is a combi contraceptive containing estrogen/progestin that also contains a folate (levomefolate calcium 0.451 mg). Beyaz is indicated for:
- Prevention of pregnancy
- Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
- Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control
Obesity drug lorcaserin rejected by FDA
On the other hand, the anti-obesity drug lorcaserin has been turned down by the US drug regulatory body. The FDA is demanding more data on the drug’s efficacy and safety. One preclinical study in rats also cause concern as it showed an increase in breast tumors. How this observation compares to the drug’s effects in humans needs to be clarified before the drug can be approved.
Aspirin paradox investigated in TIMI database
Does aspiring prevent or increase the risk for cardiac events? The role of aspirin in the management of acute coronary syndrome (ACS) was further investigated in order the clarify the so-called “aspirin paradox” which “despite the proven benefits of aspirin in the primary prevention, secondary prevention, and treatment of ACS, some studies have suggested that those already on aspirin before suffering an ACS have worse outcomes than those not having taken aspirin before the event.”
Data from the Thrombolysis in Myocardial Infarction (TIMI) trials were used with results showing that bad outcomes may present in 5% of cases, probably due to aspiring resistance.
GlaxoSmithKline settles bad drug case for $750M
Some more bad news for the British pharmaceutical company GlaxoSmithKline. It recently agreed to settle at a price of $750 million allegations related to the manufacture and marketing of contaminated drugs produce in their plant in Puerto Rico. The said plant violated good manufacturing practices, resulting in adulterated drugs, including Bactroban, Kytril and Paxil. Part of the settlement will go to a whistle blower, the company’s former global quality assurance manager who reported the violations to the US FDA. The manager repeated warned GSK of the violations but was fired instead.