Therapeutic areas in focus
Merck under official investigation in France
Merck, a science and technology company based in Germany, is under investigation after “possibly issuing misleading information” regarding its product Levothyrox, used for treating thyroid issues.
Merck changed the formula for Levothyrox in 2017, removing lactose to make it easier to handle. However, this change has been linked to side effects such as memory loss, weight gain and palpitations.
The plaintiffs have accused Merck of not providing sufficient information regarding the change in its product.
Merck has said that the proceedings, taking place in Marseille, France, are not concerned with the product’s new formula, and that it is about the way the company provided information when changing from the old formula to the new.
Mario-Pierre Stasi, the lawyer for Merck, said the company would continue to co-operate with authorities on the matter and that full legal proceedings must be allowed to run their course.
In March 2022, the Cour de Cassation ‒ France’s highest court ‒ confirmed a 2020 Lyon appeal court ruling, which ordered Merck to pay €1,000 in compensation to the 3,300 people suffering with thyroid problems in France, after the 2017 change of formula.
FDA announces recall of two blood pressure pills over cancer risk
US-based Aurobindo Pharma USA is set to recall two of its blood pressure pills over a potential cancer risk, as reported by the FDA. The drugs in question are quinapril and hydrochlorothiazide, both of which are often used to treat hypertension.
The drugs contain high levels of nitrosamine, a substance that is harmless in low doses but can increase the risk of cancer when consumed in higher levels.
Trade return management service Qualanex, has said it “will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts.” Its announcement continues that “Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex.”
This recall comes just a few weeks after the FDA had to recall another blood pressure medication, and a drug that lowers the risk of stroke or severe heart issues, due to a packaging mix-up. The drugs have been described as “pink coloured, scored, round shapes, biconvex, film-coated tablets, debossed with ‘D’ on
the scored side and ‘19’ on the other side.”
The FDA commented: “Patients should contact their doctor or healthcare provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.”
US pharmacies agree to $10bn opioid litigation settlement
CVS Health and Walgreens have become the first two US pharmacy chains to agree a settlement worth over $10bn in response to the roles they played in the US opioid epidemic. Both deny culpability.
US pharmacies are facing opioid-related lawsuits from individual states, subdivisions and Native American tribes. CVS has agreed to pay $5bn over ten years, with Walgreens agreeing to $5.7bn over 15 years.
They have also agreed to practical measures to try to combat opioid use disorder (OUD), such as providing safe and convenient disposal facilities for medicines, stricter security measures to prevent theft and technology to help pharmacists determine legitimate medical prescriptions.
Other pharmacy chains are following. According to Reuters, Walmart is close to agreeing to an upfront payment of $3.1bn to extricate itself from the litigation.
Wholesale distributers and manufacturers are also settling. Earlier this year, three US wholesaler distributers ‒ McKesson, Cardinal Health and
AmerisourceBergen ‒ agreed to $21bn. In the manufacturing industry, Johnson & Johnson paid $5bn, Teva Pharmaceutical paid around $4.3bn, with $2.4bn for AbbVie, $1.7bn for Mallinckrodt and $450m for Endo Pharma.
All funds collected from proceedings are earmarked for a range of remediation efforts to combat the opioid crisis, including campaigns to raise awareness, provision of overdose reversal agents such as naloxone, treatments for OUD and rehabilitation services.